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CONTENTS
             6 Building the body area network
             17 Industry alliance tackles technical, policy challenges                                   29
             22 European project helps manage broken hearts
                       at home
             27 Medical imaging makeover
                                                                                                    24
             29 Data acquisition systems allow stop-action cardiac
                       imaging in one scan
             33 Managing digital imaging’s mountains of data                                27
             38 Mixed-signal, embedded open doors
                       for digital imaging
             43        Automated blood test is a breeze                                          “This digital edition was designed to play on
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             60        Inside the art of pulse oximetry
     2 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Opinion




              Technology fundamental to reform
              By George Leopold


                                                                       or for blocking “fundamental reform” of a




              O
                               nce the political posturing,
                               demagoguery and horse trad-             system that accounts from anywhere be-
                               ing cease, it’s far from clear          tween one-fifth to one-sixth of the U.S.
                               whether Americans will actu-            economy, depending on which Senate floor
                               ally achieve health care re-            speech you choose to believe.
              form. The guess here is that, in                           This is indeed a sad state of affairs, but
              time-honored Washington fashion, all sides not wholly unexpected, given the political
              in this noisy, high-stakes debate will claim             and economic stakes for the health care
              political victory while condemning the other industrial complex.
              side either for effecting a “government                    Assuming Congress approves health
              takeover” of the U.S. health care system                 care legislation this year and President


3 EE Times |The diagnosis for medical electronics | December 7, 2009
Opinion

                                                                                       Barack Obama signs it
                                                                                       into law, a key question
                                                                                       in implementing re-
                                                                                       forms is what role tech-
                                                                                       nology can play in
                                                                                       reducing skyrocketing
                                                                                       medical bills.
                                                                                         Up to now, many diag-
                                                                                       nostic technologies
                                                                                       have greatly improved
                                                                                       U.S. health care while
                                                                                       saving countless lives.
                                                                                       Those technologies re-
                                                                                       main expensive, how-
                                                                                       ever, making it awfully
                                                                                       tempting for a medical
                                                                                       specialist to order
                                                                                       another high-ticket
                                                                                       test—which may or
                                                                                       may not be needed—
               Music: Cross Douglas Road by Patrick O’Rourke, www.patrickorourke.com


4 EE Times |The diagnosis for medical electronics | December 7, 2009
Opinion

               as a way to pay off the huge up-                    forms. One office worker left to take      care system, but it is a critical tool
               front investment in the latest med-                 a job at Starbucks, where she could        in the fight to put patients ahead of
               ical equipment.                                     get the medical benefits the doctor        profits and politics. p
                 If we are to reduce medical costs,                could not afford to provide.
               such practices must stop.                               It is physicians like this one who      About the Author
                                                                                                               George Leopold is news director for
                 Part of the problem with soaring                  desperately need technology’s help          EE Times.
               health care costs is that medical                   to survive and, perhaps one day,
                                                                                                                     email: gleopold@techinsights.com
               school graduates confront huge                      thrive. For technology companies that
               tuition bills that drive them into                  have created the senior position of
               lucrative specialty medicine and                    chief medical officer, a huge opportu-
               away from general practice.                         nity exists to customize existing tech-
                 One of the best stories we’ve                     nologies to serve these medical
               seen during the health care debate                  professionals and not just the spe-
               focused on a general practitioner                   cialists whose offices are already
               who was struggling to meet the                      filled with the latest diagnostic tools.
               needs of her community and keep                         None of us is getting any younger,
               her practice afloat amid a ceaseless and some of us are facing life-and-
               tide of health insurance paperwork.                 death medical decisions about our
               The MD could barely afford to em-                   aging parents. Technology alone
               ploy file clerks to handle the flood of won’t heal what ails the U.S. health


5 EE Times |The diagnosis for medical electronics | December 7, 2009
Body area nets




               Building the body area network
               By Rick Merritt

                                                                       neering at the University of Washington,




               N
                                etworked medical devices hold
                                the promise of more-effective          notes that much of that spending was for
                                and lower-cost health care, as         costly hospital care, often delivered long
                                services traditionally delivered       after the onset of chronic problems that
                                in clinical settings become            could have been better managed early on.
               accessible in the home. The rationale be-                 A critical component of the solution “is
               hind the shift is sound, but the business,              in embedded or wearable devices linked to
               regulatory and technical hurdles are many.              therapy,” said Joseph Smith, vice president
                 The problem is clear: The United States               of emerging technologies at Johnson &
               last year spent an estimated $2.5 trillion—
                                                                       Wearable devices and implants could
               18 percent of its GDP—on health care.
               Yong-Min Kim, a professor of electrical engi-
                                                                             help cure what ails health care

6 EE Times |The diagnosis for medical electronics | December 7, 2009
Health care, American style
               High costs are due in part to late-stage treatments, administered with expensive equipment in hospital settings


               $2.5 trillion                                                                                                     Johnson Services Inc. (New
               Amount spent domestically each year on health care                                                                Brunswick, N.J.), which oversees
               18%                                                                                                               dozens of medical businesses.
               Portion of U.S. GDP spent on health care                                                                            “We don’t yet have the treatment
               45%                                                                                                               paradigms for continuous care for
               U.S. share of world health care spending in dollars
                                                                                                                                 chronic diseases, but I think we will
               45-50 million                                                                                                     get there,” Smith said in September
               Number of uninsured Americans
                                                                                                                                 at the IEEE Engineering in Medicine
               66%                                                                                                               and Biology Society’s annual confer-
               Percentage of Americans who are overweight
                                                                                                                                 ence (EMBC).
               65 million                                                                                                          “We all have a responsibility to
               Number of Americans with chronic heart problems
                                                                                                                                 be involved in health care reform,”
               20 million:                                                                                                       Rebecca Bergman, a vice president
               Number of Americans with diabetes
                                                                                                                                 of new therapies at Medtronic (Min-
               100,000                                                                                                           neapolis), said at EMBC. “Tech is
               Number of people who die in the U.S. each year from preventable treatment errors
                                                                                                                                 not at the core of this issue, but we
               One hour                                                                                                          should make tech part of the solu-
               Amount of time spent on paperwork for each hour of health care delivered in the U.S.
                                                                                                                                 tion and not part of the problem.”
               50%                                                                                                                 A group from Australia reported
               Amount of U.S. health care dollars typically spent in the last six months of a patient’s life
               Sources: Yong-Min Kim, University of Washington; Joseph Smith, vice president of emerging technologies at         at the conference on a program
               Johnson & Johnson Services Inc.; EE Times


7 EE Times |The diagnosis for medical electronics | December 7, 2009
Body area nets

               that remotely monitored former car-                  Mir Imran, who in the mid-1980s de-     Business hurdles
               diac patients participating in an ex-                veloped one of the first implantable    It’s easy to think of ways to extend
               ercise program. The program,                         cardiac defibrillators. “I’m thinking   today’s wealth of consumer and
               developed in conjunction with Nokia, about clinical problems and optimiz-                    computer technologies to medical
               helped reduce the number of pa-                      ing solutions for them, and leverag-    applications. What’s harder is mak-
               tients readmitted to hospitals from                  ing electronics heavily—whether for     ing such concepts reliable enough
               the typical 28 percent to 8 percent.                 drug delivery or new kinds of im-       to earn the trust of the doctors who
                 Such efforts are fueling interest in               plants, or putting sensors where they would use them, the regulators who
               a rising tide of networked medical                   have never been, for example in a
               devices and services. “I’m in the                    hip or knee replacement.”
               thick of it,” said serial entrepreneur                  In one project, Imran is working
                                                                    with Texas Instruments to equip



            R
            R            The body electric

                                             Julien Penders, a
                                                                    cardiac stents with an RFID tag, a
                                                                    microelectromechanical system
                                                                    (MEMS) flow sensor and a tiny radio
                                                                    to report on the flow of blood
                                             program manager for
                                             body area network      through the passage. The goal is an
                                             technologies at IMEC
                                             (Leuven, Belgium),     early warning system for the nearly
                                             offers a primer on     7 percent of stents that become
                                             BANs and wearable
                                             devices.               blocked over time.
               Click image to launch video

8 EE Times |The diagnosis for medical electronics | December 7, 2009
Body area nets

               would approve them and the insurers                  geared for their special needs. But “if    Analyst Stephan Ohr, who co-
               who would pay for them.                              a couple of [medical electronics] ven-    authored a recent Gartner report on
                 Jonathan Collins, principal analyst                dors solidify around a particular wire-   telemedicine, noted that “today, a
               at ABI Research, predicts the use of                 less spec, it won’t need to be a          nurse comes to your home, takes
               wearable consumer fitness devices                    [standard on the scale of] Bluetooth,” your blood pressure and transmits
               will grow rapidly over the next few                  Collins noted.                            the reading to a remote doctor using
               years as the devices adopt standards                                                                                                      EEG
                                                                     Body Area Network for health
               like Bluetooth. By contrast, devices
                                                                     & comfort monitoring                                                       Vision         Hearing
               for professional clinical use in hospi-
               tals and homes will take longer to                                                                                 Positioning
               adopt proprietary technologies                                                                                                                       ECG
                                                                                                                                   Glucose                         Blood pressure




          R
          R
                                                                                                                    POTS
                      Heart and home
                                                                                                  Network                          DNA
                                                                                                                                  protein
                                          Philips describes how                                               Cellular                                          Toxins
                                          a variety of home
                                          sensors could work
                                          with cell phones and
                                          TVs to allow remote                                                              WLAN
                                          monitoring of patients’
                                          cardiac conditions.                                                                                                   Implants
                                                                    Source: IMEC
            Click image to launch video


9 EE Times |The diagnosis for medical electronics | December 7,
Body area nets

                an Internet connection, but more-                    care systems and services. By the       ance providers. Despite the many
                automated patient monitoring using                   end of 2008, as many as 600,000         experiments, “the business models
                wireless is still 10 years out. The                  of the estimated 2.5 million im-        in place today just do not get it
                biggest reason is that doctors don’t                 planted devices in use were linked to done,” LaLonde said. “I contend we
                trust [the new devices]—they really                  home systems that transmitted data      are in a race to the bottom, in
                don’t know what to do with the                       automatically to clinics for remote     which investment drives up expec-
                data—and insurance companies                         monitoring. But none of the compa-      tations and more investment with-
                won’t pay for them.”                                 nies providing those remote services    out capturing value.”
                   Indeed, the biggest challenge may                 is being adequately compensated
                be getting someone to pay for home                   for them, said John LaLonde, vice
                                                                     president of R&D for Boston Scien-



           R
           R            Not just a Band-Aid
                                              Bandages one day
                                                  could integrate
                                                                     tific’s pacemaker group, which has
                                                                     150,000 implant users on its re-
                                                                     mote monitoring service.
                                                                        Some companies sell the remote
                                                    active
                                                    components       services bundled into the cost of the
                                                    that stimulate   implants, LaLonde said; others
                                                   the skin to
                                              speed healing, then    lease the home devices and sell the
                                              let you know when      services outright, and a few have se-
                                              they are ready to be
                Click image to launch video   removed.               cured reimbursement from insur-


10 EE Times |The diagnosis for medical electronics | December 7, 2009
Body area nets


            R
            R           Dialysis untethered

                                              By 2014, startup
                                              Nanodialysis
                                                                        Global shipment forecasts for wireless body sensors:
                                                                        2009 vs. 2014
                                                                        Units (millions)

