The MDR Fast Track service enables MedTech companies to reach the market faster by outsourcing the regulatory burden

All existing medical devices must be MDR (Medical Device Regulation) compliant before 2025. This puts pressure not only on companies that are obliged to thrive through the process, but also on authorities who are required to handle skyrocketing demand. There is a growing need for high-quality healthcare technology, and this can be met by new innovations and qualified companies in the Healthtech segment. However, the process for market entry may be inadequate and may not meet the safety requirements.

“Our common goal is to increase the quality of peoples’ lives. We believe that it is vital to get new technologies into use in healthcare, and this must happen smoothly without risking the safety of the end users or patients,” says Pekka Pohjosaho, Head of Quality and Regulatory Affairs at Innokas Medical.

“Innokas has a front-seat view of the obstacles and challenges MedTech companies are facing today. We felt that something needed to be done to make the path less cumbersome. We have 30 years of experience in medical device design and manufacturing and have mastered the industry’s quality and regulatory requirements. We have hands-on experience of being a responsible manufacturer, good relationships with the relevant stakeholders, and the capabilities to extend this know-how to the benefit of other industry players,” continues Pekka Pohjosaho.

During last year’s strategy renewal, the company decided to act and to start developing a service that would provide customers with a shortcut to MDR approval. With the MDR Fast Track service, Innokas will assume the role of a responsible manufacturer as well as fulfill obligations and implement MDR compliance. The customer is free to focus on their core competences and on the activities where they excel. At minimum, the customer must be able to develop the idea and have the capability to prepare product sales, marketing, and distribution, and Innokas Medical can take care of the rest.

“The ownership of the product and intellectual property rights will always remain with the customer, and the product is also always sold under our customer’s brand. It is in our shared interests to achieve compliance with a reasonable amount of work and more quickly than traditionally. The goal is to enable our customers to reach a profitable, successful, and growing business,” says Janne Kostamo, Innokas Medical CEO.

In Europe, some companies already offer responsible manufacturer’s services. In its extent, the MDR Fast Track is a new concept in the Nordic market area. Innokas Medical is already piloting the service with customers.

”We can see that the service is a great asset in speeding up Healthtech innovation in the Nordics and in encouraging more companies to start developing new and intriguing medical technology solutions. MDR compliance and the regulatory field in general is considered intimidating at best, and in the worst-case scenario, it can even deter some companies entirely. This does not need to be the case. With MDR Fast Track, companies have the option to outsource the regulatory burden and to concentrate on creating great solutions,” summarizes Pekka Pohjosaho.

More information

https://www.innokasmedical.fi/mdr-fast-track/