In this presentation: • Definition of Medical devices and Diagnostics • The stages of an R&D project • The state of the art • Regulatory nuances • Future trends • Challenges and opportunities • Case studies and examples

1. Biotech Boot Camp
Session 4 – Medical Devices and Diagnostics
Presenter: Nick Weston
Melbourne, Brisbane, Sydney
28 May – 18 June, 2014

2. This session provides an overview of the global medical
devices and diagnostics sectors
Analysis includes key trends in market size & growth,
demand drivers, adoption & scope trends, emerging
themes, key areas of investment, and implications for key
stakeholders
The session also provides specific insights on what is
driving key strategic initiatives in the sectors
Session 4 Overview
2
Agenda

3. • Basic overview of Medical Devices and Diagnostics
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
3
Session 4 Overview
Medical Devices and Diagnostics

4. • Basic overview of Medical Devices and Diagnostics
• The state of the art
• Regulatory nuances
• Future trends
• Case Studies and examples
4
Session 4 Overview
Medical Devices and Diagnostics

5. • TGA defines as “any instrument, apparatus, appliance, material or
other article, whether used alone or in combination, including the
software necessary for its proper application intended by the
manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of
disease,
- diagnosis, monitoring, treatment, alleviation of or compensation
for an injury or handicap
- investigation, replacement or modification of the anatomy or of a
physiological process,
- control of conception
and which does not achieve its principal intended action in or on the
human body by pharmacological, immunological or metabolic means,
but which may be assisted in its function by such means”
Basic Overview of Medical Devices and Diagnostics
5
Definition

6. Medical devices include things such as bandages, CT machines,
knee implants, cardiac pacemakers, crutches, hospital beds and in
vitro diagnostic devices
Basic Overview of Medical Devices and Diagnostics
6
State of play

7. • Australia represents a large and highly advanced medical
device market with a
• market capitalisation of about AU$4B
• growth rate of 15% per year
• We have entered a new age of predictive, preventative
and participatory medicine driven by continuous,
ubiqitous, individualised genomics and digital monitoring
• Changing demographics, aging population, rise of
chronic conditions, escalating cost of care
• Changes to the way care is accessed, delivered, funded
Basic Overview of Medical Devices and Diagnostics
7
State of play

8. • 155 FDA personalised medicine trials initiated on or before October
2009 involve use of molecular biomarkers to guide treatment and
diagnosis*
• Global revenue for consumer medical devices was around $8.2
billion in 2013, up from $7.9 billion in 2012 Revenue expansion for
the next few years is expected to range from 5 to 9 percent, with
industry takings by 2017 amounting to $10.6 billion**
• The majority of revenue will stem from hearing aids because of their
higher average selling prices, but diagnostic devices like blood
glucose meters and blood pressure monitors will also play a part**
• Worldwide revenue for tele-health devices and services is expected
to grow tenfold from $440.6 million in 2013 to $4.5 billion in 2018**
Basic Overview of Medical Devices and Diagnostics
8
State of play
*Source: Analysis Group, 2013
**Source: IHS Technology 2013 and 2014

9. • Rational drug design or mechanism based drug (or diagnostic)
design has largely replaced trial-and-error methods
• In this strategy researchers seek to understand the disease
mechanism at a cellular level and, if possible, identify the cellular
mechanism associated with a disease (eg: many diseases can be
traced either to the underproduction of a particular protein (eg insulin
in Type 1 diabetes), the overproduction of another type of protein
(eg: the growth factor receptor HER2 in certain types of breast
cancer) or the production of a mutated version of a protein that no
longer functions properly (eg: a mutated version of a tumour
suppressor that no longer controls cell division, leading to cancer)
Basic Overview of Medical Devices and Diagnostics
9
State of play

