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Need specification v1

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Need specification v1

  1. 1. Need Specification BIOE141 Ravi Pamnani 8 October 2012
  2. 2. Always Start with the Unmet Need “I find out what the world needs. Then, I go ahead and invent it.” Thomas Edison Decent Inventor World’s Greatest Need-Finder, Screener, and SpecifierR. Pamnani Need Specification v1.pptx 2
  3. 3. The Journey to a Need Specification Spend time with the customer. Observe their daily routine, Need become an expert in their problems. Observe the problems in Identification different settings. Confirm the need assessment. Interview key opinion leaders, Need Validation review the literature, ask the following question: Why is this a problem? Will someone pay for a solution to this need? Prioritize the needs according to risk (technical, clinical, Need Screening regulatory, reimbursement), opportunity (market size, and Prioritization competition, IP), capabilities of team, etc. How will you know that you have solved the customer’s need? Define Customer Ask them for criteria to determine what results they want (not Criteria how they wan to achieve the results). Need Statement Need Background of Clinical Problem and Market Specification Evidence Supporting the Need Description of Customer Criteria Yock, Brinton. Biodesign Course Lecture, 2009.R. Pamnani Need Specification v1.pptx 3
  4. 4. Anatomy of a Need SpecificationNeed Statement Description of Customer CriteriaEvidenceSupporting the Background of ClinicalNeed Problem and MarketR. Pamnani Need Specification v1.pptx 4
  5. 5. Need Statement A way to (SOLVE PROBLEM) (FOR PATIENT POPULATION) (IN GIVEN SETTING) in order to (RESULT IN OUTCOME)R. Pamnani Need Specification v1.pptx 5
  6. 6. Need Statement Example A way to monitor the fluid status of heart failure patients at home in order to prevent hospital admissionsR. Pamnani Need Specification v1.pptx 6
  7. 7. Objective Outcomes Desired Outcomes As Measured By… Improved clinical efficacy Treatment success rates in clinical trials Increased patient safety Rate of adverse events in clinical trials Reduced cost Total cost of procedure relative to available alternatives Improved physician/facility Time and resources required to perform procedure productivity Improved physician ease of use Solution of complex workarounds and/or the simplification of workflow Improved patient convenience Frequency and occurrence of required treatment, change in treatment venue (inpatient versus outpatient, physician’s office versus home), etc. Accelerated patient recovery Length of hospital stay, recovery period, and/or days out of work Zenios et al. Biodesign: The Process of Innovating Medical Technologies. Cambridge Univ Press 2009.R. Pamnani Need Specification v1.pptx 7
  8. 8. Background of Clinical Problem and Market • Disease State Fundamentals • Existing Treatments • Stakeholder Evaluation • Market Evaluation Zenios et al. Biodesign: The Process of Innovating Medical Technologies. Cambridge Univ Press 2009.R. Pamnani Need Specification v1.pptx 8
  9. 9. Evidence Supporting the Need GAP • Treatment Gap / Cost-Benefit Analysis • Economic Burden Analysis • Market (Patient) Segmentation • Market Analysis (Size, Structure, Dynamics) • Cycle of Care / Flow of MoneyR. Pamnani Need Specification v1.pptx 9
  10. 10. Need Criteria Get into the weeds Need criteria are the key elements required and/or desired by the customer Zenios et al. Biodesign: The Process of Innovating Medical Technologies. Cambridge Univ Press 2009.R. Pamnani Need Specification v1.pptx 10
  11. 11. Need Spec Development is an Iterative Process Observation Research Need Validation/ Need Criteria Statement Prototping Zenios et al. Biodesign: The Process of Innovating Medical Technologies. Cambridge Univ Press 2009.R. Pamnani Need Specification v1.pptx 11
  12. 12. Examples of Sources for Need Criteria • Expert opinion / user input – One-on-one interviews, focus groups, online surveys – Physicians, nurses, patients, billing staff, purchasing managers, etc • Clinical efficacy, safety, and medical best practices – Meta-analyses / review articles – Randomized controlled trials – Case series, case reports – Preclinical literature – Textbooks, UpToDate – Guidelines from Clinical Societies • Reimbursement/Economic data – CMS Payment Schedules / Amounts – Economic/cost analyses (literature, AHRQ, government/Medicare reports) • Epidemiological data – Literature, CDC, WHO, etc.R. Pamnani Need Specification v1.pptx 12
  13. 13. Need Criteria Example – iRhythm Technologies A better way to detect potential rhythm disturbances in non- hospitalized patients with suspected arrhythmias Must haves • Minimal impact on patient lifestyle and comfort • Accurately allow physicians to determine if patient’s symptoms are caused by an arrhythmia • Ability to monitor and function over extended period of time until arrhythmia can be ruled out • Inexpensive Nice to haves • External device • Allows diagnosis of arrhythmia if present • Have limited to no patient involvement to function • Ability to correlate symptoms to arrhythmic eventsR. Pamnani Need Specification v1.pptx 13
  14. 14. Need Criteria Case Study
  15. 15. Ear Infections are a Common Problem • Ear infections result in 17 million office visits each year • Including 2.65 million Emergency Department visits [2,3] • 30% of all antibiotic prescriptions for children are for ear infections [1] • By age 2-3, 80% of children have had at least 1 ear infection [1] • Peak incidence is during 6-24 months old [8]R. Pamnani Need Specification v1.pptx 15
