Carmat announced on Tuesday (25 October) that it will resume production of the world’s most advanced total artificial heart. However, Stéphane Plat, Carmat’s CEO, told EURACTIV France he is concerned about the future of Europe’s MedTech sector.
Read the original article in French here.
Despite Europe boasting the world’s second-largest medical technologies industry after the US with an estimated worth of around €140 billion in 2020, Carmat CEO Stéphane Plat warned EURACTIV France that Europe may not keep that position for long, as innovation is expensive and “money is hard to find in Europe.”
French company Carmat manufactures total artificial hearts: implants that replace a person’s heart temporarily before transplantation of a real heart, or permanently in cases where such a procedure is possible.
The company, a leader in Europe’s MedTech field, has to date implanted seven of its hearts – five in Germany and two in Italy – since their commercialisation in July 2020.
Carmat announced on Tuesday that it will resume production, following a suspension of operations in December 2021 due to problems related to the quality of its products. The independent and certified body Derka gave the company a green light, meaning it can resume its activities.
However, Plat remains concerned about the sector’s future. “This question will arise for all the startups that will be created in Europe in the next three years: where should we go?” the CEO said, adding that competition, particularly from China and India, is rising.
“The Americans are resting on their laurels as leaders, and there is a strong push from the Indians, who are good with technology and have very low production costs,” said the CEO.
At the same time, “the Chinese are starting to take over a lot of start-ups,” Plat told EURACTIV France, explaining that he is “extremely worried” about the situation.
The risk is that therapies will cost more in Europe “if there is no innovation” and if “everything is purchased from outside,” he added.
Towards zero risk
Asked about the decline of the MedTech industry in France and Europe, Plat said that “there is less and less tolerance for risk in healthcare.”
“The competent authorities prefer that patients die without being involved in the decision, rather than giving them a chance to survive and be involved in a product risk,” the CEO added.
Regarding the risk of slowing down health innovation, the CEO also warned that “the competent authorities are responding to public pressure that has seized the issue,” before adding that “this society is going to be a barrier to innovation.”
On the side of the industry, the relationship to risk is different, however. “Our leitmotiv is to provide solutions. And we have to tackle risk,” Plat explained.
In June this year, EU health ministers criticised the European Commission at the EU labour council (EPSCO) for the slow implementation of two new regulations on medical devices (MDR), which they said led to fears of medical device shortages.
The EU executive then rushed to announce a series of measures to ease the transition to the new regulations.
No political will to help the sector
France is Europe’s second-largest market for medical devices, behind Germany, which is estimated at $30.7 billion according to the French healthcare association.
However, it may not be doing enough to stay on top of the competition, according to Plat.
To help the MedTech sector, the French government allocated €400 million as part of the recovery plan at the start of 2022, though, as Plat pointed out, “many Chinese are financing French companies.”
“Despite the repeated requests to the government, we must not delude ourselves, there is no political will to help the sector,” said Plat.
[Edited by Daniel Eck/Nathalie Weatherald]