10. • By understanding what protein or proteins are associated
with a particular disease, researchers can then design
drugs and diagnostics to target (or in the case of a
therapeutic, replace) those proteins
• As this technique developed, chemists created huge
compound libraries by synthesising every possible
chemical derivative of an existing molecule
(combinatorial chemistry)
• A related approach termed directed evolution is used to
generate new biologics by introducing specific mutations
to a gene sequence to create new but structurally related
proteins
Basic Overview of Medical Devices and Diagnostics
10
State of play

11. • By applying high throughput screening to these
compound libraries, diagnostic and drug development is
presently integrated and targeted
• Presently, more than 50% of approved drugs target G
protein coupled receptors (GPCRs), receptors or ion
channels with strong interest in targeting the active site of
protein kinases
• Assay development (enzymology, genetic engineering)
continues to play a vital role in developing new diagnostic
and therapeutic options
Basic Overview of Medical Devices and Diagnostics
11
State of play

12. • To screen potential drugs against a given target,
scientists design diagnostic assays to identify the drug
candidates with the most potential
• The assay must be fast but accurate as well as amenable
to scale up, so that thousands, or even millions of
compounds can be screened efficiently
• Often researchers develop assays that produce a
fluorescent signal or colour change because
fluorescence is easily measured, relatively inexpensive,
safe, and works with many different assay designs
Basic Overview of Medical Devices and Diagnostics
12
Assay development*
*Source: The Biotech Primer 2014

13. • Scientists frequently use
small molecule inhibitors to
target cellular enzymes
• Enzymes have a pocket
called an active site, a
particular location where
chemical reactions are
catalysed
• Active sites have specific
structures designed to bind
only the enzyme’s substrate
(ie: the molecule it interacts
with)
Basic Overview of Medical Devices and Diagnostics
13
Assay development*
*Source: The Biotech Primer 2014

14. • Researchers can chemically
modify substrates so that
they give off a fluorescent
signal if the enzyme acts on
them
• Enzymes treated with
affective inhibitors will not
successfully catalyse the
reaction, and thus the
substrate will not emit
fluorescence or will emit it at
reduced levels
Basic Overview of Medical Devices and Diagnostics
14
Assay development*
*Source: The Biotech Primer 2014

15. • This provides a quick assay readout
• If the target is a receptor, researchers employ a similar
strategy - scientists genetically engineer cells so that they
produce a fluorescent signal when a particular receptor is
activated (eg: a cell could be engineered to produce a green
fluorescent protein in response to activation of the breast cancer
associated HER2 receptor. Researchers would then add a drug
candidate to inhibit HER2, followed by an appropriate HER2-
activating growth factor, and measure fluorescence levels. If
fluorescence is seen then the candidate is not blocking the HER2
receptor and is proven to be an ineffective inhibitor. However, if no
fluorescence is measured the candidate may be an effective inhibitor
and researchers will continue testing this candidate).
Basic Overview of Medical Devices and Diagnostics
15
Assay development*
*Source: The Biotech Primer 2014

16. • Basic overview of Medical Devices and Diagnostics
• The state of the art
• Regulatory nuances
• Future trends
• Case Studies and examples
16
Session 4 Overview
Medical Devices and Diagnostics

17. Medical Devices and Diagnostics
17
State of the art – ‘next generation’ sequencing
• Illumina has been granted FDA approval for four
diagnostic devices that can be used for high through-put
gene sequencing
• Using capillary electrophoresis-based Sanger
sequencing, the Human Genome Project took over 10
years and cost nearly $3 billion.
• So called ‘next-generation’ sequencing, by contrast,
makes large-scale whole-genome sequencing accessible
and practical for the average researcher for less than a
grand

18. Medical Devices and Diagnostics
18
State of the art – smart-phone diagnostic devices
• The AliveCor ECG monitor creates electrical impulses from the
user’s fingertips into ultrasound signals transmitted to the mobile
device’s microphones
• The wearable sensor (foreground)
first sends its readings to the
wearer’s smart-phone, then
wirelessly to the AliveCor server
where a cardiac technician can
analyse the user’s heart rhythms
• Other smart-phone devices include
a Withings blood pressure monitor
and Sanofi’s ‘iBGStar’ blood
glucose meter

