Lean Entries Blog

Back to Entries Blog

New course makes startups ready for the market in the Danish and European health sector

13th April 2023

There can be a long way from a young company getting a good idea and it creating value in the healthcare sector. A new course in the Danish Life Science Cluster helps startups within life science and welfare technology to be ready for the market faster.

Lotte Overbjerg,  (Translated by Google Translator. See the original text in the Danish Life Science Cluster news.)

How far are we from the market? Is it worth thinking about new markets? – and how long will we need before our solution will actually create value for citizens and patients?

Through the Danish Life Science Cluster, 20 start-up companies have just started a digital process that should result in them getting their regulatory strategy in place. The goal is for the companies to be ready to meet the right standards and requirements for required certifications. The companies’ solutions range from medical software, to in vitro diagnostics and medical devices.

What the 20 startups have in common is that their solution is close to being developed, and the next step is to get ready for the complicated Danish and European healthcare markets. The considerations from the companies include:

I am considering taking the next step in my business, but I need more knowledge about opportunities and requirements before making my business plan. Stine Lee Bruhn Schrøder from the company Din Sundhedsguide.

We are considering the possibility of expanding our IVD reader platform for use in the diagnosis of certain critical diseases. So we need a strategy for how we can best meet the regulatory requirements – and an answer to how long it will take. Dino Ott from BluSense Diagnostics ApS.

Towards a regulatory strategy

We call the process that the 20 companies must go through The Regulatory Journey. It is a digital learning platform with a focus on medical software, medical equipment and equipment for in vitro diagnostics, which are regulated by the MDR or IVDR in the EU. The Regulatory Journey has been developed in collaboration between the Danish Life Science Cluster and the company Lean Entries. In the course, the companies learn to understand and organize their regulatory strategy.

Report leads to strategy

In the digital process, companies must, among other things, make clear whether their solution should be categorized as a diagnostic tool, an aid or used for prevention. Does the solution require electricity and does it use biological material? What training does the user need and what risks does the use entail? Etc., etc.

The 20 companies now have two months to complete the regulatory strategy generated by The Regulatory Journey’s digital tool, which is therefore the basis for the upcoming regulatory process.

The companies will then meet again and pitch their regulatory strategy to each other and to the group of regulatory experts who will provide feedback and further guidance. This part is an important step for validating the companies’ learning.

Saves companies time

One of the participants in the course, Jesper Sandholt, is about to start a new business, and he knows that it is necessary to have a clear strategy for the regulatory area.

We need to have clarified which challenges we will face, so that we can design our trials according to the risk group our product will end up in. It will save us a lot of time and work that we already have the regulatory focus now , so that we don’t have to reconstruct a lot later, says Jesper Sandholt from Gimtech ApS, which is developing a test kit for urinary tract infection that can be used at home.

Strengthens marketing and validation

Stine Lee Bruhn Schrøder from the company Din Sundhedsguide has developed a digital tool which supports the treatment she provides to her patients as a physiotherapist.

I am considering whether my solution can stand alone on a B2B market. But whatever I choose, this process will strengthen the marketing of my company and the validation of my solution, believes Stine Lee Bruhn Schrøder.

Dino Ott and BluSense Diagnostics already have a number of products on the market, and now they are considering the possibility of developing their IVD-reader platform to support biomarker quantification in critical illness.

The process has a very value-creating hands-on format, which forces us to have a critical view of our product and concept. It is a great advantage for us to have the opportunity to discuss our strategy with the associated consultants in order to identify the typical regulatory ‘pitfalls’ early in the development, says Dino Ott.


Posted by Heikki Pitkänen

Heikki Pitkänen
Heikki is backed up with 20 years of experience from the Medical Device industry, most recently from certification bodies, and is active in international standardization. He is passionate with the modern startup, business model and service design concepts and believes in co-operation between knowledgeable parties for reaching great achievements.

Phone: +358 20 773 9510

Follow on Twitter@Leanentries

Follow on LinkedinLean Entries Ltd