DistillerSR Evidence Matters LinkedIn Newsletter: January 25, 2023

Five Key Takeaways: Best Practices for EU MDR State of Art Framework While Achieving More Efficient Literature Reviews

At our most recent webinar, DistillerSR customers Monique Liston, Senior Medical Writer at NuVasive, and Shelley Jambresic, Senior Clinical Evaluations Manager at Geistlich Pharma, were joined by Dr. Bassil Akra, founder and CEO of Akra Team, GmhB, Dr. Julien Senac, Global Director IVDR at TüV SüD, and David Kovac, DistillerSR Account Executive to discuss the challenges of developing a methodologically sound state of the art framework while keeping up with the latest literature and tight deadlines. Watch the full webinar here.

1. State of the Art Definition Remains a Challenge for Medical Device Manufacturers

State of the art is not a straightforward definition. Generally speaking, it refers to cutting-edge, innovative technology. In the context of EU MDR, though, the term refers to the benchmark/current state of what is available in the market and intends to demonstrate the acceptability of the risk/benefit profile of a new medical device or a legacy device. Establishing state-of-the-art yields information essential for determining if the safety and performance of a device are compatible with current standards (in comparison to available treatment options). In other words, state-of-the-art establishes a reference standard used throughout the clinical evaluation reporting process. Not surprisingly, manufacturers need help developing an approach that includes a comprehensive analysis of treatment options and a succinct yet comprehensive presentation of the currently accepted safety and performance standards against which their device is measured. A perspective that is too broad, including too much detail, or a perspective that needs to be narrower, omitting relevant indications and alternative therapeutic options, will result in rejected submissions and delayed market launches.

2. Notified Bodies Want a Clear Story Backed by Sufficient Evidence

"If you can tell your medical device story to your grandmother and she understands it, then you're ready to submit it to a notified body." that's what Dr. Julien Senac from TüV SüD told Dr. Bassil Akra from Akra Team when questioned about the notified body expectation for state of the art submissions. Literature reviews help manufacturers tell a clear story to the notified bodies. However, striking a balance between cherry-picking and casting a wide net when defining your search parameters to ensure enough relevant results can be difficult. The robust justification requirement introduced by EU MDR translates into the need to gather evidence beyond your routine benchmarks and consider the complete body of evidence from currently published literature while assessing the current standard of care and the options available to surgeons and patients. And because the evidence is constantly evolving, the biggest challenge to achieving continuous compliance is keeping up with scientific literature.

3. Manufacturers Are Looking at State of the Art Benchmarks Early in the Medical Device Development Lifecycle

Integrating a comprehensive state-of-the-art benchmark analysis in the concept phase of a new medical device development enables manufacturers to ask critical questions about how the device will fit in the current market landscape and establish safety and performance parameters early. A common pitfall of rejected submissions and unsuccessful market launches is designing a device without sight of your competitive landscape and trying to match that benchmark too late in the development process.

4. Data Reuse is Enabling Medical Device Manufacturers to Achieve Efficient, Cross-Functional Evidence Management

State of the art is a living review that you must keep constantly updated to ensure you are looking at the most up-to-date scientific literature reflecting what alternative treatment options are available in the market while ensuring your device profile is still fulfilling the accepted safety and performance benchmarks. In this context, the main benefit of data reuse is the ability to quickly identify what you have previously reviewed, screened, and appraised to avoid duplicating efforts. The extended benefit for a manufacturer with a wide portfolio is to reuse the same evidence dataset for similar medical devices. The first time you run a state-of-the-art living review using a literature review management software, you are building an evidence database that can be reused and shared by multiple team members for devices with a similar intended purpose. This database will be continuously updated, ensuring you and your teams keep up with the latest evidence, saving time and effort in the compliance process.

5. Automated Literature Review Processes Translate Into Faster, Audit-Ready Regulatory Submissions

There are many software options available in the market. Finding one that is right for your team and your project requirements might entail a trial-error approach but the transition to automated, intelligent workflows will translate into consistent and efficient processes that promote cross-functional collaboration and streamline compliance. Time and cost savings remain critical decision drivers for adopting new technologies, especially considering tight budgets and sometimes steep learning curves. Demonstrating company-wide impact is critical as continuous, audit-ready and efficient evidence management affects the whole medical device lifecycle from pre-market approval through post-market surveillance.

Read the full webinar recap blog post here.

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