Compliance by Design in medical technology: innovation brake or efficiency booster?
More and more developers in medical technology are spending their time on documentation, validation and risk management. In recent years, the number of regulatory requirements and technical guidelines has increased worldwide. However, those who systematically integrate requirements into the development process at an early stage can reap decisive benefits. Compliance by Design is increasingly establishing itself as a driver of innovation and efficiency instead of being merely an obligation and a necessity.
Regulatory challenges
Regulatory requirements such as the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostics Regulation (IVDR) continue to pose considerable challenges for companies. The high effort involved in technical documentation, clinical evaluation, post-market surveillance and quality management systems ties up resources and delays the market launch. Small and medium-sized enterprises (SMEs) in particular are coming under pressure: They often lack sufficient regulatory expertise and have a hard time finding qualified personnel. According to MedTech Europe, around a third of in vitro diagnostic medical device manufacturers report problems in filling regulatory affairs positions, and the proportion is even higher among SMEs. Design for Compliance can enable a change of perspective in this area.
Compliance as a key competence
Compliance by Design means integrating regulatory requirements into technical development and process planning from the outset instead of checking them downstream. Risk analyses, validation steps and safety standards such as ISO 14971 or IEC 62304 are integrated directly into the development process. That improves product quality, reduces subsequent corrections, and shortens time to market.
According to Deloitte’s Life Sciences Regulatory Outlook 2025, the role of the compliance function is fundamentally changing: The use of artificial intelligence (AI) and generative AI enables regulatory processes to be made more efficient, scalable and strategic. Generative AI could help medtech companies achieve savings of between six and twelve percent over the next few years. Companies with revenue of between USD 20 billion and USD 26 billion could save up to USD 3.2 billion a year.
Compliance by Design in practice
Practical examples show how Compliance by Design can already be applied today. For example, a number of medical technology manufacturers use Siemens Polarion product lifecycle management software to automatically document regulatory requirements during development. That makes audits easier, speeds up approvals, and significantly shortens time to market.
Another example is the EU research project Thrombus+, which is developing a medical product to prevent thrombosis with complex hardware and software components. Legal, regulatory and safety requirements are being integrated at an early stage, with the aim, instead of responding retrospectively to compliance, of actively using regulatory requirements as part of the innovation strategy.
Challenges and opportunities for small and medium-sized enterprises
Small and medium-sized companies are under particular pressure as they have to implement regulatory requirements with limited human and financial resources. Without dedicated regulatory affairs teams, this often leads to delays, additional effort or project cancellations.
With AI-supported tools, Compliance by Design can also be implemented efficiently for smaller companies in order to better manage regulatory complexity. In combination with external specialist networks, training courses and industry-specific consulting structures, knowledge bottlenecks can be overcome. Optimized compliance is thus possible even for companies with limited resources.
Using compliance strategically
Compliance by Design is not a brake on innovation but a strategic lever: Implemented correctly, it accelerates market launch, cuts costs in the long term, and improves product safety. Companies that integrate regulatory requirements at an early stage and map them digitally gain clear competitive advantages and can successfully shape innovation cycles even with more stringent requirements. The future of medical technology belongs to those who not only adhere to compliance but actively take it into account.