One question that frequently gets asked by medical device developers is, “When should Quality and Regulatory Affairs become involved in a new R&D project?” The textbook answer could be “once the formal design project begins,” but for many projects and many companies, waiting until a formal kickoff meeting is too late.

In situations where a company has a clear delineation between the work performed to develop a prototype proof-of-concept unit and the formal design process to develop a commercially viable product, then it is possible to keep prototype activities confined to an engineering research team. However, when there is not a clear line between proof-of-concept work and production development, then waiting to involve quality and regulatory personnel is often problematic.

When companies wait too long before including Quality and Regulatory personnel in the development process, the following issues can occur:

• Design planning and project scheduling are inaccurately estimated. This can lead to unrealistic expectations with Executive Management, causing strain on the design team and conflict between departments.
• Safety, regulatory, and other requirements are not initially identified. This can cause product delays because the design team will have to spend time adding new design specifications to meet overlooked requirements, or worse, may have to completely redesign elements of the product. This ultimately will add project delays that could have been avoided.
• Tasks or steps of the design process get overlooked. These oversights can result in delays, as the design team must go back and address the issues that were missed. In the worst-case scenarios, skipped steps could nullify work performed at a later design stage because the work must be repeated with an updated design.
• Documentation is not thorough and/or accurate. Inaccuracies in documentation can lead to a wide variety of issues that cause time delays and budget losses. Errors in design testing reports can cause teams to repeat the testing. Incorrect specifications can result in physical components being purchased that are unusable in production or software code that needs to be debugged or rewritten.
• Design reviews are inadequate and do not involve all the necessary reviewers. When this occurs, errors that should have been detected early aren’t discovered until later in the process. The result is that tasks may need to be repeated, or work redone. When significant deficiencies in the design processes and documentation are identified during an FDA inspection, the result can be an FDA warning letter and product recall.

On the other hand, when Quality and Regulatory are engaged early, teams benefit from clearer design inputs, more realistic schedules, and fewer surprises during testing and review. This alignment from the outset minimizes rework, builds stakeholder confidence, and keeps development on track. It also ensures that objectives remain consistent throughout the lifecycle, resulting in a more streamlined and efficient process. Moreover, early involvement helps avoid costly missteps, budget overruns, and fosters innovation by embedding compliance into design decisions, ultimately accelerating timelines. Industry leaders, such as Intertek, note that integrating compliance in early design stages is a key driver for shortening time-to-market and reducing risk in product development.

Partnering for Success

Bringing Quality and Regulatory into the R&D process early isn’t just a best practice, it’s a strategic advantage. Avoiding costly delays, ensuring compliance, and building a stronger foundation for FDA approval all begin with proactive planning and cross-functional collaboration.

CieloWorks’ team of expert consultants specializes in providing expert Quality and Regulatory support to medical device developers and manufacturers. Whether you’re refining a prototype or preparing for market launch, our team is here to guide you through every step of the process.

Contact CieloWorks today to learn how we can help streamline your development and ensure regulatory success.