                                                                        Segment                           2009             2014               CAGR
                                              (Eindhoven,                                                                                   (’09 –’14)
                                              Netherlands) hopes
                                              to field a wearable       Sports and fitness               10.42           180.55           76.91%
                                              system for patients
                                              with kidney failure,      In-home health
                                              eliminating regular
                                              trips to the hospital.
                                                                        management                         0.35           59.41         179.31%
                Click image to launch video

                   There are technical issues, too. For
                                                                        Hospital/clinic-based              0.88          180.48         189.95%
                                                                        monitors
                example, making sure that digital
                health records can be read by any                       Total                            11.65           420.44         104.87%
                system in a way that’s both secure                      Source: ABI research

                and bandwidth-stingy is “a monumen- skin, but few users will fuss with the                          “That’s the big problem, and so far
                tal task involving many disciplines,                   gels. So researchers are working on        researchers are just scratching the
                and it’s going to take 10 years to re-                 a class of dry sensors that could be       surface of it,” said Lindsay Brown, a
                solve,” said entrepreneur Imran.                       worn in clothing, reliably detecting       body area networking specialist at
                   As for hardware, today’s monitor-                   microvolt-level biosignals while filter-   IMEC (Leuven, Belgium).
                ing devices often require conductive                   ing out the noise that comes from            Engineers at Analog Devices Inc.
                gels to make good contact with the                     brushing against skin and cloth.           are combining capacitive converters


11 EE Times |The diagnosis for medical electronics | December 7, 2009
Body area nets


            R
            R           Watch your step

                                              Sensors that clip
                                              on to shoes could
                                                                        A low-energy Bluetooth variant de-


                                                                    will be ratified in December. Compa-
                                                                    nies including CSR, Nordic Semi-
                                                                                                              ical Implant Communications Service
                                                                    signed to work on button-cell devices (MICS) band, a 402- to 405-MHz snip-
                                                                                                              pet of spectrum approved in the mid-
                                                                                                              1990s for communications with
                                              monitor the gait of
                                                                    conductor and Texas Instruments           external programmers and gateways.
                                              people who have
                                              difficulty walking,   are testing chips for it. An IEEE         The FCC approved 1-MHz sidebands
                                              helping to prevent
                                                                    802.15.6 standard for BANs, mean-         for MICS in March that developers
                                              debilitating falls.
                Click image to launch video
                                                                    while, is in an early stage of defini-    such as Saurin Shah of Medtronic will
                                                                    tion. The FCC could rule before the       support in next-generation chip sets
                and a ring of electrodes in a design
                                                                    end of the year on a request from GE for various uses, including one-way
                that could enable better sensors as
                                                                    Healthcare to allow a Wi-Fi variant for links between external devices.
                well as touch-sensitive surfaces. ADI
                                                                    BANs in the 2,360- to 2,400-MHz             “The jury is still out on [which
                is also working on ways to inject a
                                                                    band. ZigBee is yet another player        wireless approach will be] the win-
                signal into the body to measure im-
                                                                    with its own health care profile.         ner,” said Karthik Vasanth, product
                pedance, for gauging fat content or
                                                                        The Continua Health Alliance, an      line manager for the medical busi-
                even for modeling the dynamics of
                                                                    ad hoc industry group promoting           ness unit at Texas Instruments.
                the skin, said Paul Errico, a strategic
                                                                    home care systems and services,             Multiple wireless links will proba-
                marketing manager with ADI’s con-
                                                                    has blessed both Bluetooth and            bly coexist in tomorrow’s BANs,
                sumer health segment.
                                                                    ZigBee to date.                           and all of them will likely have to be
                   Another issue is which wireless
                                                                        Implants are already using the Med-   tooled or retooled to meet medical
                technologies BANs should ride.

12 EE Times |The diagnosis for medical electronics | December 7, 2009
Body area nets


           R
           R            Night patrol

                                             A wireless monitor
                                                                     Tapping into the brain
                                                                     Neural stimulators open new directions for implants beyond the heart
                                             worn at home can
                                             check for sleep apnea   Now that implants are a well-   this tipping point,” said                       company acquired in 2005 by
                                             with as much accuracy   established therapy for a       Christopher Chavez, who                         St. Jude Medical. That group
                                             as the more-complex
                                                                     handful of heart conditions,    heads a neuromodulation                         will see its business in neural
                                             and more-expensive
                                                                     medical electronics compa-
               Click image to launch video
                                             systems now used only
                                             in clinics.
               applications’ unique requirements.
                  At EMBC, a Shenzhen, China, re-
                                                                     nies are working on a host of
                                                                     new devices and uses for
                                                                     them. Many of the efforts are
                                                                                                     R Videos
                                                                                                     R
               search institute showed a modified                    focused on the brain.
               802.15.4 media access controller                        A growing body of research
               using simplified protocols to en-                     suggests that well-targeted
               hance sensor node battery life. And                   electrical stimulation of
               Qualcomm showed a compressed                          nerves can generate positive       Tim Denison, a senior engineering              Mir Imran gives a tour of his design
                                                                                                        manager at Medtronic in Minneapolis,           for the first implanted cardiac defibril-
               sensing algorithm that reduces the                    results across a broad range       shows a prototype for an implant that          lator, approved by the FDA in 1985
               amount of data acquired and sent                      of conditions, from addiction      listens to brain waves and stimulates          and now used by thousands. Now a
                                                                                                        neurons to test for a variety of ailments.     serial entrepreneur, Imran is helping
               on a BAN using any radio. Thus far,                   to epilepsy, Parkinson’s           See the full story at:                         to establish a foundry for implants.
               the company has applied it to blood                   disease and depression. “I         www.eetimes.com/showArticle.jhtml;?
                                                                                                        articleID=219500873"
               pressure and heart rate sensors. p                    think we are on the verge of

13 EE Times |The diagnosis for medical electronics
Body area nets




                   implants rise from $24 mil-                eight uses for neural stimula-   declining number of smokers       some kinds of pain and de-
                   lion in 2000 to an estimated               tors thus far. “We believe       and rising use of stents to       generative diseases,” said
                   $320 million this year,                    each one is less than 10 per-    lessen need for heart im-         Richard Kuntz, chief science
                   Chavez said. Industrywide,                 cent penetrated in its target    plants. By contrast, more than    officer at Medtronic.
                   neural implants represent                  application, and 10 new uses     a third of global health issues     Earlier this year, Medtronic
                   about a $2 billion business                are still waiting to be ap-      are neurological in nature, a     said it had begun animal tri-
                   today, growing at double-digit             proved,” Chavez said.            percentage that is expected to als of a closed-loop system
                   rates to about $3.9 billion in               The shift comes at a good      expand as people live longer.     to listen and respond to brain
                   2014, he estimated.                        time for implant makers,           Pacemaker giant Medtronic       waves automatically.
                     The U.S. Food and Drug                   which are expecting the          already has devices for ail-        Neural stimulators have
                   Administration has approved                                                 ments like Parkinson’s and        been shown to be effective in
                                                             Neural stimulators are            “has a pipeline [of neural im-    tests, though much of the un-
                                                                                               plants in development for]        derlying brain science remains
                                                             effective in tests, but
                                                                                               OCD [obsessive-compulsive         a mystery. For example, de-
                                                             much of the underlying            disorder, depression, epilepsy, pressed patients who did not
                                                             science is a mystery              migraine, fecal incontinence,     respond to shock therapy can


14 EE Times |The diagnosis for medical electronics | December 7, 2009
Body area nets

                   be shown smiling in videos when                                                           with tissues taught to beat on their
                   stimulated by a neural implant.                                                           own,” said Joseph Smith, vice pres-
                     “It’s a little eerie,” said Kuntz.
                                                                                        The future           ident of emerging technologies at
                   “We really don’t know how it works,                                  belongs to           Johnson & Johnson Services Inc.
                   because we are talking about                                           genetic            (New Brunswick, N.J.).
                   some of the most complicated                                                                But a more immediate task for
                                                                                        therapies,
                   physiology of the body.”                                                                  companies such as Medtronic lies
                     Jonathan Sackner-Bernstein, an
                                                                                           some              in shrinking the size of today’s
                   associate center director at the                                    researchers           10-cc cardiac implants, eliminating
                   FDA, took a contrarian position in                                     argue              the electronic leads that are the
                   one of several forums on deep                                                             cause of most failures.
                   brain stimulation at an IEEE bio-                                                           “We believe it is possible to get
                   engineering conference in Septem-                    tions in genetic therapies.          this device down to 1 cc in size
                   ber. “You still have to have brain                     Indeed, the long-term future be-   without a lead, so the device itself
                   surgery [to have an implant in-                      longs to biological treatments,      is in the heart,” said Rebecca
                   stalled], and I am not sure many                     many researchers believe. For ex-    Bergman, a vice president of new
                   people would want to have a scar                     ample, “we need to think different   therapies at Medtronic. “We hope
                   across their skull,” he said, calling                and make a cell a genetically con-   [to have such prototypes] in
                   instead for more radical innova-                     trolled, programmable pacemaker,     animals to define those issues



15 EE Times |The diagnosis for medical electronics | December 7, 2009
Body area nets

                   in the near future.”                                                                      designed by an expanding set of
                     Others see further directions                      ‘The next                            sometimes small companies and
                   for implants.                                        revolution                           startups. Today most implants are
                     “The next big revolution will be                   will be                              made by large, vertically integrated
                   implantable, closed-loop drug                                                             companies, such as Medtronic and
                                                                        closed-
                   delivery systems,” said Mir Imran,                                                        St. Jude Medical, that control most
                   who developed one of the first                       loop                                 aspects of the design.
                   implantable cardiac defibrillators.                  drug                                   “If you develop an implant today,
                   “There are therapeutic proteins                      delivery                             you have to go to a dozen manufac-
                   and peptides available, but they                                                          turers to put it all together,” Imran
                                                                        systems’
                   have to be delivered directly into                                                        said. “You end up spending three
                   the brain because the stomach                        as an artificial pancreas for dia-   times as long and 10 times as
                   chews them up.”                                      betes, Imran said.                   much money to get the result you
                     Such devices will eliminate side                     Imran is working on as many as     should.” — Rick Merritt
                   effects when drugs are delivered to five different implant concepts
                   the entire body. Closed-loop sys-                    today. He also acquired Modulus       About the Author
                   tems that can sense the need for a (San Jose), an implant maker, to                        Rick Merritt is editor at large
                                                                                                              of EE Times.
                   drug and deliver a proper dosage                     bolster its role as a foundry for
                   will be key to breakthroughs such                    devices that he believes will be            email: rmerritt@techinsights.com



16 EE Times |The diagnosis for medical electronics | December 7, 2009
Telehealth




                Industry alliance tackles
                technical, policy challenges
                By Dylan McGrath


                                                                        to transmit their vital signs seam-




                I
                       nformation technology is already
                       used today to exchange health-                   lessly to the health care profes-
                       related information, but proponents              sionals monitoring their status.
                       of the nascent telehealth concept                Such technology, they argue, would
                       see an opportunity to do far more.               improve the quality of care while
                They envision a world in which elderly                  requiring fewer face-to-face doctor
                patients and others with chronic health                 visits, thereby increasing the effi-
                problems use connected medical devices                  ciency of health care delivery and


