Templates create value in Life Science

When you take a look at DTU Science Park in both Hørsholm and Lyngby, the campuses are filled with Medtech, Pharma and Biotech startups and companies. At a closer look, you can also spot another type of companies that offer consultancy and IT services to these research-heavy engineering companies.

MyBlueLabel Compliance Services is one of these companies. MyBlueLabel combines decades of experience from Life Science industries and IT with digital innovation, offering software that fast-tracks regulatory compliance in Life Science companies, making the development and launch of new products easier and faster. In a world with standardized rules and requirements, it is not about tailored solutions. 
“One may be tempted to tailor solutions to the individual organization, but the regulations that Life Science companies must comply with follow the same fixed standards, no matter the company size. We have therefore developed templates that we update continuously, and we also share the most recent information and knowledge about regulatory demands. Our combination of software and consulting creates a very much needed overview and ensures that the approval process is smooth and secure,” explains Kenn Milton, CEO and founder of MyBlueLabel.

General Knowledge & Insights

Kenn Milton has a degree in Electrical Engineering from DTU and has been working in several large international IT and consulting houses as well as Life Science companies. Five years ago, he returned to Denmark and started MyBlueLabel Compliance Services, which is located at Agern Allé 24 in DTU Science Park.

“All the large Life Science companies have for several years invested in a number of ​​different programs and systems: one system for document management, another system for changes and testing, a third one for deviations and a separate system for testing and verification — and I could go on and on,” says Kenn Milton.

 MyBlueLabel provides one system that leads you through the entire process, and since many large companies have already invested a lot of money and resources in systems for various reasons, we typically appeal to medium-sized MedTech, Pharma and Biotech companies. We have also chosen to assist smaller companies and especially startups, for whom approval processes can be extremely challenging. The complexity of requirements can be unmanageable for a small organization with little experience to draw on.”

MyBlueLabel Compliance Services has therefore initiated a dialogue with DTU Science Park’s Incubator Futurebox, with the aim to explore the possibilities of a collaboration that can benefit startups in the DTU Community.

EU regulations to be tightened

The complexity and requirements for Life Science companies will increase even more from May, when the new EU regulation for Medical Devices called MDR will be enforced.

“It will especially affect the requirements for Digital Health, Post Market Surveillance and Risk Management, and it further contributes to the trend we have witnessed during the recent years. More and more companies are going directly to the United States because it has become more difficult to obtain approval in Europe. It used to be the other way around, so it’s a spectacular development,” says Kenn Milton.

Recently in fall 2020, Kenn and his coworkers advised four Life Science startups that participated in the Danish Tech Challenge in Futurebox in Lyngby.

MyBlueLabel offers compliance services, consultancy and digital solutions that set new global standards. MyBlueLabel specializes in optimizing approval processes for life science companies to reduce their time to market for new products. The company was founded in 2012 by CEO Kenn Milton.

Kenn has worked for several large companies: Novo Nordisk, Leo Pharma, Novartis og Ambu. Later, Jacob Knudsen joined as Partner and the company employees 17 persons. Just in 2020 and in 2021 MyBlueLabel has helped +20 aspiring SMEs with scale-up potentials such as Airofit, GeneTelligence and MC2. Furthermore, MyBlueLabel advises start-up companies and has recently partnered with Danish Tech Challenge where they advised four life science start-ups.

The article was originally published in Danish in DTU Science Park News.