The common objective of French Medtechs is to deploy their technology internationally. The reason behind their desire to internationalize is to tackle a huge market, take advantage of consumption habits and regulatory aspects, as well as to search for global partners.
American healthcare culture
Americans are accustomed to paying for their health care, and according to a recent analysis by Commonwealth Fund report, they spend nearly twice as much on it than Europeans. This situation is one of the factors driving several French MedTechs to expand to the United States. The adoption of new technologies is faster in the USA compared to Europe. Also, by expanding to the US, niche solutions have the possibility of becoming an international benchmark. All these together make a conducive environment for accelerated sales and development cycles, leading to commercial success.
Strengthening of the CE marking
Regulation is another aspect that is an encouraging factor, particularly with regard to medical devices. The United States is a single market, whereas the European Union is the outcome of a market association with occasionally conflicting regulations. Moreover, on May 26, 2021, European regulations were considerably strengthened which led to a certain alignment of the requirements with those of the Food and Drug Administration in the United States and with less clarity in terms of process. The French MedTech can take advantage of this rebalancing in terms of regulation and settle in the United States very soon even just after their founding. A testament to this is Paris-based AVATAR MEDICAL whose CEO, Xavier Wartelle, in a Maddyness article, said that they quickly launched on the spot, without waiting to be well established in France, to be able to face the real competition from day one.
While there are certain enticing opportunities in the US MedTech space, the U.S. healthcare system is extremely complex and heavily regulated. It is ridden with separate rules, funding, enrollment dates, and out-of-pocket costs for employer-based insurance, private insurance from healthcare.gov, Medicaid, and Medicare, in all its many pieces. That is why French Medtech startups should absolutely get support in their US development project. If that is the case, don’t hesitate to reach out to us