19. Medical Devices and Diagnostics
19
State of the art – microfluidic biosensor
• In personal medicine, researchers have developed a microfluidic
electrochemical detector for in vivo continuous monitoring
(MEDIC) that is inserted into a vein
• Its probe is tipped with a gold electrode and an ‘aptamer’ (a single-
stranded DNA or RNA molecule capable of specifically binding to
proteins or other cellular targets) that can detect changes in
electrical charge as the circulating drug binds to the aptamer
• The device requires no exogenous reagents, operates at room
temperature, and can be reconfigured to measure different target
molecules by swapping modular probes
• Not yet tested in humans but could establish a new paradigm in
real time drug dosage monitoring
Real-Time, Aptamer-Based Tracking of Circulating Therapeutic Agents in Living Animals, Sci Transl Med 27
November 2013: Vol. 5, Issue 213, p. 213ra165 , Sci. Transl. Med. DOI: 10.1126/scitranslmed.3007095
http://stm.sciencemag.org/content/5/213/213ra165.abstract

20. Medical Devices and Diagnostics
20
State of the art – big data analysis of patient data
• Big data driven decision making relies on insights from patterns
found in patient data to create predictive models of the likely
percentage of patients that have a particular condition (having regard
to their test results), what the rise in that percentage will be then
analyse potential early intervention strategies
• Specific diagnostic tests are being used or developed (eg: blood lipid
levels) linked to associated genetic regions to power these insights
• Patient data can mean anything from ER visits, lab results, pharmacy
prescriptions, waist thickness or blood pressure measures, to
customised DNA analysis chips to whole genome sequencing

21. Medical Devices and Diagnostics
21
State of the art – big data analysis of ‘digital exhaust’
• Pairing ‘digital exhaust’ with structured data is bearing fruit in early
clinical insights previously unavailable
• ‘Digital exhaust’, or ‘data exhaust’ is the unstructured data trail left by
interactions in a digital environment such as the use of connected
devices, sensors and payment systems and includes data on what
was clicked on, what was searched for, where people went, their
locations, IP addresses, purchases, clinical notes, genomic data,
medical device data and so on
• State of the art use of digital exhaust is finding patterns in
unstructured data, that is data that is not formally organised into a
relational database, and generating predictive clinical insights
Source: Burrill Transforming Healthcare Report 2014

22. Medical Devices and Diagnostics
22
State of the art – the rise of ‘tele-health’
• Providers are expected to increasingly use tele-health
solutions to monitor transitional patients, patients with
chronic conditions or to just monitor diet and exercise
and send reminders
• Evidence suggests that in-home monitoring and other
tele-health programs demonstrate rapid uptake of
integrating current telecommunications capability with
healthcare delivery (eg: U.S. Department of Veterans Affairs’
Veterans Health Administration reports that the number of U. S.
veterans receiving tele-health services is growing 29% p.a.)
Source: Burrill Transforming Healthcare Report 2014

23. • Basic overview of Medical Devices and Diagnostics
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
23
Session 4 Overview
Medical Devices and Diagnostics

24. Medical Devices and Diagnostics
24
Regulatory nuances – Medical devices
Higher
risk
Lower
risk
Medical device classification Examples
• Class I • Cervical collars
• Class Is (intended to be
supplied sterile)
• Class Im (with measuring
function)
• Sterile adhesive dressing
strips
• Handheld ultrasound
• Class IIa
• Class IIb
• Intravenous tubing, contact
lenses, catheters
• Dressings, condoms
• Class III
• AIMD (active implantable
medical device)
• Biological heart valves,
intrauterine contraceptive
devices
• Cochlear implants

