At first, the idea of me putting together a seed accelerator program based on wireless health products was daunting. After all, I am not in that field and certainly have little knowledge of the science involved in developing medical devices. As for wireless, I do have a communications background from my career at Bell Labs, AT&T and Lucent Technologies although not necessarily cellular. Then I realized that a seed accelerator is actually focused on positively affecting the “process” of startups not the technologies and products of the startups. I can deal with that!
I began looking at the current process being used. Not necessarily a pretty picture. The length of time it takes to get from idea to market is extremely long if you are developing a medical device. I understand that a lot of this time is to ensure that the product does what is says it will do while not harming the patient. That responsibility falls onto the Food and Drug Administration (FDA), which has a long and involved process for bringing new drugs to market that takes 10 years to get through.
They were reasonable about devices to conclude that maybe there should be a shorter process for devices without risking harm to patients, and developed the 510 (k) process where some devices can be approved in a matter of months versus years; a big breakthrough. They did make provisions that result in longer approvals by requesting more tests (clinical trials) whose complexity can add years and millions of dollars to the product development cycle. The good news is that the Center for Devices and Radiological Health (CDRH) who is responsible for approving medical devices has been studying ways to make the program more effective and be better prepared for new technologies like wireless being added to new devices. You can read about their plans here.
I have no intention of trying to become involved in the changes at CDRH or their 510 (k) process. Since I am looking at the process itself, I started to look at the process and see if there are things that startups, especially first time entrepreneurs, can do to get closer to the Months to Approval that I mentioned above versus the Years and Millions of Dollars alternative. So, I talked to entrepreneurs who have been in the medical device space and have successfully navigated the approval process along with others who seemed trapped in it. I also talked with lawyers who have helped clients with their applications and listened to people who have years of experience with the FDA. I learned that there are a number of things that entrepreneurs can do that will help them through the process many of which can be included in a seed acceleration 90 day program.
Personal Health devices like the Nike iPod Touch application or the Fitbit product require no FDA approval and can get to market much quicker. With an increased interest on personal health, there will be many new wireless personal health products introduced over the next few years. Obviously, there are lots of things you can accomplish during a seed accelerator program to assist companies startup process.
Once a medical device is approved by the FDA, it can be brought into the market. The next important step is for the product to be reviewed by the Center for Medicare and Medicaid (CMS) who determines if and how much they will allow patients to be reimbursed when they have the devices prescribed for them. There are currently some problems with wireless medical devices within the current CMS policies, but, as with the FDA 510 (k) process, these have been identified and CMS is working on resolving the issues. In the meantime, there are things that entrepreneurs can do to facilitate the CMS process that can be covered in the seed acceleration 90 day program.
My next big question was “Can I develop a program that addresses the main issues that I described above and includes other relevant information that will accelerate companies working in this sector in 90 days?” Again, I talked to a lot of people currently operating in this space along with the service providers who support them, and created a set of program milestones. I got great feedback especially in relation to the milestones. There is a significant learning curve with first time entrepreneurs that can be positively impacted in a seed acceleration program. As an side, if you put an entrepreneur who has developed medical devices together with an entrepreneur who has developed wireless devices the result is a set of first time entrepreneurs who will have a learning curve.
So, I’ll end here for now. In my next post in the series, I’ll begin to discuss the process of putting the program together. One last point, as I have been working through the process, I originally used Wireless Medical and Personal Health as the title. As I move along, I get input and adjust accordingly. One recent recommendation was to shorten the title to Wireless Health. The rationale was that the title was too long and this shorter version includes both the medical device and personal health device spaces. It also reduces the number of keystrokes, which may not seem like much, but over time will be significant. So, I have adopted that recommendation.
As I said above, I look for input and I believe this will be a program that will get better based on continuous process improvement. So, if you have any thoughts or suggestions, please send them along in the comments.