MedTech: why scaling up needs the United States
- Despite solid scientific evidence, AI in healthcare is struggling to become part of routine clinical practice, as illustrated by Volta Medical, a Marseille-based start-up specialising in cardiology.
- The US market is virtually unavoidable: a cardiac ablation procedure is reimbursed at $26,000 there, compared to €7,000 in France, creating a net margin four times higher.
- Europe remains fragmented — a single CE mark, but as many reimbursement systems as there are countries — compared to a unified and far more lucrative US market.
- The FDA assesses the scientific rigour of a submission, whilst European bodies merely verify regulatory compliance, thereby stifling innovation.
- Success in MedTech requires a combination of clinical robustness, entrepreneurial capability and a business model capable of breaking with the sector’s traditional logic.
The technological maturity of artificial intelligence in healthcare is now increasingly evident; its potential having been demonstrated by numerous research findings. Yet its adoption in routine care remains rare with few tools entering clinical practice, whilst doctors’ scepticism and patients’ concerns persist. Understanding why and how a few players manage to cross this threshold has become a major strategic challenge for digital health. The experience of Volta Medical, a Marseille-based start-up specialising in cardiology founded by Théophile Morh Durdez in 2016, offers an illuminating example in this regard.
An algorithm at the service of the electrocardiology
Volta Medical has tackled one of the most persistent problems in interventional cardiology: the treatment of persistent atrial fibrillation (AF). This arrhythmia is the most common in the world and affects around 12 million patients in Europe. It is characterised by a disordered quivering of the atria caused by disturbances in the heart’s electrical conduction. It significantly increases the risk of stroke, dementia and heart failure. In the most complex cases, which account for three-quarters of patients, catheter ablation treatment has a long-term success rate of between 50–60 %, due to limited reproducibility between practitioners.
Cardiologists specialising in arrhythmias at Saint-Joseph Hospital in Marseille had developed a real-time analysis technique using electrocardiograms, enabling them to identify the areas requiring treatment on a personalised basis. Whilst the results were promising, the technique relied entirely on their visual perception and remained non-reproducible. “The aim was to replicate what the doctors were doing with their eyes, but using a machine, to make the technique reproducible,” summarises Théophile Morh Durdez. Then a young engineer from Ecole Polytechnique (IP Paris), he coded the first prototype from the very office of the electrophysiology department, after having observed more than a hundred ablations. “It’s a collaboration between two worlds – the world of medicine and that of engineering,” he emphasises. This consistently encourages Volta’s engineers to spend time in the operating theatre and attend cardiology conferences.
To become profitable, on average, start-ups developing medical devices raise around $150 million.
By 2025, Volta employed around 100 staff, has raised over €90 million, and 2,400 patients have been treated at its partner centres. Its Tailored AF randomised trial, published in Nature Medicine, demonstrates an 18% increase in long-term success rates among patients with persistent AF.
The law of margins: is the US market unavoidable?
“To become profitable, on average, start-ups developing medical devices raise around $150 million,” says Théophile Mohr Durdez. “This obviously alters the company’s governance, which is then entrusted to venture capital funds.” Beyond this dependence on investors, it is the structure of the markets themselves that creates the decisive asymmetry.
Reimbursement for an AF ablation procedure amounts to $26,000 to $29,000 in the United States, compared with around €7,000 in France. As US operational costs are barely twice as high, the net margin there is structurally four times higher for the same volume. Added to this is the fragmentation of the European market: a single marketing authorisation (the CE mark), but as many reimbursement systems as there are countries, each with its own language and rules. Faced with a unified and better-paying US market, a strategic choice is therefore necessary. For Volta, this translates into a marketing investment five times greater than in Europe: $5 million a year across the Atlantic, compared to €1 million on the continent. Although reimbursement levels are much higher in the United States and this has a significant impact on the entire medical device industry, Théophile Mohr Durdez notes that this does not necessarily make the American system desirable, both from a societal perspective and in terms of the efficiency of the healthcare system.
This American focus does not, however, mean abandoning European roots. Whilst at Volta, half the management team is American and the chairman of the board is Californian, the headquarters remain in Marseille. The European ecosystem remains highly conducive to clinical research. The Tailored AF study bears this out: 70% of its patients were European, and the quality of research conducted in France and Germany is excellent. Developing in Europe and prioritising commercialisation in the United States is an optimal model, according to Théophile Mohr Durdez.
Nicolas Castoldi, Deputy Director of Innovation at AP-HP, observes the paradox this reveals at the systemic level: “On the one hand, I have researchers leaving the United States; on the other, I have French start-ups heading there. Each of these two movements is rational, but we must try to reflect and work together.”
This trend takes on particular significance in light of the Choose France for Science programme, launched in May 2025 by the French President following the scientific policy introduced by the Trump administration. Nicolas Castoldi, who is overseeing its development, offers a surprising initial assessment: of the first fifty successful applicants selected, nineteen are American nationals. “We naively thought this would primarily be a programme for European researchers wishing to return to Europe,” he admits. “In truth, an exodus has begun in the United States, particularly in the field of health sciences. It is the start of something — not a collapse, but it is real.”
Two regulatory hurdles Europe is struggling to overcome
In Europe, authorisations are issued by private, for-profit notified bodies, whose approach is to verify compliance with a regulatory text point by point through standards. “The question is not: is this scientifically credible? The question, for the European auditor, is: do the company’s claims comply with the regulations and, by extension, can I shift my responsibility onto the company?”, explains Théophile Mohr Durdez. The FDA, the Food and Drug Administration, as a public body, on the other hand, questions the overall scientific consistency of the dossier, since its mission is to improve the health of American patients and not to grow a business.
On the subject of reimbursement, Patrick Jourdain, CEO of Ramsay GDS, also defends France on a point that is often underestimated: research funding. Ramsay thus has a private clinical research unit, validated and funded by the Ministry, which enables its clinicians to publish around a thousand articles a year. But the difficulty arises precisely when innovation has to enter the market. “In France, the question is how you fit a new payment into an already very constrained tariff. Basically, it reduces your margin.” In the United States, the bundled payment mechanism creates the opposite effect: a second stay for the same condition is billed to the facility where the first stay took place. American hospitals therefore have a direct financial interest in investing in anything that improves long-term success rates.
Scaling up a digital innovation in healthcare therefore depends neither solely on the quality of the algorithm nor on the volume of clinical publications. As Patrick Jourdain puts it, it involves simultaneously building ‘two pillars’: clinical robustness, which underpins therapeutic legitimacy, and entrepreneurial capacity, which structures access to markets and capital. Nicolas Castoldi adds a third dimension: that of the business model itself: “There are two main models in MedTech — the single-use device, or the new, even more expensive version of the same product. What’s interesting is the challenge of breaking these models by offering things that are potentially much cheaper and more effective.” It is precisely this challenge that Volta is attempting to meet — and whose sustainability, still a matter of debate, could redefine the rules of the game for a whole generation of digital health innovators.
