Regulations are clearly important for protecting patients, but sometimes I wonder if they also slow down new ideas from reaching the market. For example, small companies might have innovative device designs, but the cost and time required to obtain FDA approval can hold them back. On the other hand, without strong regulations, unsafe devices could easily reach patients and cause harm.
So I’m curious — do you think regulations mostly help innovation by keeping things safe and organized, or do they slow it down by making the process too hard for new ideas to grow? What could be the optimal point for both sides?
I think that its really hard to say if one side dominates over the other in terms of whether regulations slow down medical device development or help innovation. I think regulations equally slow down innovation but also benefit innovation and ultimately keep the public safe. Regulation helps establish trust in both patients and doctors making them more willing to purchase or utilize a medical device because it has undergone such scrutinous regulatory steps. To put it into perspective, if you were offered two pacemakers to be implanted and one has undergone multiple trials and has been in development for 8 years versus the other that has had one smaller trial and has been in development for several months, odds are you would trust the device that has been in development longer as has faced much more scrutiny from the FDA. These regulations are in place for a reason and prevent individuals from being harmed, or in the worst cases mortally wounded by the medical device. That being said, they almost certainly slow innovation to some degree and can gatekeep companies with lower budgets and resources from developing medical devices. Clinical trials, documentation, and regulatory filings with the FDA take years and millions if not billions of dollars which makes it incredibly difficult for startups with limited funding. There is certainly an uneven amount of burden on smaller companies as larger companies can more easily deal with the cost of regulatory compliance making innovation in technology more limited. This also prevents many companies from seeking more novel solutions or devices if the idea is high risk and may leave the prospect of FDA approval uncertain. I think its difficult to say what an optimal point may be for both sides, but I think offering accommodations for lower funded companies to develop their devices while still maintaining the level of scrutiny that is needed to keep the general public safe. Do you think the FDA should create alternative regulatory pathways or financially support smaller companies in order to even the playing field and allow for more innovation?
