Here’s an opinion on EU MDR that most people aren’t discussing:
Adopting EU MDR is either going to make or break some regulatory teams. Let me explain.
Over the past few years the amount of incredibly dedicated, experienced and talented Regulatory Affairs professionals I’ve met have blown me away.
In an area that’s often given a backseat in the corporate world, RA, Quality and compliance folks continue to beat the odds and deliver high caliber work in time.
Despite constant pressure to ‘cut corners’ and ‘just get it submitted’ you continuously re-commit your focus to not only getting your devices approved, but by doing it ethically.
Now with EU MDR looming, we are starting to feel yet another squeeze on RA teams across the globe. The clock is ticking, the requirements are tougher, and more PMS and follow-up work is stacked high on top of an already stretched out team.
I know this is the case in the majority of companies, because I spend the majority of my days speaking with Team Leads and Medical writers.
EVERYONE is feeling the stress of the deadline. Combine that with shriveling corporate budgets and sales driven priorities and you get a really tough situation for those in charge of putting full Tech Files together and sent off to Notified Bodies.
I strongly believe that every firm can get their devices certified under MDR when the time comes, BUT it’s going to require something that not everyone will be willing to do.
It’s going to require a new approach. Without it, deadlines will be missed, quality will suffer and CAPAs will plague teams for years to come.
Our world is CER and Literature Search. These two documents are essential in your MDR submission, and we have dedicated ourselves to them because of the incredible strain their completion can place on your team.
If you’ve ever conducted and written an Literature Search before, they are a PAIN. Running the same searches across multiple global databases, compiling the results, reviewing everything and making your assessments, and on and on…
All culminating in the drafting of a massive document including all your work, summary tables + calculations, trending data, references etc.
Now check it 5 times for mistakes… and start on your CER 🙂
We’ve gone through this more than anyone, and we see time and time again that the process is simply TO TIME CONSUMING AND ARDUOUS TO BE WASTED ON YOUR TEAM.
The typical RA team is swamped compiling everything, juggling CAPAs and Notified Body responses, and now with MDR they are even more overloaded. It has become not worth their time to spend weeks formatting and editing documents for Literature Search and/or CERs.
What’s required instead is a re-thinking of how RA teams get this work done. Systems should be in place, workflows should be hyper optimized to MAXIMIZE team members efforts and device knowledge.
When simply ‘hiring a bigger team’ isn’t an option for you, how can you be expected to just ‘optimize’? What does that even mean?
To us it means identifying the parts of the work that take the most time and effort, and figuring out a way to exponentially improve them.
We’ve invested several years and countless dollars into the creation of our Literature Review/CER system, and even more sweat and time into the building of our dedicated team.
So we meticulously assembled an experienced team of experienced medical writers and Regulatory Industry veterans and worked side by side to craft tools that make them up to 20x more efficient at their job.
WITHOUT cutting corners or sacrificing the crucial attention to detail and thought that’s always required of high caliber work.
Together, our new process is the answer to your budget and workload problems that MDR is causing your team.
No more inflated budgets, ambiguous consulting hours agreements, and missed deadlines.
No more scrambling to get your research done so that your team can rush out a CER with your Tech file in time.
Use our team and process to supercharge your already fantastic team. We focus on the Literature Search (and full CER if you need it) while your attention and energies can get re-applied where they matter most.
I guarantee our quality and timelines will blow you away. Send me a message today and I’ll get you a free proposal and quote for how we can help your team hit those deadlines year after year.
Or check out our free resources (contact us for even more unpublished guides and whitepapers we’ve written for our team).
-Ethan Drower, Operating Partner