Outsourced vs. DIY Regulatory Services

As the saying goes, time is money. A medical device or invitro diagnostic (IVD) manufacturer, whether a start-up or an established multi-national firm, must carefully balance the time its new or ongoing product development is taking against available resources. The more time – and effort – 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, as a result, a planned new product won’t even make it onto the market or an existing one won’t be able to stay on the market. This will prevent the products’ manufacturer from being able to recoup and expand on its initial or ongoing investments. And most importantly, if this happens, the products won’t be able to achieve their intended clinical benefits.

Regulatory challenges like meeting the Medical Device Regulations (MDR) and Invitro Diagnostic Device Regulations (IVDR) in the European Union and heightened cybersecurity scrutiny from regulators around the world makes it particularly difficult to meet market launch and recertification timelines. Pure Global 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 in a constantly changing regulatory environment, 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.

Balancing Time and Resources

If you are a medical device or IVD manufacturer, Pure Global 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 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’s Post-Market Clinical Follow-up? Does your regulatory and engineering staff have the know-how to assess and mitigate current and ongoing cybersecurity risks of your software-based devices?

If you’ve identified gaps in coverage or expertise for any of these items or other critical global regulatory demands, consider going to an outside source to help fill those gaps vs. doing it on your own. Consider using a consulting firm that has a rich set of services, has experience with similar products and challenges to yours that can help 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 across the globe, or running a part of or all of your regulatory operations as an outsourced consultant.

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Feel free to check out our website for more information or contact us to discuss your specific challenges and how Pure Global can help.

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