This blog is based on a webinar hosted by Vitaccess in collaboration with Odelle Technology. Odelle Technology is an established consultancy dedicated to helping MedTech, BioTech, and diagnostic businesses navigate public and private healthcare sectors across Europe. For access to this webinar, and all webinars hosted by Vitaccess, please visit our dedicated webinars page.
Achieving market access for novel medical devices is increasingly driven by evidence of the product’s value in the real-world setting. Medical devices are an essential component of modern healthcare, encompassing a range of instruments and software directed at the prevention, diagnosis, and treatment of health conditions. Real-world data (RWD)—generated from various sources outside of traditional clinical trials, such as electronic health records, administrative/claims data, or patient-reported data—can provide meaningful evidence to support medical device product claims and value propositions, while addressing the needs of diverse stakeholders.Â
Real-world data in the medical device post-market setting
The European Medical Device Regulation (EU MDR) is a set of regulations governing the production and distribution of medical devices in Europe, implemented fully as of May 2021. As a result of the MDR, medical device manufacturers are required to collect more evidence via post-market clinical follow-up (PMCF) activities, continually and throughout the device’s entire lifecycle, to maintain ongoing risk management and clinical evaluation of their device.
In this context, RWD can provide valuable insight into medical devices, diagnostic products, and performance and outcomes from a broad population. The question is then how to generate meaningful RWD while remaining compliant with all relevant rules and legislation.
Considerations to make:
- The type of medical device
- The depth and detail of data needed
- Existing sources of data.
Payers at all levels are interested in outcomes and performance and standardization data, but it needs to be meaningful; in other words, it’s important not to gather data for data’s sake. Further to this, things will change—including what stakeholders want, how they want to see it, and when—and variation and conflicting needs will always exist.
The approach to take:
- Develop a plan and do it early (at least 1-2 years before launch)
- Don’t be afraid to ask for advice (including formal advice from regulators and national health technology agencies, and informal advice from regional payers and medical societies)
- Seek out win-win partnerships to build RWD.Â
At Vitaccess, we are experts at supporting BioTech and pharma to generate meaningful datasets for diverse end-goals. To find out more, contact us at info@vitaccess.com.
References
https://www.castoredc.com/whitepaper/pmcf-medical-devices-guide/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8092069/
By Fatemeh Amini and Mark Larkin
