NextGen MedTech – From idea to market acces

The central idea behind NextGen MedTech is that, rather than considering regulatory requirements and clinical evidence only in later stages of development, all relevant requirements are integrated holistically from the outset. This creates a continuous development process that promotes transparency, reduces iterations and strengthens manufacturers‘ innovative capabilities. Companies benefit from TÜV SÜD’s global network of experts, which combines regulatory, clinical and technical expertise.

The NextGen approach includes:
• Early integration of regulatory and risk considerations to ensure predictability and compliance
• Clinical requirements and evidence concepts from the outset to efficiently prepare studies and evidence
• Technical validation, usability and verification run in parallel to shorten development cycles
• Iterative quality assurance with agile feedback loops
• Digital tools and structured dialogue with TÜV SÜD experts to provide clarity at an early stage, avoid development errors and accelerate market access

“NextGen MedTech means understanding product development as an integrated process that combines innovation, quality and safety,” explains Ralf Gansel, Head of Sales DACH in the Medical Devices division at TÜV SÜD. “When technical, clinical and regulatory aspects interact from day one, market access is faster and products are more sustainable.”

TÜV SÜD will present this approach at COMPAMED 2025, which will take place alongside MEDICA in Düsseldorf. Visitors will be able to experience practical scenarios, from initial ideas and risk analyses to market launches and lifecycle support. At its stand, TÜV SÜD will offer space for technical discussions and individual exchanges on best practice examples from ongoing projects. The trade fair team will also provide information on new services relating to usability engineering, post-market surveillance and clinical evaluation. The team will also present testing services that complement traditional testing and certification, such as targeted test campaigns and simulation and verification services. These services make products validatable and marketable at an early stage.

“NextGen MedTech” addresses the key challenges facing the industry: regulatory requirements are becoming more complex, time to market is becoming shorter, and budgets are becoming tighter. At the same time, the demand for quality, safety and innovation is growing. Cybersecurity is a key component here: TÜV SÜD offers comprehensive testing and inspection services, including threat modelling, vulnerability analysis, penetration testing and comprehensive cybersecurity concept reviews, either on the customer’s premises or in its own laboratories. These services enable the early verification of networked medical devices‘ resistance to attacks and compliance with regulatory requirements in accordance with MDR/IVDR or relevant standards such as IEC/TR 60601-4-5 and UL 2900-2-1.

TÜV SÜD is also focusing on future topics such as robotics in the operating theatre environment. While robotic systems, assistive devices and automated controls in the operating theatre offer new potential, they also present challenges in terms of complexity and safety. TÜV SÜD’s expertise in functional safety and cybersecurity enables it to assist manufacturers in designing robotic applications that are validatable, safe, and compliant with regulations.

In this challenging area, TÜV SÜD provides a methodological framework that creates transparency, reduces development risks, and systematically exploits efficiency potential, supporting companies of all sizes, from start-ups to global medtech companies, in accelerating their innovation cycles and bringing safe, high-performance medical devices to market more quickly. In this way, TÜV SÜD supports companies of all sizes in accelerating their innovation cycles and bringing safe, high-performance medical devices to market more quickly.

About COMPAMED
COMPAMED in Düsseldorf is considered the leading international trade fair for medical technology suppliers. Around 750 exhibitors present innovative components, modules, OEM equipment, microtechnology, raw materials, production equipment and more. The two specialist forums, the COMPAMED HIGH-TECH FORUM and the COMPAMED SUPPLIERS FORUM, also offer exciting presentations and opportunities for professional exchange.

https://www.compamed-tradefair.com

About TÜV SÜD Medical & Health Services
TÜV SÜD has over 30 years of experience in testing, certifying and approving medical devices and in vitro diagnostics in accordance with the regulatory requirements of various markets. The focus is on safety, quality, sustainability, and successful market launch. With a global network of accredited testing laboratories, TÜV SÜD is considered a leading service provider in the medical technology industry. Further information:

• TÜV SÜD Medical & Health Services
• Exhibitor Profile TÜV SÜD