Hard at work

In the third quarter, Biohit focused on the basics.

Our toiling has naturally been guided by the strategy published in November 2023. In other words, we have been laying the groundwork for our global conquest, but with our feet set firmly on the ground.

The FDA project of GastroPanel in the US is progressing as planned. We are cooperating with local partners and our goal is still to obtain a marketing authorisation during 2026. In addition, since the spring we have been working on another significant market launch which, if pulled off, would lead to sales starting from the middle of next year. On top of these two big fish, we are working on numerous smaller fry.

A lot of effort has also been put in to expanding the product portfolio. We have eased the friction resulting from regulation through product development investments. We have invested in talent and equipment alike. Furthermore, our organisational structure has been reformed to improve the strategic and operational performance of product development.

Managing all dimensions of product development is especially important right now when legacy products are being brought into compliance with the IVDR requirements. The IVDR, or In Vitro Diagnostic Medical Devices Regulation, is an EU-level regulation. New diagnostic devices have had to be IVDR-compliant since 26 May 2022. The so-called legacy devices that were on the market before this must be brought into compliance within the transition period. Depending on the classification of the devices, the transition period runs until the end of 2027, 2028 or 2029.

This task puts a strain on the entire health technology industry. For scale, according to the European Commission’s estimate, 70% of the clinical decisions made by doctors are made by using devices covered by the IVDR. The majority of these are legacy products rolled out before 26 May 2022.

The challenge for legacy products is that not all the data and documentation required by the new IVDR necessarily exists. This means that tests, studies and new documentation are needed to demonstrate compliance. In other words, the IVDR constitutes retrospective product development that ties up a lot of resources. The magnitude of the task seems to have come as a surprise to the regulator, and it has been necessary to extend the IVDR deadlines along the way.

The IVDR workload has weighed heavily on operators in the sector. At Biohit, new R&D investments, a comprehensive cooperation network and prioritisation ensure that product development comes up with new products as well, in addition to the job that is the IVDR. In the current regulatory environment, the timeline from idea to cash is measured in calendar years. That is why we have to have enough balls in the air at all times.

The mundane, basic work easily flies under the radar. However, it is precisely this day-to-day toil that allows us to get into position and, when the time comes, knock it out of the park. As the old adage goes: “Luck is what happens when preparation meets opportunity”.

One good example of a win that we worked long and hard for is South Korea. We primed the market for GastroPanel for years and, gradually, the work done is beginning to show in the revenue as well.

Along with our own actions, strong global growth drivers add to our faith in the future. The population is ageing, gastrointestinal problems are common and there is a dire shortage of healthcare resources.

In other words, in the small Roihupelto industrial area of Helsinki, we are working on solutions to global problems.

All is still well at Laippatie.

Jussi Hahtela

CEO

Biohit Oyj