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.
As many users under this post have mentioned, a balance of both the medical device’s own regulatory experts and an outsource to consultants would be the best in both worlds. Both regulatory experts and consultants have their own skills and weaknesses. Each group can help each other out in areas they are lacking in when it comes to following the FDA regulations and guidelines in what direction and path the combination product should follow. Having as many experts as they can is generally beneficial to help with the complex regulatory pathways, risks, and approval from the FDA.
Beginning with personal regulatory experts, these are people that have deeper knowledge about the medical device that is being developed or proposed. They know the ins and outs of the device through and through, but that does not mean that they will be able to create that device perfectly or get it approved immediately. They help the project teams with claims, usually they have to guess the FDA’s reactions, ask for input, and usually stay in touch with the FDA. The FDA approval process is extremely difficult especially when it comes to combination devices or those classified as Class III with high-risk to users. Throughout the lesson, Class II and Class III medical devices are more strict since there is the 510(k) and PMA process that needs to be done. Failure to follow these procedures can lead to regulatory clearance delay which can delay the whole project altogether. It is quite difficult with all the standards, regulations, and testing required as these topics are constantly changing. These personal regulatory experts may be able to do this, but they can overlook many items, especially if project teams are in a rush to get the regulatory portion approved, so they can immediately start developing the product, test it, and sell it without a strict deadline.
With the help of consultants, these are people that have general knowledge and more experience in engineering, medicine, clinical trials, regulatory affairs, marketing, and sales. They are people with an outsider’s point of view on the device the project teams are working on. They do not know what that device is intended to do, thus they are learning it for themselves and are there to provide their opinions and expertise in areas that are perhaps lacking or missed. Many internal regulatory experts can miss small details that can turn the project around or something detrimental to the project. Since they have more knowledge depending on their field of knowledge and experience, they can help, for example, navigate the regulatory process and find any issues regarding regulation faster. Their main job is to ensure compliance is being met. It does not matter the longevity or size of the company. Not all companies are perfect and are capable of navigating regulatory pathways on their own. No matter how many times these internal groups have done it and are successful, guidelines and regulations are constantly changing for newer medical devices being made.