  16. 16. Typical progression of an ear infection Eustachian Tube becomes Child catches a cold swollen at opening to nose Fluid begins slowly draining Fluid accumulates in the (2 weeks - 6 months) middle ear (OME) Infection subsides Infection spreads from nose (24 - 72 hours) into fluid in ear (AOM) Inflammation causes painR. Pamnani Need Specification v1.pptx 16
  17. 17. Ear Fluid vs. Ear Infection Otitis Media with Effusion (OME) = “ear fluid” [1] ” • Also known as “glue ear” or “serous otitis media” • Fluid is present in the ear but it is not infected • Typically precedes and follows an ear infection • Bulging or full ear drum • Symptoms = hearing loss (typically 25dB) • Cloudy and opaque • Anibiotics will not help • Air-level or bubbles Acute Otitis Media (AOM) = “ear infection” [1] ” • Fluid is usually still present • Middle ear is infected and inflamed causing pain • Symptoms: otalgia (ear ache), fever, otorrhea (discharge) • Can resolve on its own, antibiotics has limited effectiveness – may speed up resolution in some cases • Red or pink ear drum • Inflamed tissue Age Condition Treatment 2004 updates by AAP: < 6 month Certain / Uncertain Diagnosis Antibiotics …but only 15% of pediatricians follow 6 month - 2 years Uncertain Diagnosis Wait and see this guideline [5] > 2 years Certain Diagnosis but non-severe Wait and seeR. Pamnani Need Specification v1.pptx 17
  18. 18. Existing Treatment Options Otitis Media w/ Effusion Acute Otitis Media • Fluid not infected so antibiotics won’t help • 80-90% of AOM will resolve on its own Watchful • Correct diagnosis between AOM vs. OME • Challenging to convince concerned waiting [5] can be difficult (pediatricians = 50% parents with a crying baby to “wait” accurate; pediatric ENT = 75%) • N/A unless progresses to AOM • Questionable efficacy: shorten symptoms • Difficulty in diagnosis and alternatives for by 1 day in 5-14% of children [1] Antibiotics [4] acute treatment leads to overuse, even in • Antibiotic resistance = top concern for AOM CDC • Ineffective for chronic OME (incision closes • Does not resolve underlying infection, Myringotomy in a couple of days), but can relieve pain but may relieve pain symptoms [6,7] symptoms while a single episode of OME temporarily while AOM resolves on own resolves Laser • Better for chronic OME (incision closes in • Does not resolve underlying infection, myringotomy several weeks) but still not great, can but may relieve pain symptoms [7] relieve pain symptoms while OME resolves temporarily while AOM resolves on own • Ventilates middle ear for 12-14 months – Tympanostomy • Ventilates middle ear for 12-14 months – only indicated in chronic OME with hearing tubes [6,7] only when 3 infections in 6 months loss • Can be effective , considered a potentially • Can be effective in reducing pain Otovent / Ear effective alternative while waiting and symptoms over time while AOM resolves Popper [9] seeing, since low cost on ownR. Pamnani Need Specification v1.pptx 18
  19. 19. Typical progression of an ear infection 16 million 650,000 Ear infection onset, Pediatrician visit Antibiotics may be Myringotomy + significant pain prescribed (even if not Tympanostomy tube indicated); may or may ENT visit placement under general not resolve pain anesthesia Assuming 2 visits per child, and two ears per child – 325,000 children undergoing surgery / 8 million total children seeking care ~4% of children seeking medical care require an interventionR. Pamnani Need Specification v1.pptx 19
  20. 20. Need Criteria – Hands-On A way to relieve the symptoms of ear infections in children with non-chronic, middle ear fluid that is more effective than systemic antibiotics. Must haves • • • • Nice to haves • • •R. Pamnani Need Specification v1.pptx 20
  21. 21. Need Criteria – Hands-On – Example A way to relieve the symptoms of ear infections in children with non-chronic, middle ear fluid that is more effective than systemic antibiotics. Must Have Nice to Have • Can be performed without general • Cost less than antibiotic treatment anesthesia • Able to be done at the time of diagnosis • Relieve symptoms more effectively than • One-time solution antibiotic treatments (61% resolution within 24 hours [11]) • Can be done at home • Cost less than myringotomy ($179 - non- • Causes no pain facility) • Causes minimal peri-operative pain • Tolerable by x% of children • Skill level: pediatricianR. Pamnani Need Specification v1.pptx 21
  22. 22. References and Citations 1. Klein. Acute otitis media in children: epidemiology, pathogenesis, clinical manifestations, and complications. UpToDate 2010 2. Johnson. Pediatric Acute Otitis Media: The Case For Delayed Antibiotic Treatment. J Emerg Med 2007;32(3):279-284 3. CDC. National Hospital Ambulatory Medical Care Survey. 2005 Outpatient Department Summary. 4. Tahtinen. A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media. NEJM 2011;364(2):116-126. 5. Tarkan. Ear Infections Too Often Misdiagnosed, Then Overtreated. 2/12/2008. http://health.nytimes.com/ref/health/healthguide/esn-earinfections-ess.html 6. Kerr. Pediatric Tympanostomy Tube Use Steadily Rising; Trend Shows Significant Overuse. Medscape. 5/4/2009. http://www.medscape.com/viewarticle/702400. 7. Isaacson. Overview of tympanostomy tube placement and medical care of children with tympanostomy tubes. UpToDate 2010 8. Bhattacharya. Ambulatory pediatric otolaryngologic procedures in the United States: characteristics and perioperative safety. Laryngoscope 2010;120(4):821-825 9. Otovent® Auto Ear Inflation. Invotec International, Inc. Accessed 9/30/2012. http://www.invotec.net/otovent.htmlR. Pamnani Need Specification v1.pptx 22