Streamlining verification and validation in Medical device development
Meeting the Compliance Challenge with Client-Centric Approaches
The changing landscape of medical device regulations, specifically the IVDR and MDR introduced in 2022, has significantly raised the stakes for manufacturers. With stricter legal requirements and impending deadlines—2027 for certain devices—the pressure to comply has become undeniable.
But within this challenge lies an opportunity. By rethinking traditional verification and validation (V&V) methods, companies can not only align with compliance requirements, but also reduce development time and costs. A focus on client needs from the outset is the key to transforming a complex process into a streamlined, efficient one.
Challenges in verification and validation processes
Verification and validation are critical stages in medical device development, ensuring safety, compliance, and product functionality. However, these phases often carry significant hurdles. Two primary issues contribute to the complexity and inefficiency of V&V processes:
- Unclear Requirements in the Early Stages
Teams sometimes struggle to identify core functionalities stemming directly from client needs. This often results in unnecessary "nice-to-have" features, increasing the complexity of projects and delaying timelines.
- Legacy Requirements That Fail Modern Needs
Revisiting specifications of legacy devices reveals a tendency to simply copy and paste outdated requirements. These irrelevant specifics add complexity where none is needed, translating into bloated and costly V&V phases.
"Without a strategic shift, these challenges can lead to costly delays, regulatory risks, and quality issues. A clear focus on client needs and effective risk management is essential for redefining success in V&V practices.”
— Rikard Wikner, Section manager MedTech R&D at AFRY.
Why is IVDR and MDR Compliance urgent?
The IVDR and MDR regulations have turned what were once industry recommendations into formal legal requirements. These changes require medical device manufacturers to adapt quickly to stay compliant and competitive.
Time is of the essence. A transitional period has been set for existing devices, but the deadlines – 2027 for certain legacy devices – leave little room for procrastination or error. Failure to address V&V inefficiencies now carries substantial risks, from market withdrawals to damaged reputations and financial strain.
For companies willing to act with urgency and precision, however, the reward is clear. By addressing these challenges head-on, they can drive better outcomes for clients while improving cost efficiency.
How to Streamline V&V Processes
- Customer needs at the core
- Revisiting and optimising legacy specifications
- Innovative testing solutions
By taking a structured approach to defining requirements early on, you can eliminate guesswork and establish a solid foundation for verification and validation (V&V) activities. Instead of prioritising broad or unnecessary features, focus on answering the critical question: “What must our product deliver to meet the client’s goals, and why?”. Tools like traceability matrices and modular test plans can be applied to ensure that every client requirement is addressed, while reducing the number of test cases needed, effectively streamlining the process.
Medical devices that have been on the market for years often carry the risk of outdated specifications being perpetuated over time. Revisiting these documents with a fresh, critical perspective can help identify and eliminate redundancies, streamlining processes and reducing unnecessary verification efforts. By questioning legacy assumptions, companies can refine their V&V plans, ensuring resources are allocated to what truly matters—achieving compliance and maintaining optimal functionality.
Rethinking traditional V&V testing methods provides another opportunity to cut costs and stay efficient. Instead of relying solely on fixed testing slots, companies can adopt “free testing” throughout development. This iterative process, together with regular reviews and feedback, helps identify weaknesses early, reducing the likelihood of surprises during final stages.
Additionally, alternative methods like statistical analysis or demonstrations can often replace more labour-intensive testing, saving time and money while maintaining precision.
To further improve efficiency, teams should strive to write V&V plans alongside user and system requirements from day one. This practice ensures that testing approaches are aligned with design objectives and mitigates costly rework down the road.
"Examples show that poorly defined requirements lead to bloated testing phases, increased project costs, and significant delays. A meaningful connection between these requirements and client expectations ensures every step of V&V serves a purpose and adds value.” says Rikard Wikner.
AFRY can help you navigate the process
At AFRY, we understand the complexities of medical device compliance and can help you tackle these challenges head-on. With expertise across systems engineering, project management, and verification and validation processes, we bring deep knowledge from a wide range of industries to each project.
Our approach is flexible, tailored to our clients’ specific needs, and supported by over 1000 Life Science experts across our network. Whether it’s revisiting specifications for legacy devices or building innovative solutions from the ground up, we can guide you through every step of your project.
