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EF: If 2020 was the year of diagnostics and 2021 the year of vaccines, what do you think will be the key healthcare talking points for 2022?

2022: In terms of medical devices, 2022 will be about medical device regulation (MDR). The MDR is a new regulation that applies to all medical devices, but particularly to legacy devices that must be transferred from the old system ((AI) MDD) to the new system.There are massive problems with the capacity of the system to migrate all products. To find pragmatic solutions, we are meeting with the European Commission, the German government, and other national governments in Europe. The impact of the current situation will lead to losing about 30% of the products in the market and even 10% of European companies being left out of business. There are approximately 450 thousand medical devices under the current (AI)MDD system, which would mean losing 150 thousand different medical devices in Europe.

In Germany, 83% of all MedTech companies are small and medium-sized companies. Right now, around 30% of them still don't have access to a notified body, which means they are in danger of running their business. This was already a big challenge last year, and this year it got even more relevant as companies must decide now which products will be placed on the market and which not.

Regarding new innovative products, we see companies preferring the US market rather than placing the products on the market in Europe, which is making us fall behind in terms of access to better products, especially with regard to patient care.

Moreover, with the COVID-19 pandemic and the current situation in Ukraine, costs are rising significantly, and the supply chain is being challenged. In Germany, most companies have fixed contracts for reimbursement, which are not flexible and cannot be changed. These mostly low-priced contracts, in combination with the current high costs for raw materials, intermediate products, and energy, lead to exceptional economic situations.

On top of that, there is a third big topic: the Green Deal of the European Commission and the goal to make Europe the first climate neutral continent. There is a program with more than eighty directives and regulations coming up for the industry to be more sustainable—with massive effects and impacts. Besides the MDR, this program is a big challenge for the industry! Therefore, we are working within BVMed on a sustainability strategy as well. These three topics are the biggest concerns we are facing in Germany and all over Europe.

EF: Could you elaborate on the sustainability strategy you have?

MPM: We have commissioned a groundbreaking study on the MedTech industry's economic, ecological, and social footprint in Germany. The methodology of the industry's social and ecological footprint is based on the standardized calculation of the Value Balancing Alliance in consensus with the World Trade Organization and the G20. Only a few companies have calculated the social and ecological footprint for their internal records so far. We are the first association worldwide to do an analysis of the whole sector in a country, and we are very proud of this. Once published, facts and figures will demonstrate where our work is being well done, where we should improve, and where we can and must move forward. But for all improvements, we first must know where the problems are so we can then put our efforts to improve where they are needed the most to obtain a climate-friendly and sustainable system.

With the Green Deal in Europe and a strong Green Party at the federal level and also in the regional governments (Bundesländer), the focus is set. Politicians are advocating policies that save the environment and stop climate change.

In Germany, we have a national Supply Chain Due Diligence Act that will be effective in January 2023. A similar act is being proposed at a European level, but still as a draft. In Germany, hospitals that buy from medical device companies already ask for the social and ecological footprint as part of their contracting process.

With the information from our study, companies will be able to measure their footprint and use it as a benchmark. For the first time in Germany, we can compare and see how we are performing with regard to our ecological and social footprint. Once we identify where the problems are, we can work on a strategy and act on it.

It is exciting to be frontrunners for transparency and a willingness to improve.

September 2022