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Innovation & Commercialisation
Dr. Mark Bruzzi BioInnovate 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 Company Examples
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-€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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BioInnovate Fellowship Programme Intensive Introduction
Timeline Phase Description Phase Primary Outputs Identify “Needs” Distil to 12-16 “ Needs Statements” Intensive Introduction “Bootcamp” Identify I 5 Wk Clinical Immersion Needs Identification & Verification 8 Wk II Invent Invent 8 - 12 Proposed Concepts 8 Wk Needs Screening III Implement Implement 2 - 4 Evolved Concepts Solution Refinement Wk IV
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Clinical Area 2011/12: Cardiology
Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage Wards Cath-Lab Non-invasive testing Echo Stress Test Specialist Units CCU ICU HDU Cardiothoracic surgery Vascular surgery Outpatients -Diabetes Cardiac Rehab Physiotherapy Specialist Clinics Cheat pain/Heart Failure /Lipid/ Smoking Cessation Occupational Therapy
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Impact on MedTech Ecosystem
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 Connectivity ● MedTech Cluster Sustainability ● ● Increased MedTech Value ● International Competitiveness Industry Workforce Skills R&D capability Connectivity for Innovation INDUSTRY Academia Graduate Education Structured PhD Translational Research Specialist Training Clinic Patient-care HCPs Healthcare Collaboration
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Defining Innovation
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Defining Innovation … "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
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Framing the Problem “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
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Perspectives on Medical Device Innovation
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Philosophy 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
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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: 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 Ross Jaffe, Versant Ventures, CA, USA
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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 Ross Jaffe, Versant Ventures, CA, USA
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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 Treatments
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Cost vs Effectiveness
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Understanding the Problem
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? What the process has taught us is that you need to answer the big questions early
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Problem Identification
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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Define a Needs Statement
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.”
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Define a Needs Statement
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
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Why Needs Identification / Specification is so Important
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! Greg Lambrecht, Intrinsic Therapeutics
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Desired Outcomes - Objectives
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 You have come to Medtronic with concepts: The question is that have you all the pieces of the pie??
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Determining the ‘Right Need’
Understanding Causes (Biology to molecular level) Effects & Symptoms (Patient Impact: Pain, Mortality) Classical Patient Populations & Sub-classical cohorts (1) Disease State Size & Trends Severity & Impact on the patient population Current Treatments (2) Market Available Technology: Existing & Emerging Status of the competition in this space: Patents, IP etc What are the barriers to technology advancement (3)Technology Identify the Decision makers/Purchasing power Who are the Key Opinion Leaders & Health Care Providers (4) Stakeholders 34
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Identifying Opportunities
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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 flow breakeven
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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 Opportunity Or Patient Benefit + Market Opportunity Leveraging Existing Technology is quicker!
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What is the burden of proof required?
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) device Approx: > 8 years for PMA device
More time taken= higher cost Approx: 5 years for 510 (k) device Approx: > 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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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 43 43
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Why Med Tech’s Fail Bad Need! Product doesn’t work
No one willing to pay for it Not enough patients Bad IP, management, luck The FDA & US-only strategy Bad Need!
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The Cost of Failure Solve the right need! $10-$200 million
people’s time Between 3-20 years 3-25% of your life 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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Resources Text: Biodesign By Zenios, Makower, Yock www.ebiodesign.org
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BioInnovate Classes BioInnovate I BioInnovate II Identifying Problems
Needs Finding, Needs Filtering Inventing Solutions Concept Generation, Concept Selection BioInnovate II Implementation Project development strategies and planning For More Information Contact
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Thanks!
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