Close interlinking of evidence, regulation, and transformation required
This article originally appeared in HCM Magazin (hcm-magazin.de) on 30 June 2026.
Artificial intelligence is increasingly becoming a transformative factor in the further development of medicine and healthcare. Péter Török assesses how AI is affecting medical technology.
Medical technology stands at the threshold of an AI revolution as a central player in the industry. As an innovation booster for better patient care and more efficient operations, AI can dramatically shorten development cycles and make manufacturing more intelligent. While the pressure to act grows on established MedTech players, new entrants – from agile start-ups to tech giants – are pushing into the market with AI-based solutions.
Implementation must happen now
To avoid falling behind, manufacturers must move quickly into implementation. From research and development (R&D) through production and supply chain to marketing and sales – there are opportunities to create value everywhere. At the same time, significant challenges arise across the entire product life cycle; more than technological expertise is required when it comes to the sustainable use of AI. Frameworks such as the MDR, IVDR, and the EU AI Act shape the MedTech industry, and a new competence profile is emerging at the intersection of AI, regulatory affairs, and digital health.
Responsibility for the entire life cycle
How can AI-supported medical devices be developed, approved, monitored, and integrated into care responsibly? This is exactly where one of the most important competence gaps in modern healthcare is emerging. AI in medical technology is not only a technical challenge. It is at the same time a regulatory, clinical, organizational, ethical, and strategic leadership task.
The importance of this credo for the European medical technology sector is illustrated by the "Facts & Figures 2025" of MedTech Europe: the industry has more than 930,000 employees; it comprises more than 38,000 companies – especially small and medium-sized ones – and represents a market of around 170 billion euros. The sector is highly innovative, economically significant, and directly linked to patient safety and quality of care. AI-supported medical devices are moving from research and development into regulated product environments at an ever faster pace. AI-supported medical technology is thus already a regulatory reality; moreover, it is not about individual technologies. Each use case raises specific questions, for example about
- validation,
- data quality,
- clinical evidence,
- risk management,
- cybersecurity,
- human oversight, and
- post-market surveillance.
In Europe, this development coincides with new regulatory requirements in the context of the EU AI Act.
A new competence profile for MedTech
In the context of AI-supported medical devices, the critical question is whether the right questions are asked early enough:
- Which target groups are represented in the data?
- How does performance change across patient cohorts, clinical workflows, and real-world care settings?
- How are updates, bias, cybersecurity, human oversight, and post-market performance managed over time – especially in complex care environments?
Against this background, professionals are needed who can combine AI and digital health competence with regulatory intelligence, quality management, clinical evidence, risk assessment, health technology assessment, and responsible leadership. Medical technology companies need people who understand technology, consider regulatory requirements early on, and responsibly accompany AI-supported innovation across the entire product and care life cycle – from development through implementation to continuous monitoring.
A service provider offering a complete support package
Product design, development, regulation, evidence, quality management, and implementation must be connected, and innovation must be steered responsibly.
Our interdisciplinary teams at Silurus Software support MedTech companies in developing reliable and regulatory-compliant software solutions, from clinical applications and medical imaging to interoperability, cloud platforms, and AI-supported healthcare software. At DMEA, it was recently particularly interesting to see how strongly topics such as AI, interoperability, cybersecurity, and regulatory requirements are shaping the future of healthcare technologies. At the same time, it became clear how important real engineering experience and a deep understanding of clinical environments have become. The Silurus teams reliably and sustainably provide the competence and performance needed to close this competence gap.
Péter Török, Founder and CTO, Silurus Software.