Developing combination products—such as drug-eluting stents, growth factor-releasing bone void fillers, or cell-seeded scaffolds—poses unique challenges because these products involve both medical device and drug/biologic regulations. Unlike standalone medical devices, combination products require careful coordination between different regulatory pathways, often involving multiple FDA centers like CDRH (for devices), CDER (for drugs), and CBER (for biologics). For example, a company developing a drug-coated implant must determine whether the primary mode of action is drug-related or device-related. This decision impacts whether the product follows the IND/NDA pathway (for drugs) or the IDE/PMA pathway (for devices). Misjudging this can cause delays, additional testing requirements, and regulatory setbacks. To manage these challenges, companies submit a Request for Designation (RFD) to the FDA early in development. This helps clarify which FDA center will lead the approval process. However, even with an assigned regulatory pathway, companies must integrate multiple compliance standards, such as Good Manufacturing Practices (GMP) for drugs and Quality System Regulations (QSR) for devices.
Because of the complexity, I think companies should have their own regulatory team rather than rely on outside consultants. An in-house team understands the product better and can work with the FDA more efficiently. However, consultants bring experience from many different cases and can help avoid mistakes.
Should medical device companies hire their own regulatory experts or outsource to consultants when dealing with complex combination products? Which do you think is the better approach, and why?
A mix of both would probably be the most advantageous for medical device companies. You would get the best of both worlds: on the one hand, an internal team with an intricate understanding of the product and its development that can make quick choices and comminate them across departments as well as constant surveillance over the project, and on the other hand, external consultants can provide insight into complications that might be overlooked by the internal team and help with ever-changing regulatory requirements. This way you would only need external input as needed while keeping an internal team with a focus on the product.
An important consideration when deciding to use in house or external consultants is the longevity and size of the company. If the company has prior experience with similar devices, developing in house consulting will probably be more efficient since they will already know the nuances of their products and how to navigate regulatory considerations. However, is a company is small or new, it would be extremely difficult to develop in-house consulting with enough expertise. It might also be less expensive to not employ a consulting team full-time. However, as mentioned above, it would most likely be beneficial for companies to use a hybrid approach if possible. This way, you will have some in-house consultants who are already familiar with your product. External consultants may be better suited for keeping up with recent changes in regulatory rules, and may also have some unique perspectives from working with other types of products.
I agree that balancing in-house and external expertise can be beneficial, however, I would also like to emphasize the product development timeline and regulatory complexity. For projects with tight deadlines, relying only on external consultants can lead to bottlenecks due to limited availability or slower response times. In-house experts can address urgent issues quickly because they are integrated into the project team and understand internal workflows and timelines. External consults can bring regulatory foresight, especially in global market requirements beyond the FDA, i.e. EU MDR or Japan's PMDA standards. For companies aiming for international product launches, this broader regulatory perspective could be crucial in avoiding delays in non-U.S. markets. Companies need to assess their strategic goals when determining the right mix of regulatory resources.
Having an in-house regulatory team is really important, especially for companies with a lot of complex combination products. They know the company’s processes inside and out and can handle the mix of device and drug/biologic regulations more easily. That said, consultants bring useful outside experience and can help speed up the process, particularly for companies that don’t deal with combination products all the time. A good mix of having an in-house team with consultants on call when needed could be the best way to go.
