Regulatory Science

I heard an interesting new term today (new to me at least!) that I thought greatly impacts the line of work I am in. Regulatory science is "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products". This involves not only developing devices and getting them approved by governing bodies but reducing the time and cost it takes to get the device to market.

The regulatory pathway in many of the leading nations has been a major gatekeeper and an extremely high expense for the majority of medical device companies. Finding ways in innovate this process could speed up this timeline and reduce the costs.

One step the FDA has recently done is developed a partnership with the Medical Device Innovation Consortium (MDIC) which is an independent nonprofit corporation. MDIC will help to determine which areas of the medical device pathway should be focused on to reduce costs/time.

The topic of innovation within regulations of medical devices is very interesting to me and I think something that should be focused on. It seems as if the FDA is also focused on this issue based on their new partnership with MDIC as well as other projects such as the collaboration between the NIH to "fast-track" innovations to the public.

It should be kept in mind that the end goal of this is to bring the most safe and effective devices to users and patients. There has to be a happy medium between innovation and regulation.

--Jillian F. Walker