The Gap Between Good Tech and Actually Using It with Stéphane Tholander
Stéphane Tholander is a chemist by training who has spent fifteen years building digital health companies in Europe. He co-founded Sybil Tech, the first French company to receive CE marking in class 2A under the new medical device regulation, founded Agora Health to reduce time to market for digital medical devices, and launched AppThera, a platform for prescribing digital therapies. He is currently vice president of France Biotech overseeing digital health.
The conversation covers the structural reasons digital health tools fail to reach patients, what the European regulatory environment produces that the US market does not, and the specific design decisions that closed the gap between a digital therapeutic prescription and a patient actually using the tool.
The Payer Is Not the User
In healthcare, the person who pays for a tool is rarely the person who uses it, and the person who uses it is rarely the patient it is supposed to help. That misalignment sits upstream of most adoption failures. Purchasing decisions get made by administrators evaluating cost and operational fit. Clinicians are asked to use tools they had no role in selecting. Patients are handed prescriptions for things nobody has made easy to access. Each stakeholder has different incentives, different constraints, and different definitions of what success looks like.
Building without mapping all three is how you get tools that clear every procurement hurdle and still never reach the patient.
The Prescription to Download Gap
AppThera was built to close a specific gap. Digital therapeutics were available, some were reimbursed through France's PECAN framework, which provides a reimbursement pathway for remote monitoring solutions and digital therapeutics across all indications, and physicians still were not prescribing them. When they did prescribe them, data from the US and German markets showed that only half of patients went to the app store and downloaded the app.
The prescription existed. The reimbursement pathway existed. The clinical evidence existed. Fifty percent of patients never made it to the intervention.
AppThera's response was systematic friction removal at every step between prescription and use. A vetted catalog structured consistently so GPs with ten to fifteen minutes per patient did not have to evaluate individual tools or meet with representatives from each app. Presenting AppThera as a single marketplace category removed the cognitive load of evaluation from an already overloaded clinician. A simple logging system. Integration into national healthcare IT infrastructure, including patient social security cards and physician professional cards, so prescribing took one or two clicks. Confirmation sent back to the physician when the patient completed the download. The result was more than 80% of patients reaching the app.
That gap, from 50% to 80%, is a design outcome. It is what happens when you map the full patient journey and remove obstacles rather than assuming motivated patients will navigate friction on their own.
What High Regulatory Bars Produce
France's reimbursement pathway for digital health is demanding. CE marking, compliance with national IT healthcare regulations, and clinical evidence requirements that in most cases mean randomized controlled trials showing measurable impact on organizational outcomes or quality of life. The bar is high enough that as of this conversation, none of the digital therapeutics seeking full reimbursement had yet succeeded.
That sounds like a barrier. It is also what produces trust. When something clears that bar, physicians have a reason to believe in what they are prescribing. Patients have a reason to use what they have been prescribed. The evaluation has already happened.
The US market operates differently. The FDA does not regulate every category of digital tool, the market is crowded with unvetted solutions, and neither clinicians nor patients have a reliable mechanism for distinguishing what works from what does not. The result is not more adoption but more paralysis. Clinicians faced with hundreds of tools and no vetting framework default to using none of them. More access, less confidence. France has less access and more confidence. High bars slow entry and also create the conditions for sustained use once entry is achieved.
Regulators Are Always Catching Up
The notified bodies responsible for EU medical device audits, independent certification companies in each country rather than a centralized body like the FDA, had to learn how to apply a physical device framework to software in 2021. APIs, autonomous systems, embedded software: none of it fit cleanly into existing categories. Everyone learned together.
The same dynamic is playing out now with the AI Act and generative AI. Regulators are working out how to certify LLMs in 2025 and 2026 using the same process they used to figure out software medical devices four years ago. The cycle repeats. The organizations that build well in this environment invest in clinical evidence before the framework requires it, because the framework will eventually require it.
The Catalog Principle
The most transferable insight from AppThera's model is the catalog approach. A single vetted gateway, consistently structured, integrated into existing workflows, requiring minimal additional steps from the clinician. The right thing to do made into the easy thing to do.
This principle applies everywhere. Clinical decision support tools that get used are the ones that fit existing workflows rather than adding to them. AI tools that achieve sustained adoption are the ones that remove burden rather than creating new tasks. The technology does not matter if the path to using it is harder than the path to not using it. Remove the friction and the behavior follows.
What Europe Is Still Building Toward
CE marking creates a regulatory passport that opens EU markets once, which is genuinely valuable. But national IT requirements, country-specific reimbursement processes, and clinical evidence standards that have not been harmonized mean that building for Europe in practice often means building for each country in sequence.
France Biotech and European digital health leaders are pushing for harmonized assessment frameworks so that a tool developed anywhere can access the full European market at once. That work is ongoing. The willingness to name what is not working yet is what makes progress possible.
Principles for Healthcare Leaders
Map all three stakeholders before you build. The payer, the user, and the patient have different incentives and different definitions of success. Misalignment between them is where implementations collapse regardless of how good the technology is.
The prescription to download gap is real everywhere. A clinical decision does not equal patient access. Map the full journey from decision to use and remove friction at every step.
High regulatory bars create trust. Markets flooded with unvetted tools create paralysis. Clinical evidence requirements, however demanding, build the conditions for adoption by giving clinicians a reason to prescribe and patients a reason to engage.
Regulators will always be catching up. Invest in clinical evidence before the framework requires it.
Make the right thing the easy thing. Catalog models, integrated workflows, minimal additional steps. When you reduce the cost of doing the right thing, clinicians do it.
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Dr. Aditi Joshi is the CEO of Ardexia and host of the Ardexia podcast. She's an emergency physician who has built multiple digital health programs across three continents and specializes in turning failed digital health implementations into measurable clinical and financial success.