FHI Tech Stories: Diagnotix managed to adapt to stricter European regulations in time

Diagnotix is making steady progress in the diagnostic laboratory market in the Benelux. In this episode of FHI Tech Stories we speak with Steven Boom, quality assurance manager at Diagnotix. He talks about the (niche) market in which Diagnotix operates, challenging European regulations and sharing knowledge through, for example, FHI.

By: Dimitri Reijerman

Diagnotix, based in Appingedam, is a specialist company active in the Laboratory Technology sector. Boom outlines the primary activities: “We make medical devices for in-vitro diagnostics. With our tests, healthcare institutions and hospitals can carry out examinations on body material, such as blood and urine, in order to detect or not detect certain substances. These could, for example, be markers for specific conditions or measurements aimed at specific medications. This way you can determine whether the doses are correct and the medicine is working.”

Diagnotix focuses mainly on LC-MS determinations, where LCMS stands for Liquid Chromatography-Mass Spectometry. That is a way to measure substances very accurately. “We specialize in determinations, especially for hospitals, in order to demonstrate certain processes in the body,” Boom explains. LC-MS technology is currently the highest achievable in medical diagnostics and is considered the 'gold standard'.

The company has existed since 2018 and Diagnotix now employs twelve people. Boom: “We are active in a fairly small market with only a few parties that make these tests. We do notice that new European regulations are causing parties to stop doing so. We try to distinguish ourselves further by delivering slightly higher quality.”

Impact of IVDR regulations

The regulations cited by Boom have a significant impact on the market, says the Diagnotix manager: “The European regulation for medical devices for in-vitro diagnostics (IVDR) has been applicable to our market since 2022. These European regulations apply to all European member states. In practice, this means that very high requirements apply in terms of safety and performance. As a manufacturer, you have to demonstrate the effectiveness of your product much more than in the past. In practice, you therefore need to conduct more studies to demonstrate clinical performance. For some companies, this has meant not recovering costs and sometimes divesting their diagnostics business altogether.”

But there are more consequences, Boom believes: “The IVDR also hinders us from quickly developing new products. In fact, we have to prove that our products work in whole new ways. In the past, a validation report was sufficient, but now you have to give a very specifically defined clinical purpose to a new product. As a manufacturer, you have to put yourself much more in the healthcare provider's shoes by very carefully prescribing what a product is intended for.”

Adapt and benefit

Diagnotix has been able to adapt to the stricter IVDR rules and is benefiting from this: “We have managed to capture a significant part of the Dutch market since our existence and Diagnotix is receiving increasing interest from abroad. We need to gain more brand awareness within the EU. Since the corona crisis is over, we can also go to international fairs again. We are now looking for distribution partners within the EU.”

As an FHI member, Diagnotix is now also actively sharing knowledge about the European IVDR rules: “We have been asked to tell something about the IVDR at FHI. Because there are many questions among manufacturers and suppliers about these regulations. That's why, for example, I participated in a webinar on this topic. We also became a member because we have gained knowledge about regulations in a very specific area. We also want to share this knowledge with other members who are active in this industry.”