Regulatory strategy is a plan of action designed to achieve a specific regulatory goal, such as to obtain approval or clearance of a new orthopaedic product. Since regulatory requirements continue to evolve and become increasingly complex, solid regulatory strategy and execution can maximize the opportunity to achieve the regulatory goal and provide a competitive advantage.
A good approach to strategy development begins by involving internal stakeholders to thoughtfully identify product attributes that could have regulatory impact, then conducting regulatory intelligence on possible precedents, documenting the strategy, verifying the strategy’s viability and finally by reviewing (and if necessary, revising) the strategy as circumstances change.
1. Identify Product Attributes
The objective at this stage of strategy development is to comprehensively identify the attributes of the proposed product so that the regulatory implications of its intended use, design and performance can be thoughtfully assessed. While the regulatory affairs member of the team will often have lead responsibility for developing the regulatory strategy, the strategy is likely to more fully reflect company objectives and be successful if relevant internal stakeholders are involved in this phase of the process. The stakeholders will vary depending upon the specific product or project, but would typically minimally include regulatory, R&D/engineering, marketing and medical/clinical affairs. Other relevant functions could include quality, reimbursement, manufacturing and supply chain, as well as external stakeholders such as from partner companies, key suppliers or consultants.
Since a regulatory strategy will typically vary based upon the specific facts at hand, it is important to fully understand the proposed product. Therefore, it is helpful to begin by formulating a series of open-ended questions that will help ensure that the strategy development team is aware of and appropriately considers factors that may have regulatory impact. If the product is early in development, such an exercise may help crystallize certain aspects of the design or features that have not yet been finalized, or that influence the design in order to minimize issues with regulatory impact. Consider the following types of issues, as well as any unique issues raised by the specific product:
- Intended use (intended users, use environment, patient population, unmet medical need)
- Design and features (unique features/functionality, novel mechanism of action or materials)
- Proposed claims (highest priority and nice-to-haves)
- Similar products (data then required, how you will support differences between the products)
- Target markets (desired or required staging of approvals)
- Anticipated data to support claims and meet regulatory and reimbursement objectives (bench, animal, clinical, usability)
- Anticipated regulator concerns (impact on clinical practice, new precedents, new or special patient or user population, potential for off-label use/claims)
- Jurisdictional concerns (possible drug, biologic or combination product instead of device)
- Postmarket concerns (adverse events and malfunctions reported for similar products)
- Potential need for post-approval studies
2. Conduct Regulatory Intelligence
Once you have thoroughly identified product attributes with potential regulatory impact, determine what regulatory precedents are available that could impact your regulatory strategy. Keep in mind that while there may be no product that raises precisely the same issues as your proposed product, you can often find analogous products, even in medical specialty areas outside of orthopaedics, that could help inform your strategy.
For regulatory strategies to market a new product in the U.S., FDA’s website is often an excellent place to start. In recent years, FDA has increasingly asked companies to ratchet up the level of detail in 510(k) summaries that are posted upon device clearance, which helps shed more light on prior products and the studies required for their clearance. Commercial regulatory intelligence systems are also available to make searching the FDA 510(k) database more efficient. For novel devices that have gone through the de novo classification process, more detailed FDA review summaries are available. For PMA devices, even more extensive information is available on review requirements in FDA’s Summary of Safety and Effectiveness. Advisory panel meeting transcripts can provide additional insight into FDA’s thinking for particular products or issues in the medical specialty area. FDA databases on MDRs and recalls give insight into postmarket concerns that may sometimes influence FDA’s premarket requirements.
An increasingly helpful source of information is the clinicaltrials.gov website, which may help identify products in clinical investigation, inform clinical trial design strategy and provide insight into study results. Websites of competitors are sometimes also a good source for gathering information about clinical study design, potential labeling claims and other issues. Consultants can also offer valuable insight based upon their experience with similar products.