Ensuring Quality in Medical Device Design Verification and Validation

Employee Spotlight - Clayton Cole

Nathan White, Co-Founder and VP of Product Design and Development

Nate has over 20 years of medical device product development experience, with diverse roles in technology innovation, R&D engineering, manufacturing engineering, program management, technical leadership, and organizational leadership. He has an extensive background in complex technologies, including minimally invasive laparoscopy, endoscopy, interventional cardiology and radiology, surgical stapling, vessel sealing, and ablation therapies. He is a named inventor on more than 30 U.S. patents. He holds a B.A. in Engineering Sciences from Dartmouth College and an M.S. in Mechanical Engineering from Stanford University, Design Division, and Biomechanics Division. Throughout his career, Nate has helped dozens of companies conceptualize, develop, and commercialize novel medical products and technologies for improved patient outcomes.

 

Introduction

After design and development, the next step towards market-ready production is completing formal testing: Design Verification and Validation (V&V). This phase ensures that the medical device meets all regulatory requirements, performs reliably and safely in real-world conditions, and is ready for human-use manufacturing.

Verification and Validation Phase

Design Verification Testing

Design Verification is the demonstration by objective evidence – by inspecting, measuring, and testing – that the design outputs (specifications) have been met and satisfy the design inputs (requirements).  Design Verification testing is conducted using approved protocols that identify specifications, acceptance criteria, sample size requirements, statistical methods, and test methods.  It may include bench performance testing, simulated use testing, system verification testing, and environmental testing. 

Safety and Performance Testing

Safety and performance testing are integral to the verification process. These tests evaluate production-equivalent devices and are conducted to ensure that the device performance meets the established requirements and operates safely and effectively.

Evironmental Testing

One critical aspect of verification testing is environmental testing. This involves subjecting the device to the full range of anticipated environmental conditions of shipping and storage, such as high and low temperatures, humidity, and vibration, to ensure it can withstand various environments. These tests verify the performance of the device for its actual commercial use case.

Design Validation Testing

Design Validation testing, on the other hand, demonstrates that the product meets the user needs and requirements for its intended use. This involves testing the device in real-world conditions to confirm that it performs as intended. Validation tests are designed to simulate actual usage scenarios, comprehensively evaluating the device’s performance, reliability, and safety.

Usability Testing

Usability testing is a crucial part of validation. It involves observing real users as they interact with the device to demonstrate that potential use errors have been sufficiently mitigated to prevent serious harm. This is particularly important for devices that are new to the world and requiring users to adopt a new procedural workflow.

Pre-Clinical Testing

Pre-clinical data is often required for novel medical devices to validate their performance and safety in a simulated clinical setting. This involves evaluating the device under approved protocols on a suitable pre-clinical model by medical professionals to gather data on its efficacy and safety and may be required as part of the regulatory approval path of a new device. 

Clinical Testing

Many devices also require Clinical data to validate the safety and efficacy of the treatment. This is the first time the device is being used in human patients, and rigorous production controls are implemented for product manufacturing and product sterility.  The clinical data collected typically becomes the cornerstone of the regulatory approval process and the gateway into the New Product Introduction (NPI) phase.

Conclusion

The Verification and Validation phase is a critical step in ensuring that a medical device is safe, effective, and ready for the market. At Meddux, we thoughtfully and collaboratively execute these activities by focusing on rigorous testing and statistical analysis to ensure that the devices under our care meet the required quality and performance standards.  We conduct the controlled manufacturing of devices for pre-clinical and human clinical studies that enable expert physicians to demonstrate the safety and efficacy of the product, which is then used for the regulatory approval process.

Key Takeaways:

  • Comprehensive Testing: Verification and validation ensure the device meets all regulatory and performance requirements.
  • User-Centric Validation: Usability and clinical testing validate the device’s performance in real-world conditions.
  • Regulatory Compliance: Meticulous documentation and adherence to regulatory standards are crucial for successful product approval.

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