05-10-2026
News
VR and XR solutions are already demonstrating their potential in healthcare. But developing a technology that works is only part of the journey. Getting it reimbursed, adopted and, ultimately, into the hands of patients is another challenge altogether. During the first VR Health Champions webinar, experts and health-tech companies explored why market access remains one of the biggest hurdles facing immersive healthcare solutions in Europe.
The webinar, “If VR works, why isn’t it reaching patients?”, held on 18 September, brought together market access expertise with the first-hand experience of companies currently navigating European healthcare systems. Cristiana Costa from Instituto Pedro Nunes (IPN) opened the session by introducing the VR Health Champions project and its support for healthcare VR and XR companies across development, clinical validation, regulatory support and market access. She also highlighted the project’s upcoming bootcamp and funding opportunity for SMEs, which is currently being shaped around the needs of the market. Michael Barngrover from XR4Europe moderated the discussion, which then built on the findings of the VR Health Champions Market Access Landscape Report, presented by András Perényi from Syreon Research Institute, before moving from theory to practice with insights from Cornel Amariei, founder and CEO of .lumen, and Maciej Stanuch, CEO of MedApp.
The message was clear: a good technology alone does not guarantee patient access.
A working solution is not enough
For healthcare innovators, reaching the market is very different from simply launching a product. In many European healthcare systems, patients do not pay the full cost of medical technologies themselves. This means that developers often need to convince public healthcare payers that their solution delivers sufficient clinical and economic value to justify reimbursement. This is where Health Technology Assessment, or HTA, becomes critical. Developers need evidence not only that their technology works, but also that it provides value compared with existing options. For VR companies, however, the process becomes complicated very quickly.
“Developers who are developing VR technologies for healthcare, even if they have a very promising technology, face a labyrinth when it comes to market access.” András Perényi, Syreon Research Institute
One reason is simple: most existing reimbursement frameworks were not designed with immersive technologies in mind. Traditional HTA systems have largely developed around pharmaceuticals, medical procedures and conventional medical devices. Digital reimbursement pathways are emerging, but many are designed primarily for software or mobile applications. VR often falls between these existing categories. It combines software and hardware, and in healthcare its therapeutic effect may depend on both. Some solutions are designed for home use, while others can only be used in clinical settings.
One Europe, many routes to reimbursement
The Market Access Landscape Report highlights just how fragmented the European picture remains. According to the report, only Germany, France and Belgium were identified as having dedicated national reimbursement pathways for digital health technologies. Other countries offer more limited schemes, for example at regional level or for selected categories of technology, while in many European markets no general dedicated digital reimbursement pathway could be identified. And even where a pathway exists, that does not necessarily mean a VR solution will qualify. For companies looking to expand across Europe, the consequence is significant. Each market needs to be understood individually.
Cornel Amariei, .lumen captured the challenge in one sentence: “We have one regulation, but we don’t have one market. That’s the reality.”
European medical device regulation may be harmonised, but reimbursement, purchasing decisions, local relationships and expectations around clinical evidence remain far more fragmented. Amariei gave the example of .lumen’s clinical investigations. Although studies carried out in Romania should formally carry the same weight elsewhere in the EU, the company is repeating clinical investigations in Germany to strengthen its position in that particular market. Market access, therefore, is not only about satisfying a formal process. Local trust, institutions and context matter too.
For start-ups, focus matters
If every European market works differently, where should a start-up begin? For Amariei, the answer comes down to two things: clustering and ranking. Rather than automatically targeting the largest markets, companies should look at reimbursement pathways alongside their own resources, fundraising position, business development plans and technical readiness.
“As a startup, you can’t do everything. Even as a big company, you can’t do everything, but specifically as a start-up, focus is incredibly important.”Cornel Amariei, .lumen
The biggest market may not be the easiest or most suitable place to start. A smaller market may offer earlier traction, while larger and more complex markets can become longer-term targets. Maciej Stanuch, MedApp shared a similar view from MedApp’s experience:
“As a start-up, you cannot choose to be everywhere. You need to start somewhere.”
That means choosing markets where a company understands the ecosystem, has access to the right expertise or already has relationships that can help it navigate the system.
The details can change the whole pathway
Another theme emerged strongly during the discussion: market access cannot be separated entirely from regulatory and product strategy. For medical technologies, the way a product is described can affect its classification, evidence requirements and certification process. Stanuch explained how significant this can become. In MedApp’s case, a feature showing the precise positioning of a needle changed the regulatory classification of the planned product from Class IIa to Class IIb. The company ultimately decided to separate the feature into another product rather than increase the regulatory burden and cost of its existing solution. His broader point was that companies need to understand these implications early. From an investor perspective, this also matters because certification and reimbursement directly affect when a company can realistically begin generating revenue.
Think about access before the product is finished
This does not mean designing a product around reimbursement rules. Perényi stressed an important distinction during the discussion: companies should not change the core product simply to fit today’s reimbursement framework. But they should understand early what evidence, documentation and tests will be needed later. It allows companies to consider market access alongside product development and fundraising from an early stage. If they wait until the technology is finished, they may discover that the clinical studies or usability testing they have already completed do not provide the evidence required for reimbursement. Repeating that work can be far more expensive than preparing for it from the beginning. Perényi clarified that the goal is not to design the product around regulation, but to plan the development pathway and evidence-generation strategy with future market access in mind.
The challenge is not proving that VR has value
Perhaps the most important conclusion from the webinar is that the conversation around healthcare VR is evolving. The question is increasingly not whether immersive technology can create value, but how healthcare systems recognise that value and how companies can demonstrate it in a way that leads to adoption and reimbursement.
As Perényi put it: “The problem is with the processes of how to prove that the given technology can deliver this value to the patients and to the society.”
That gap between a promising technology and a solution that patients can actually access is precisely where projects such as VR Health Champions aim to make a difference. The project supports European VR and XR healthcare companies across development, clinical validation, regulatory strategy and market access, bringing together 19 partners across nine countries. And the conversation will continue.
What do XR healthcare innovators need next?
To better understand the needs and challenges faced by early-stage XR healthcare innovators, VR Health Champions is currently running a Market Validation Survey. The findings will help shape a future accelerator programme and ensure that the support offered reflects the real needs of companies working in this space. The survey takes just 3–5 minutes to complete, and we invite XR healthcare innovators and other relevant stakeholders to share their experience and perspective.
Take part in the VR Health Champions Market Validation Survey:
https://innostars-nexus.replit.app/public/surveys/vrhc-bootcamp
