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.

I agree with you that engineers should have a basic understanding of regulations and that the bulk of compliance work should be handled by regulatory specialists. Engineers should focus on ensuring that designs are innovative and technically sound while keeping in mind the regulatory requirements that must be met. This prevents wasted effort on developing something that would never gain approval. Without at least a working knowledge of regulations, projects risk facing costly delays or even rejection later in the process. Regulatory experts should take the lead in ensuring that devices align with standards and manage any direct communication with the FDA. As you mentioned, the best approach is collaboration between engineering and regulatory teams. Engineers can concentrate primarily on design while maintaining enough regulatory awareness to integrate compliance considerations from the start of a project. This way, both creativity and compliance are balanced. I also agree with your point about company size influencing how much regulatory knowledge engineers need. To expand on that, some companies choose to outsource their regulatory affairs to external specialists so they can dedicate more resources to product development. Outsourcing can also help companies operate more effectively in global markets by leveraging the expertise of professionals who are familiar with different regulatory authorities and requirements.

I agree with everyone's response regarding the need for engineers to understand the regulatory basics in order to create products that don't need revision early on in the design process, since they can avoid potential roadblocks before they even happen. I also agree that different teams need to work together. The regulatory specialist can have knowledge of the niche aspects of regulation, and the engineer can have knowledge of the niche aspects of engineering. If both these members, however, have basic knowledge of one another's fields, this would allow for the most effective collaboration that enhances safety and speed. Additionally, to bring in a new perspective, I think physicians and those who are or will be using the medical devices should also have knowledge of the engineering and regulatory aspects. Communicating with these physicians will allow for better device development, and they will be specialized in the biological and medical aspects that the device is trying to solve.  

Another layer to add to the discussion is education. Many biomedical engineering programs include regulatory coursework so future engineers can understand the regulatory aspects. Take NJIT, for example, the undergraduate capstone course (BME495 & BME496) requires regulatory knowledge, and IE492 is mandatory as well, which is a regulation and teamwork course. Having this education in the degree work, as well as when an engineer joins the company, could benefit the company immensely, as giving the base knowledge to all, even if they think they know it, will allow everyone to be on the same page and work effectively as a team. 

Something that nobody else has brought up is the advent of AI in regulation and how this will play a role in teamwork. I believe AI will allow engineers to design devices better since AI can tell the engineers which aspects of their device will not pass through regulations. For example, AI built into CAD software could flag compliance issues in real time. Additionally, AI can allow the regulatory team to tackle more projects that require finer revisions since the AI can handle the general and relatively easy tasks. This will increase efficiency. However, there are issues with confidentiality and how accurate the AI is. Do you think engineers will still just need a basic regulatory understanding in the future, or will tools like AI and stricter liability make regulatory knowledge an essential part of the engineering role itself?

In medical device development, regulatory basics should primarily be the responsibility of the regulatory affairs team, as they are trained to interpret and apply complex regulations. However, accountability does not stop there engineers, quality assurance specialists, and project managers must also have a solid understanding of regulatory requirements to ensure compliance throughout the development process. Senior management plays a crucial role by providing resources and fostering a compliance focused culture. Cross functional teams should collaborate to integrate regulatory standards from the earliest design stages rather than treating them as an afterthought. This shared responsibility helps reduce the risk of costly delays, recalls, or rejections during approval processes. Ultimately, regulatory basics are a collective responsibility, but the regulatory affairs department leads the effort to guide and ensure compliance.

I agree that engineers should have a layer of responsibility for regulatory basics. Understanding of FDA regulations is important for proper design of medical devices, but with constantly changing guidelines, having a perfect understanding of regulatory regulations for engineers is unfeasible. This is why regulatory affairs professionals are needed on cross-functional teams to identify these changes and advise the proper teams to make necessary adjustments. An engineer is responsible for developing a product that is FDA-compliant with the regulations that have been identified in the project plan. More recently, many medical devices are finding themselves in "in-between" categories in the FDA medical device classifications due to the incorporation of more novel software methods. This can mean that it is more probable than ever for accelerated changes to occur in regulations. Familiarity with compliance and regulations are necessary, but should not fall for engineers to be the largely responsible party. With many project teams, regulatory affairs are a collective responsibility as mentioned. With this in mind, would it be more effective to provide resources for engineers to track changes in regulatory bodies in a more proactive manner, or should engineers react to them as the changes occur?