25. Medical Devices and Diagnostics
25
Regulatory nuances – IVD tests
Higher
risk
Lower
risk
Medical device classification Examples
Class 1 IVD or Class 1 in-
house IVD: no public health
risk or low personal risk
• Glucose meter
Class 2 IVD or Class 2 in-
house IVD: low public health
risk or moderate personal risk
• Pregnancy and fertility self-
testing kits
Class 3 IVD or Class 3 in-
house IVD: moderate public
health risk or high personal risk
• Viral load and genotyping
assays for HIV and Hepatitis
C
Class 4 IVD or Class 4 in-
house IVD: high risk
• Blood testing

26. Medical devices and diagnostics
26
Registration procedure
The medical device registration procedure involves
a Conformity Assessment and compliance with
the Essential Principles and other key
elements

27. Medical devices and diagnostics
27
Conformity Assessment
• The Conformity Assessment procedures are more
rigorous the higher the risk class
• Devices are monitored at all stages of the product
lifecycle and may be selected for review at any point
• Evidence for ongoing Conformity Assessment obligations
must be generated through the manufacturing process
and supply phase
• On obsolescence, the TGA must be notified so that the
product can be removed from the ARTG

28. Medical devices and diagnostics
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Essential Principles
There are six general Essential Principles that apply to all
devices
1. Use of medical devices not to compromise health and safety
2. Design and construction of medical devices to conform to safety
principles
3. Medical devices to be suitable for intended purpose
4. Long-term safety
5. Medical devices not to be adversely affected by transport or
storage
6. Benefits of medical devices to outweigh any side effects

29. Medical devices and diagnostics
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Essential Principles
There are nine further Essential Principles about design
and construction that apply to devices on a case-by-case
basis
1. Chemical, physical and biological properties
2. Infection and microbial contamination
3. Construction and environmental properties
4. Medical devices with a measuring function
5. Protection against radiation

30. Medical devices and diagnostics
30
Essential Principles
There are nine further Essential Principles about design
and construction that apply to devices on a case-by-case
basis
6. Medical devices connected to or equipped with an
energy source
7. Information to be provided with medical devices.
8. Clinical evidence
9. Principles applying to IVD medical devices only

31. Medical devices and diagnostics
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Essential Principles
• From concept and prototype stage, the Essential
Principles must be incorporated into the design
• It is the manufacturer’s responsibility to demonstrate
compliance with the Essential Principles for their medical
devices
• There are six general Essential Principles that apply to all
devices. There are a further nine Essential Principles
about design and construction that apply to devices on a
case-by-case basis
• These are detailed in the seminar “Medical Devices and
Diagnostics” presentation deck

32. Medical devices and diagnostics
32
Other key elements
• optional use of recognised standards
• ongoing monitoring
• regulatory controls for manufacturing
• the ARTG listing as the central point of control
• potential penalties for breaches
• a range of corrective actions that may be taken if there is
a problem with a medical device

33. • The Therapeutic Goods Administration (TGA) is the
competent authority for medical devices in Australia
• TGA is a unit of the Australian Government Department
of Health and Ageing and is responsible for administering
the provisions of the legislation under the Therapeutic
Goods Act 1989 (the Act)
• The Act covers medical devices as well as Active
Implantable Medical Devices (AIMDs)
• The applicant must have information available to
demonstrate the quality, safety and performance
of the medical device
Medical Devices and Diagnostics
33
Regulatory nuances

34. • The organisation is divided into several parts where the
Office of Devices, Blood and Tissues is responsible for
medical devices
• On 4 October 2002 a new Global Harmonization Task
Force (GHTF) harmonized regulatory system was
introduced by the Therapeutic Goods Regulations 2002
(the Regulations)
• The transition period for the new system ended on 4
October 2007
Medical Devices and Diagnostics
34
Regulatory nuances

35. • Manufacturers of medical devices need to adjust to the
regulatory framework in the country where the product is
sold, an expense for manufacturers selling their products
in several countries
• Competent authorities worldwide are working to
collaborate more and harmonise the regulations
• Not as hard as it sounds for the reason that medical
device requirements are basically the same in most
countries but are implemented in different ways
Medical Devices and Diagnostics
35
Regulatory nuances

