Aaron Goodstein, Senior Director, Medical Safety Operations, Medical Devices & Global External Innovation
Medical device development follows a well-established path. Many of these steps overlap with each other as scientists and researchers invent, refine and test the devices to evaluate both efficacy and patient safety. Design reviews are an essential part of the medical device design process. They are conducted during various stages of the design process to ensure that the device remains safe and complete during every stage of its development. It is the responsibility of the manufacturer or designer to plan and prepare for these reviews. Design reviews need to be performed by individuals with an objective lens to ensure a fair analysis of the medical device design and development process, to build the safest possible device and improve patient outcomes. For this reason, it is critical that there are independent reviewers who are unbiased and have a knowledge of the technical aspects of the product participating in the process.
Traditionally, independence is defined as being independent from the project under review. However, a more holistic definition of independence should include independence from the commercial and R&D organizations responsible for the timeline and business outcomes. This type of reporting structure further removes the potential for unintended commercial pressure and the unconscious developer bias it may impart on the review process.
In addition to the concept of independence, a key technical area that is sometimes overlooked is the medical safety aspects, from user need through design realization. An independent medical safety organizationcan help bring a unique perspective around pathology, user needs and an ability to speak on behalf of the patients they have treated over the course of their clinical careers. While design frequently incorporates independent reviewers from an engineering perspective, having an independent medical voice during this process may provide invaluable insight that allows teams to identify potential challenges to design validations and safety concerns earlier in the project. This has the potential to reduce overall cycle time for product development and decrease post-market issues – and also to promote optimal patient safety outcomes. An independent medical organization that has responsibility for the oversight of products throughout the product lifecycle is positioned to b bring knowledge from not only their clinical experience but from the performance of predicate or similar devices to the design team early in the development process.
The independent medical safety role may support the R&D organization during product development through inputs and reviews of various deliverables throughout the development process. In the pre-clinical space, independent medical safety review of identified user needs, verification and validation plans ensures that the reviews of residual risk throughout the project are not inadvertently influenced by any bias. The independent medical safety function can also play a key role in the safety oversight of clinical trials and other means of clinical evidence generation.
Design reviews have always included a level of independent engineering review of the technical aspect of the product, but whether or not those engineers are truly independent remains a question in the R&D process. Device manufacturers may benefit from incorporating an independent medical safety review that focuses on the safety elements of the device and emphasizes the importance of the safety of the device. Striving for true independence within the medical devices design process can help promote the safety of patients around the globe.