Change as a stepping stone – sailing through challenges with the right partner at your side

These are turbulent and disturbing times. With no other alternative, we have gradually become accustomed to the pandemic that has dominated the news, our work and our personal lives for two long years. All this time, the medical sector has been very much in the public eye. Dramatic cases of severe illness, research into medicines to relieve symptoms, racing to find the right treatment and protecting hospital personnel from infection were just some of the critical aspects. Now there seems to be light at the end of the tunnel. Nonetheless, apart from the limited human resources, other effects are becoming increasingly apparent. Medical devices are in short supply due to the lack of raw materials and because established delivery routes have been cut off. Exorbitant price increases are inevitable. The situation is exacerbated by the war in Europe, right on our doorstep. The conflict in Ukraine has caused our deepest fears to surface, prompting us to question our actions and set new priorities.

We too have noticed the feeling of unease and uncertainty in the industry. At the end of April, after a two-year break, the German Cardiac Society’s annual conference took place in person in Mannheim once again, with additional digital options. Over 10,000 attendees seized the opportunity to present themselves, participate in discussions, find out about the latest trends and generally exchange notes. We couldn’t wait to finally showcase our business concept face to face. After all, MedtecBerater was launched in the middle of the pandemic (we are currently celebrating our second anniversary!). We met with numerous people, thereby gaining invaluable insight and inspiration for our work. And if we learned one thing from all these conversations, it’s that nothing can be planned these days.

As if the above crises weren’t enough, medical technology manufacturers are facing the additional challenge of having to bring their products into line with the new EU Medical Device Regulation (MDR), which entered into force on 26 May 2021. Although they have been tried and tested in practice for years, established companies are now having to get their products re-certified, carry out new medical studies, adapt technical documentation to the changed requirements and go through the complex application process. In some cases, start-ups and small companies with new products are undergoing this process for the first time, including an administrative burden in both financial and personnel terms that is difficult to assess. On top of the rigorous licensing requirements, there is no telling how long the process will take. The responsible authorities are dealing with a huge backlog of applications and review procedures, all at the same time. This means enormous delays. In many cases, it’s unclear whether manufacturers of niche medical products will make the effort to apply for a new certificate, which will then cause problems for specialised clinics. As one congress attendee in Mannheim put it, “Products will disappear, others will simply be out of stock. The industry is in a state of emergency”.

Obviously, the MedtecBerater consultants cannot solve the global and political problems. But we can be the lynchpin of medical technology companies, however. As soon as a new product is developed or an established device has completed the accreditation process, we can assign staff at short notice and on a flexible basis. Our team of experienced healthcare providers and nursing staff familiarise themselves with the technical details and application of the products, then travel from clinic to clinic to train the medical professionals or the patients themselves in how to use the devices. Thanks to our expertise and flexible schedule, we can help our clients come through the crisis relatively unscathed. Let’s join forces to shape the change.