Dr Mark Bruzzi BioInnovate Ireland National University of Ireland Galway Agenda Introduction to BioInnovate Ireland Defining Innovation Perspectives on Medical Device Innovation Identifying Problems ID: 243126
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Slide1
Innovation & Commercialisation
Dr. Mark Bruzzi
BioInnovate
Ireland
National University of Ireland GalwaySlide2
Agenda
Introduction to
BioInnovate
Ireland
Defining Innovation
Perspectives on Medical Device Innovation
Identifying Problems
From Clinical Need to market opportunity
Filters for Successful Medical Device Innovation
ExamplesSlide3Slide4
Medical Technology Industry in Ireland
Ireland is home to a significant
medical
device industry
cluster
(11 of top 13 Medical
Device
Companies
are
located in Ireland
)
Approx. 250 Med Tech companies in Irl (50% indigenous), 25,000 peopleExports of over €7.2billion annually(8% of Total Irish Exports)Slide5
BioInnovate
Ireland
Medical Device Innovation Training Programme
BioInnovate
Ireland is a consortia of
4
Universities
Medical, Engineering, Business Schools
(NUI Galway,
UL, UCC, DCU)
Industry
Sponsors
: Medtronic, Boston Sci,Creganna Tactx
, Lake Region Medical, SteripackActivity:
Fellowship: Modular Industry
/ Graduate Training
GALWAY
Limerick
Cork
DublinSlide6
Why Medical Devices?
Biotech
Medtech
Technology
Drugs – Molecular / Genetic research
Devices, implants & Diagnostics
Company Examples
Pfizer
MSD
Medtronic,
Stryker
Product Development cycle
5-12 years
2-7 years
Capital requirements
€300m - €1bil
€10-€100mSlide7
BioInnovate
Ireland
Fellows
2011 Fellows – CV Disease
2012 Fellows – Urology / Radiation OncologySlide8
BioInnovate
Ireland Fellowship
10 month fellowship programme for
medical device innovation
Based on
Stanford
Biodesign
programme:
Identify – Invent – Implement
Active partnership between
Academia, Industry
and Clinicians
Building on existing strengths and activities in the MedTech
Ecosystem
Clinical Immersion -
Provide an environment for Needs Identification
Accessing Research centres
Introduction to a Network of Leaders
Mentorship from Industry, Clinicians, VCs
Learning by Doing!Slide9Slide10
Phase
Primary Outputs
Phase Description
Timeline
I
III
IV
5 Wk
8 Wk
II
8 Wk
Identify
Invent
Implement
Invent
8 - 12
Proposed Concepts
Implement
2 - 4
Evolved Concepts
12- 16 Wk
Identify
200-300 “Needs”
Distil to
12-16
“ Needs Statements
”
Intensive Introduction
“
Bootcamp
”
Needs Screening
Clinical Immersion
Needs Identification
& Verification
Solution Refinement
BioInnovate
Fellowship ProgrammeSlide11
Clinical Area 2011/12: Cardiology
Interventional
Cardiology
Cardiothoracic
Surgery
Vascular
Surgery
Ambulance –
Croi Calls
A&E
-Triage
Wards
Specialist Units
CCU
ICU
HDU
Non-invasive testing
Echo
Stress Test
Cath-Lab
Cardiothoracic
surgery
Vascular
surgery
Cardiac
Rehab
Physiotherapy
Occupational
Therapy
Outpatients
-Diabetes
Specialist Clinics
-Cheat pain/Heart Failure /Lipid/ Smoking CessationSlide12
INDUSTRY
Impact on MedTech Ecosystem
Industry
Workforce Skills
R&D capability
Connectivity
for Innovation
Clinic
Patient-care
HCPs
Healthcare
Collaboration
Academia
Graduate EducationStructured PhDTranslational ResearchSpecialist Training
Connectivity
●
MedTech Cluster Sustainability ●
●
Increased MedTech Value ● International Competitiveness
Generation of highly skilled graduates for the Irish MedTech Sector
Increase in collaboration between Industry, Academia and the Clinic Help generate a culture of innovationSlide13
Defining Innovation Slide14
"Innovation is creativity with a job to do“
Innovation is people creating value by implementing new ideas
Innovation = Invention + Exploitation
Innovation is a process that transforms ideas into outputs, which
increase customer value
“Identifying and defining a problem to be solved”
Mir
Imran
,
InCube
Defining Innovation …Slide15
“The formulation of a problem is far more essential than its solution, which may be merely a matter of mathematical or experimental skills. To raise new questions, new possibilities, to regard old problems from a new angle requires creative imagination and marks real advances in science”
Albert Einstein
Framing the ProblemSlide16Slide17
Perspectives on Medical Device Innovation Slide18
Everyone can innovate
if given access to a great problem and a great team.
