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Ensuring Medical Device Success: The Role of Design Controls, Validation, and Verification

Guest blog article by Martjin Gijzel- Testing and Verification Lead at Fearsome 


Introduction


The medical device industry operates under stringent regulations that enforce a structured design process known as Design Controls. These controls, while seemingly restrictive, promote fundamental design principles applicable across industries. By adhering to this disciplined approach, we ensure we're building the right product through a robust verification and validation (V&V) process.



User Needs and Design Inputs


In any product development project, the initial step is to define the requirements. This involves determining the product's intended use and user needs, as well as identifying stakeholder requirements. Subsequently, defining the product requirements and features necessary to achieve these goals. User needs represent the highest level of product requirements, referred to as "User Needs," complemented by the detailed product requirements known as "Design Inputs."



Demystifying Validation & Verification


Validation provides objective evidence that a medical device fulfils a user need within its intended use case. This is paramount for ensuring the device's efficacy and safety. It involves gathering data throughout the design and development process, culminating in clinical trials and evaluations. Verification, on the other hand, confirms that the Design Input translates accurately into the Design Output. This occurs iteratively throughout the design and development cycle. Both V&V are essential for ensuring a successful medical device, acting as crucial feedback loops within the design process.



Integration of V&V in the Design Process


Product design is an iterative process despite the FDA waterfall diagram suggesting otherwise. 


The design process is a continuous loop, requiring V&V at each stage to guarantee success and effectiveness. Early-stage user studies and the development of test methods alongside product development are crucial for validation and verification, respectively. These iterations allow for adjustments early on, keeping projects on track and achieving their intended goals.


Underestimating Test Method Development


In my experience, the effort required to develop and validate robust test methods for verifying requirements is often underestimated. At Fearsome, we address this by providing training that emphasises the importance of looking ahead while writing Design Inputs. This includes considering how the design input will be verified, what will be measured, and under which conditions testing should occur.


To visualise this iterative process and the need for forward-thinking, we utilise the V-Model diagram.


Traceability & Planning,  The Cornerstone of Efficiency


Maintaining traceability is a regulatory requirement but also essential for efficiently covering all requirements throughout development. Maintaining a clear link between Design Inputs, Outputs, and V&V activities allows for early identification and mitigation of potential issues. This proactive approach reduces the risk of costly redesigns or recalls.


At Fearsome, we leverage Greenlight Guru software to provide graphical traceability overviews, facilitating the planning and execution of V&V activities. Integrating this with a Risk Management and Traceability Matrix, we define the appropriate statistical sample size for each test activity based on internal procedures. These details are then documented in the Test Protocol(s), which are again linked and traceable through Greenlight Guru.



Post-market Activities: Maintaining Safety & Efficacy


Greenlight Guru also assists in tracing design changes based on post-market feedback back to associated verification and validation tests. This ensures that changes are effective and do not have unforeseen negative impacts on the product, ultimately maintaining its safety and efficacy.



Conclusion:


In conclusion, the rigorous application of Design Controls, including meticulous validation and verification processes, is essential for the successful development of medical devices. By emphasising user needs, maintaining thorough traceability, and proactively addressing potential issues, we can ensure that our products not only meet regulatory standards but also provide safe and effective solutions for end-users. At Fearsome, we are committed to fostering a culture of continuous improvement and forward-thinking in our design processes. By leveraging advanced tools like Greenlight Guru and integrating comprehensive risk management strategies, we are poised to navigate the complexities of the medical device industry with confidence and precision. Ultimately, our goal is to deliver innovative medical devices that enhance patient outcomes and uphold the highest standards of quality and safety.



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