Quick Tip: To ensure continued safety, build a robust post-market surveillance process
Design and development of medical devices involves many assumptions and trade-offs. Reasonably foreseeable misuse is a wildcard you must manage through a robust post-market surveillance process.
Design and development of a medical device is a complex, iterative process that involves many assumptions and trade-offs.
This is especially true for novel devices aiming to treat or diagnose a challenging medical condition using sophisticated technology, and operating in an inter-connected use-environment. Engineers make many assumptions about various use-scenario to facilitate design choices that lead to a sufficiently safe and effective medical device. They do the best they can, but they operate within a design space defined by limitations of technical and clinical expertise available at the time.
Reasonably foreseeable misuse, which includes both unintentional mistakes and intentional acts of misuse, proves to be a wildcard that often leads to unintended consequences and surprises during the post-market phase. There is only limited awareness of potential misuse(s) at the design stage, mainly due to a general lack of involvement from clinical and medical experts in the industry. Accelerated launch timelines and other business priorities also tend to limit the time spent in early risk identification due to potential misuse(s) that should be considered reasonably foreseeable.
That is why it is important to diligently document assumptions and rationale for various design choices during the development phase. There should be a focused effort to continually review and evaluate these assumptions both during development and during the post-market phase. Invest in a robust post-market surveillance process that provides timely intelligence and continually improves your awareness of potential safety risks. Ideally, this should be a dedicated, fully supported process separate from your complaints handling process. This will allow you to quickly detect potential safety signals and analyze them to confirm and escalate for timely action. In addition, it is a good practice to create a feedback loop back to the design and development process to facilitate better, more robust products in the future.
