As the saying goes, time is money. A medical device or in vitro diagnostic (IVD) manufacturer, whether a start-up or an established multinational firm, has to carefully balance the time its new or ongoing product development is taking against available resources. The longer it takes to get a new product to market, or keep an existing one on the market, the greater the risk that allocated resources will dry up and that the product won’t even make it to or stay on the market to recoup and expand on its initial or ongoing investments. And most importantly, if this happens, the product won’t be able to achieve its intended clinical benefits.

New regulatory challenges like the upcoming Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR) in the European Union as well as heightened cybersecurity scrutiny from regulators makes it particularly difficult to meet market launch and recertification timelines. Emergo by UL has been hearing from its medical device and IVD manufacturer clients that their staff often don’t have the capacity to efficiently manage many of the regulatory hurdles in front of them. Their staff may have the capability to clear the hurdles, but the time it takes to come up to speed, learn what to do, build up appropriate processes, etc. can put them at the back of the pack. And, in the world of regulatory affairs, history does not necessarily repeat itself. A medical device that “cruised through” the FDA 510(k) process several years ago would not necessarily “cruise” to the finish line today.

Internal capacity versus regulatory demands

If you are a medical device or IVD manufacturer, Emergo by UL recommends that you take a careful look at your internal capacity to manage and understand new and ongoing regulatory demands. For example:

• Do you have a full understanding of the clinical data you will need to collect for your EU Post-Market Clinical Follow-up (PMCF) under MDR?
• Do you have the expertise or manpower to design, set up, run, and analyze results from any required clinical studies like for MDR PMCF?
• Does your regulatory and engineering staff have the know-how to assess and mitigate current and ongoing cybersecurity risks of your software-based devices? And, keep in mind that this can be particularly challenging if your devices are connected to a network.

If you’ve identified gaps in coverage or expertise for any of these items or other critical regulatory demands, consider going to an outside source to help fill those gaps. A third-party consultancy that has experience with similar products and challenges to yours can help, as well as answer and deal with these types of questions. Just a few examples include supporting or conducting a single regulatory submission, developing a regulatory strategy for a fleet of products, or running a part of or all of your regulatory operations as an outsourced consultant.

James Keller is Business Development Director at Emergo by UL.

Learn more about regulatory affairs business process services and outsourcing:

• Business process services for medical device and healthcare technology companies
• RA/QA consulting for medical device and IVD manufacturers