For many years, we at Entrhal have been developing, producing, and distributing innovative test devices and solutions for CSSD and patient safety. But the environment in which we operate has changed drastically in recent years – and certainly not for the better.
The Challenge of the MDR
The introduction of the Medical Device Regulation (MDR) has become a major burden, especially for small and medium-sized enterprises. We feel this pressure every single day.
The requirements are extremely high – from extensive documentation and complex certifications to regular audits. For a company of our size, this doesn’t only mean a lot of extra work, but also significant costs. Money we would much rather invest in research, development, and product improvements is instead tied up in bureaucracy.
On top of that, the MDR consumes our human resources. Team members who could otherwise dedicate their time to projects, product development, or customer support now need to handle regulatory tasks. For a small team like ours, this is a huge challenge.
Price Pressure in german Hospitals – Especially for Single-Use Instruments
At the same time, we see the struggles german hospitals are facing:
Many facilities are under financial stress, dealing with budget cuts, staff shortages, and rising operating costs. These conditions – shaped by political decisions and economic constraints – put hospitals under increasing pressure, and in turn, affect their partners.
We notice this most clearly with our Clinastar single-use instruments. Hospitals are often forced to decide based primarily on the lowest price. Understandably so, when budgets are tight – but this makes it difficult to truly recognize the value of quality, reliability, and patient safety.
We know our customers are dealing with the same challenges as we are. That’s why it’s so important to us to find solutions together that are both economically viable and put safety in the OR first.
A Big Market – Yet Difficult
Germany is one of the largest and most important MedTech markets in Europe. In theory, this should provide a stable foundation for growth and innovation. But the combination of MDR-related costs, price pressure – especially in the single-use segment – and global economic uncertainty makes it increasingly difficult for smaller companies to unlock their potential here.
Economy in Crisis Mode
On top of that, recent global crises have made things worse:
- Supply chain disruptions
- Rising energy prices
- Inflation
All of these developments hit us directly. While we are doing everything we can to ensure the availability of our products, the overall economic situation in Germany is far from stable.
Our Commitment Despite All Obstacles
As Floris and Andreas highlighted in our recent interview:
Despite all these challenges, we want to keep developing solutions that deliver true value to our customers and increase patient safety.
Even in difficult times, we strongly believe that innovation, quality, and customer focus are the keys to success for small companies like ours.
We are convinced:
It takes courage, perseverance, and a clear vision – and that’s exactly what drives us at Entrhal every single day.
And because we don’t want to tell this story from our perspective alone, we will soon launch MedTech Insights – Voices from Around the World. In this new format, we will also share the perspectives of our distributors in different countries – their unique challenges on the ground, their solutions, and their views on the MedTech industry. This will help us create a truly global picture that shows: we all face similar questions – and we can learn from one another.
👉 Follow us here on LinkedIn to stay updated on the launch of MedTech Insights – and discover new perspectives from around the world of MedTech with us.