Innovation & Commercialisation Dr. Mark Bruzzi BioInnovate Ireland

1. Innovation & Commercialisation Dr. Mark Bruzzi BioInnovate Ireland National University of Ireland Galway

2. 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

4. Medical Technology Industry in Ireland • Ireland is home to a significant medical • device industry cluster • (11 of top 13 Medical DeviceCompanies • 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)

5. 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, • CregannaTactx, Lake Region Medical, Steripack • Activity: • Fellowship: • Modular Industry / Graduate Training GALWAY Dublin Limerick Cork

6. Why Medical Devices?

7. BioInnovate Ireland Fellows 2011 Fellows – CV Disease 2012 Fellows – Urology / Radiation Oncology

8. BioInnovate Ireland Fellowship • 10 month fellowship programme formedical 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!

10. BioInnovate Fellowship Programme Timeline Primary Outputs Phase Description Phase Identify 200-300 “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 12- 16 Wk IV

11. 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

12. 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

13. Defining Innovation

14. 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

15. 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

17. Perspectives on Medical Device Innovation

18. 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

19. 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

20. You cannot have a successful medical product unless you can build a sustainable (and preferably growing) business around it • You need: Medical Device Innovation in Context • 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

21. 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

22. Identifying Problems

23. What Creates Medical Device Opportunities? Ross Jaffe, Versant Ventures, CA, USA

24. 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

25. Cost vs Effectiveness

26. 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?

27. 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”

28. 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.”

29. 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

30. 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

31. Desired Outcomes - Objectives Ross Jaffe, Versant Ventures, CA, USA

32. From Clinical Needs to Market Opportunities: The Big Questions

33. The Big Questions

34. 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

35. Identifying Opportunities

36. 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

37. 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

38. 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!

39. 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?

40. Approx: 5 years for 510 (k) device Approx: > 8 years for PMA device

41. 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?

42. Filters for Successful Medical Device Innovation

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 43

44. Why Med Tech’s Fail • 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!

45. The Cost of Failure • $10-$200 million • 20-120 people’s time • Between 3-20 years • 3-25% of your life Solve the right need!

46. 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

47. Resources • Text: Biodesign By Zenios, Makower, Yock • www.ebiodesign.org • www.bioinnovate.ie

48. 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

49. Thanks!