17 EE Times |The diagnosis for medical electronics | December 7, 2009
Telehealth

                containing its cost.                                a sea change in how they conduct                adoption of telehealth solutions is
                   Before that vision can be realized               business.                                       the lack of open, standards-based
                on a grand scale, however, there are                    According to Rick Cnossen, direc-           architectures.
                technical, regulatory and cultural                  tor of personal health enabling for               Cnossen, who is also president
                hurdles to clear, including getting                 Intel’s Digital Health Group, an                and chairman of the Continua
                health care professionals to accept                 immediate obstacle to widespread                Health Alliance, believes telehealth




                   The making of an implant
                   Although the market for internal medical devices is expanding rapidly, the process for making implants
                   still relies heavily on painstaking manual labor




                     Welcome to the foundry                             Small hybrids                                Ties that bond
                     Mir Imran, developer of one of the first           Imran describes the unique (hybrid, dense    Wire bonding is one of the methods used to
                     implantable defibrillators, opened the doors       and flexible) printed-circuit boards used    deliver dense boards for implants.
                     of his Silicon Valley company Modulus to           in implants.
                     show how implants are made.
                   Click images to launch video



18 EE Times |The diagnosis for medical electronics | December 7, 2009
Telehealth

                will not achieve its potential unless               terfaces and revolutionized the way            than 200 member companies, span-
                devices are based on nonproprietary computers communicate with pe-                                 ning the gamut from tech heavy-
                protocols and are interoperable.                    ripheral devices.                              weights like IBM, Intel and Samsung
                   “We’ve seen this [interoperability                   The Continua Health Alliance is            Electronics to powerful health insur-
                scenario] play out time and time                    a nonprofit industry coalition dedi-           ance firms such as Aetna Inc. and
                again,” said Cnossen. He pointed to                 cated to establishing a system of              Kaiser Permanente Inc.
                the standardization effort around                   interoperable, connected personal                Continua includes technical work-
                the Universal Serial Bus, which dis-                health products. The organization,             ing groups that evaluate existing
                placed a plethora of proprietary in-                established in 2006, now has more




                     Some assembly required                             In the can
                     Technicians attach a battery and lead              The pc board is then folded and inserted
                     wires to each implant by hand.                     into a titanium container.



                   Click images to launch video


19 EE Times |The diagnosis for medical electronics | December 7, 2009
Telehealth

                                                                        standards and work with standards     have achieved certification.
                                                                        bodies such as the IEEE and ISO to      Cnossen said he expects the
                                                                        bridge gaps on the road to interop-   pace of certifications to pick up a
                                                                        erable telehealth solutions. Con-     bit “now that we’ve got the ball
                                                                        tinua’s policy working groups lobby   rolling.” The alliance is currently

                     Laser welding                                      governments with an eye toward        working on version two of its
                                                                        influencing legislation.              guidelines.
                     In one of the few automated processes in
                     the final assembly stage, a laser welder             Taking a page from the playbook       Continua’s initial thrust has heav-
                     seals the titanium can.
                                                                        of the Wi-Fi Alliance, Continua has   ily focused on the technical as-
                                                                        also established a rigorous test      pects of creating interoperability
                                                                        and certification program to ensure   between devices, Cnossen said,
                                                                        that products bearing the Continua    but lately there has been a shift
                                                                        logo are fully interoperable.         toward more focus on the organiza-
                                                                          In February, Continua announced     tion’s policy activities.
                                                                        it had completed the first version      In the United States, that effort
                     A plastic hat
                                                                        of its design guidelines, developed   consists primarily of pushing for
                     A plastic header is fitted onto the can,
                     forming a seal that also shields the lead          for device manufacturers that in-     more reimbursement for telehealth
                     wires that attach to the body.                     tend to put their products through    services from Medicare and Medic-
                                                                        the Continua certification process.   aid. Similar lobbying efforts are
                   Click images to launch video
                                                                        Since then, a total of eight products under way in other regions, notably


20 EE Times |The diagnosis for medical electronics | December 7, 2009
Telehealth

                Europe and Japan, Cnossen said.                         Another hurdle that telehealth       technology, Cnossen said. “They
                   Telehealth is taking off, Cnossen                must clear, however, is getting doc-     know this is happening. They want
                said, but it would grow more quickly                tors to buy in. With demands on their to work with the industry.” p
                if government programs reimbursed                   time rising for training and other ac-
                providers for more services. “Gov-                  tivities, physicians are wary of how      About the Author
                                                                                                              Dylan McGrath is West Coast online
                ernments can be a little slow to                    much effort might be required to              editor at EE Times.
                change,” he said. “They like to see a accumulate and monitor the poten-                             email: dmcgrath@techinsights.com
                lot of data.”                                       tially voluminous data generated by
                   But with the debate currently                    connected healthcare devices.
                raging in Washington over U.S.                          Software that manages the flow of
                health care reform, and with a new                  information and provides high-level
                political party in power in Japan for               analysis is therefore required,
                the first time in decades, this is a                Cnossen said.
                time when Continua’s policy efforts                     Regulatory bodies that approve
                could have an impact, according                     medical equipment for disease
                to Cnossen.                                         monitoring, such as the U.S. Food
                   “In the U.S., we have a great op-                and Drug Administration are also
                portunity over the next six months                  cautious, he said.
                that could be very positive for tele-                   Continua has had preliminary dis-
                health legislation,” he said.                       cussions with the FDA about the


21 EE Times |The diagnosis for medical electronics | December 7, 2009
HeartCycle




                   European project helps manage
                   broken hearts at home
                    By Peter Clarke



                             mix of hardware and software built




                   A
                                                                                           HeartCycle aims to create a closed-loop
                             into everyday items such as cloth-                         feedback system to help cardiac patients
                             ing and bedding could let cardiac                          monitor their conditions without numerous
                             patients manage their health at                            visits to their physicians. The system
                             home under the European Union’s                            would report automatically to clinicians so
                   HeartCycle project. The four-year collabora-                         that if changes needed to be made in the
                   tive research effort is part of a wider push                         treatment protocol or in the patient’s
                   to find innovative ways to deliver health                            lifestyle, that information could be con-
                   care more effectively—and at lower cost—                             veyed over a computer network.
                   as Europe’s population grays.                                           While face-to-face consultations are

22 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
HeartCycle

                   more personal, the monitoring en-                                                            Measurements, detection, prediction
                   abled by systems such as Heart-
                   Cycle could alert patients and clini-                                       Important
                   cians quickly to small changes in a                                       decision point!
                   patient’s condition that might not
                   otherwise be spotted until they be-
                                                                                                                                    Telemedicine




                                                                                                                                                                    Analysis, decisions
                   came serious problems. Such sys-
                   tems would complement face-                                                                                         platform
                                                                                                                                    (e.g. MOTIVA)
                   to-face visits, though ideally the lat-                                              “At home”/Patient
                   ter would be required less often—                                                         platform       “At home”                 Medical
                   and would less often take place                                        Patient         (e.g. MyHeart)    healthcare              professionals
                   under dire circumstances.
                      The HeartCycle project launched
                   on March 1, 2008, and has a budget                                                                             Value is created
                   of 22 million euros (about $33 mil-                                                                          by closing the loop!
                   lion), with the EU providing about 14
                   million euros (about $21 million).
                   The work is led by Philips Research
                   (Aachen, Germany) and involves 17
                   other academic and industry groups,                                                                       Therapy, feedback
                   including Clothing Plus Oy (Kankaan-
                   paa, Finland), Koninklijke Philips
                                                                                        The HeartCycle closed-loop management approach comprises two loops.
                   Electronics NV (Amsterdam, Nether-
                   lands) and Medtronics Iberica SA

23 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
HeartCycle

                   (Madrid, Spain).
                      Developing “the next generation of
                   telemonitoring systems requires a
                   multidisciplinary approach” that in-
                   volves more than just bridging exist-
                   ing islands of automation and
                   networking, said HeartCycle project
                   coordinator Harald Reiter, who is
                   based at Philips Research. “Defi-
                   nitely, the project is based on inno-
                   vation,” Reiter said. “If you just try                               Bio-impedence monitor.
                   to use the existing technology, it is
                   not enough.”
                      To that end, the project targets the
                   “domestication” of a number of sen-
                                                                                                                 Matsense sensor
                   sor types and equipment. Some of
                   the technology is in use now in hos-
                                                                                                                 foil for the Smartbed
                   pitals but is being customized for                                                            system.
                   home use; other work involves novel
                   sensors.
                      One technology is a bio-impe-
                   dence monitor (BIM), used to meas-
                   ure the presence of fluid in the
                   tissues. BIM systems can be used

24 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
HeartCycle


                   to predict decompensation, or the                            is the MatSense foil, a bed-sized
                   inability of the heart to maintain ad-                       pressure sensor on which the pa-
                                                                                                                                                                A vest with
                   equate circulation.                                          tient sleeps. Composed of an array
                      Frequent home bio-impedence                               of capacitive sensors, it can provide                                           textile
                   measurement can open up the pre-                             both ballistocardiogram and move-                                               electrodes
                   diction window for decompensation                            ment signals.                                                                   is one
                   from only one or two days (via sim-                             Specific algorithms are being                                                element of
                   ple blood-pressure measurement) to                           developed to calculate heartbeat                                                the in-home
                   two weeks, according to Heartcycle                           intervals, respiration cycle and                                                bio-impedance
                   documentation. “This allows treating                         movement. The technology can be                                                 monitor.
                   the patient at home, and the hospi-                          used to monitor sleep quality,
                   tal is avoided,” said Reiter.                                as a change in sleep patterns could
                      The challenge is to remake bulky
                   hospital equipment so that patients
                                                                                                                        The goal is a daily measurement procedure
                   can manage the gear in a home set-
                   ting. Toward that end, electronic tex-
                                                                                                                        that takes only 15 minutes. Use of the vest
                   tile developer Clothing Plus is                                                                      ensures that electrodes are positioned the
                   working on a measurement vest that                                                                   same way on the body each time the test
                   would let patients easily position                                                                   is run. The measurement is started via an
                   electrodes in the correct place for                                                                  interfacing PDA and runs automatically.
                   testing and might have to be worn
                   for only 10 minutes a day.
                      Another sensor within the program

25 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
HeartCycle

                   presage the need for an in-person                              Thus far, the EU project has under-                                             The Clothing
                   exam or a change in medication.                              taken extensive consultation to                                                   Plus-designed vest
                     The flow of data and intelligence                          develop the usage cases and the                                                   should need to be
                   across networks and around the                               requirements for equipment and                                                    worn for only a few
                   system is a key aspect of the Heart-                         software. Preparatory work has also
                                                                                                                                                                  minutes a day.
                   Cycle project. For example, auto-                            begun for a program of clinical trials.
                   mated systems are needed to                                  All of the equipment must be CE
                   monitor the data, extract useful in-                         certified for medical device use, and
                   formation and alert professionals at                         that requires planning.
                   appropriate times.                                             A longer-term goal is to include
                     “There are not enough nurses to                            data from implanted devices such
                   be looking at the data all the time,”                        as pacemakers, although that work
                   said Reiter. “This is our main focus.                        is still in the conceptual stage,
                     “While the networks for communi-                           Reiter said.
                   cation will be ZigBee, Bluetooth,                              Clinical trials of HeartCycle tech-
                   USB and so on, the algorithms to                             nology are due to start in March
                   alert the nurses [must be devel-                             2011 and could take six months to
                   oped]; this is our major work.”                              one year to complete.
                                                                                  Successful completion “would            The Smartbed, based on the MatSense foil,
                     About the Author                                           mark the end of the project, but          captures a person’s vital signs—including heart
                     Peter Clarke is European news                              before that we will have pretrials to     rate, breathing rate and sleep quality—during the
                     director for EE Times.
                                                                                test and justify certain elements,        night in an unobtrusive way, without the need to
                              email: pclarke@techinsights.com                   including sensors and electronics,”       glue electrodes to the skin.
                                                                                said Reiter. p