36. • The Global Harmonization Task Force (GHTF) is a group
of representatives from regulatory authorities in USA,
European Union, Japan, Australia and Canada that work
to harmonise the regulations for medical devices and
improve device safety, effectiveness and quality
• The group has developed guidelines for pre-market
evaluation, post-market surveillance, quality systems,
auditing and clinical safety/performance
• Australia has gone down the road of following guidelines
along the lines of the EMEA regulations
Medical Devices and Diagnostics
36
Regulatory nuances

37. • Medical devices must be registered in the database
Australian Register of therapeutic Goods (ARTG) before
entering the Australian market.
• Sponsors apply using the Devices Electronic Application
Lodgement (DEAL) system
• Sponsors are responsible for all activities concerning
medical devices while manufacturers have certain
obligations to help sponsors fulfil the requirements
Medical Devices and Diagnostics
37
Regulatory nuances

38. • Medical devices are divided into five classes; class I,
class IIa, class IIb, class III and Active Implantable
Medical devices (AIMD)
• Class I represents the lowest
• risk and class III and Active Implantable Medical devices
the highest risk
• Class I devices includes low risk devices that are sterile
and/or have a measuring function
• AIMDs are treated as class III devices
Medical Devices and Diagnostics
38
Regulatory nuances
Classification

39. • In vitro-diagnostic devices (IVDs) are divided into four
different classes; class I, II, III and IV
• Class I devices present no public health or a low
personal risk
• Class II devices present a low public health risk and
moderate personal risk
• Class III devices present a moderate public health risk or
high individual risk
• Class IV devices present a high public health risk
• Medical devices are given Global Medical Device
Nomenclature (GMDN) codes
Medical Devices and Diagnostics
39
Regulatory nuances
Classification

40. • The sponsor is responsible for registering the medical
device in the ARTG
• To do so, the medical device must be classified according
to the Australian system and suitable quality
management systems must be applied and risk analysis
been done to comply with the Essential Principles
described in Schedule 1 of the Therapeautic Goods
(Medical Devices) Regulations 2002
Medical Devices and Diagnostics
40
Regulatory nuances
Product registration – Essential Principles

41. • The post marketing surveillance system puts obligations
on the manufacturer but the sponsor is the responsible
legal entity and therefore must participate in the system
• A quality management system is required for medical
devices class IIa, IIb, III and AIMDs to get a Conformity
Assessment certificate approved
• Standards are recommended but are not mandatory
Medical Devices and Diagnostics
41
Regulatory nuances
Product registration – Conformity Assessment

42. • Australia has its own standard orders but the
international ISO standards can be used
• Standards for quality management systems (ISO 13485),
risk management (ISO 14971), clinical trials (ISO 14155)
and biocompatibility (ISO 10993) are recommended
depending on the type of medical device
• The manufacturer is required to have made a
documented risk analysis of the product
Medical Devices and Diagnostics
42
Regulatory nuances
Product registration - Standards

43. There are three documents that are necessary to register a
medical device in Australia:
• a conformity assessment certificate which can be issued
by TGA or an overseas notified body (not required for
medical devices in class I that do not have a measuring
function or intended to be supplied in a sterile state)
• a Declaration of Conformity
• an application to include the medical device in the ARTG
Medical Devices and Diagnostics
43
Regulatory nuances
Registration

44. Manufacturers with a CE certificate must give to the TGA
the following information:
• copies of the current CE certificates held by the manufacturer
• copies of the Initial Certification audit report
• copies of the current CE design Examination Or Type Examination
• Certificate, if applicable
• copies of the Design Examination or Type Examination reports
issued by the Notified Body in support of the certificate, if applicable
• evidence of close out of non-conformities
Medical Devices and Diagnostics
44
Regulatory nuances
Registration

