Outsourcing this step?
Here's what you want to gain:
All medical devices must be tested. However, the varied aspects of device testing can be unfamiliar ground, and standards are often vague guidelines, open to interpretation. OEMs of all sizes are left to question, what is the best test method? How many cycles do we perform? What loading profiles must we consider?
You may even wonder, should we contract out this testing?
Based on your company’s size and internal resources, in-house testing may not be feasible. However, Justin Metcalf, Director of Engineering at MED Institute, suggests that companies that have the bandwidth and expertise to control their own testing should do so. The benefits are numerous: ultimate control of resources and time, and the ability to keep the key stakeholders, like project managers, intimately involved throughout the process. If you must contract out some or all of your testing, consider the following factors when assessing partners.
Regulatory Expertise and the Ability to Advise
If you seek to outsource, Metcalf urges you to be aware: not all contract labs have a full understanding of the regulatory approval process—the origins of acceptance criteria, for example, and ways that engineers ultimately contribute to device approval.
He elaborated that, while a lab may have a particular capability—like device fatigue testing, for instance—it may lack any experience of participating in the clinical feedback loop that makes that analysis relevant. Thus, the burden of understanding the tests and subsequent results may still rest on OEMs. This shouldn’t pose a problem if your company has a clear understanding of what testing needs to be done with your device, but it’s a different story if the device is new to your team.
It’s important as well to understand the lab’s full range of expertise, and that means examining their accreditations (like ISO 17025) and asking about their history in testing specific devices. You’ll want to know how extensively the lab has worked with devices similar to yours, and inquire about the necessity of each test for FDA approval.
OEMs that lack internal testing knowledge may also need guidance on tests that are needed to satisfy FDA standards.
Metcalf says that experienced external test labs should be able to show expertise in dealing with FDA. That means offering information on what tests they have performed in the past, what has achieved regulatory approval from FDA and international regulatory bodies, and what has served as a barrier to approval.
Many firms also participate in FDA research agreements or sit on industry groups with FDA members, gaining knowledge to maintain an open line of communication about what the Agency may require for device testing in the future. In some cases, external firms can even facilitate conversation between FDA and an OEM.
Finally, some firms believe that using an external lab can reduce the impression of bias during regulatory submissions.
Kent Vilendrer, Founder, President and CEO of Medical Device Testing Services, says, “Quality protocols that are backed by certification are important both to upper management, as a basis of business decisions, and to regulatory agencies that will be evaluating the data.”