26 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Digital imagi ng




                   Medical imaging makeover
                    By Nicolas Mokhoff



                                 igital medical imaging is an en-




                   D
                                                                                        standards had to be established. The
                                 abler for the anticipated adop-                        Medical Imaging & Technology Alliance,
                                 tion of electronic medical                             a division of the National Electrical Manu-
                                 records by health care providers                       facturers Association, is the collective
                                 industrywide, replacing analog                         voice of medical imaging equipment devel-
                   films—which must be carried by hand from                             opers and manufacturers. One of the
                   one health care provider to the next—with                            group’s goals is expanded global accept-
                   digital bits that are acquired, processed,                           ance of the Digital Imaging and Communi-
                   seamlessly streamed to multiple locations                            cation in Medicine standard. DICOM allows
                   via wired and wireless transmission, and                             digital imaging technologies to interact
                   archived electronically for ready
                   retrieval.
                                                            Films                       carried by hand are giving way
                      For it all to work as envisioned,                                    to bits seamlessly streamed
27 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Digital imagi ng

                   seamlessly, so imaging results can                             Analog Devices’ Scott Pavlik de-      sheer volume. Samplify’s answer is a
                   be shared among all the parties re-                          tails what he calls the most cutting-   solution whose signal compression
                   sponsible for a patient’s care, with                         edge technology for heart imaging in    ratios provide reductions in data ac-
                   an eye toward effecting the best                             the emergency room: CT scanners         quisition rates from 2:1 up to 3:1.
                   course of treatment.                                         with data acquisition systems that      Allowing the raw data to be readily
                     Radiology began as a medical sub-                          can enable stop-action imaging of a     repurposed avoids the need to repeat
                   specialty in the first decade of the                         beating heart in one scan. The          costly medical imaging procedures.
                   1900s, after the discovery of X-rays.                        equipment produces a complete             Texas Instruments’ Suribhotla
                   For the first 50 years of radiology,                         image in just one rotation around       (Raja) Rajasekhar addresses the
                   the primary examination involved                             the body, completing the scan so        trends and challenges affecting the
                   creating an image by focusing X-rays                         quickly that the heart does not move    electronics for various imaging
                   through the body part of interest                            appreciably during the procedure. In    modalities, including digital X-ray,
                   and directly onto a single piece                             this way, the scan does not need to     ultrasound, CT scan and MRI. Digital
                   of film inside a special cassette.                           be synchronized with the period be-     imaging in the 21st century, Ra-
                   Digital imaging techniques emerged                           tween heartbeats.                       jasekhar notes, promises superior
                   in the 1970s with the first clinical                           Samplify’s Allan Evans and Al         diagnostic capability, image archiv-
                   use and acceptance of the com-                               Wegener observe that the sharing of     ing and on-demand image retrieval
                   puted tomography (CT) scanner.                               medical imaging data among health       anytime, anywhere. p
                     In the three contributed articles                          care providers requires portability
                   that follow, authors from Analog De-                         not only of the reconstructed images     About the Author
                   vices, Samplify and Texas Instru-                            but also of the raw data used to re-     Nicolas Mokhoff is research editor
                                                                                                                         of EE Times.
                   ments touch upon the main issues                             construct the images. The challenge
                   that make digital medical images                             in archiving such data in the context          email: nmokhoff@techinsights.com
                   such powerful diagnostic tools.                              of electronic medical records is its

28 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Signal acqui s i t i on




                   Data acquisition systems allow
                   stop-action cardiac imaging in one scan
                   By Scott Pavlik


                              he most cutting-edge technology




                   T
                                                                                        during the procedure; therefore, the proce-
                              for heart imaging in the emer-                            dure does not need to be synchronized
                              gency room is a computed to-                              with the period between heartbeats.
                              mography (CT) scanner that can                              If this can be achieved, the patient does
                              provide a high-quality image of a                         not need to go through the extensive prep
                   patient’s heart with one scan and very little                        of having an ECG (electrocardiogram) at-
                   prep time. Two factors are key to achieving                          tached and monitored to pinpoint the exact
                   this: The CT scanner can do the entire                               time between beats when the heart is still.
                   image in one rotational scan around the                              The resultant time savings enables a quick
                   body, and the scanner is fast enough so                              diagnosis and saves costs.
                   that the heart does not move appreciably                               To get a complete, accurate image in one

29 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Signal acqui s i t i on

                   revolution, a 256-slice scan must be                         Those specs lead to a system that                     diode. The photodiode current (I) is
                   done, for a sufficient horizontal reso-                      needs 256,000 channels of fast,                       converted to voltage (V) through a
                   lution of about 0.5 mm. To achieve                           accurate data acquisition. Each                       low noise I-V amplifier/integrator.
                   sufficient radial resolution, about                          channel includes a crystal scintilla-                 The I-V channels are then multiplexed
                   1,000 scanning channels are used.                            tor that converts X-ray energy into                   through a 24-bit, 128-channel A/D
                                                                                light, which is detected by a photo-                  converter, and the digital outputs are
                                                                                                                                      fed to the signal processor to pro-
                                                                              Single slice       vs.     Multi slice                  vide the decoded CT image.
                                                                                                                                        Analog Devices Inc.’s ADAS1128
                                                                                                                                      24-bit, 128-channel A/D converter
                                                                                                                                      packs this capability into a 10 x




                                 Detector array
                                                                                                                                CrystalScintillators
                                                                                                                                convert X-rays to light,
                                                                                                                                followed by photo diodes
                                                                                                                                that generate current
                                                                                                                                proportional to light and
                                                                            Linear pixel          vs.   Grid area pixel         X-ray intensity, which is
                                                                            detector array              detector array          measured by Current-to-digital
                                                                            (1 pixel by Y pixels)       (X pixel by Y pixels)   converters
                    Data Acquisition Systems (ADCs)
                     1,000 AFE signal chains per slice

30 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Signal acqui s i t i on

                   10-mm mini-BGA using 4.5                                      Ultrasonic             the moving particles can be used
                                                                                                Frequency and/or
                   mW/channel. The total power                                   Transducer    phase of reflected
                                                                                                        to calculate the particle, or flow,
                                                                                              sound changes with
                   for the data acquisition section                                                     velocity. With a finely focused ul-
                                                                                                  speed/direction
                   is then just over 1 kW for a                                                      of blood flow
                                                                                                        trasound beam, the velocity can
                   256-slice system, enabling a                                                         be plotted across the width of
                   better than 50 percent power                                                         the blood vessel to determine
                   reduction over typical equip-                                                        uniformity of blood flow. If the ve-
                   ment of comparable complexity.                                                       locity plot is the classic parabola,
                   Overall power is further re-                                                         then there is smooth, laminar
                   duced by the improved speed.                                                         flow; a distorted pattern would
                   Applications include dynamic                                                         reveal obstructions or structural
                   imaging, to observe the heart                                                        problems in the vessel.
                   or other organs in motion.                                                              The use of a pulse ultrasound
                                                                                                        waveform provides additional in-
                   Finding blood flow anomalies                                                         formation by measuring transit
                   The blood delivery system has       A CW signal or pulse is sent into the blood      time to provide a map of a given
                   two major components: the           stream and reflected back from the cells.        vessel. While the technique can
                   heart and the vascular system                                                        be valuable for diagnosing and
                   of arteries, veins and capillaries.      uous wave (CW) signal, usually a        locating vascular disease, it will also
                   Doppler ultrasound imaging systems sine wave, or pulse into the blood            become increasingly useful for diag-
                   can be used to determine blood flow stream which is reflected back from nosing traumatic injury and stroke.
                   rates as well as identify blockages,     the blood cells. As in all Doppler sys- The pulse ultrasound image can be
                   restrictions or leaks.                   tems, the change in frequency result- used to find stoppage or leakage in
                     Doppler ultrasound sends a contin- ing from the wave’s interaction with        the flow pattern.

31 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Signal acqui s i t i on

                     Ultrasound signal acquisition is at-                           Doppler ultrasound enables fast point-of-care diagnosis
                   tenuated by the square-of-the-dis-                               of vascular anomalies that can lead to disease
                   tance law, both in transmission and
                   in reflection, leading to the need to                                                   Stroke
                                                                                                           •Progressive blockage of brain arteries (ischemic)
                   handle a dynamic signal range ap-                                                       •Rupture or aneurysm (hemorrhagic)
                   proaching 160 dB. One development                                                       Carotid artery blockage
                                                                                                           •Progressive blockage of arteries to brain
                   that provided ultrasound systems                                                        •Most common cause of paralyzing strokes
                   with the accuracy and discrimination                                                    Heart disease
                                                                                                           •No. 1 cause of death in the U.S.
                   needed to provide clear images was
                   a combined low-noise amplifier and                                                      Abdominal aortic aneurysm (AAA)
                                                                                                           •Tenth leading cause of death in men 50+
                   I&Q demodulator or phase shifter                                                        •700,000 undiagnosed in U.S.
                   developed by Analog Devices. The
                   concepts have been expanded to
                   yield the AD9276/77.
                     Ultrasound designers can now de-
                   velop smaller systems for use in
                   point-of-care applications. p
                                                                                                           Peripheral artery disease
                                                                                                           •Poor circulation in the legs
                     About the Author                                                                      •Can cause serious disability
                                                                                                           •Can lead to amputation
                     Scott Pavlik is worldwide strategic                                                   •20% of people 70+ have PAD
                     marketing manager for Analog
                     Devices’ Healthcare Group. He holds
                     a BSEE from Clarkson University.

