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?