Thomas L.Friedman author of the bestselling book “The World Is Flat: A Brief History of the Twenty-First Century” in a recent open-ed piece in New York Times, writes about a new breed of very lean start-up, where the principals are rarely in the same office at the same time, and which takes advantage of all the tools of the flat world teleconferencing, e-mail, the Internet and faxes to access the best expertise and low-cost, high-quality manufacturing anywhere, is the latest in venture investing. His poster child example is EndoStim; the company is developing a proprietary implantable medical device to treat acid reflux.
While this is a relatively new phenomenon in the world of medical device industry with the trend for outsourcing of manufacturing and clinical trials to countries outside North America. This is not uncommon in the world of Internet, wherein many disruptive technologies utilized in the past has given us wonderful tools from Email -Hotmail to Search engines- Google.
Health care industry is still in infancy in adopting disruptive technologies. This has resulted in ever rising costs in health care delivery. Only in the past couple of years, new breed of companies in medical device world have moved away from old school of manufacturing using expensive technologies to the current generation of lean manufacturing and using disruptive technologies.
If we look into the cycle of a medical device development by FDA, it is fairly complex and it has to be done that way because a medical device is not like your car or bike, if it breaks down early in the morning when you are ready to go, yes it can cause inconvenience to you but it is not the end of the world, if a medical device breaks down it can cause grievous injury to the user or even cause catastrophic complication like death. So the current process of approval is fairly complex and lengthy and justified.
Total Product Life Cycle. David W. Feigal, M.D., M.P.H., Director, Center for Devices and Radiological Health, FDA (www.fda.gov)
This is one of the main reasons for high cost of health care delivery.However,there are other reasons too..
But, in a recent post in Healthbeat blog , Medical Device Start-Up Generates Controversy Naomi Freundlich posts
Medical innovation needs to move away from the profit-driven motive that has led to expensive new technologies that drive up health care costs without a comparable effect on improving the nation’s health.In these changing times, as the government revisits how devices are tested and approved and comparative-effectiveness studiesnot marketingwill help doctors decide which treatments are best, companies like EndoStim will face a far rougher road to success.
While we cannot predict the success or failure of EndoStim and its technology,but the future is bright for companies which utilize disruptive technologies and use Internet as part of their product cycle to create next generation Innovative medical devices.
More thoughts in my next upcoming article on Medical Devices and Disruptive Technologies