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Novel Technology Development – In this blog, Mark Carol, MD, a senior consultant at the Foundation, shares his insight for successful technology development in the medical device space. Using a real-world case study, this blog addresses many common mistakes made by new companies and how to avoid them to make it to market successfully.

On May 26, 2021, the European Union (EU) implemented REGULATION (EU) 2017/745, the “Medical Device Regulation,” or MDR. After its first year in existence, the medtech community’s initial concerns with the MDR’s requirements have now become a matter of increasing frustration for many, including those of us who are dedicated to advancing the clinical adoption of focused ultrasound. This commentary examines the current situation for EU medical devices and the MDR’s impact on focused ultrasound’s technological development.

Intensity modulated radiation therapy (IMRT) technology was pioneered in the early 1990s by a small startup, NOMOS, founded by a neurosurgeon and staffed by engineers with no background in the field of radiation oncology. The regulatory application process for the NOMOS Peacock product began a short three years after initial testing of the system. This was possible in part because IMRT was built on a stable, already authorized radiation therapy platform with easily identifiable predicate devices.

An important change in reimbursement for German patients with essential tremor has occurred. On April 21, 2022, the German Federal Joint Committee governing healthcare in Germany (Gemeinsamer Bundesausschuss or G-BA) favorably amended its ruling on patient eligibility for focused ultrasound treatment and reimbursement.