45. • The manufacturer is also required to submit the
information required under Quality System
Documentation a completed essential principles
checklist, risk management report, clinical evidence and
labelling, instructions for use and advertising material
• For class III devices and AIMDs the manufacturer shall
also submit a Design Dossier which is a compilation of
quality management system design and development
records showing conformity to essential principles
Medical Devices and Diagnostics
45
Regulatory nuances
Registration

46. • TGA may on review of this information conduct a reduced
assessment of the quality system or may in some cases
do an on-site audit
• Information provided with the medical device is required
at a minimum to be in English
• If a device belongs to class I or II and the device can be
used safely for its intended use without instructions a
document of instructions for use need not to be provided
with the device
• The registration is valid for five years
Medical Devices and Diagnostics
46
Regulatory nuances
Registration

47. • Basic overview of Medical Devices and Diagnostics
• The state of the art
• Regulatory nuances
• Future trends
• Case Studies and examples
47
Session 4 Overview
Medical Devices and Diagnostics

48. Medical Devices and Diagnostics
48
Future trends – electroceuticals
• GSK interested in new device-based brain therapies and
seeks innovative technologies that advance the
understanding of brain circuitry, and potential therapies
that address electrical signalling defects in neuro-
degenerative diseases such as Parkinson’s, cardiac
diseases such as hypertension, and metabolic diseases
such as diabetes
• the challenge is to translate biological understanding into
engineering specifications
• The first step is to better map disease associated neural
circuits

49. Medical Devices and Diagnostics
49
Future trends – more ‘next generation’ sequencing
• In 2014 expect to see rapid uptake of high through-put
gene sequencing in the clinic
• Personalised medicine relies on accurate diagnostics so
that the right dose of the right drug for the right time can
be prescribed
• Pharmacogenomics is also useful in drug design,
predictive effectiveness of a therapy and in avoiding
adverse drug reactions - a leading cause of death in
patients
• Screening for genes that predispose to disease allows
selection of appropriate research protocols

50. Medical Devices and Diagnostics
50
Future trends – games as diagnostic devices
• Melbourne based Grey Innovation is developing a world
first attention training program which will also serve as a
tool for diagnosis, quantitative assessment and treatment
of Autism spectrum and developmental delay disorders in
children
• The software detects, at a Bigdata level, nuanced
biometric data from the player
• Expect to see development of more games that run on
portable devices that will offer parents and clinicians clear,
objective measurements and quantifiable measures (in the
case of Tali, for improvements in areas crucial for learning and social
interaction)

51. Medical Devices and Diagnostics
51
Future trends – ‘tele-health’ will continue to rise
• Expect to see research and development of on in-home
monitoring and other tele-health devices that integrate
telecommunications capability with healthcare delivery
• Remote patient monitoring technologies remotely collect,
track, and transmit health data from a patient’s home to a
health care provider and help engage patients in the
management of their own care
• Expect to see development of applications and devices
with increasingly sophisticated diagnostic capability
See: http://www.commonwealthfund.org/Publications/Case-Studies/2013/Jan/Telehealth-Synthesis.aspx

52. • Basic overview of Medical Devices and Diagnostics
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
52
Session 4 Overview
Medical Devices and Diagnostics

53. Medical Devices and Diagnostics
53
Case Studies and Examples
Creating clinical insights from ‘digital exhaust’
IBM, University of Toronto and The Hospital for Sick Children
• This Canadian collaboration has developed a system called
Artemis to capture and analyse huge amounts of physiological
data from premature babies and then present that information to
physicians and nurses
• Instead of a physician or nurse reading the monitoring machines
every 30 or 60 minutes, the system’s deep analytics is capable of
processing 1256 readings per second from ‘digital exhaust’ data
that would previously have become wasted or lost, and providing
real time analysis
• The Artemis system helps clinicians detect life-threatening
infections in neo-natal babies days sooner than is otherwise
possible today

