Medical Device Idea Generation Fred B. Dinger, III President & CEO ENTrigue Surgical and C2M...

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