New medtech pilot environment established in Finland aims to slash market entry time

These enable the development of comfortable-to-wear, skin-like wearable sensors for continuous monitoring of cardiovascular diseases and microfluidics biochemical sensors for ultra-sensitive cancer diagnostics.

Jussi Hiltunen is Research Professor, Sensing Solutions at VTT.

Hiltunen said: “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.”

Typically, when innovative startups collaborate with research centres to develop novel technologies for medical applications, they tend to run into issues when the time comes to bring the products into a regulated manufacturing environment.

Without the appropriate facilities or partners, the journey of new innovations often comes to a halt.

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.

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 speeds up and reduces the cost of the process of transferring research innovations to the CE certification phase in Europe and the FDA process in the United States.

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 the glucose levels of patients with diabetes more comfortably or detect cancer at an early stage from the skin or at a molecular level, improving prognosis.