                             email: scott.pavlik@analog.com


32 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Data Compres s i on




                   Managing digital imaging’s
                   mountains of data
                   By Allan Evans and Al Wegener



                            t no time has digital imaging been




                   A
                                                                                        only for archiving of final images created
                            more important to medical imag-                             by medical imaging technologies, but also
                            ing applications than in today’s cli-                       for storage of the raw data from which
                            mate of health care reform.                                 those images are formed. In an environ-
                            Indeed, the current U.S. economic                           ment where medical records are trans-
                   stimulus program calls for $19 billion in                            ferrable from one health care provider
                   funding to facilitate health care providers’                         to another, portability of the raw data en-
                   adoption of electronic medical records.                              ables that data to be repurposed for dif-
                     Such a move will drive up demand not                               ferent end uses and thereby avoids the

33 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Data Compres s i on

                   need to repeat costly medical imag-                          data from a single CT scan can be       Among the imaging modalities,
                   ing procedures.                                              reused to form volumetric images        CT scans could benefit the most
                     Among the imaging modalities,                              that can support multiple end uses.
                                                                                                                           from raw-data portability
                   computed tomography may stand to                               For example, when the X-ray data
                   benefit the most from raw-data                               from the scan is first captured, gen-
                   portability to support multiple end                          erally an image is reconstructed to     ogist may retrospectively recon-
                   uses. First, CT scans are expensive,                         support an initial diagnosis by the     struct new volumetric images using
                   running in excess of $1,000 per                              attending radiologist. If a second      different back-projection algorithms
                   scan, second only to MRI. Second,                            opinion is required, a second radiol-   to highlight certain anatomical




                   Click either image for correct answer


34 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Data Compres s i on




                   Click either image for correct answer


                   features. If the diagnosis requires                            CT image data captured in digital        CT image data captured in
                   surgical intervention, the surgeon                           form becomes portable across             digital form becomes portable
                   may utilize the CT data to plan a                            health care providers, enabling the
                                                                                                                         across health care providers
                   laparoscopic or endoscopic proce-                            patient to seek the provider who can
                   dure. Finally, the CT data might be                          provide the greatest probability of a
                   used a fourth time, as registration                          successful outcome, without having      bility of medical imaging data among
                   of the anatomical features to                                to pay each provider to repeat the      health care providers requires not
                   guide the surgeon during the surgi-                          costly scans.                           just portability of the reconstructed
                   cal procedure.                                                 As we have just illustrated, porta-   images, but also portability of the

35 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Data Compres s i on

                   X-ray or sonogram data used to re-                              Signal compression holds            the authors challenge the readers to
                   construct the images. The challenge                          promise for enabling portability       pick which image was formed from
                   for archiving this data in the context                                                              raw data and which one from com-
                                                                                    of medical imaging data
                   of electronic medical records is its                                                                pressed data.
                   sheer volume.                                                                                         Samplify has performed similar
                     A modern CT machine captures                               greatly exceeds the time to repeat     studies with ultrasound OEMs, using
                   X-ray data at a rate of 1 Gbyte/                             the scan.                              images formed from pre- and post-
                   second, resulting in 30 Gbytes for a                            Signal compression represents a     beamformed data at compression
                   30-second scan. Ultrasound can                               promising solution to the problem of   ratios of up to 3:1. Another image
                   generate similar volumes of data,                            portability of medical imaging data.
                   with each frame composed of hun-                             In a paper presented at the SPIE
                   dreds of scan lines that themselves                          Medical Imaging Conference in Feb-
                   are composed of thousands of sam-                            ruary, Samplify Systems, GE Health-
                   ples. At 30 frames per second, ultra-                        care and Stanford University
                   sound data acquisition can exceed                            demonstrated the efficacy of signal
                   20 Mbytes/s and result in data sets                          compression, in both lossless and
                   on the order of 10 Gbytes for scans                          near-lossless modes, to achieve
                   lasting a few minutes.                                       compression ratios that provide
                     The size of these data sets can be                         compelling reductions in data acqui-
                   a limitation to their portability if they                    sition rates, from 2:1 up to 3:11. A
                   cannot be easily provided on a stor-                         set of images accompanying this ar-
                   age medium to the patient, or if the                         ticle (page 34) presents one of the
                   time to transmit them from one                               image pairs used in the survey that
                   health care provider to another                              was highlighted in the SPIE paper;

36 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Data Compres s i on

                   set accompanying this article (page                          promise of reducing health care         bedded in the data acquisition
                   35) repeats the image comparison,                            costs by increasing the portability     silicon without added cost relative to
                   but with ultrasound images. Again,                           of medical imaging data and there-      that of existing A/D converters built
                   the authors challenge the readers                            by reducing the need for duplicate      on legacy processes. p
                   to find any differences—and this                             scans.                                  References
                   time we have even made it easier                                Moreover, signal compression can     1Wegener A., Chandra N., Ling Y., Senzig R.,
                                                                                                                        Herfkens R. 2009. Real-time compression of raw
                   by showing wire phantoms.                                    provide this benefit while actually     computed tomography data: Technology, architec-
                      By providing a 75 percent reduc-                          decreasing the cost of medical          ture and benefits. Proceedings of the SPIE Medical
                                                                                                                        Imaging Conference, Vol. 7258 (March).
                   tion in the storage or transmission                          imaging equipment, by reducing data     http://tiny.cc/6Nemt
                   requirements for medical imaging                             acquisition times.
                   data, signal compression makes the                              In CT machines, faster data ac-
                   data portable by enabling the data                           quisition rates result in lower costs
                   sets to be provided to the patient on                        for mechanical rotary joints or slip
                   low-cost dual-layer DVDs or by reduc-                        rings as well as for the RAID drives
                   ing the transmission time for send-                          used to buffer the data prior to
                   ing the data sets from one provider                          image reconstruction.
                   to another.                                                     Similarly, signal compression in
                      Signal compression provides the                           ultrasound machines reduces I/O
                                                                                bottlenecks between the analog
                     About the Authors                                          front end and the digital signal
                     Allan Evans is vice president of marketing                 processing elements.
                     at Samplify Systems Inc.
                                                                                   Signal compression can be em-
                     Al Wegener is Samplify founder and CTO.

                             email: AEvans@samplify.com; AWegener@samplify.com


37 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
M ixed-signa l apps




                   Mixed-signal, embedded
                   open doors for digital imaging
                   By Suribhotla (Raja) Rajasekhar


                              igital imaging in the 21st cen-




                   D
                                                                                        ties in imaging systems, leading to tremen-
                              tury comes with the promise of                            dous advancements in medical imaging. At
                              superior diagnostic capability,                           the same time, embedded processors
                              image archiving and on-demand                             have dramatically increased the capabili-
                              retrieval anytime, anywhere.                              ties for medical image processing and real-
                   Since the advent of digital techniques for                           time image display for faster and more
                   medical imaging in the early 1970s, digital                          accurate diagnosis.
                   imaging has grown significantly in impor-                               The convergence of these technolo-
                   tance. Recent advances in design capabili-                           gies, coupled with emerging standards for
                   ties for mixed-signal semiconductors offer                           electronic health records, is providing the
                   unprecedented electronics packing densi-                             impetus for better patient care.

38 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
Technology fundamentals
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Technology fundamentals

