3 December 2020 -
medtech-INSIDE – financial column, part 2: “Fast-track approval and reimbursement in the US: the Breakthrough Devices Program”
While the EU is significantly raising approval hurdles with the MDR, the US is putting medtech innovations in the fast lane with the Breakthrough Devices Program
By: Dr André Zimmermann, partner at Tübingen-based industry investor SHS. He has developed global connections in the medical technology sector as a business development expert.
Putting the brakes on innovation: the European MDR
It goes without saying that medical technology products should only be approved following careful testing and thorough review. Unfortunately, the European Union is set to unleash a regulatory monster from May 2021 onwards in the form of the MDR (Medical Device Regulation). In order to offer the medtech companies affected the regulatory services needed, the inspection agencies in the member states will require hundreds of experts who are simply not available on the market. This will slow down market access for medtech innovations.
Paving the way for innovations: the FDA Breakthrough Devices Program
The US Food and Drug Administration (FDA) is taking a more efficient route to promoting medtech innovations with its new program. The aim of this program is to facilitate faster access to market for innovative medtech products and diagnostic systems, provided that these assist patients with life-threatening or irreversibly debilitating diseases or conditions. The concept is designed to help patients quickly, without compromising on safety.
Faster US approval
The Breakthrough Devices Program is like an approval fast lane. The basic requirement for the FDA is that the new product provide for better diagnosis or more effective treatment of life-threatening or irreversibly debilitating diseases or conditions compared to the present standard. If a product is eligible, the medtech manufacturer is given extensive support throughout the entire Breakthrough Devices Program. The FDA provides a sufficient number of trained staff for this. These FDA experts not only provide written feedback, but are also available for meetings that can be held every 10 to 14 days. By comparison: such important meetings only take place every 75 days in the standard process.
The Breakthrough Devices Program not only covers the approval process, but also reimbursement via the Centers for Medicare and Medicaid Services (CMS). The US legislator has recognised that this requirement must also be met so that medtech innovations quickly get to where they are needed: patients. Without the breakthrough status, it takes at least two to three years for cost reimbursement for patients.
A real opportunity for innovative manufacturers
Three SHS portfolio companies have just discovered at first hand how well the Breakthrough Devices Program works. At the end of an intensive process with the FDA, the three companies – Neuro Event Labs, Salvia and Miracor – have been awarded the coveted Breakthrough Devices Designation. These innovative medtech companies have therefore cleared a major hurdle in gaining access to the US market.