Innovation is a collaborative process that brings together
multiple disciplines
.
Innovation starts with a problem
looking for a solution
NOT
with a solution looking for a problem.
Innovation is
iterative
: as you develop and test solutions you learn more about the problem.
Innovators should be willing to take risks, fail, and learn from their failures.
Fail Fast and Fail Early
PhilosophySlide19
Aligning Objectives & Motivation
Patient Benefit Vs Successful Business?
Clinical need must have financial plan to get the solution to patients
i.e. Patient benefit + MarketSlide20
Medical Device Innovation in Context
You cannot have a successful medical product unless you can build a sustainable (and preferably growing) business around it
You need:
Ross Jaffe, Versant Ventures, CA, USA
A patient who needs and wants the product
A provider who wants to use the product
Someone who will pay for the product
An organization that can develop, make, and deliver the product at a profit
Someone willing to invest resources to develop the product and build the businessSlide21
Medical device success is as much about business as it is about clinical issues or technology
Technical/clinical innovation is necessary, but not sufficient
You must build a successful business around the technology
Ross Jaffe, Versant Ventures, CA, USASlide22
Identifying ProblemsSlide23
What Creates Medical Device Opportunities?
23
Ross Jaffe, Versant Ventures, CA, USASlide24
Where can Clinical Needs by Identified?
Patient Morbidity
Invasive Surgery
Blood, pain, infection
ICU
Long recovery
“Inoperable”
Poor Outcomes
Low success rates
High / expensive reintervention rates
Complications
Expensive TreatmentsSlide25
Cost
vs
EffectivenessSlide26
What are the signs and symptoms?
Who are the patients?How many patients are there?
How and where do the Patients present?What is the Flow of care?Current treatments: Are they addressing the actual problem without causing additional complications?
Will you target the cause or the effects?
Understanding the ProblemSlide27
Identifying Problems
Observation
Problem Identification
Need
Statement
A statement that focuses on the goal or endpoint not the problem
“The genetic code of the solution”Slide28
Focus
On Goal, Not Problem
Need Statement: “A way to close sternotomy without risk of sternal
-wire breaking
.”
Focuses
on sternal-wire, closes out other approachesFocuses on part of the procedure that doesn’t deliver
result
Good
: “A way to close
sternotomy
quickly and securely
.”Better: “A way to perform CABG without sternotomy.”Best: “A way to revascularize heart muscle without access morbidity.”
Define a Needs StatementSlide29
Get
SpecificNeed Statement:
“A way to improve outcome of spine surgery.” Not clear which surgery, initial diagnosis, or how to improve
Better
: “A way to reduce risk of re-
herniation
after lumbar discectomy for sciatica.” Clear about procedure, diagnosis and complication
Define a Needs StatementSlide30
Needs Innovation
→ Product Innovation
Guides Brainstorming
Facilitates Concept Screening
Forms part of IP strategy
Focusses
Clinical Trial
Guides Marketing
Basis for reimbursement argument
Getting it wrong is really bad & expensive!
