The Medical Device Innovation Process

Transcription

1 The Medical Device Innovation Process From Idea to Product William Durfee Department of Mechanical Engineering University of Minnesota Minneapolis, USA 1

2 I have this great idea for a new wadigitator! YOU Wonderful! Here is $100M! MED TECH STRATEGIC 2

3 What actually makes a winning idea A significant opportunity Has patent protection Technology is proven in animals or FIH There is a regulatory path It can be reimbursed The competition is quiet 3

4 What s the State of the Industry? 4

5 Revenues of global med tech industry (bn USD) 5.1% growth/year Source: EvaluateMedTech,

6 Growth and Market Share, Size of bubble is estimated 2022 WW sales Source: EvaluateMedTech,

7 Cardiology Market Share in 2015 Source: EvaluateMedTech,

8 Hot Items in Med Tech TAVR Hi Tech Prostheses Digital Health Neuromodulation Surgical Robots Diagnostics Personal Genome Sequencing 8

9 Med Tech Trends to Track Procedures Disease Management Hospital Clinic Clinic Home Treat Symptoms Manage Care Better outcomes at lower cost Better Value 9

10 What s the Future? Digital Health Portable, wearable devices Cloud-based data Location-free medicine Personalized Healthcare Personal genome Sensitive diagnostics Patient-tailored treatment more effective Big Data Healthcare analytics Data-based effectiveness and cost metrics 10

11 Healthcare apps on Apple ios and Google Android, ,000 total 26,864 widely used 2% for professionals Source: IMS Health

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13 Patients Armed with Knowledge heart al e repla e e t 4.2M hits 13

14 Personalized Medicine $95.3M $1.2K 14

15 Big Data for Outcomes Analytics Comprehensive health care database for research & innovation 15

16 Innovating in the Med Tech Space 16

17 Med Tech Development Process Rough Sketch Animation Prototype Bench Testing Animal Testing First in Human Testing Clinical Trial Product Launch PMA (FDA) 17

18 Med-Tech Innovation Process Understand the opportunity Disease state Current solutions Define the need Create the solution Know the customer Observe Invent! Build and Test Commercialize Prototype Test Screen Repeat Startup Exit 18

19 Get a minimum viable product in front of your customer as quickly as possible Iterate based on result of customer testing Business Model Canvas 19

20 How Do I Determine If My Idea Has Value? 20

21 The 3 F s Does anyone want it? Market Feasibility Financial Feasibility Technical Feasibility Will $ be made? Can it be made? Is it a strategic fit to the organization? 21

22 Market Feasibility Financial Feasibility Technical Feasibility Market Feasibility Does anyone want it? 22

23 Needs-Driven Innovation 23

24 Understanding Customer Needs That does t ea e do t liste to usto ers, ut it s hard for the to tell you hat they a t he they e e er see a ythi g re otely like it. - Steve Jobs, Fortune, Jan. 2000

25 How to Find the Needs Understand the disease state Research current practice Immerse yourself in the environment Observe Ask questions Conduct one-on-one interviews Probe to find the pain points Look for the problem, not for the solution If you are the physician-inventor, determine if others have the same problem 25

26 Determine the Stakeholders Physician? Nurse? Patient? Caregiver? 26

27 Market Feasibility Financial Feasibility Technical Feasibility Technical Feasibility Can we make it? 27

28 Generating Ideas GOAL s of ideas The more ideas you have the more good ideas you will have

29 Build Your Idea I ha e a idea for a e gi e that gets 8 pg Prototype to learn Prototype to communicate A working prototype will sell your idea 29

30 Low-Resolution Prototyping

31 Supermarket meat aisle is your source for prototype testing

32 Virtual Prototyping

33 Test Your Solution Bench testing Optimize engineering design Simulate clinical anatomies Accelerated wear testing Animal model testing Validate device in real anatomy and physiology Understand biocompatibility Obtain data for 510(k) submission Clinical testing (FIH, RCT) Obtain outcomes data For FDA PMA submission Guide clinical decisions 33

34 Intellectual Property Is Essential Patent protection is essential to med tech development Value of startup is its people and its patents

35 We regularly sear h pu lished patents to see where our o petitors are goi g. VP Research and Business Development, Medtronic, 2014 If you do t o it, o e o to a other idea. A serial med tech entrepreneur,

36 Regulatory boards require evidence to support claims that a technology is Safe (Europe, CE mark) Safe and effective (U.S., FDA) FDA Device Class Class I (low risk) FDA exempt: register but no clearance needed Class II (moderate risk) 510(k) path: follow a predicate device Class III (high risk, life sustaining) Pre-market approval (PMA) path: expensive, clinical trials 36

37 Reimbursement Matters Requires evidence to support claims that a technology leads to better patient outcomes at lower cost than existing solutions ibot: DEKA& J&J Independence Technology 37

38 ibot Wheelchair Case Study 1990: DEKA/J&J partnership. Development begins, code name Fred. 1999: Clinical trials begin FDA approval (Class III, PMA). Sales begin. Retail price $26K, Medicare paid $5K 2009 Discontinued 2014: FDA changed to Class II 2015: DEKA/Toyota partnership. Redesigning for lower cost. 38

39 Market Feasibility Financial Feasibility Technical Feasibility Financial Feasibility Will $ be made? 39

40 Financial projections should answer these questions: Time to market? Development costs? Market share? Cost of goods sold? Sales growth timeline? Y1 Sales (units) Y2 Y3 Y4 Y5 20,000 20,000 20,000 20,000 20,000 40

41 Financing Your Idea 41

42 Why Investors Matter cash Investors move money from those who have it (investors) to those with the ideas (you) Investors can take the risk time 42

43 FAMILY & YOU FRIENDS $ ANGEL INVESTORS VENTURE CAPITALISTS & STRATEGICS $$ $$$$

44 Non-Traditional Funding Sources Government grants SBIR/STTR (U.S.) Crowd funding $100K in 24 hrs 44

45 When do I talk to investors? Need Concept Prototype Bench Tests Reg Approval Clinical FIH Animal Tests Reimb Distribution Patient 45

46 Forget the detailed business plan 46

47 Pitching Your Idea Tell them How it works What need it addresses How it will get paid for How it changes outcomes Use Physical prototypes Hands-on demos Animations Have A 30 min version A 10 min version A 30 s version 47

48 Wrap-Up 48

49 Stay Current Attend conferences (TCT, ICI, DMD) Read the academic literature (get on a citation alert service) Visit academic research labs Study what NIH and DoD are funding (basic research and SBIR) Read recent patents 49

50 Why You Matter Companies look to physician-inventors and universities for new ideas Most innovation comes from the user While companies excel at executing ideas, you have the ideas, 50

51 I have identified a significant opportunity! Surgeons need a way to walmulate and none like their current method! The wadigitator device I conceived solves this problem and is easy to manufacture! Interesting! Keep me informed as you move this idea along! 51

52 April 10-12, 2018 Minneapolis, USA 52

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