Will The Medical Device Industry finally get a break or just encounter another roadblock? It is clear to all involved in this industry, that the regulatory approval process has become longer and more arduous over the past couple of years. The proof of that statement is that better than half of the 510k with clinicals approvals, initially market in Europe because of the length of time that it takes to get through the process.
Traditionally, a 510k is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective and substantially equivalent to a legally marketed device that is not subject to premarket approval (PMA). A 510k is a premarket notification to FDA that is required at least 90 days before marketing unless the device is exempt from 510k requirements. Hard statistics have not been published detailing the average length of time from submission to approval, but it is safe to say the average is much longer than 90 days. The entire Medical Device Manufacturing Industry is negatively impacted by these delays. Approval delays impede development progress and potentially harm patients from receiving “new therapies”.
The 510k process is 35 years old and is in need of review and reform. The Institute of Medicine (IOM) has reported that the current 510k process lacks the legal prowess to be considered a reliable barometer of safety and effectiveness of moderate risk devices and cannot be transformed into one. Where does the agency go from here? The short lists of groups who are at odds with the FDA are patient groups, congressional representatives and industry members.
The entire Medical Device Contract Manufacturing Industry is also feeling the impact of not only slow processing and approval times their customers are experiencing, but other factors including lack of funding and the impending Medical Device Excise tax. The trickledown effect has impacted affiliated businesses such as medical device contract assemblers and packagers, contract sterilization service organizations, molders and catheter extrusion houses.
The multinational companies such as Medtronic, J&J and Boston Scientific have all announced plans to downsize in 2012-13. (1) As suggested, there are many factors contributing to this downturn. The FDA is by all means, one of them. Will they pull themselves up by the bootstraps and streamline the 510k process or will they wallow in the existing quagmire?
(1) Qmed, Medical Device Companies Cut (Jobs) and Run, http://www.qmed.com/mpmn/gallery/image/medical-device-companies-cut-jobs-and-run