Medical Device Idea Generation
Fred B. Dinger, IIIPresident & CEOENTrigue Surgical andC2M Medical
Stanford Taiwan Biomedical ConferenceSeptember 2008
Generating Ideas
Solving existing problems Solving problems not yet realized Creating new ideas using existing
technologies
How are ideas generated?
Generating Ideas
Problem – passing suture through tissue during shoulder surgery
Solving Existing Problems
Generating Ideas
Solution - ExpresSew™ Suture Passer
Solving Existing Problems
Generating Ideas
Problem – difficult to tie knots in suture to hold tissue in place during rotator cuff surgery
Solving Existing Problems
Generating Ideas
Solution - Opus™ Knotless Suture Anchor
Solving Existing Problems
Generating Ideas
Problem – nasal sinus cavities are difficult to access with standard hand-held instruments
Solving Existing Problems
Generating Ideas
Solution - SerpENT™ Articulating Instrument
Solving Existing Problems
Generating Ideas
Problem – difficult and time consuming to suture septum in place after septoplasty surgery
Solving Existing Problems
Generating Ideas
Solution - ENTact™ Septal Stapler
Solving Existing Problems
Generating Ideas
Solving Problems Not Yet RealizedProblem – using hand-held instruments to remove tissue from joints or sinus cavities (effective, but took a lot of effort and was time consuming)
Generating Ideas
Solving Problems Not Yet RealizedSolution – using powered rotary shavers to rapidly remove tissue from joints and sinus cavities
Generating Ideas
Solving Problems Not Yet RealizedProblem – using pre-operative x-rays to estimate the location of instruments during surgery. As tissue was removed, the location landmarks changed.
Generating Ideas
Solving Problems Not Yet RealizedSolution – using image guided surgery systems to provide real-time feedback of location of instruments
Generating Ideas
Ideas only need to be original in their applications
Generating Ideas
Creating New Products from Existing Technologies
Pacemaker Barricade Light
Generating Ideas
Creating New Products from Existing Technologies
Suture Anchor Tent Stake
Harpoon
Generating Ideas
Keep your solutions as simple as possible!
The best ideas are often the most simple and straight forward
Generating Ideas
Protect Your Ideas
Keep detailed notes (with dates) Use a Patent Attorney Consider how you would work around the
patent, then patent those ideas as well to further protect your idea.
Be selective – don’t waste money filing patents on non-feasible ideas.
Patent your Product or Idea
Advance Your Ideas
Reduce your patents to practice with prototypes, working models, etc.
Obtain data to prove feasibility File for the applicable government or
regulatory clearances/approvals. Avoid the temptation to broaden your scope
– stay focused on primary goal.
Required Accomplishments
Classify Your Device
Class I – most are exempt from Premarket Notification 510(k)Hand-held instruments, elastic bandages, exam
gloves, enema kits, etc. Class II –require a Premarket Notification 510(k)
Powered wheelchairs, surgical drapes, external infusion pumps, bone void fillers, powered cutting instruments, etc.
Class III – most require Premarket Approval (PMA)Pacemakers, heart valves, hip and knee
replacements, spinal implants, etc.
FDA Device Applications in 2005
Fund Your Ideas
SelfFamilyFriendsCredit CardsAngel Investors (usually local)State Seed Money
Start-up Funds
Fund Your Ideas
Prove your conceptFormalize your Business PlanInvestigate State Funding options Network with people to get appointments
with Venture Capital Fund managers and Business Development managers from large companies
Funding the Growth and Transition
Create Value
Start with a technical teamKeep team focused on important tasks Add employees logically (and slowly)
Creating Value from the beginning
Create Value
Revenue from commercial productsPatent Portfolio (owned and licensed)R&D Product PipelineKey Employees
Value Builders for a Start-up Company
Be Persistent
FedEx – deemed to be unfeasible MTV – was told their concept would never work OBI – could not get anyone to believe its
products would work Xomed Surgical – market analysts determined
that there was no growth opportunity for them
Companies that succeeded after being told that they would not make it
Idea Generation Summary
Create ways to solve problemsPatent your product ideasReduce your ideas to practiceFund your ideas / companyBe focused and persistent
Stanford Taiwan Biomedical Conference
Thank You