The medical device industry’s anxiety over pending changes to the FDA’s 510(k) process is clear to see amid a slowly unfolding process that’s forcing OEMs to rethink entirely how they will operate on a changing landscape. With the industry awaiting guidance, manufacturers are mired in a holding pattern. But the story does not end there, unfortunately.
Beyond the spectra of 510(k) changes, manufacturers are experiencing similar angst over coming changes to the industry's IEC 60601-1 standard governing the safety and reliability of electro-medical equipment and systems. So the alarming reality now for the industry, with both the 510(k) process and the IEC 60601-1 standard in a state of flux, can be sadly summed up in two words: uncertainty reigns.
FDA, for example, is declaring its intention to adopt the changes in 2013 but has not confirmed that this will actually happen. With FDA appearing to sit on the fence over this significant initiative, the issue is certainly getting plenty of attention. Amid the confusion, what guidance can we offer to OEMs these days?
Our advice is to start at square one: OEMs should acquire and become familiar with the IEC 60601-1 Edition 3 changes covered in a document that is several hundred pages long. Having gained an understanding of the changing standard, OEMs should then start to integrate changes where possible into their processes.
The revised standard, as I have noted, is very prescriptive, adding a variety of new controls and testing and documentation requirements that OEMs will need to comply with prior to moving a device into production.
Why act now on the revised IEC 60601-1 standard? For starters, depending on the timing of the revised standard’s adoption, companies with products coming to market may face the challenge of going back into their design files to ensure the standard is met—a costly and disruptive process to say the least.
What OEMs can begin doing now, for example, is create a work-around in areas concerning product components that could become obsolete over the next few years. Ultimately, it will fall to OEMs to ensure all device components in use are safe and reliable under the new standard—so the sooner manufacturers get required changes in gear, the better their chances of success. This is doubly true for smaller players, who will face greater risks than the larger and more resourceful major players amid the changing regulatory landscape.
The risk and change management issues now looming for manufacturers can be seen to underscore the importance of having a reliable partner to provide expertise and guidance throughout the design, testing and production process. Companies like Celestica are doing their part to assist industry partners by providing ongoing support in all areas, so as to help OEMs successfully manage the significant risks that many of them are facing today.
Preparing now to meet the new standard can pay significant cost and time dividends in the future. And failing to act can only create even greater risks for industry players.
Duarte-Lonnroth is director of quality, regulatory affairs, healthcare for Celestica (Toronto, ON, Canada).