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?

@jacobchabuel I think you give great points regarding safety and how the public would view a device if it were not tested beforehand. To answer your question, I think the FDA should create a program that will financially support smaller companies to even the playing field and allow more innovation. Big companies have a lot of financial support and can tackle the larger problems in the medical field more easily. However, smaller companies are positioned to target niche gaps that still have huge clinical importance. This will allow for thorough innovation. However, as you mentioned, the smaller companies do not necessarily have the financial means to jump through all the requirements of the FDA, and this can slow down their innovation. With financial support from the FDA, these smaller companies can bring about innovation to properly address the gaps in medical device development, helping out more of the population. 

An issue I see with my approach, however, is that with smaller companies targeting more niche issues, the profit that comes from their devices will also be smaller since they are targeting a subset of the population. This could lead to a feedback loop where the company needs more and more money to handle the smaller issues. The FDA already has the Breakthrough Devices Program, where faster access to medical devices is provided by speeding up the entire process, from development to De Novo marketing authorization. This fast track is a regulatory alternative that can help smaller companies push forward faster to generate more revenue if the fast track is adjusted to allow smaller companies to get priority in review and funding. However, ensuring that the regulations are strict and all the companies adhere to the safety rules is essential for patients to get the security they deserve. 

Additionally, the FDA can take a different approach from finance to help the smaller companies innovate. In the EU MDR framework, there are ways for companies to get "conditional approvals" for devices to reach patients faster. More evidence is collected post-market for this approach. This could allow smaller companies to innovate much faster, instead of waiting almost a decade before the patient even sees the device. The FDA can also use regulatory sandboxes, which are controlled environments where companies can test their devices under supervision but with less rigid requirements. 

My proposed approach focuses on smaller companies targeting smaller problems. However, what are your thoughts on smaller companies targeting bigger problems to become more financially stable, and the bigger companies targeting smaller problems with their increased financial assets? Do you think a balance between the two can be achieved? 

Regulations in medical device development are designed to protect patient safety and ensure product effectiveness, but their impact on innovation is often debated. On one hand, strict regulatory requirements can slow innovation by adding time, cost, and complexity to the development process. Small startups, in particular, may struggle with the resources needed to meet compliance demands. On the other hand, regulations create a standardized pathway that builds trust among healthcare providers, patients, and investors, ultimately encouraging the adoption of new technologies. By enforcing rigorous testing and quality standards, regulations also help filter out unsafe or ineffective devices that could harm patients and damage industry credibility. In many cases, the challenge lies not in the regulations themselves but in how efficiently companies navigate them. When integrated early into the design and development process, regulatory requirements can actually guide innovation in safer and more reliable directions. Therefore, while regulations may appear to slow innovation in the short term, they often strengthen and sustain it in the long run.

You both raise great arguments regarding how, depending on the company's resources, the FDA can either encourage or impede innovation. I agree that funding and initiatives like Breakthrough Devices benefit smaller businesses, but I wonder if there's another aspect that we don't discuss as much: how rules might be scaled according to patient involvement and risk.

A pacemaker and a digital health monitoring app are two examples of devices that are not equally dangerous. While high-risk devices must still be thoroughly examined, perhaps extending a more risk-based regulatory system could allow low-risk but innovative technologies to reach patients more quickly.

Including clinicians and patients earlier in the regulatory process is another concept. Early collaboration among regulators, patients, and innovators regarding unmet requirements and acceptable risks could change the focus of the process from obstacles to collaboration. Some advisory boards already do this, but broadening it might lead to more innovative ideas.

Last but not least, businesses aren't the only ones who can innovate. Another option is public-private partnerships, in which startups, hospitals, and regulatory bodies split the cost of gathering evidence, particularly for uncommon diseases or specialized equipment that wouldn't otherwise receive financing.

Therefore, I would like to know if you believe that a stronger risk-based approval pathway could strike a better balance than just adding financial support?

I think that regulations are extremely important for public transparency and risk reduction. They set a baseline of what needs to be done at minimum to allow for a product to go out onto the market, which is important for the safety of everyone. However, I do believe that, especially for small cap companies, it causes immense barriers. For example, the FDA regulations regarding GMP are often times very expensive to start and uphold. If you are a relatively new company, for example in the cancer therapy field, competing against the bigger, more large cap companies is nearly impossible. Although this is true, it is necessary to have regulations because smaller companies also do not have credibility for their products. Stryker, a very large cap medical device company has lots of credibility and is known to uphold regulatory standards, and since they have been in business for so long, it is easy to do so because they have already put systems in place to do this. Stryker has higher credibility, so its ease of product development and manufacturing products into the market will be significantly easier. Getting approval as a smaller company is extremely difficult and takes relatively a more intense testing process due to the fact that they do not have as much credibility in following regulations, but also, they have to put so much money into regulatory processes and building up a system to follow those regulations when manufacturing their products. I do not really see any changes you could make for this since smaller companies are not as reliable as larger companies, and although it sucks for these smaller companies to have to put so much money into these extra factors, it is a necessary sacrifice they have to make for the safety of the public and for relative transparency.

I think regulations mostly help innovation rather than slow it down because without them there would be no structure, no trust, and no way to ensure that devices are actually safe for patients. I think this way because when I worked on a project for my research lab, I saw how much effort it took just to get consistent results from a prototype. If every company could put products into the market without strict review, a lot of unsafe or ineffective devices would slip through. While the process can feel slow, that slowness is what builds confidence for both doctors and patients. That said, the system could still be improved. I believe stronger support for small innovators and streamlined review for low-risk devices would make the process more balanced, but not at the cost of safety. For me, patient trust is more valuable than speed. Would you personally feel more comfortable using a device that came to market quickly or one that took longer but went through rigorous testing?

To me, regulation can seem like a double edge sword, but I'd like to say outright that I think safety is paramount. With this in mind, the FDA's intense and rigorous observations should build trust for all. Everyone would promotes or uses the device should be confident in the device's ability to help and should be vetted rigorously to ensure its effectiveness. Without it, theres a risk of causing last harm to patients world wide. I think because of this, there is a burden on companies or researchers to push a breakthrough idea, especially for it to have enough gas to take off, especially if it's something that could really be successful. Larger companies have the benefit of having large stocks of resources and funding, while smaller companies don't and could stall great ideas. I think ultimately though, I think the regulations help keep things safe overall and it shows through tier regulation devices that we have (class I, II, and III), which can help devices that don't pose as much of a risk to push through quicker.