Presentation on theme: "Innovation & Commercialisation"— Presentation transcript:
1 Innovation & Commercialisation Dr. Mark BruzziBioInnovate IrelandNational University of Ireland Galway
2 Agenda Introduction to BioInnovate Ireland Defining Innovation Perspectives on Medical Device InnovationIdentifying ProblemsFrom Clinical Need to market opportunityFilters for Successful Medical Device InnovationExamples
4 Medical Technology Industry in Ireland Ireland is home to a significant medicaldevice industry cluster(11 of top 13 Medical Device Companiesare 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)
5 BioInnovate Ireland Medical Device Innovation Training Programme BioInnovate Ireland is a consortia of 4 UniversitiesMedical, Engineering, Business Schools(NUI Galway, UL, UCC, DCU)Industry Sponsors : Medtronic, Boston Sci,Creganna Tactx, Lake Region Medical, SteripackActivity:Fellowship:Modular Industry / Graduate TrainingGALWAYLimerickCorkDublin
6 Why Medical Devices? Biotech Medtech Technology Company Examples Drugs – Molecular / Genetic researchDevices, implants & DiagnosticsCompany ExamplesPfizerMSDMedtronic,StrykerProduct Development cycle5-12 years2-7 yearsCapital requirements€300m - €1bil€10-€100m
8 BioInnovate Ireland Fellowship 10 month fellowship programme for medical device innovationBased on Stanford Biodesign programme: Identify – Invent – ImplementActive partnership between Academia, Industry and CliniciansBuilding on existing strengths and activities in the MedTech EcosystemClinical Immersion - Provide an environment for Needs IdentificationAccessing Research centresIntroduction to a Network of LeadersMentorship from Industry, Clinicians, VCsLearning by Doing!
12 Impact on MedTech Ecosystem Generation of highly skilled graduates for the Irish MedTech SectorIncrease in collaboration between Industry, Academia and the ClinicHelp generate a culture of innovationConnectivity ● MedTech Cluster Sustainability ●● Increased MedTech Value ● International CompetitivenessIndustryWorkforce SkillsR&D capabilityConnectivity for InnovationINDUSTRYAcademiaGraduate EducationStructured PhDTranslational ResearchSpecialist TrainingClinicPatient-careHCPsHealthcareCollaboration
14 Defining Innovation … "Innovation is creativity with a job to do“ Innovation is people creating value by implementing new ideasInnovation = Invention + ExploitationInnovation is a process that transforms ideas into outputs, whichincrease 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
18 PhilosophyEveryone 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 patientsi.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 itYou need:A patient who needs and wants the productA provider who wants to use the productSomeone who will pay for the productAn organization that can develop, make, and deliver the product at a profitSomeone willing to invest resources to develop the product and build the businessRoss 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 sufficientYou must build a successful business around the technologyRoss Jaffe, Versant Ventures, CA, USA
23 What Creates Medical Device Opportunities? Unmet clinical need – diagnostic and/or therapeuticNew insight into physiology of a diseaseNew insight into diagnostic or therapeutic approachTechnological innovation that improves an existing diagnostic or therapeutic approachChange in healthcare delivery system that creates pressure to change diagnostic or therapeutic approachSome combination of the aboveRoss Jaffe, Versant Ventures, CA, USA
24 Where can Clinical Needs by Identified? Patient MorbidityInvasive SurgeryBlood, pain, infectionICULong recovery“Inoperable”Poor OutcomesLow success ratesHigh / expensive reintervention ratesComplicationsExpensive Treatments
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?What the process has taught us is that you need to answer the big questions early
27 Problem Identification Identifying ProblemsObservationProblem IdentificationNeed StatementA 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 ProblemNeed 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 resultGood: “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 SpecificNeed Statement: “A way to improve outcome of spine surgery.”Not clear which surgery, initial diagnosis, or how to improveBetter: “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 InnovationGuides BrainstormingFacilitates Concept ScreeningForms part of IP strategyFocusses Clinical TrialGuides MarketingBasis for reimbursement argumentGetting it wrong is really bad & expensive!Greg Lambrecht, Intrinsic Therapeutics
31 Desired Outcomes - Objectives As measured by …Improved Clinical EfficacyTreatment Success Rates in Clinical TrialsIncreased Patient SafetyRate of adverse events in clinical trialsReduced CostTotal cost of procedure relative to available alternativesImproved Physician/ facility productivityTime and resource required to perform the procedureImproved physician ease of useSolution of complexitiesImproved patient convenienceFrequency and occurrence of required treatment, change in treatment venueAccelerated patient recoveryLength of hospital stay, recovery period, and/or days out of workRoss Jaffe, Versant Ventures, CA, USA
32 From Clinical Needs to Market Opportunities: The Big Questions
33 The Big QuestionsYou have come to Medtronic with concepts: The question is that have you all the pieces of the pie??
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 StateSize & TrendsSeverity & Impact on the patient populationCurrent Treatments(2) MarketAvailable Technology: Existing & EmergingStatus of the competition in this space: Patents, IP etcWhat are the barriers to technology advancement(3)TechnologyIdentify the Decision makers/Purchasing powerWho are the Key Opinion Leaders & Health Care Providers(4) Stakeholders34
36 Large Market Opportunity Market Size = # of Patients X $ per PatientHow large a market is attractive?Market size has to be considered in light of capital required toget 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 OpportunityOrPatient Benefit + Market OpportunityLeveraging Existing Technology is quicker!
39 What is the burden of proof required? Regulatory AffairsFDAClass I → Device Exemption PathwayClass II → 510(k) PathwayClass III → Premarket Approval (PMA) pathwayEurope (Medical Device Directive)Class IClass IIaClass IIbClass IIIWhat is the burden of proof required?
40 Approx: 5 years for 510 (k) device Approx: > 8 years for PMA device More time taken= higher costApprox: 5 years for 510 (k) deviceApprox: > 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 etcWhat ‘gap’ are youtargeting?
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: 20094343
44 Why Med Tech’s Fail Bad Need! Product doesn’t work No one willing to pay for itNot enough patientsBad IP, management, luckThe FDA & US-only strategyBad Need!
45 The Cost of Failure Solve the right need! $10-$200 million people’s timeBetween 3-20 years3-25% of your lifeSolve the right need!
46 Successful Medical Device Innovations ‘Ticking the Boxes’Device addresses an important clinical need wellLarge market with attractive market dynamicsReasonable clinical and regulatory pathwayClinical proof required for FDAClinical proof required for marketReasonable path to attractive reimbursementProprietary technologyKnowledgeable and experienced managementReasonable capital requirements to achieve positive cash flow from product
47 Resources Text: Biodesign By Zenios, Makower, Yock www.ebiodesign.org
48 BioInnovate Classes BioInnovate I BioInnovate II Identifying Problems Needs Finding, Needs FilteringInventing SolutionsConcept Generation, Concept SelectionBioInnovate IIImplementationProject development strategies and planningFor More Information Contact