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

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Presentation on theme: "Innovation & Commercialisation Dr. Mark Bruzzi BioInnovate Ireland National University of Ireland Galway."— Presentation transcript:

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 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)

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, Creganna Tactx, Lake Region Medical, Steripack Activity: Fellowship: Modular Industry / Graduate Training GALWAY Limerick Cork Dublin

6 Why Medical Devices? BiotechMedtech Technology Drugs – Molecular / Genetic research Devices, implants & Diagnostics Company Examples Pfizer MSD Medtronic, Stryker Product Development cycle 5-12 years2-7 years Capital requirements 300m - 1bil10-100m

7 BioInnovate Ireland Fellows 2011 Fellows – CV Disease2012 Fellows – Urology / Radiation Oncology

8 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!


10 Phase Primary Outputs Phase Description Timeline I III IV 5 Wk 8 Wk II 8 Wk Identify Invent Implement Invent Proposed Concepts Implement Evolved Concepts Wk Identify Needs Distil to Needs Statements Intensive Introduction Bootcamp Needs Screening Clinical Immersion Needs Identification & Verification Solution Refinement BioInnovate Fellowship Programme

11 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 Cessation

12 INDUSTR Y Impact on MedTech Ecosystem Industry Workforce Skills R&D capability Connectivity for Innovation Clinic Patient-care HCPs Healthcare Collaboration Academia Graduate Education Structured PhD Translational 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

13 Defining Innovation

14 "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 …

15 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


17 Perspectives on Medical Device Innovation

18 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

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 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

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? Unmet clinical need – diagnostic and/or therapeuticNew insight into physiology of a diseaseNew 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

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 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

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 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 doesnt 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

29 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

30 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

31 Desired Outcomes - Objectives Desired OutcomesAs measured by … Improved Clinical EfficacyTreatment Success Rates in Clinical Trials Increased Patient SafetyRate of adverse events in clinical trials Reduced CostTotal 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 recoveryLength of hospital stay, recovery period, and/or days out of work Ross Jaffe, Versant Ventures, CA, USA

32 From Clinical Needs to Market Opportunities: The Big Questions


34 (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

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 flow breakeven Rule of Thumb: In general, an attractive market size is, at minimum, 10X capital required to get product to cash flow breakeven

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 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

44 Product doesnt work No one willing to pay for it Not enough patients Bad IP, management, luck The FDA & US-only strategy Why Med Techs Fail Bad Need!

45 $10-$200 million peoples time Between 3-20 years 3-25% of your life The Cost of Failure 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 Text: Biodesign By Zenios, Makower, Yock Resources

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

49 Thanks!

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