Regulatory

New Medtech Pilot Environment Established in Finland

The facility is unique in Europe and is focused on medical devices employing photonics technology.

A new facility in Oulu, Finland, will allow medtech startups and researchers to produce regulatory-compliant test devices that meet industry standards and manufacture validation-ready batches that satisfy CE and FDA requirements. Photo: VTT Technical Research Centre of Finland.

 VTT Technical Research Centre of Finland has opened a new pilot line environment for medical devices in Oulu, Finland. The facility aims to accelerate the commercialization of patient-friendly innovations.

This unique-to-Europe pilot environment enables fluent R&D&I processes offering novel technologies, prototype design, and manufacturing, fulfilling tight industrial quality requirements. 

VTT has invested €3.4 million in a state-of-the-art cleanroom and manufacturing equipment for the pilot line environment. The facility will produce small and middle-sized prototype series for advanced electronic, photonic, microelectronic, and microfluidic component and integration technologies. These innovations will foster the development of comfortable-to-wear, skin-like wearable sensors that continuously monitor cardiovascular diseases and microfluidics biochemical sensors for ultra-sensitive cancer diagnostics. 

Typically, when startups collaborate with research centers to develop novel medical technologies, they encounter issues in trying to bring the products into a regulated manufacturing environment. Without the appropriate facilities or partners, the journey of new innovations often stops. Large-scale pilot manufacturers tend to either focus on large-scale prototype production or only manufacture-completed designs. 

The journey from breakthroughs in medical technology to introducing devices to patient care is slow and expensive due to the complexity of the needed technologies and regulations. Furthermore, for device manufacturers, the high cost of setting up a pilot production line is a significant obstacle, and small prototype batches are not cost-effective. 

“Potentially life-saving breakthroughs are constantly made in research labs around the world, and many of them have the potential to make unpleasant health monitoring, medical examinations and procedures more patient-friendly. However, bringing these products to market has been a major pain point for the industry for decades due to challenges in scaling pilots and long certification processes. The pilot line we have established provides a state-of-the-art environment where development-phase prototypes can be manufactured following requirements for medical devices,” said Jussi Hiltunen, a research professor of Sensing Solutions at VTT. 

The pilot environment provides the ability to produce early test devices that follow industry standards and regulations, with the added capability to also produce batches large enough for validation needs. This accelerates and reduces the cost of transferring research innovations to the CE certification phase in Europe and the U.S. Food and Drug Administration approval process. 

Key focus areas for the pilot line include preventive monitoring of cardiovascular diseases, metabolic syndromes, and early cancer detection, as well as cancer recurrence. The new medical devices can, for example, continuously measure diabetics’ glucose levels more comfortably or detect cancer at an early stage from the skin or at a molecular level, improving prognosis. 

“Future health technologies will resemble thin, almost undetectable devices—almost like invisible tattoos. For patients whose condition requires daily monitoring or who are undergoing a monitoring process as part of their care, it provides a comfortable alternative to having to wear a clunky medical device that can catch on door handles and be bothersome in the shower, for instance,” noted Kari Rönkä, vice president of Sensing Solutions at VTT. 

Another important area for the pilot line is rapid diagnostics. Rather than sending a patient sample to a central laboratory that may be in a separate city, clinicians can perform a reliable test immediately at the site. This saves time and costs, and helps the patient get the proper care more quickly. A stretch goal for VTT is to help bring to market innovations that enable continuous and reliable measurement of the same precise parameters as blood tests without the need for lab visits or needles.

The pilot line began operating in early 2025. VTT will collaborate with medical device product companies and manufacturers as well as with universities and other research and healthcare organizations. VTT is a major technology developer and pilot manufacturer in Europe. It coordinates in the EU ChipsAct program, a PhotonMed-pilot manufacturing project with 39 participating organizations and a €32 million budget. The program strives to establish medical device compliant production capabilities for the latest photonics technologies.

VTT is a visionary research, development and innovation partner. The entity boasts more than 80 years of experience of top-level research and science-based results.

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