Firm and rigorous regulations in the medical device industry is essential for both consumer safety and innovation. It is pretty clear cut as to why it matters for consumer safety, given that it minimizes risk of harm during consumer use and ensures that the device being used won't do more harm (whether immediate or longterm) than good. But it can also spark innovation by providing a goal for industry players to reach in the best way possible. Loose regulations gives industry players too much room for development, which can create inefficiencies or unnecessary adjustments to a medical device. Meanwhile being given a clear set of limits provides the R&D team, although restricting, provides them more guidelines on what can be permitted and used, and allows every aspect and part of the medical device to be scrutinized and inspected to root out inefficiencies or maybe even innovated to provide a much more efficient and preferable use.

In my opinion, I believe that the medical industry in general, which encompasses device, drug development, etc., needs to be heavily regulated as to not create downstream issues that worsen the consumer's health. Although slow moving, this bureaucratic process of gaining approval after each developmental stage is essential to making sure nothing is being missed and that all parties are striving towards the common goal of good, not just to necessarily make money. If you want a good example of how regulations matter, look into blood testing machine Theranos, which was proven to be a scam.

I do agree that firm regulations are critical to the medical device industry; however, I do think a balance needs to be struck between safety and the opportunity to bring innovations to market. Ultimately, regulations create a baseline of safety that ensures design teams engineer solutions in a manner that respects patients' health/safety. However, overly rigid/slow-moving regulatory processes may stifle innovative progress. For example, smaller startup companies with a great idea and limited resources may not have the funds to keep up with long approval times/compliance costs. Thus, these ideas would never reach patients. 

On the other hand, as you had cited, the Theranos case highlights the danger of insufficient oversight, as that can not only lead to patients being harmed but also the erosion of public trust in medical technologies. I am aware that the FDA has already created "fast track" approval pathways for certain digital health and AI diagnostic tools, but amidst this back-and-forth, I think an essential question is, "How regulators can ensure safety standards are still met to protect patients, while also generating opportunities for smaller innovators to compete with established corporations (e.g., Medtronic/Stryker, etc.)?"