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A new roadmap for supporting healthtech innovation in Estonia is in the works. On 12 September, various stakeholders, including government ministries, industry, and academia representatives, signed a memorandum of understanding on creating a roadmap.
The agreement was signed by the Estonian Ministry of Social Affairs, the Ministry of Economic Affairs and Communications, the Enterprise Estonia (EIS), Tehnopol, the Health Founders Estonia, the Estonian Association of Information Technology and Telecommunications, Metrosert, and Tartu Biotechnology Park.
According to Jaanika Merilo, head of digital health and care at the Ministry of Social Affairs, the new healthtech innovation roadmap should be published within weeks.
Still, it has taken more than a year to complete. She said signing the memorandum is the first step in showing that all the stakeholders will work together toward creating a new ecosystem.
With such an agreement in place, the stakeholders will continue to map all of the players in the healthtech ecosystem, Merilo said, noting who is engaged in the ecosystem, their various roles, and what could be done to create a better ecosystem. She noted that this mapping process and the resulting roadmap should be ready by the end of September. In some ways, the “pieces of the puzzle” already exist; it’s now up to the various stakeholders to unify their plans.
“Everyone has plans for the next two years,” said Merilo. “We are glueing it all together.”
The same cause
Merilo has held her current position at the Ministry of Social Affairs since October 2024, but she joined the ministry in March 2023 and has been the head of the government’s e-Health Strategy since March 2024. She has extensive experience in digitalisation stretching back two and a half decades in Estonia and Ukraine, where she was advisor to the Deputy Prime Minister and Minister of Digital Transformation for six years. In this capacity, Merilo was once also a deputy mayor in the Ukrainian city of Dnipro, where she helped oversee a digitalisation project.
According to Merilo, discussions around the healthtech innovation roadmap grew from the government’s e-Health strategy, which was published earlier this year. While efforts had been made to support Estonia’s healthtech sector, she noted that a roadmap covering all system participants has not yet been developed.
“It has often been about just the government, academia, private companies, or associations,” said Merilo. “Everybody has been doing their own thing,” she said. “The value of the current roadmap is that all the stakeholders are engaged for the same cause.”
The concept of the healthtech innovation roadmap is to combine all of these activities into one roadmap, where each actor plays a complementary role and different gaps are identified and addressed. The government, for example, might provide legislative support, or so-called regulative and data sandboxes, that will allow entrepreneurs to trial new products and services before bringing them through demanding European regulatory processes. Other institutions might better support mentorship, research, or exporting Estonian products and services as part of the roadmap.
“It’s been amazing to see the ministries and associations at the same table trying to solve the same puzzle,” said Merilo. “We have a common goal, which means we can collaborate.”
A challenging sector
The goal of the healthtech innovation roadmap is to support person-centred healthcare. This can be achieved by providing high-quality health data to researchers and companies and supporting healthcare specialists with “new solutions, agile infrastructure and agile legislation,” Merilo said. Healthcare professionals, for example, need digital tools to achieve personalised medicine, and to produce these tools, there has to be support for innovation. She described such multi-sided support as the “cornerstones of the foundation” of the innovation roadmap.
One reason that healthtech is challenging in particular is that it is highly regulated, she noted. A company launching a business-to-business application can move from concept to first sales within months, whereas a healthtech startup might need years to sell a product for clinical use. Healthtech companies might need to access large amounts of data to develop their product, and then run clinical trials to have the data package necessary to submit to European regulators.
While much of regulatory compliance was self-certified under previous legislation, in recent years, the European Medical Device Regulation (MDR) and In Vitro Diagnostic (IVDR) Regulation have required companies to submit their products to notified bodies for clearance. Companies are also expected to provide up-to-date surveillance data after launching products. They will also have to meet requirements in the AI Act and European Health Data Space, which came into force over the past two years.
According to Merilo, the government plans to make navigating this regulatory scene easier for Estonian companies. “We understand that you cannot overregulate and expect innovation,” she said. “If it takes seven years to launch a new product, that’s not innovation.”
Piloting innovation
One way the government can help is by making tools and data accessible to healthtech companies, allowing them to develop and test their ideas before investing in clinical trials. The government could also create a regulatory environment enabling them to run their products in controlled, real-life environments. Companies could seek regulatory clearance for placement on the European clinical market if successful.
Efforts are underway to standardise healthcare data and make it more accessible for national and cross-border use. While electronic healthcare data has been collected for 25 years, it’s often fragmented. Estonia also has regions where Estonian is not the primary language used in healthcare. This issue must be addressed if data is consolidated and available to the healthtech community.
“Having high-quality standardised data that is smoothly yet safely available for secondary use is critical for creating new solutions and training AI,” said Merilo.
