The medtech market is highly regulated and complex. Due to the additional workload caused by regulatory requirements, medtech manufacturers often face a shortage of specialized developers. In addition to the resulting delays, scaling issues with existing platforms are among the most common challenges. Dr. Linda Szántó (Managing Director) and Péter Török (CTO) of Silurus share their observations of the market.
This article was published on July 8 in MTD (Medical Technology Dialogue).
In your view, what are currently the biggest challenges for medtech software manufacturers in Germany?
Dr. Linda Szántó: We’ve observed that with the MDR, IEC 62304, and, looking ahead, the EU AI Act, the requirements for software development, documentation, and operation have increased significantly. Many companies are well-positioned technologically but are struggling to efficiently integrate these requirements into their development processes. This leads to delays and increased resource requirements.
How does this manifest itself in projects?
Péter Török: A common critical pattern is the separation of development and compliance: software is first developed functionally and then “brought into compliance” with regulatory requirements afterward. This is inefficient and risky. From our perspective, regulatory compliance must be an integral part of the development process, from concept through architecture and risk management all the way to testing and documentation.
Many providers position themselves as software service providers in the healthcare sector. Where do you see your specific point of differentiation?
Péter Török: What sets us apart is our combination of software development and in-depth regulatory expertise. Our teams routinely work in accordance with standards such as IEC 62304, ISO 14971, and MDR requirements. This means we develop software that not only functions technically but is also audit-ready, including traceability, risk assessment, and a validatable test strategy.
Germany has a strong medtech industry, but it also faces structural challenges. What do you see as the market’s most distinctive features?
Dr. Linda Szántó: Germany is characterized by a strong structure of small and medium-sized enterprises, particularly in the medtech sector. At the same time, the IT landscapes in hospitals and at manufacturers are often heterogeneous and have evolved over time. In addition, we see a pronounced shortage of skilled professionals with an interdisciplinary profile, that is, developers who are proficient in both modern software architecture and development processes as well as regulatory requirements.
You serve different customer groups. Let’s start with medtech software manufacturers: Where do you focus your efforts there?
Dr. Linda Szántó: We provide support in three key areas: First, in scaling existing systems, for example with regard to cloud infrastructures and performance. Second, in accelerating development processes within regulatory frameworks. Third, in further developing QA and DevOps structures to enable release cycles that are both more efficient and compliant.
What role does quality assurance play in this context?
Péter Török: A central role. Traditional QA processes are often still heavily manual and therefore difficult to scale. We rely on automated testing strategies, CI/CD approaches, and virtual testing environments, but always in accordance with regulatory requirements, particularly regarding traceability and validation.
How do you specifically support hospital IT projects?
Péter Török: The focus here is clearly on interoperability. Systems must communicate with one another via standards such as HL7, FHIR, or DICOM. The challenge lies less in developing individual components than in integrating them into existing system landscapes. This is precisely where we bring extensive project experience to the table, particularly in the field of medical imaging.
AI-supported diagnostics is a growing field. What requirements do you see here?
Péter Török: In addition to traditional regulatory requirements, there’s an extra layer here: the validation and transparency of algorithms. Many research projects have powerful models but lack the necessary infrastructure for production use. We help transform these solutions into scalable, regulatory-compliant platforms.
What impacts do you expect from the AI Act?
Dr. Linda Szántó: The AI Act will further increase regulatory complexity, particularly through additional requirements for documentation, risk assessment, and monitoring. For companies, this means a further increase in development effort. At the same time, the ability to efficiently implement regulatory requirements will become a clear competitive advantage.
How do you ensure that your teams consistently meet regulatory requirements?
Dr. Linda Szántó: On the one hand, through the careful selection and ongoing training of our employees. On the other hand, through our many years of project experience in regulated environments. We have been working with major medtech companies for many years and are accustomed to delivering results in audit-relevant contexts.
In conclusion: How do you see the market evolving?
Dr. Linda Szántó: We expect increasing specialization. At the same time, the demands on software, regulation, and data management are rising.
Péter Török: Companies will increasingly rely on partners who can integrate these disciplines. Pure software expertise will no longer be sufficient in this environment.