The Rapid Evolution of Laboratory Testing for Medical Devices—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief
 
Medical device manufacturing is challenging. Not only is it difficult to fabricate the device itself, but it is critical it is done so with patient safety being considered as most important. As such, it is vital to ensure all processes resulted in a product that’s ready to be used within a healthcare setting or even within a patient’s body (temporarily or permanently). Manufacturers can use internal personnel to accomplish this assurance, but it may be better for many to rely on an independent, third-party to assess the end result.
 
A major challenge for these testing partners, however, has been the changing face of technology within the medical device space. New innovations are leveraging ever increasingly sophisticated components, adding to the complexity of their testing. It is crucial testing providers ensure their capabilities keep pace with an industry that continues to evolve.
 
With this in mind, Christopher Scott, vice president of Eurofins Medical Device Testing, offered some of his own insights on this environment that continues to transform and addressed questions of how laboratories performing testing solutions are handling it.
 
Sean Fenske: What is the most significant change you’ve seen recently in medical device testing?
 
Christopher Scott: Although there are always updates and changes to testing requirements and standards, as well as the expectations from the regulatory agencies, I think the most significant evolution is actually the direction medical device manufacturers are driving in the industry. With advances in manufacturing processes and the incorporation of computer technologies into medical devices, the pace of innovation is exponentially greater than it was just a few decades ago. As a result, the demands for testing have expanded greatly as well.
 
Fenske: But to follow up on that point, the medtech sector has always been innovative, hasn’t it?
 
Scott: It certainly has been, but historically, many of the advancements in the industry have been incremental, building on existing technologies and using well-known materials. I think many observers would have attributed this to a risk-averse culture promoted by regulators and acquiesced to by manufacturers. There may be some truth in that, but I would suggest there was also a dependency on manufacturing technologies that limited breakthrough advancements and computing power that was not quite ready for incorporation into mainstream device designs. As these new tools, processes, and technologies have been embraced by the medical device industry, we are seeing significant step changes in designs and a culture of rapid innovation that is beginning to resemble the tech sector.
 
Fenske: How have regulators and standards organizations kept up with the rapid innovation?
 
Scott: It’s a great question because keeping up with rapid innovation requires a nimble responsiveness that is difficult if historically bureaucratic workflows are maintained. Thus, these groups are being challenged to adapt.
 
Fenske: So how are companies and testing laboratories, such as your own, dealing with this if regulators and standards organizations are struggling to keep up with technology?
 
Scott: Actually, the overarching requirements of the regulatory agencies still hold firm. Any new medical device must be safe and effective, and the basic approach of design verification and validation within a risk-based framework is as applicable for the latest breakthrough devices as it was for devices developed decades ago. What has changed, however, is that there are not as many detailed consensus standards to guide manufacturers with generally accepted limits and specifications that can accommodate devices incorporating newer technologies. The agencies have become prolific in publishing Guidance Documents to shed light on current thinking and expectations, which is very helpful.
 

The change for manufacturers is incorporating novel technologies. For testing laboratories, the change is that more emphasis is placed on design rationales for testing done to support design verifications and validations, as compared to checking a box after a standard test method has been completed. It is becoming more common for customized test methods to be developed and used if standard methods do not meet the intention of confirming a device’s safety or effectiveness.
 
Fenske: What should companies be thinking about when they approach a laboratory for testing?
 
Scott: Of course, you want to be working with an expert in the field. Someone who understands not just the testing aspect, but also the expectations of the regulatory agencies, and can provide guidance if there is a novel aspect to your device, or if a test’s results are not quite as was hoped for or expected.
 
Additionally, you should be thinking about the entire spectrum of testing that will be required throughout the lifecycle of your product, not just the immediate testing need. There is a lot of value in partnering with a laboratory that can support you throughout the development and commercialization of your device. Having a single point of contact that can provide a broad range of the testing needed is much easier than working with fifteen to twenty different laboratories.
 
For larger manufacturers with a global footprint, you will want to consider a laboratory that operates on the same scale as yourself. A partner that can support your testing needs regardless of what continent your product is manufactured, regulated, or sold. Additional benefits would include the ability to balance capacity across multiple lab locations and the ability to conduct business in the language, time zone, and currency of your choice.
 
Fenske: Is there any other advice you would offer someone who is looking for laboratory testing?
 
Scott: I’d suggest the same level of diligence be applied as is done when sourcing a key raw materials supplier or subcontractor. A laboratory should be viewed as a critical partner in ensuring the success of your products and business. A partnership is, of course, a two-way relationship, and you need to feel as though your laboratory shares that sense of collaboration and mutual desire for the success of your products.
 
Fenske: What do you predict for the future of medical device testing?
 
Scott: I think if we look at the accelerating rate of technological advancement all around us in our day-to-day lives, it helps to paint the picture of what we can expect to see in the medtech sector. It’s exciting to reflect back on the advances we’ve seen over the past decades, and even more exciting to think about what lies ahead. Wherever the winds of change take our clients, Eurofins Medical Device Testing stands ready to provide the spectrum of testing needed to bring their devices to market.
 
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