The resources required for compliance with the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (EU IVDR) represent a sea change, not a wave, requiring an ongoing increase in resources beyond transition periods.
A Sea Change for MedTech
Once the transition occurs, the processes put into place for creating the required Post-Market Clinical Follow-Up Plans (PMCFs) must continue for MedTech companies to maintain compliance and remain on the EU market. Each report supporting a PMCF is interdependent on information in other reports. Convincing a notified body to approve a product as compliant demands that a consistent narrative is carried through all the reports supporting compliance. Telling the same evidence-based story requires coordination within a cross-functional team.
“There is definitely an increased need for synchronization between processes,” said an Associate Director of Regulatory Affairs at a top ten medical device company during a recent webinar.
“The fact that these processes have to talk to each other, that in many instances questions that we get from notified bodies may not be necessarily related to the content of say, a PMS report, but to an input into that report [means] it's very important that organizations and we as manufacturers have a very well established cross-functional group …that we are saying the same story in a consistent manner throughout our documentation.”
Starting with Systematic Literature Review
Determining what the story will be begins with Systematic Literature Review (SLR).
Using technology to enhance SLR is not as simple as monitoring literature. The wrong technology partner will not ease the burden of SLR. It will only change the nature of the work being done from generating reports to fixing what the technology did wrong in its reports.
Even if an initiative reduces the overall time spent on SLR, new processes need to be in lockstep with existing ones.
“The challenge in gathering data is the mass of data available and finding applicable data to your product,” said Martin King, a MedTech industry expert and consultant. “This is where you need intelligent systems or teams to go after that data and find that data for you and consolidate it into a reviewable form. If you can't get that data into a reviewable form, then you're not able to process it. You have to be able to get data into a reviewable and presentable form.”
If SLR data is not in the right form, manufacturers may optimize aspects of one existing process at the cost of impeding work by other functions in teams required for compliance. As with the humans involved in the complex work of compliance with EU regulations, those implementing new technologies must coordinate with multiple functions or risk worsening an already difficult process.
“If you take literature search as an example, you have to manually go through hundreds, sometimes thousands of publications from keyword searches to curate it,” said Lana Feng, Ph.D., CEO of Huma.AI, in a recent MedTech Intelligence interview.
“The industry is trying to meet that challenge, and is relying on existing solutions, trying to hire as many business analysts and experts as they can. And some of the big manufacturers have hundreds of thousands of products. It just does not scale; it’s a huge problem.”
You cannot accelerate one part of the compliance process without taking the whole process into consideration - work that takes considerable MedTech experience across functions to perform.
Technology Partners for Post-Market Intelligence
Because the demands of MDR and IVDR are not going anywhere, technology is needed to optimize the processes of compliance. But unless that optimization occurs in sync with processes as they currently exist, implemented by a technology partner that has the expertise to understand what those processes are - any gains achieved will be lost elsewhere.
MedTech companies are best served by working with technology partners who have real-world expertise in EU MDR and IVDR compliance.
“The future,” said Dr. Feng, “is to build out a partnership with the industry to help them understand and reframe the challenges, and adopt new agile technologies, including machine learning and NLP to help them solve their complex regulatory, compliance, and post-market challenges."
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