Regulation as a lever in the research project

 

11 November 2025

The goal of the day is clear: to demystify regulatory requirements and demonstrate how early insight into certification and legislation can strengthen the chances of bringing health technologies safely and efficiently from idea to market.

At the regulatory theme day, participants are equipped to navigate the regulatory landscape through concrete examples, hands-on exercises, and experience-based presentations.

Regulation is the next step in the research project

Medical doctor and PhD student Frederik Duedahl is part of the RAPTOR project, which is researching an AI model for the detection of lung cancer, developed in collaboration between OUH and the University of Southern Denmark. The project is currently in a phase where regulatory aspects are highly relevant, yet can seem overwhelming.

- My biggest takeaway is that it is not solely my responsibility as a researcher. We need to ensure that we seek support for this part of our project. As a researcher, you often take pride in your work, and it can feel like a failure if there is something you cannot handle yourself. But it is not, and that is why initiatives like MedTech Odense, which bring together competencies and guidance, are such a great idea, says Frederik Duedahl, who works at the Department of Cardiothoracic Surgery at Odense University Hospital.

His next step is to seek support to move the RAPTOR project forward in the regulatory process.

Increased knowledge can strengthen communication of regulatory matters

Lone Boysen Lauridsen works with innovation and digital skills training at the Learning and Research House at the Hospital of Southern Jutland. She is part of an innovation service for staff with promising ideas, where they can receive advice and guidance on how to approach their ideas.

 

There are many requirements that need to be met. It is important that employees can receive advice and support to bring their ideas forward, so they do not stall.

Lone Boysen Lauridsen, Learning and Research House, Hospital of Southern Jutland

 

She keeps up to date with developments in regulatory requirements, which is why she attended the theme day. She is particularly interested in the RegMetrics platform presented during the event.

- It is important to have support tools – both for those of us who advise on projects and for the staff who carry them out. There are many requirements to comply with. It is essential that employees can receive advice and support to bring their ideas forward, so they do not stall, she explains.

Another participant interested in the digital platform is Kirsten Klejs Breiting from the research support unit OPEN at OUH, which assists healthcare researchers in the Region of Southern Denmark with their research projects.

- We are interested in finding out how we can best support researchers – both in terms of classification and in relation to the legislation and standards they need to follow, she says.

- We need to put the digital platform into use so that researchers can progress several steps further before they come to us.

Regulation can be integrated into applications

Although it may appear to be a barrier, regulatory considerations can be transformed into a lever and a guiding element in research and innovation projects.

 

"You need to start looking at regulatory aspects early, as there are many elements within regulation that you can use in funding applications.”

Rita Hendricusdottir, CEO, RegMetrics

One of the day’s speakers is Rita Hendricusdottir, CEO of a startup that has developed the RegMetrics platform. The digital platform guides innovators through the early regulatory stages and helps build a strategic approach in projects.

She highlights one point that is particularly important for academics working on developing medical products or software.

- You need to start looking at regulatory aspects early, as there are many elements within regulation that you can use in funding applications. There are specifications for how you can conduct testing and which requirements you need to meet when developing your product. Thinking about regulatory aspects early can therefore save you a lot of time later on, she says.

MedTech Odense focuses, among other things, on regulatory aspects and works to increase the sharing of knowledge and know-how in this area within the field of health technology.

The RegMetrics platform will soon be available to employees at SDU and in the Region of Southern Denmark. If you are an employee, you can create an account using your rsyd or SDU email.