  • 1.
  • 2. CONTENTS 6 Building the body area network 17 Industry alliance tackles technical, policy challenges 29 22 European project helps manage broken hearts at home 27 Medical imaging makeover 24 29 Data acquisition systems allow stop-action cardiac imaging in one scan 33 Managing digital imaging’s mountains of data 27 38 Mixed-signal, embedded open doors for digital imaging 43 Automated blood test is a breeze “This digital edition was designed to play on most browsers using Adobe Flash 8.0 or 47 Camera in a pill surveys GI tract higher. Should you encounter any difficulties in viewing the edition, we suggest that you click on the logos below to install the most recent 52 Body fat meter is thinly priced versions of Adobe Flash and Shockwave players.” 60 Inside the art of pulse oximetry 2 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 3. Opinion Technology fundamental to reform By George Leopold or for blocking “fundamental reform” of a O nce the political posturing, demagoguery and horse trad- system that accounts from anywhere be- ing cease, it’s far from clear tween one-fifth to one-sixth of the U.S. whether Americans will actu- economy, depending on which Senate floor ally achieve health care re- speech you choose to believe. form. The guess here is that, in This is indeed a sad state of affairs, but time-honored Washington fashion, all sides not wholly unexpected, given the political in this noisy, high-stakes debate will claim and economic stakes for the health care political victory while condemning the other industrial complex. side either for effecting a “government Assuming Congress approves health takeover” of the U.S. health care system care legislation this year and President 3 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 4. Opinion Barack Obama signs it into law, a key question in implementing re- forms is what role tech- nology can play in reducing skyrocketing medical bills. Up to now, many diag- nostic technologies have greatly improved U.S. health care while saving countless lives. Those technologies re- main expensive, how- ever, making it awfully tempting for a medical specialist to order another high-ticket test—which may or may not be needed— Music: Cross Douglas Road by Patrick O’Rourke, www.patrickorourke.com 4 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 5. Opinion as a way to pay off the huge up- forms. One office worker left to take care system, but it is a critical tool front investment in the latest med- a job at Starbucks, where she could in the fight to put patients ahead of ical equipment. get the medical benefits the doctor profits and politics. p If we are to reduce medical costs, could not afford to provide. such practices must stop. It is physicians like this one who About the Author George Leopold is news director for Part of the problem with soaring desperately need technology’s help EE Times. health care costs is that medical to survive and, perhaps one day, email: gleopold@techinsights.com school graduates confront huge thrive. For technology companies that tuition bills that drive them into have created the senior position of lucrative specialty medicine and chief medical officer, a huge opportu- away from general practice. nity exists to customize existing tech- One of the best stories we’ve nologies to serve these medical seen during the health care debate professionals and not just the spe- focused on a general practitioner cialists whose offices are already who was struggling to meet the filled with the latest diagnostic tools. needs of her community and keep None of us is getting any younger, her practice afloat amid a ceaseless and some of us are facing life-and- tide of health insurance paperwork. death medical decisions about our The MD could barely afford to em- aging parents. Technology alone ploy file clerks to handle the flood of won’t heal what ails the U.S. health 5 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 6. Body area nets Building the body area network By Rick Merritt neering at the University of Washington, N etworked medical devices hold the promise of more-effective notes that much of that spending was for and lower-cost health care, as costly hospital care, often delivered long services traditionally delivered after the onset of chronic problems that in clinical settings become could have been better managed early on. accessible in the home. The rationale be- A critical component of the solution “is hind the shift is sound, but the business, in embedded or wearable devices linked to regulatory and technical hurdles are many. therapy,” said Joseph Smith, vice president The problem is clear: The United States of emerging technologies at Johnson & last year spent an estimated $2.5 trillion— Wearable devices and implants could 18 percent of its GDP—on health care. Yong-Min Kim, a professor of electrical engi- help cure what ails health care 6 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 7. Health care, American style High costs are due in part to late-stage treatments, administered with expensive equipment in hospital settings $2.5 trillion Johnson Services Inc. (New Amount spent domestically each year on health care Brunswick, N.J.), which oversees 18% dozens of medical businesses. Portion of U.S. GDP spent on health care “We don’t yet have the treatment 45% paradigms for continuous care for U.S. share of world health care spending in dollars chronic diseases, but I think we will 45-50 million get there,” Smith said in September Number of uninsured Americans at the IEEE Engineering in Medicine 66% and Biology Society’s annual confer- Percentage of Americans who are overweight ence (EMBC). 65 million “We all have a responsibility to Number of Americans with chronic heart problems be involved in health care reform,” 20 million: Rebecca Bergman, a vice president Number of Americans with diabetes of new therapies at Medtronic (Min- 100,000 neapolis), said at EMBC. “Tech is Number of people who die in the U.S. each year from preventable treatment errors not at the core of this issue, but we One hour should make tech part of the solu- Amount of time spent on paperwork for each hour of health care delivered in the U.S. tion and not part of the problem.” 50% A group from Australia reported Amount of U.S. health care dollars typically spent in the last six months of a patient’s life Sources: Yong-Min Kim, University of Washington; Joseph Smith, vice president of emerging technologies at at the conference on a program Johnson & Johnson Services Inc.; EE Times 7 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 8. Body area nets that remotely monitored former car- Mir Imran, who in the mid-1980s de- Business hurdles diac patients participating in an ex- veloped one of the first implantable It’s easy to think of ways to extend ercise program. The program, cardiac defibrillators. “I’m thinking today’s wealth of consumer and developed in conjunction with Nokia, about clinical problems and optimiz- computer technologies to medical helped reduce the number of pa- ing solutions for them, and leverag- applications. What’s harder is mak- tients readmitted to hospitals from ing electronics heavily—whether for ing such concepts reliable enough the typical 28 percent to 8 percent. drug delivery or new kinds of im- to earn the trust of the doctors who Such efforts are fueling interest in plants, or putting sensors where they would use them, the regulators who a rising tide of networked medical have never been, for example in a devices and services. “I’m in the hip or knee replacement.” thick of it,” said serial entrepreneur In one project, Imran is working with Texas Instruments to equip R R The body electric Julien Penders, a cardiac stents with an RFID tag, a microelectromechanical system (MEMS) flow sensor and a tiny radio to report on the flow of blood program manager for body area network through the passage. The goal is an technologies at IMEC (Leuven, Belgium), early warning system for the nearly offers a primer on 7 percent of stents that become BANs and wearable devices. blocked over time. Click image to launch video 8 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 9. Body area nets would approve them and the insurers geared for their special needs. But “if Analyst Stephan Ohr, who co- who would pay for them. a couple of [medical electronics] ven- authored a recent Gartner report on Jonathan Collins, principal analyst dors solidify around a particular wire- telemedicine, noted that “today, a at ABI Research, predicts the use of less spec, it won’t need to be a nurse comes to your home, takes wearable consumer fitness devices [standard on the scale of] Bluetooth,” your blood pressure and transmits will grow rapidly over the next few Collins noted. the reading to a remote doctor using years as the devices adopt standards EEG Body Area Network for health like Bluetooth. By contrast, devices & comfort monitoring Vision Hearing for professional clinical use in hospi- tals and homes will take longer to Positioning adopt proprietary technologies ECG Glucose Blood pressure R R POTS Heart and home Network DNA protein Philips describes how Cellular Toxins a variety of home sensors could work with cell phones and TVs to allow remote WLAN monitoring of patients’ cardiac conditions. Implants Source: IMEC Click image to launch video 9 EE Times |The diagnosis for medical electronics | December 7,
  • 10. Body area nets an Internet connection, but more- care systems and services. By the ance providers. Despite the many automated patient monitoring using end of 2008, as many as 600,000 experiments, “the business models wireless is still 10 years out. The of the estimated 2.5 million im- in place today just do not get it biggest reason is that doctors don’t planted devices in use were linked to done,” LaLonde said. “I contend we trust [the new devices]—they really home systems that transmitted data are in a race to the bottom, in don’t know what to do with the automatically to clinics for remote which investment drives up expec- data—and insurance companies monitoring. But none of the compa- tations and more investment with- won’t pay for them.” nies providing those remote services out capturing value.” Indeed, the biggest challenge may is being adequately compensated be getting someone to pay for home for them, said John LaLonde, vice president of R&D for Boston Scien- R R Not just a Band-Aid Bandages one day could integrate tific’s pacemaker group, which has 150,000 implant users on its re- mote monitoring service. Some companies sell the remote active components services bundled into the cost of the that stimulate implants, LaLonde said; others the skin to speed healing, then lease the home devices and sell the let you know when services outright, and a few have se- they are ready to be Click image to launch video removed. cured reimbursement from insur- 10 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 11. Body area nets R R Dialysis untethered By 2014, startup Nanodialysis Global shipment forecasts for wireless body sensors: 2009 vs. 2014 Units (millions) Segment 2009 2014 CAGR (Eindhoven, (’09 –’14) Netherlands) hopes to field a wearable Sports and fitness 10.42 180.55 76.91% system for patients with kidney failure, In-home health eliminating regular trips to the hospital. management 0.35 59.41 179.31% Click image to launch video There are technical issues, too. For Hospital/clinic-based 0.88 180.48 189.95% monitors example, making sure that digital health records can be read by any Total 11.65 420.44 104.87% system in a way that’s both secure Source: ABI research and bandwidth-stingy is “a monumen- skin, but few users will fuss with the “That’s the big problem, and so far tal task involving many disciplines, gels. So researchers are working on researchers are just scratching the and it’s going to take 10 years to re- a class of dry sensors that could be surface of it,” said Lindsay Brown, a solve,” said entrepreneur Imran. worn in clothing, reliably detecting body area networking specialist at As for hardware, today’s monitor- microvolt-level biosignals while filter- IMEC (Leuven, Belgium). ing devices often require conductive ing out the noise that comes from Engineers at Analog Devices Inc. gels to make good contact with the brushing against skin and cloth. are combining capacitive converters 11 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 12. Body area nets R R Watch your step Sensors that clip on to shoes could A low-energy Bluetooth variant de- will be ratified in December. Compa- nies including CSR, Nordic Semi- ical Implant Communications Service signed to work on button-cell devices (MICS) band, a 402- to 405-MHz snip- pet of spectrum approved in the mid- 1990s for communications with monitor the gait of conductor and Texas Instruments external programmers and gateways. people who have difficulty walking, are testing chips for it. An IEEE The FCC approved 1-MHz sidebands helping to prevent 802.15.6 standard for BANs, mean- for MICS in March that developers debilitating falls. Click image to launch video while, is in an early stage of defini- such as Saurin Shah of Medtronic will tion. The FCC could rule before the support in next-generation chip sets and a ring of electrodes in a design end of the year on a request from GE for various uses, including one-way that could enable better sensors as Healthcare to allow a Wi-Fi variant for links between external devices. well as touch-sensitive surfaces. ADI BANs in the 2,360- to 2,400-MHz “The jury is still out on [which is also working on ways to inject a band. ZigBee is yet another player wireless approach will be] the win- signal into the body to measure im- with its own health care profile. ner,” said Karthik Vasanth, product pedance, for gauging fat content or The Continua Health Alliance, an line manager for the medical busi- even for modeling the dynamics of ad hoc industry group promoting ness unit at Texas Instruments. the skin, said Paul Errico, a strategic home care systems and services, Multiple wireless links will proba- marketing manager with ADI’s con- has blessed both Bluetooth and bly coexist in tomorrow’s BANs, sumer health segment. ZigBee to date. and all of them will likely have to be Another issue is which wireless Implants are already using the Med- tooled or retooled to meet medical technologies BANs should ride. 12 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 13. Body area nets R R Night patrol A wireless monitor Tapping into the brain Neural stimulators open new directions for implants beyond the heart worn at home can check for sleep apnea Now that implants are a well- this tipping point,” said company acquired in 2005 by with as much accuracy established therapy for a Christopher Chavez, who St. Jude Medical. That group as the more-complex handful of heart conditions, heads a neuromodulation will see its business in neural and more-expensive medical electronics compa- Click image to launch video systems now used only in clinics. applications’ unique requirements. At EMBC, a Shenzhen, China, re- nies are working on a host of new devices and uses for them. Many of the efforts are R Videos R search institute showed a modified focused on the brain. 802.15.4 media access controller A growing body of research using simplified protocols to en- suggests that well-targeted hance sensor node battery life. And electrical stimulation of Qualcomm showed a compressed nerves can generate positive Tim Denison, a senior engineering Mir Imran gives a tour of his design manager at Medtronic in Minneapolis, for the first implanted cardiac defibril- sensing algorithm that reduces the results across a broad range shows a prototype for an implant that lator, approved by the FDA in 1985 amount of data acquired and sent of conditions, from addiction listens to brain waves and stimulates and now used by thousands. Now a neurons to test for a variety of ailments. serial entrepreneur, Imran is helping on a BAN using any radio. Thus far, to epilepsy, Parkinson’s See the full story at: to establish a foundry for implants. the company has applied it to blood disease and depression. “I www.eetimes.com/showArticle.jhtml;? articleID=219500873" pressure and heart rate sensors. p think we are on the verge of 13 EE Times |The diagnosis for medical electronics