Why Needs Identification / Specification is so Important
Greg
Lambrecht
, Intrinsic TherapeuticsSlide31
Desired Outcomes - Objectives
Desired Outcomes
As measured by …
Improved Clinical Efficacy
Treatment Success Rates in Clinical Trials
Increased Patient Safety
Rate of adverse events in clinical trials
Reduced Cost
Total cost of procedure relative to available alternatives
Improved Physician/ facility productivity
Time and resource required to perform the procedure
Improved
physician ease of use
Solution of complexities
Improved
patient convenience
Frequency and occurrence
of required treatment, change in treatment venue
Accelerated patient recovery
Length of hospital stay, recovery period, and/or days out of work
Ross Jaffe, Versant Ventures, CA, USASlide32
From Clinical Needs to Market Opportunities
:
The Big QuestionsSlide33
The Big QuestionsSlide34
(2) Market
(1) Disease State
Understanding Causes (Biology to molecular level)
Effects & Symptoms (Patient Impact: Pain, Mortality)
Classical Patient Populations & Sub-classical cohorts
Size & Trends
Severity & Impact on the patient population
Current Treatments
Determining the ‘Right Need’
(4) Stakeholders
(3)Technology
Available Technology: Existing & Emerging
Status of the competition in this space: Patents, IP etc
What are the barriers to technology advancement
Identify the Decision makers/Purchasing power
Who are the Key Opinion Leaders & Health Care ProvidersSlide35
Identifying OpportunitiesSlide36
Large Market Opportunity
Market Size = # of Patients X $ per Patient
How large a market is attractive?
Market size has to be considered in light of capital required to
get product to cash flow breakeven
“Rule of Thumb”:
In general, an attractive market size is, at minimum,
10X capital required to get product to cash flow
breakevenSlide37
Intellectual Property
Is your concept:
Novel?
A method or a product / technology?
Can it be protected (patentable)?
Does your concept have Freedom to Operate?
When / where should you protect a concept?
First to file, costs, whereSlide38
Technology Vs Science
What are you trying to achieve?
In what timeframe?
Patient Benefit Vs Market Opportunity
Or
Patient Benefit + Market Opportunity
Leveraging Existing Technology is quicker!Slide39
Regulatory Affairs
FDA
Class I → Device Exemption Pathway
Class II → 510(k) Pathway
Class III → Premarket Approval (PMA) pathway
Europe (Medical Device Directive)
Class I
Class
IIa
Class
IIb
Class
III
What is the burden of proof required?Slide40
Approx: 5 years for 510 (k) device
Approx: > 8 years for PMA deviceSlide41
Stakeholders & Gap Analysis
Who are the Stakeholders?
How will they be affected?
How influential are they
?
Effects of your innovation on patient/ clinician/ buyer/ payer/ supplier/manufacturer in terms of benefits and costs/turf wars etc
What ‘gap’ are you
targeting?Slide42
Filters for Successful Medical Device InnovationSlide43
43
Needs Finding and Early Concept Assessment
Pietzsch, J. B., Pate-Cornell, M. E., Yock, P. G., Aquino, L. M., Linehan, J. H.,
Medical Device Development Process, Journal of Medical Devices 3: 2009
Slide44
Product
doesn’t workNo one willing to pay for
itNot enough patientsBad IP, management,
luck
The FDA & US-only strategy
Why Med Tech’s Fail
Bad Need!Slide45
$10-$200 million
20-120 people’s time
Between 3-20 years3-25% of your life
The Cost of Failure
Solve the right need!Slide46
Successful Medical Device Innovations
‘Ticking the Boxes’
Device addresses an important clinical need well
Large market with attractive market dynamics
Reasonable clinical and regulatory pathway
Clinical proof required for FDA
Clinical proof required for market
Reasonable path to attractive reimbursement
Proprietary technology
Knowledgeable and experienced management
Reasonable capital requirements to achieve positive cash flow from productSlide47
Text:
Biodesign
By
Zenios
,
Makower
, Yock
www.ebiodesign.org
www.bioinnovate.ie
ResourcesSlide48
BioInnovate
Classes
BioInnovate
I
Identifying Problems
Needs Finding, Needs Filtering
Inventing Solutions
Concept Generation, Concept Selection
BioInnovate
II
Implementation
Project development strategies and
planning
For More Information Contact info@bioinnovate.ie
Slide49
Thanks!