54. Medical Devices and Diagnostics
54
Case Studies and Examples
Telemedicine
Verizon’s home health monitoring platform, CHM device
• Approved under s 510(k) by FDA in 2013 as a Class II
medical device, the Converged Health Management
(CHM) device is a remote monitoring platform
intended to collect and store biometric data in a cloud
server
• It can be used as a stand-alone device or in
combination with other patient monitoring devices
• Verizon is the largest mobile phone carrier in the U.S.
with over 100 million subscribers

55. Medical Devices and Diagnostics
55
Case Studies and Examples
R&D Tax Incentive Biotechnology Guidance example in context
Biofnatics – Development of biodegradable coronary stents for
use in heart surgery*
• Coronary vascular stents are scaffolds that hold a blocked vessel
open to restore blood flow to the cardiac muscle
• There are no biodegradable polymer drug eluting stents (DES)
included on the ARTG but there is one clinical trial underway in
multiple sites throughout Australia [Boston Scientific’s EVOLVE
(NCT01135225)] anticipated to complete in May 2016**
• The Australian New Zealand Clinical Trials Register and
ClinicalTrials.gov list 10 other trials of biodegradable stents for
coronary artery disease (CAD)**
* Fictitious example from AusIndustry R&D Tax Incentive Biotechnology Guidance product, April 2013
** HealthPACT Technology Brief, 2013

56. Medical Devices and Diagnostics
56
Case Studies and Examples
R&D Tax Incentive Biotechnology Guidance example in context
Biofnatics – Development of biodegradable coronary stents for
use in heart surgery*
Two major recent studies**
• Raber, L. Kelbaek, H. et al (2012). 'Effect of biolimus‐eluting stents
with biodegradable polymer vs bare‐metal stents on cardiovascular
events among patients with acute myocardial infarction: the
COMFORTABLE AMI randomized trial', JAMA, 308(8), 777‐87.
• Han, Y. L. Zhang, L. et al (2012). 'A new generation of biodegradable
polymer‐coated sirolimus‐eluting stents for the treatment of coronary
artery disease: final 5‐year clinical outcomes from the CREATE
study', EuroIntervention, 8(7), 815‐22.
* Fictitious example from AusIndustry R&D Tax Incentive Biotechnology Guidance product, April 2013
** HealthPACT Technology Brief, 2013

57. Medical Devices and Diagnostics
57
Biofnatics* v. real world competition
Technology name Company Geography
Marketed
Nobori®, biolimus-eluting biodegradable
polymer, stainless steel scaffold stent
BioMatrix Flex®, the biolimus A9™
biodegradable polymer DES, stainless steel
scaffold
Excel sirolimus-eluting biodegradable polymer
metal scaffold stent
Supralimus sirolimus-eluting biodegradable
polymer stainless steel scaffold
Orsiro limus-eluting biodegradable polymer
cobalt chromium alloy
Terumo
Biosensors
International
JW Medical
Systems
Sahajanand
Medical
Technologies
Biotronik AG
Europe, Latin
America,
Asia and Japan
EU, Mid East, Africa
and some in Asia
China
India
Europe
* Fictitious example from AusIndustry R&D Tax Incentive Biotechnology Guidance product, April 2013
Source: HealthPACT Technology Brief, 2013

58. Medical Devices and Diagnostics
58
Biofnatics* v. real world competition
Technology name Company Geography
Close to launch
Drug Eluting Absorbable Metal Scaffold
(DREAMS), magnesium alloy scaffold
SYNERGY™ Everolimus-Eluting Platinum
Chromium Coronary Stent System
Biotronik AG
Boston
Scientific
Corporation™
Europe
Europe (select
centres)
TIVOLI® rapamycin†-eluting cobalt chromium
scaffold stent
Essen
Technologies™
China
ISAR® rapamycin†-eluting stainless steel scaffold
stent
Deutsches
Herzzentrum
Muenchen
Germany
* Fictitious example from AusIndustry R&D Tax Incentive Biotechnology Guidance product, April 2013
Source: HealthPACT Technology Brief, 2013