Design Verification of Medical Devices can be overwhelming. One of the simplest, most effective techniques is just to have someone else check your work. This strategy is in fact so successful that you can make a whole career out of it. This is my specialty, Medical Device Design Verification and I am grateful for the opportunity to lead a whole team of rather unique individuals at Sunrise Labs who do this work too. This discipline has a lot of variations and many different names of varying degrees of accuracy and precision, e.g. Quality, QA, SQA, Test Engineering, SW Test, V&V, Verification, etc. But at Sunrise we call it Design Verification (DV).
You can be forgiven for thinking of us as “Test” and that our job starts when development finishes. But having DV working alongside the developers from the beginning produces better results. Being that second set of eyes for Software Development, Electrical Engineering, Mechanical Engineering, and Systems Engineering while they are doing what they do helps them do it better. But we do more than just look because when designers are working on a problem, they can get tunnel vision – it’s just human nature. And we help them keep a broader view.
We are there to maintain a bigger perspective, to remember what it originally was that the team set out to do, and what we promised the customer. Just as much it is our job to remember the doctors, patients, and others who will use these devices… their safety is our primary concern.
But we are also trying to find any snags or defects well ahead of release. Catching design flaws late is more expensive to fix and delays can derail a project. During development and while the developers are trying to work out how to make the devices work, we’re trying to work out how to prove that it works. Can it be tested? Can it be measured in some way? Can I try to damage it or try to divert it? While they’re trying to get it to work, we’re trying to get proof that it works (and/or breaks “properly”).
DV has two main functions; first, to repeatedly demonstrate (and document) the safety of our medical devices. And second, making sure that the devices really do meet the requirements and more than meet the document’s agreed-upon requirements but actually work the way they’re supposed to work in a consistent and effective manner.
Some of the key activities we focus on are listed below:
- Design Reviews
- Requirement Analysis/Feedback/Tracing
- Bug fix verification
- Testing (ad hoc and formal)
- Risk Management / Risk Control / Risk Reduction
And when we’re done, what we have is a dossier of credible evidence ready to put in front of the client, the FDA, and ultimately the end-users; evidence of a safe and effective medical device.
The culture at Sunrise is a culture of trust and respect. And in this environment, my team and I point out potential problems, ask difficult questions, and sometimes just break stuff. We do this without being adversaries, without systemic conflict, and our colleagues value our work and our skills. A culture of respect is a culture tolerant of dissent. It’s a culture of safety. And our patients deserve as much.
About Sunrise Labs:
Founded in 1992 to produce robust, reliable, cost-effective medical designs, Sunrise Labs turns ideas into commercial medical device solutions. Today clients leverage the extensive knowledge of our 100+ in-house employees to solve their design challenges.