Friday, April 30, 2010
Thursday, April 15, 2010
Sunday, April 11, 2010
Smart Medical Devices Panel
Regulation of Smart Medical Devices
Regulations Of Smart Devices
View more presentations from Anupendra Sharma.
Takeaways
1. Spend a lot of time with your customers. They will tell you about features you don’t even know you want (e.g. Sentillian - People like to remind you to feed their dogs)
2. It takes a long time to get insurance companies to reimburse for things.
3. Follow the money. Doctors need to see the advantage or get paid to try new things that are different or difficult.
4. Adoption presents challenges. It takes time to change behavior
5. Patients are not compliant. Find creative ways to make them (Microchips, Sentillian)
6. You can design it here, and build it in Asia
7. Some other countries will provide subsidies and tax credits (Hong Kong)
Opportunities
8. Obesity (Diabetes) and Aging (Elderly) are big themes
9. Cameras ($2), motors and accelerometers ($2.50) are very inexpensive basic components of many companies. You can find all these easily here in Boston (Analog)
10. Miniaturization is going to be a big opportunity
11. Mobile phones are more widespread and interesting than PCs; build on this platform
12. There are opportunities to develop smart algorithms to flag data
13. We’re going to be flooded with data. This could be a n opportunity
Technology
14. Getting iphone applications through Apple isn’t easy. They’re scrutiny can be tougher than the FDA
15. Perfect A/C current needed even with ultra low power in the body. DC is poison according to the FDA
16. Long-life, low-power batteries are going to be critical for invasive devices (lasting 25-30 years)
FDA/Regulatory
17. FDA is uncertain. There will be changes to the 510K process
18. 510Ks take 3 months; PMAs can take years. Acceptance rate is high but not 67%- 80%. Means companies will fail and investors will lose money. The risk is only increasing
19. Investors now want to know where you will fall from a classification standpoint (since the FDA is reassessing the 510k process today). Get a regulatory expert early and get an informal meeting with the FDA, walking them through the plan
20. To get approvals, first get it in South Africa. Then get a European CE Mark – it makes you more interesting to strategics. Finally go for the FDA
Marketing
21. If you get a clinician on board, think about compensation. If you give them equity, they cannot do trials in their facilities
22. When talking to doctors, overemphasize the clinical benefits, underemphasize the technology.
23. Reimbursement strategy is the way to go.
24. Try to avoid outcomes data if you can. However, its going to be tough. In the old days you could. Every hospital wants to see it in their own format. 45 patients could be sufficient.
25. With relationships these trials could be done here inexpensively. Someone in the audience is spending $10K to do such a trial
Funding
26. VCs won’t pay to get data. Get money from the Army, NASA, grants, SBIRs. Leave things in the university labs as long as possible
And finally
27. Everything Tom does is measured in terms of the price of Guinness in Ireland!
Thursday, April 8, 2010
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