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Innovation & Commercialisation
Dr. Mark BruzziBioInnovate Ireland
National University of Ireland Galway
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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
•Examples
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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 people
•Exports of over €7.2billion annually(8% of Total Irish Exports)
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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, Steripack
•Activity:• Fellowship:• Modular Industry / Graduate Training
GALWAY
Limerick
Cork
Dublin
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Why Medical Devices?
Biotech Medtech
Technology Drugs – Molecular / Genetic research
Devices, implants & Diagnostics
Company Examples PfizerMSD
Medtronic,Stryker
Product Development cycle
5-12 years 2-7 years
Capital requirements
€300m - €1bil €10-€100m
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BioInnovate Ireland Fellows
2011 Fellows – CV Disease 2012 Fellows – Urology / Radiation Oncology
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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!
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Phase
Primary OutputsPhase Description
Timeline
I
III
IV
5 Wk
8 Wk
II
8 Wk
Identify
Invent
Implement
Invent8 - 12
Proposed Concepts
Implement2 - 4
Evolved Concepts
12- 16 Wk
Identify200-300 “Needs”
Distil to 12-16
“ Needs Statements”
Intensive Introduction “Bootcamp”
Needs Screening
Clinical ImmersionNeeds Identification
& Verification
Solution Refinement
BioInnovate Fellowship Programme
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Clinical Area 2011/12: Cardiology Interventional
CardiologyCardiothoracic
SurgeryVascular Surgery
Ambulance – Croi Calls
A&E-Triage Wards
Specialist UnitsCCUICUHDU
Non-invasive testingEcho
Stress Test
Cath-Lab
Cardiothoracic surgery
Vascular surgery
Cardiac Rehab Physiotherapy
Occupational Therapy
Outpatients-Diabetes
Specialist Clinics -Cheat pain/Heart Failure /Lipid/ Smoking Cessation
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INDUSTRY
Impact on MedTech Ecosystem
IndustryWorkforce SkillsR&D capability
Connectivity for Innovation
ClinicPatient-care
HCPsHealthcare
Collaboration
AcademiaGraduate Education
Structured PhDTranslational Research
Specialist 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 innovation
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Defining Innovation
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"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 …
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“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 Problem
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Perspectives on Medical Device Innovation
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• 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
Philosophy
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Aligning Objectives & Motivation
Patient Benefit Vs Successful Business?
Clinical need must have financial plan to get the solution to patients
i.e. Patient benefit + Market
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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 business
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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, USA
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Identifying Problems
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What Creates Medical Device Opportunities?
Unmet clinical need – diagnostic and/or therapeutic
New insight into physiology of a disease
New insight into diagnostic or therapeutic approach
Technological innovation that improves an existing diagnostic or therapeutic approach
Change in healthcare delivery system that creates pressure to change diagnostic or therapeutic approach
Some combination of the above
23
Ross Jaffe, Versant Ventures, CA, USA
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Where can Clinical Needs by Identified?
Patient MorbidityInvasive SurgeryBlood, pain, infectionICULong recovery“Inoperable”
Poor OutcomesLow success ratesHigh / expensive reintervention ratesComplications
Expensive Treatments
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• 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 Problem
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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”
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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 approaches
Focuses 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 Statement
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Get Specific
• Need 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 Statement
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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 Therapeutics
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Desired Outcomes - ObjectivesDesired 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, USA
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From Clinical Needs to Market Opportunities:
The Big Questions
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The Big Questions
Market
Regulatory
Stakeholders
Sales
Clinical StrategyTechnology
IP
Reimbursement
Competition
Funding
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(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 Providers
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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 flowbreakeven
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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, where
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Technology Vs Science
•What are you trying to achieve?•In what timeframe?
Patient Benefit Vs Market OpportunityOrPatient Benefit + Market Opportunity
Leveraging Existing Technology is quicker!
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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?
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Approx: 5 years for 510 (k) deviceApprox: > 8 years for PMA device
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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?
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Filters for Successful Medical Device
Innovation
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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
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• Product doesn’t work• No one willing to pay for it• Not enough patients
• Bad IP, management, luck• The FDA & US-only strategy
Why Med Tech’s Fail
Bad Need!
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• $10-$200 million
• 20-120 people’s time
• Between 3-20 years
• 3-25% of your life
The Cost of Failure
Solve the right need!
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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 product
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• Text: Biodesign By Zenios, Makower, Yock
• www.ebiodesign.org
• www.bioinnovate.ie
Resources
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BioInnovate ClassesBioInnovate 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 [email protected]
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Thanks!