The journey of health technology from laboratory to market is a complex process that requires deep understanding of regulatory requirements, patient safety, and risk management. Health technology product development differs significantly from other industries, as each stage from innovation to commercialization is strictly regulated and requires specialized expertise. Procurement organizations and health technology product manufacturers face an increasingly complex environment where success demands a strategic approach and appropriate expert support.
Key challenges in health technology commercialization
Health technology companies face several critical challenges in commercialization, with regulatory requirements forming perhaps the most significant barrier. The EU Medical Device Regulation MDR (2017/745) and In Vitro Diagnostic Regulation IVDR (2017/746) have significantly tightened requirements. These regulations require comprehensive clinical evaluation that continues throughout the device lifecycle, even after market placement.
Patient safety and risk management are at the core of health technology. Medical devices and software require systematic risk assessment according to standards ISO 14971 and IEC 62304. Software-based solutions particularly bring new types of challenges, as ensuring their safety requires deep understanding of both technical and clinical considerations. Usability requirements according to standard IEC 62366 add further complexity.
How does expert support accelerate market access?
Expert support can significantly accelerate the health technology product development process and reduce commercialization-related risks. Experienced support can help avoid common pitfalls and ensure that product development proceeds in compliance from the beginning. Usability testing and service design integrated into the product development process help create solutions that respond to real user needs and meet safety requirements.
Building a quality management system according to ISO 13485 standard is a mandatory requirement for CE-marked health technology product manufacturers. System development requires deep understanding of organizational operating principles and their development. We have expertise in a broad range of standards and regulations, including MDR, IVDR, FDA, ISO 13485, and IEC 62304. Our international network enables finding specialized expertise for organizational specific needs.
Regulatory environment management and patient safety
Regulatory compliance and ensuring patient safety are cornerstones of health technology commercialization. Quality system development is not merely a bureaucratic requirement, but a strategic tool that enables the development of safe and effective products. Clinical evaluation as part of the medical device lifecycle ensures device safety and performance across all risk classes.
The impacts of regulatory reforms on business can be significant, as the IVDR implementation demonstrated in May 2022. Organizations need deep expertise to keep pace with the changing regulatory environment. Risk management processes must be integrated as part of product development, not added as an afterthought layer.
Post-market data collection and utilization in product development projects has become an increasingly important part of regulatory compliance. Using agile methods in health technology product development requires special diligence to ensure regulatory compliance. Operational health audits can help identify critical development areas from legislative requirements perspective and ensure competitiveness preservation in the changing operating environment.
