Now that we are 1 year in to this administration and the announcement to overhaul the FDA regulations, I thought this might be a interesting topic to revive. How do you think President Trump’s promise to simplify FDA regulations has been accomplished?

Well, so far no medical device regulations have been changed as far as I know. A new FDA head, Scott Gottlieb, was appointed in April. Last fall, Gottlieb solicited input from the Medical Device, Pharma, Biologics and Food industry. He asked for ideas on which regulations to eliminate. This is problematic because when undertaking an improvement project (especially one of this magnitude and impact) it is important to get feedback from all stakeholders. This should also include doctors, hospitals, and most importantly patients/general public.

In my opinion, the Trump administration has shown a lot of dysfunction and incompetence. I don’t have much confidence in their ability overhaul the regulations or if they do eliminate regulations it will be what is best for the patient.