Yet another amazing panel last night on Smart Medical Devices. We had an engaging audience and more importantly, panelists with amazing insights into opportunities in the area. Unfortunately there is no video but here are some introductory slides and also some key takeaways for anyone that is interested in the space (thanks to Anupendra Sharma, Panel Moderator, for compiling these together).
- 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 your device to remind them to feed their dogs, AgaMatrix – Rubber grips on the device was the key selling point more than the complex DSP algorithms).
- It takes a long time to get insurance companies to reimburse for things.
- Follow the money. Doctors need to see the advantage or get paid to try new things that are different or difficult.
- Adoption presents challenges. It takes time to change behavior.
- Patients are not compliant. Find creative ways to make them (Microchips, Sentillian).
- You can design it here, and build or run operations from Asia. Places like Hong Kong provide free space and lot of subsidies and tax credits for Startups.
- Obesity (Diabetes) and Aging (Elderly) are big themes.
- Cameras ($2), piezoelectric motors and accelerometers ($2.50) are very inexpensive innovative components that can be integrated to create the next generation smart devices.
- Miniaturization is going to be a big opportunity.
- Mobile phones are more widespread and interesting than PCs; build on this platform and use them as channels.
- All the devices will become interconnected and will stream constant data. The data deluge offers lot of opportunities to develop smart algorithms to analyze, filter and flag data.
- Getting iPhone applications through Apple isn’t easy. They’re scrutiny can be tougher than the FDA
- Perfect A/C current needed even with ultra low power in the body. DC is poison according to the FDA
- Long-life, low-power batteries are going to be critical for invasive devices (lasting 25-30 years)
- FDA approvals causes some uncertainty. There will be changes to the 510K process
- 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
- 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
- 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
- If you get a clinician on board, think about compensation. If you give them equity, they cannot do trials in their facilities
- When talking to doctors, overemphasize the clinical benefits, under-emphasize the technology.
- Reimbursement strategy is the way to go.
- 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.
- With relationships these trials could be done here inexpensively. Someone in the audience is spending $10K to do such a trial
- 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