In my opinion, engineers should definitely have at least a basic understanding of regulations. Even though Regulatory Affairs professionals are the ones who specialize in compliance, I don’t think engineers can just ignore it. If we design something that doesn’t line up with FDA or ISO requirements, then we’ve wasted time, money, and effort on something that may never be approved. To me, that feels like a huge risk that could be avoided if engineers kept compliance in mind from the start.
That being said, I don’t think engineers need to become experts in Regulatory Affairs either. If we spend all our time focused on compliance rules, it takes away from the creative side of design and problem-solving, which is where engineers add the most value. I think the best approach is a balance: engineers should know enough to design with compliance in mind, but the detailed rules and submissions should stay in the hands of specialists.
Personally, I believe smaller companies might need engineers to handle more of the compliance work, while larger companies can afford to keep those roles separate. But no matter the size, I think engineers should at least understand the basics so we’re not creating designs that regulatory teams later have to reject.
What do you think: should engineers take on more of the responsibility for regulations, or is it better for them to focus on design and let specialists handle compliance?
I like how you framed this because it made me think of how it really is all about balance. I agree that engineers don't need to be regulatory experts, but they need to know the "rules of the game", the basics, so that they don't waste coming up with unrealistic ideas that will never get passed. At the same time, I don't think engineers should be buried in paperwork or spend all their time studying FDA regulations, I think that's the whole purpose of having a regulatory specialist. To me, the best setup is a strong communication between engineering and regulatory teams. Engineers will focus on the design and innovation while making sure they check in with regulatory specialists throughout the process to make sure their ideas aren't straying too far from what is feasible for approval. It also, like you mentioned, probably depends on the company size and in a smaller company engineers might have to wear multiple hats and take on some regulatory responsibilities. Either way, engineers should have baseline understanding of FDA/ISO requirements to make the process smoother and avoid wasted effort.
This is a great question that relates to a reply I gave in another thread.
As you’ve noted, engineers may have more or less responsibility depending on the size of the company they are working for. For instance, smaller companies may only employ one regulatory specialist, or even have their engineers take on a dual regulatory role during the design & approval process. Because of this, they may take a bit longer to bring their products to market since they may not have established credibility yet. Despite this, they could ensure their products meet customers’ requirements while maintaining FDA compliance through their extensive efforts for approval. Smaller firms likely will also promote greater creativity by narrowing down the most feasible ideas to keep in line with the FDA’s conditions.
Larger companies, on the other hand, employ dedicated regulatory and engineering departments. Through this, they have employees who specialize in maintaining up-to-date compliance knowledge and advising engineering teams accordingly. These companies may likely have established credibility within the industry, which gives them the advantage of speed to release products. However, engineers may have less regulatory insight because of this separation you mentioned, which hinders their ability to understand what they can and cannot use in their designs per FDA regulations. They may also be less creative, since they need to meet strict, inflexible deadlines.
Ultimately, engineers who comprehend these regulations (regardless of whether they’re in a startup or a large corporation) will indeed have an advantage. By understanding the nuances of, for instance, wording their Requests for Designation, Premarket Approval Applications, or 510ks, depending on whether it’s a new device or not, and Investigational Device Exemptions for clinical research, they will easily navigate the approval process compared to those who are reliant on others for that information. This way, they can gain the experience they need to not just speed up the design and approval process, but also to communicate with regulatory specialists across departmental lines and guarantee the product will be authorized.
