An expansive study shows the US has emerged over Europe as the preferred launch site for new medical technology because the Food and Drug Administration responds more effectively to innovation than do European regulators.
As medical devices and diagnostics become ever more sophisticated and complex, companies are opting to launch new products in the US rather than Europe, according to an expansive study from UCLA Biodesign, the healthcare technology innovation hub at the University of California Los Angeles, and global management consulting firm Boston Consulting Group (BCG).
The March 2022
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.