  • 14. Body area nets implants rise from $24 mil- eight uses for neural stimula- declining number of smokers some kinds of pain and de- lion in 2000 to an estimated tors thus far. “We believe and rising use of stents to generative diseases,” said $320 million this year, each one is less than 10 per- lessen need for heart im- Richard Kuntz, chief science Chavez said. Industrywide, cent penetrated in its target plants. By contrast, more than officer at Medtronic. neural implants represent application, and 10 new uses a third of global health issues Earlier this year, Medtronic about a $2 billion business are still waiting to be ap- are neurological in nature, a said it had begun animal tri- today, growing at double-digit proved,” Chavez said. percentage that is expected to als of a closed-loop system rates to about $3.9 billion in The shift comes at a good expand as people live longer. to listen and respond to brain 2014, he estimated. time for implant makers, Pacemaker giant Medtronic waves automatically. The U.S. Food and Drug which are expecting the already has devices for ail- Neural stimulators have Administration has approved ments like Parkinson’s and been shown to be effective in Neural stimulators are “has a pipeline [of neural im- tests, though much of the un- plants in development for] derlying brain science remains effective in tests, but OCD [obsessive-compulsive a mystery. For example, de- much of the underlying disorder, depression, epilepsy, pressed patients who did not science is a mystery migraine, fecal incontinence, respond to shock therapy can 14 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 15. Body area nets be shown smiling in videos when with tissues taught to beat on their stimulated by a neural implant. own,” said Joseph Smith, vice pres- “It’s a little eerie,” said Kuntz. The future ident of emerging technologies at “We really don’t know how it works, belongs to Johnson & Johnson Services Inc. because we are talking about genetic (New Brunswick, N.J.). some of the most complicated But a more immediate task for therapies, physiology of the body.” companies such as Medtronic lies Jonathan Sackner-Bernstein, an some in shrinking the size of today’s associate center director at the researchers 10-cc cardiac implants, eliminating FDA, took a contrarian position in argue the electronic leads that are the one of several forums on deep cause of most failures. brain stimulation at an IEEE bio- “We believe it is possible to get engineering conference in Septem- tions in genetic therapies. this device down to 1 cc in size ber. “You still have to have brain Indeed, the long-term future be- without a lead, so the device itself surgery [to have an implant in- longs to biological treatments, is in the heart,” said Rebecca stalled], and I am not sure many many researchers believe. For ex- Bergman, a vice president of new people would want to have a scar ample, “we need to think different therapies at Medtronic. “We hope across their skull,” he said, calling and make a cell a genetically con- [to have such prototypes] in instead for more radical innova- trolled, programmable pacemaker, animals to define those issues 15 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 16. Body area nets in the near future.” designed by an expanding set of Others see further directions ‘The next sometimes small companies and for implants. revolution startups. Today most implants are “The next big revolution will be will be made by large, vertically integrated implantable, closed-loop drug companies, such as Medtronic and closed- delivery systems,” said Mir Imran, St. Jude Medical, that control most who developed one of the first loop aspects of the design. implantable cardiac defibrillators. drug “If you develop an implant today, “There are therapeutic proteins delivery you have to go to a dozen manufac- and peptides available, but they turers to put it all together,” Imran systems’ have to be delivered directly into said. “You end up spending three the brain because the stomach as an artificial pancreas for dia- times as long and 10 times as chews them up.” betes, Imran said. much money to get the result you Such devices will eliminate side Imran is working on as many as should.” — Rick Merritt effects when drugs are delivered to five different implant concepts the entire body. Closed-loop sys- today. He also acquired Modulus About the Author tems that can sense the need for a (San Jose), an implant maker, to Rick Merritt is editor at large of EE Times. drug and deliver a proper dosage bolster its role as a foundry for will be key to breakthroughs such devices that he believes will be email: rmerritt@techinsights.com 16 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 17. Telehealth Industry alliance tackles technical, policy challenges By Dylan McGrath to transmit their vital signs seam- I nformation technology is already used today to exchange health- lessly to the health care profes- related information, but proponents sionals monitoring their status. of the nascent telehealth concept Such technology, they argue, would see an opportunity to do far more. improve the quality of care while They envision a world in which elderly requiring fewer face-to-face doctor patients and others with chronic health visits, thereby increasing the effi- problems use connected medical devices ciency of health care delivery and 17 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 18. Telehealth containing its cost. a sea change in how they conduct adoption of telehealth solutions is Before that vision can be realized business. the lack of open, standards-based on a grand scale, however, there are According to Rick Cnossen, direc- architectures. technical, regulatory and cultural tor of personal health enabling for Cnossen, who is also president hurdles to clear, including getting Intel’s Digital Health Group, an and chairman of the Continua health care professionals to accept immediate obstacle to widespread Health Alliance, believes telehealth The making of an implant Although the market for internal medical devices is expanding rapidly, the process for making implants still relies heavily on painstaking manual labor Welcome to the foundry Small hybrids Ties that bond Mir Imran, developer of one of the first Imran describes the unique (hybrid, dense Wire bonding is one of the methods used to implantable defibrillators, opened the doors and flexible) printed-circuit boards used deliver dense boards for implants. of his Silicon Valley company Modulus to in implants. show how implants are made. Click images to launch video 18 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 19. Telehealth will not achieve its potential unless terfaces and revolutionized the way than 200 member companies, span- devices are based on nonproprietary computers communicate with pe- ning the gamut from tech heavy- protocols and are interoperable. ripheral devices. weights like IBM, Intel and Samsung “We’ve seen this [interoperability The Continua Health Alliance is Electronics to powerful health insur- scenario] play out time and time a nonprofit industry coalition dedi- ance firms such as Aetna Inc. and again,” said Cnossen. He pointed to cated to establishing a system of Kaiser Permanente Inc. the standardization effort around interoperable, connected personal Continua includes technical work- the Universal Serial Bus, which dis- health products. The organization, ing groups that evaluate existing placed a plethora of proprietary in- established in 2006, now has more Some assembly required In the can Technicians attach a battery and lead The pc board is then folded and inserted wires to each implant by hand. into a titanium container. Click images to launch video 19 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 20. Telehealth standards and work with standards have achieved certification. bodies such as the IEEE and ISO to Cnossen said he expects the bridge gaps on the road to interop- pace of certifications to pick up a erable telehealth solutions. Con- bit “now that we’ve got the ball tinua’s policy working groups lobby rolling.” The alliance is currently Laser welding governments with an eye toward working on version two of its influencing legislation. guidelines. In one of the few automated processes in the final assembly stage, a laser welder Taking a page from the playbook Continua’s initial thrust has heav- seals the titanium can. of the Wi-Fi Alliance, Continua has ily focused on the technical as- also established a rigorous test pects of creating interoperability and certification program to ensure between devices, Cnossen said, that products bearing the Continua but lately there has been a shift logo are fully interoperable. toward more focus on the organiza- In February, Continua announced tion’s policy activities. it had completed the first version In the United States, that effort A plastic hat of its design guidelines, developed consists primarily of pushing for A plastic header is fitted onto the can, forming a seal that also shields the lead for device manufacturers that in- more reimbursement for telehealth wires that attach to the body. tend to put their products through services from Medicare and Medic- the Continua certification process. aid. Similar lobbying efforts are Click images to launch video Since then, a total of eight products under way in other regions, notably 20 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 21. Telehealth Europe and Japan, Cnossen said. Another hurdle that telehealth technology, Cnossen said. “They Telehealth is taking off, Cnossen must clear, however, is getting doc- know this is happening. They want said, but it would grow more quickly tors to buy in. With demands on their to work with the industry.” p if government programs reimbursed time rising for training and other ac- providers for more services. “Gov- tivities, physicians are wary of how About the Author Dylan McGrath is West Coast online ernments can be a little slow to much effort might be required to editor at EE Times. change,” he said. “They like to see a accumulate and monitor the poten- email: dmcgrath@techinsights.com lot of data.” tially voluminous data generated by But with the debate currently connected healthcare devices. raging in Washington over U.S. Software that manages the flow of health care reform, and with a new information and provides high-level political party in power in Japan for analysis is therefore required, the first time in decades, this is a Cnossen said. time when Continua’s policy efforts Regulatory bodies that approve could have an impact, according medical equipment for disease to Cnossen. monitoring, such as the U.S. Food “In the U.S., we have a great op- and Drug Administration are also portunity over the next six months cautious, he said. that could be very positive for tele- Continua has had preliminary dis- health legislation,” he said. cussions with the FDA about the 21 EE Times |The diagnosis for medical electronics | December 7, 2009
  • 22. HeartCycle European project helps manage broken hearts at home By Peter Clarke mix of hardware and software built A HeartCycle aims to create a closed-loop into everyday items such as cloth- feedback system to help cardiac patients ing and bedding could let cardiac monitor their conditions without numerous patients manage their health at visits to their physicians. The system home under the European Union’s would report automatically to clinicians so HeartCycle project. The four-year collabora- that if changes needed to be made in the tive research effort is part of a wider push treatment protocol or in the patient’s to find innovative ways to deliver health lifestyle, that information could be con- care more effectively—and at lower cost— veyed over a computer network. as Europe’s population grays. While face-to-face consultations are 22 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 23. HeartCycle more personal, the monitoring en- Measurements, detection, prediction abled by systems such as Heart- Cycle could alert patients and clini- Important cians quickly to small changes in a decision point! patient’s condition that might not otherwise be spotted until they be- Telemedicine Analysis, decisions came serious problems. Such sys- tems would complement face- platform (e.g. MOTIVA) to-face visits, though ideally the lat- “At home”/Patient ter would be required less often— platform “At home” Medical and would less often take place Patient (e.g. MyHeart) healthcare professionals under dire circumstances. The HeartCycle project launched on March 1, 2008, and has a budget Value is created of 22 million euros (about $33 mil- by closing the loop! lion), with the EU providing about 14 million euros (about $21 million). The work is led by Philips Research (Aachen, Germany) and involves 17 other academic and industry groups, Therapy, feedback including Clothing Plus Oy (Kankaan- paa, Finland), Koninklijke Philips The HeartCycle closed-loop management approach comprises two loops. Electronics NV (Amsterdam, Nether- lands) and Medtronics Iberica SA 23 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 24. HeartCycle (Madrid, Spain). Developing “the next generation of telemonitoring systems requires a multidisciplinary approach” that in- volves more than just bridging exist- ing islands of automation and networking, said HeartCycle project coordinator Harald Reiter, who is based at Philips Research. “Defi- nitely, the project is based on inno- vation,” Reiter said. “If you just try Bio-impedence monitor. to use the existing technology, it is not enough.” To that end, the project targets the “domestication” of a number of sen- Matsense sensor sor types and equipment. Some of the technology is in use now in hos- foil for the Smartbed pitals but is being customized for system. home use; other work involves novel sensors. One technology is a bio-impe- dence monitor (BIM), used to meas- ure the presence of fluid in the tissues. BIM systems can be used 24 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 25. HeartCycle to predict decompensation, or the is the MatSense foil, a bed-sized inability of the heart to maintain ad- pressure sensor on which the pa- A vest with equate circulation. tient sleeps. Composed of an array Frequent home bio-impedence of capacitive sensors, it can provide textile measurement can open up the pre- both ballistocardiogram and move- electrodes diction window for decompensation ment signals. is one from only one or two days (via sim- Specific algorithms are being element of ple blood-pressure measurement) to developed to calculate heartbeat the in-home two weeks, according to Heartcycle intervals, respiration cycle and bio-impedance documentation. “This allows treating movement. The technology can be monitor. the patient at home, and the hospi- used to monitor sleep quality, tal is avoided,” said Reiter. as a change in sleep patterns could The challenge is to remake bulky hospital equipment so that patients The goal is a daily measurement procedure can manage the gear in a home set- ting. Toward that end, electronic tex- that takes only 15 minutes. Use of the vest tile developer Clothing Plus is ensures that electrodes are positioned the working on a measurement vest that same way on the body each time the test would let patients easily position is run. The measurement is started via an electrodes in the correct place for interfacing PDA and runs automatically. testing and might have to be worn for only 10 minutes a day. Another sensor within the program 25 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 26. HeartCycle presage the need for an in-person Thus far, the EU project has under- The Clothing exam or a change in medication. taken extensive consultation to Plus-designed vest The flow of data and intelligence develop the usage cases and the should need to be across networks and around the requirements for equipment and worn for only a few system is a key aspect of the Heart- software. Preparatory work has also minutes a day. Cycle project. For example, auto- begun for a program of clinical trials. mated systems are needed to All of the equipment must be CE monitor the data, extract useful in- certified for medical device use, and formation and alert professionals at that requires planning. appropriate times. A longer-term goal is to include “There are not enough nurses to data from implanted devices such be looking at the data all the time,” as pacemakers, although that work said Reiter. “This is our main focus. is still in the conceptual stage, “While the networks for communi- Reiter said. cation will be ZigBee, Bluetooth, Clinical trials of HeartCycle tech- USB and so on, the algorithms to nology are due to start in March alert the nurses [must be devel- 2011 and could take six months to oped]; this is our major work.” one year to complete. Successful completion “would The Smartbed, based on the MatSense foil, About the Author mark the end of the project, but captures a person’s vital signs—including heart Peter Clarke is European news before that we will have pretrials to rate, breathing rate and sleep quality—during the director for EE Times. test and justify certain elements, night in an unobtrusive way, without the need to email: pclarke@techinsights.com including sensors and electronics,” glue electrodes to the skin. said Reiter. p 26 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 27. Digital imagi ng Medical imaging makeover By Nicolas Mokhoff igital medical imaging is an en- D standards had to be established. The abler for the anticipated adop- Medical Imaging & Technology Alliance, tion of electronic medical a division of the National Electrical Manu- records by health care providers facturers Association, is the collective industrywide, replacing analog voice of medical imaging equipment devel- films—which must be carried by hand from opers and manufacturers. One of the one health care provider to the next—with group’s goals is expanded global accept- digital bits that are acquired, processed, ance of the Digital Imaging and Communi- seamlessly streamed to multiple locations cation in Medicine standard. DICOM allows via wired and wireless transmission, and digital imaging technologies to interact archived electronically for ready retrieval. Films carried by hand are giving way For it all to work as envisioned, to bits seamlessly streamed 27 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 28. Digital imagi ng seamlessly, so imaging results can Analog Devices’ Scott Pavlik de- sheer volume. Samplify’s answer is a be shared among all the parties re- tails what he calls the most cutting- solution whose signal compression sponsible for a patient’s care, with edge technology for heart imaging in ratios provide reductions in data ac- an eye toward effecting the best the emergency room: CT scanners quisition rates from 2:1 up to 3:1. course of treatment. with data acquisition systems that Allowing the raw data to be readily Radiology began as a medical sub- can enable stop-action imaging of a repurposed avoids the need to repeat specialty in the first decade of the beating heart in one scan. The costly medical imaging procedures. 