Good points. I have been working in the medical device business for 20+ years from breast implants to urology to heart & brain catheters to drug device combination product to treat cancer.
Incentive to innovate falls off the cliff under FDA’s recent unwarranted regulatory aggressiveness by career bureaucrat physicians and PhDs with zero commercial experiences. Case in point is people like FDA’s Head of Urology and FDA’s revising the old rules on 510(k) clearance by raising the bar. Granted many foreign regulatory agencies like Korea and Japan are not easy deal with BUT they demand that the device must be approved in US before they consider approving the device for use in their countries. Canadian FDA on the other hand is pleasure to work with and breath of fresh air.
Obamacare will make it worse under social medicine disguise punishing the device companies by lowering the reimbursable rate for treatments. Physicians push back to the device makers resulting in less investment in cutting edge technologies. I personally witnessed a promising technology dropped as not economically viable under the current Medicare reimbursable rate as these are driven down further with each passing year. Many of the therapies may find use for other ailments (often thru off label use which gets adopted later) but again no incentive in socialized medicine. What’s WORSE was Obama slipped in additional medical device tax increase under Obamacare further constraining an industry once known as the best in the world.
