Medical Device Clinical Studies Only the necessary evil or crucial success factor? Stuttgart, April 05, 2017

Transcription

1 Axel Fischer, Activoris Medizintechnik GmbH Martin Conrad, HiTec Consult GmbH Medical Device Clinical Studies Only the necessary evil or crucial success factor? Stuttgart, April 05, 2017

2 AGENDA Company Introductions Activoris Medizintechnik GmbH HiTec Consult GmbH Regulatory Background Clinical Evaluations New MDR The Commercial View Motivation, Methods of market research Results Summary, Conclusion 2

3 COMPANY INTRODUCTION Activoris Medizintechnik GmbH 3

4 COMPANY INTRODUCTION HiTec Consult GmbH Management Consultancy established 1999 Since 2003 market leading executive consultancy in the medical device industry in Germany Since 2005 organizational as well as marketing & sales consulting mainly for foreign companies entering the DACH or European markets In 2010 start of a dedicated qualitative and quantitative market research team Current Practice Groups: 4

5 CLINICAL EVALUATION Demonstrates the clinical effectiveness (your claim) and safety of a medical device Part of the technical documentation / design dossier Based on clinical data Existing data (of equivalent medical devices) New ( own ) data 5

6 NEW MDR Increased Requirements for Clinical Evaluations Qualification of authors Yearly updates to CER by post-market-surveillance Search requirements for state fo the art Narrowing equivalent devices New medical devices Re-classification of some implants form 2b to 3 Longer development times higher budgetary requirements 6

7 MEDICAL DEVICE TRIALS MAY BE DIFFICULT Difficult to blind, randomize, control May depend on physician technique Device modifications occur during trial Endpoints highly diverse Typically smaller than pharma trials Typically, single pivotal trial Designed to support a reasonable assurance of safety and effectiveness for the marketing application 7

8 AFTER CE Get re-imbursement and generate sales Products are being developed for market success 1 st hurdle: CE Mark 2 nd hurdle: reimbursement Obtaining re-imbursement will require to effectively demonstrate superior performance of the device (see health technology assessments HTA ) 3 rd hurdle: market success Increasing price pressure calls for differentiation by innovation Valuable clinical data Supports CE marking of your medical device Supports re-imbursement Supports marketing and sales 8

9 MEDTECH STARTUPS AND EXIT Only 25% of acquisitions in the medtech industry occur within < 6 years of a company s inception Pre-revenue exits are not the rule Regulatory approval is not the holy grail Hirsch, R, 2013: The Medical Device Milestone Map 9

10 MEDTECH EXIT VALUATION DRIVERS Ferrari, 2005 Clinical Impact Franchise Value, Strategic Need Hirsch, 2013 External Factors Market Competition Factors specific to the acquirer Economic Strategic fit Financial (tax) Target Company Uniqueness of the device and its underlying technology Disruption/Innovation vs. current medical practice Strength of IP Clinical body of evidence supporting the safety and efficacy 10

11 VALUE INFLECTION POINTS FOR MEDTECH INVESTORS Malish, 2016: Intellectual Property Price, entry barrier for competition Feasiblity Moving the technology out of the lab, Proof-of-Concept Prototypes Controlled Cesign according to specifications Finalize design, verify, and validate Achieve approval Kofol, 2013: Technology / IP: does it work how you say it will / can you protect it Clinical: can you demonstrate it works in humans Regulatory: will regulators let you sell it Market: will someone want it and pay for it Hirsch, 2013: Development Stage Milestones Clinical & Regulatory Milestones Commercialization Milestones 11

12 INNOVATORS If you fail to plan you plan to fail? All developers of innovative medical devices should be prepared to include proper clinical trials into their development planning Message from an Investor: A clear Clinical Strategy is essential to Financing Christian Schneider, Managing Partner at Vesalius BioCapital Sàrl Today s developments competitive environment of tomorrow Startup business plans should contain a clinical plan Study size is key to successful out-licensing Comparable to a phase-2-study with three-digit patient number 12

13 MARKET RESEARCH How do German start-ups vs. established companies estimate the value of clinical trials? How do commercial decision makers in hospitals value clinical studies? 13

14 MARKET RESEARCH Methodology of the presented results Quantitative & qualitative market survey (CATI) 2015 & 2016 Medical device start-ups, SMUs & hospitals / hospital groups within DACH Founder, CTO, QM & RA Officer, Head of Purchase & Commercial Directors Scope of the survey: Relevance of clinical sudies for regulatory affairs / marketing / purchase / reimbursement Process of clinical studies Basic competency assessment of the interviewee This creates an almost 360 perspective on the process for the DACH market 14

15 MARKET RESEARCH RESULTS Which kind of clinical study do you conduct? 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Start-Up SMU Total Qualified answer No qualified answer Not able to give an answer at all 15

16 MARKET RESEARCH RESULTS For what do you want to use the clinical studies? 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Start-Up SMU Total Regulatory Affairs Marketing Both Was not able to give an answer 16

17 MARKET RESEARCH RESULTS Do you use external expertise? 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Start-Up SMU Yes No 17

18 MARKET RESEARCH RESULTS Are clinical studies important for your purchase decision? 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Hospital MDK & bargaining with reimbursment authorities Internal cost savings Marketing Other 18

19 MARKET RESEARCH GENERAL OUTCOME The level of competency is frighteningly low It is no wonder that QM & RA is quite often labeled as a department only costing money. The chances for combined Regulatory Affairs & Marketing usage of clinical studies are not even remotely explored Faced with an expected increase of 60% of the clinical studies within four years, budget problems and lack of qualified personal, only roughly one third rely on external expertise Clinical studies are a must to convince either the medical or the commercial staff (depending on the marketing & sales strategy). Without Clinical Studies no CE Without Clinical Studies no Reimbursement Without Clinical Studies no Sales Why do you only talk about CE & Reimbursement and not Sales when it is time to fight for your Clinical Studies budget? 19

20 THANK YOU FOR YOUR ATTENTION! End of Presentation Any Questions? Axel Fischer Activoris Medizintechnik GmbH +49 (0) Martin Conrad HiTec Consult GmbH +49 (0)