1900s, after the discovery of X-rays. equipment produces a complete Texas Instruments’ Suribhotla For the first 50 years of radiology, image in just one rotation around (Raja) Rajasekhar addresses the the primary examination involved the body, completing the scan so trends and challenges affecting the creating an image by focusing X-rays quickly that the heart does not move electronics for various imaging through the body part of interest appreciably during the procedure. In modalities, including digital X-ray, and directly onto a single piece this way, the scan does not need to ultrasound, CT scan and MRI. Digital of film inside a special cassette. be synchronized with the period be- imaging in the 21st century, Ra- Digital imaging techniques emerged tween heartbeats. jasekhar notes, promises superior in the 1970s with the first clinical Samplify’s Allan Evans and Al diagnostic capability, image archiv- use and acceptance of the com- Wegener observe that the sharing of ing and on-demand image retrieval puted tomography (CT) scanner. medical imaging data among health anytime, anywhere. p In the three contributed articles care providers requires portability that follow, authors from Analog De- not only of the reconstructed images About the Author vices, Samplify and Texas Instru- but also of the raw data used to re- Nicolas Mokhoff is research editor of EE Times. ments touch upon the main issues construct the images. The challenge that make digital medical images in archiving such data in the context email: nmokhoff@techinsights.com such powerful diagnostic tools. of electronic medical records is its 28 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 29. Signal acqui s i t i on Data acquisition systems allow stop-action cardiac imaging in one scan By Scott Pavlik he most cutting-edge technology T during the procedure; therefore, the proce- for heart imaging in the emer- dure does not need to be synchronized gency room is a computed to- with the period between heartbeats. mography (CT) scanner that can If this can be achieved, the patient does provide a high-quality image of a not need to go through the extensive prep patient’s heart with one scan and very little of having an ECG (electrocardiogram) at- prep time. Two factors are key to achieving tached and monitored to pinpoint the exact this: The CT scanner can do the entire time between beats when the heart is still. image in one rotational scan around the The resultant time savings enables a quick body, and the scanner is fast enough so diagnosis and saves costs. that the heart does not move appreciably To get a complete, accurate image in one 29 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 30. Signal acqui s i t i on revolution, a 256-slice scan must be Those specs lead to a system that diode. The photodiode current (I) is done, for a sufficient horizontal reso- needs 256,000 channels of fast, converted to voltage (V) through a lution of about 0.5 mm. To achieve accurate data acquisition. Each low noise I-V amplifier/integrator. sufficient radial resolution, about channel includes a crystal scintilla- The I-V channels are then multiplexed 1,000 scanning channels are used. tor that converts X-ray energy into through a 24-bit, 128-channel A/D light, which is detected by a photo- converter, and the digital outputs are fed to the signal processor to pro- Single slice vs. Multi slice vide the decoded CT image. Analog Devices Inc.’s ADAS1128 24-bit, 128-channel A/D converter packs this capability into a 10 x Detector array CrystalScintillators convert X-rays to light, followed by photo diodes that generate current proportional to light and Linear pixel vs. Grid area pixel X-ray intensity, which is detector array detector array measured by Current-to-digital (1 pixel by Y pixels) (X pixel by Y pixels) converters Data Acquisition Systems (ADCs) 1,000 AFE signal chains per slice 30 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 31. Signal acqui s i t i on 10-mm mini-BGA using 4.5 Ultrasonic the moving particles can be used Frequency and/or mW/channel. The total power Transducer phase of reflected to calculate the particle, or flow, sound changes with for the data acquisition section velocity. With a finely focused ul- speed/direction is then just over 1 kW for a of blood flow trasound beam, the velocity can 256-slice system, enabling a be plotted across the width of better than 50 percent power the blood vessel to determine reduction over typical equip- uniformity of blood flow. If the ve- ment of comparable complexity. locity plot is the classic parabola, Overall power is further re- then there is smooth, laminar duced by the improved speed. flow; a distorted pattern would Applications include dynamic reveal obstructions or structural imaging, to observe the heart problems in the vessel. or other organs in motion. The use of a pulse ultrasound waveform provides additional in- Finding blood flow anomalies formation by measuring transit The blood delivery system has A CW signal or pulse is sent into the blood time to provide a map of a given two major components: the stream and reflected back from the cells. vessel. While the technique can heart and the vascular system be valuable for diagnosing and of arteries, veins and capillaries. uous wave (CW) signal, usually a locating vascular disease, it will also Doppler ultrasound imaging systems sine wave, or pulse into the blood become increasingly useful for diag- can be used to determine blood flow stream which is reflected back from nosing traumatic injury and stroke. rates as well as identify blockages, the blood cells. As in all Doppler sys- The pulse ultrasound image can be restrictions or leaks. tems, the change in frequency result- used to find stoppage or leakage in Doppler ultrasound sends a contin- ing from the wave’s interaction with the flow pattern. 31 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 32. Signal acqui s i t i on Ultrasound signal acquisition is at- Doppler ultrasound enables fast point-of-care diagnosis tenuated by the square-of-the-dis- of vascular anomalies that can lead to disease tance law, both in transmission and in reflection, leading to the need to Stroke •Progressive blockage of brain arteries (ischemic) handle a dynamic signal range ap- •Rupture or aneurysm (hemorrhagic) proaching 160 dB. One development Carotid artery blockage •Progressive blockage of arteries to brain that provided ultrasound systems •Most common cause of paralyzing strokes with the accuracy and discrimination Heart disease •No. 1 cause of death in the U.S. needed to provide clear images was a combined low-noise amplifier and Abdominal aortic aneurysm (AAA) •Tenth leading cause of death in men 50+ I&Q demodulator or phase shifter •700,000 undiagnosed in U.S. developed by Analog Devices. The concepts have been expanded to yield the AD9276/77. Ultrasound designers can now de- velop smaller systems for use in point-of-care applications. p Peripheral artery disease •Poor circulation in the legs About the Author •Can cause serious disability •Can lead to amputation Scott Pavlik is worldwide strategic •20% of people 70+ have PAD marketing manager for Analog Devices’ Healthcare Group. He holds a BSEE from Clarkson University. email: scott.pavlik@analog.com 32 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 33. Data Compres s i on Managing digital imaging’s mountains of data By Allan Evans and Al Wegener t no time has digital imaging been A only for archiving of final images created more important to medical imag- by medical imaging technologies, but also ing applications than in today’s cli- for storage of the raw data from which mate of health care reform. those images are formed. In an environ- Indeed, the current U.S. economic ment where medical records are trans- stimulus program calls for $19 billion in ferrable from one health care provider funding to facilitate health care providers’ to another, portability of the raw data en- adoption of electronic medical records. ables that data to be repurposed for dif- Such a move will drive up demand not ferent end uses and thereby avoids the 33 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 34. Data Compres s i on need to repeat costly medical imag- data from a single CT scan can be Among the imaging modalities, ing procedures. reused to form volumetric images CT scans could benefit the most Among the imaging modalities, that can support multiple end uses. from raw-data portability computed tomography may stand to For example, when the X-ray data benefit the most from raw-data from the scan is first captured, gen- portability to support multiple end erally an image is reconstructed to ogist may retrospectively recon- uses. First, CT scans are expensive, support an initial diagnosis by the struct new volumetric images using running in excess of $1,000 per attending radiologist. If a second different back-projection algorithms scan, second only to MRI. Second, opinion is required, a second radiol- to highlight certain anatomical Click either image for correct answer 34 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 35. Data Compres s i on Click either image for correct answer features. If the diagnosis requires CT image data captured in digital CT image data captured in surgical intervention, the surgeon form becomes portable across digital form becomes portable may utilize the CT data to plan a health care providers, enabling the across health care providers laparoscopic or endoscopic proce- patient to seek the provider who can dure. Finally, the CT data might be provide the greatest probability of a used a fourth time, as registration successful outcome, without having bility of medical imaging data among of the anatomical features to to pay each provider to repeat the health care providers requires not guide the surgeon during the surgi- costly scans. just portability of the reconstructed cal procedure. As we have just illustrated, porta- images, but also portability of the 35 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 36. Data Compres s i on X-ray or sonogram data used to re- Signal compression holds the authors challenge the readers to construct the images. The challenge promise for enabling portability pick which image was formed from for archiving this data in the context raw data and which one from com- of medical imaging data of electronic medical records is its pressed data. sheer volume. Samplify has performed similar A modern CT machine captures greatly exceeds the time to repeat studies with ultrasound OEMs, using X-ray data at a rate of 1 Gbyte/ the scan. images formed from pre- and post- second, resulting in 30 Gbytes for a Signal compression represents a beamformed data at compression 30-second scan. Ultrasound can promising solution to the problem of ratios of up to 3:1. Another image generate similar volumes of data, portability of medical imaging data. with each frame composed of hun- In a paper presented at the SPIE dreds of scan lines that themselves Medical Imaging Conference in Feb- are composed of thousands of sam- ruary, Samplify Systems, GE Health- ples. At 30 frames per second, ultra- care and Stanford University sound data acquisition can exceed demonstrated the efficacy of signal 20 Mbytes/s and result in data sets compression, in both lossless and on the order of 10 Gbytes for scans near-lossless modes, to achieve lasting a few minutes. compression ratios that provide The size of these data sets can be compelling reductions in data acqui- a limitation to their portability if they sition rates, from 2:1 up to 3:11. A cannot be easily provided on a stor- set of images accompanying this ar- age medium to the patient, or if the ticle (page 34) presents one of the time to transmit them from one image pairs used in the survey that health care provider to another was highlighted in the SPIE paper; 36 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 37. Data Compres s i on set accompanying this article (page promise of reducing health care bedded in the data acquisition 35) repeats the image comparison, costs by increasing the portability silicon without added cost relative to but with ultrasound images. Again, of medical imaging data and there- that of existing A/D converters built the authors challenge the readers by reducing the need for duplicate on legacy processes. p to find any differences—and this scans. References time we have even made it easier Moreover, signal compression can 1Wegener A., Chandra N., Ling Y., Senzig R., Herfkens R. 2009. Real-time compression of raw by showing wire phantoms. provide this benefit while actually computed tomography data: Technology, architec- By providing a 75 percent reduc- decreasing the cost of medical ture and benefits. Proceedings of the SPIE Medical Imaging Conference, Vol. 7258 (March). tion in the storage or transmission imaging equipment, by reducing data http://tiny.cc/6Nemt requirements for medical imaging acquisition times. data, signal compression makes the In CT machines, faster data ac- data portable by enabling the data quisition rates result in lower costs sets to be provided to the patient on for mechanical rotary joints or slip low-cost dual-layer DVDs or by reduc- rings as well as for the RAID drives ing the transmission time for send- used to buffer the data prior to ing the data sets from one provider image reconstruction. to another. Similarly, signal compression in Signal compression provides the ultrasound machines reduces I/O bottlenecks between the analog About the Authors front end and the digital signal Allan Evans is vice president of marketing processing elements. at Samplify Systems Inc. Signal compression can be em- Al Wegener is Samplify founder and CTO. email: AEvans@samplify.com; AWegener@samplify.com 37 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9
  • 38. M ixed-signa l apps Mixed-signal, embedded open doors for digital imaging By Suribhotla (Raja) Rajasekhar igital imaging in the 21st cen- D ties in imaging systems, leading to tremen- tury comes with the promise of dous advancements in medical imaging. At superior diagnostic capability, the same time, embedded processors image archiving and on-demand have dramatically increased the capabili- retrieval anytime, anywhere. ties for medical image processing and real- Since the advent of digital techniques for time image display for faster and more medical imaging in the early 1970s, digital accurate diagnosis. imaging has grown significantly in impor- The convergence of these technolo- tance. Recent advances in design capabili- gies, coupled with emerging standards for ties for mixed-signal semiconductors offer electronic health records, is providing the unprecedented electronics packing densi- impetus for better patient care. 38 E E T i m e s |The diagnosis for medical electronics | D e c e m b e r 7 , 2 0 0 9