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Biotech Boot Camp
Session 4 – Medical Devices and Diagnostics
Presenter: Nick Weston
Melbourne, Brisbane, Sydney
28 May – 18 June, 2014
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
• 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
• 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
• 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
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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
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
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
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
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
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
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
• 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
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
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
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
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
Medical devices and diagnostics
28
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
Medical devices and diagnostics
29
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
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
Medical devices and diagnostics
31
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
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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
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
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
• 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
• 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
• 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
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
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
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)
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
• 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
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
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
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
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
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
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

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Nw biotech fundamentals day 2 session 4 medical devices and diagnostics

  • 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 28 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 29 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 31 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