Verification and Validation in Medical Device Development: Getting It Right
Essential tips that you can’t afford to overlook…
In medical device innovation, one topic separates the game-changers from the wannabes: Verification and Validation (V&V). If you're not yet familiar with V&V, you're in the right place. This article will provide a comprehensive understanding of V&V, its importance in the medical device industry, and essential best practices for successful implementation. So, let's explore the world of V&V and its vital role in crafting top-tier medical devices.
V&V may not sound glamorous, but it's a pivotal part of creating top-notch medical devices. In this blog, We’ll demystify what it entails, help you understand the importance of it, and share a couple of best practices to implement it effectively.
Decoding V&V: The Dynamic Duo
In Medical Device Development, V&V stands for Design Verification and Design Validation. They are essential processes for ensuring the product's quality, reliability, and performance. Think of them as the tag team that guarantees your medical device is the real deal.
Let's dissect this duo. The FDA defines design verification and validation in the federal regulation 21 CFR 820.
Design Verification: “Are we building it right?”
Design verification is about confirming that your device design aligns seamlessly with the initial requirements.
Design Validation: “Are we building the thing right?”
Design Validation takes things up a notch. Validation assesses whether your device, when subjected to real-world conditions, genuinely meets user needs and its intended purpose.
Why Does V&V Even Matter?
V&V isn't just some regulatory hurdle; it's your golden ticket to success. Here's why it should be on your radar:
Regulatory harmony: bodies like the FDA demand a rigorous V&V dance. Ignoring it could lead to a nightmarish tangle of delays and rejections.
Quality is non-negotiable: top-tier devices mean happy patients and fewer post-launch hiccups. V&V ensures your device shines from the get-go.
Spare your wallet: early issue detection is a financial godsend. V&V saves you from the financial nightmare of recalls and late-stage revisions.
Learning from 483 Letters
Reviewing FDA 483 letters might not sound like the most thrilling task, but it's a goldmine of insights for anyone in the medical device industry. Between 2018 and 2022, nearly a thousand 483 letters were issued, and within this sea of correspondence, some intriguing patterns emerge.
All of these letters (100%) were related to Quality Management System (QMS) issues. If you're well-acquainted with 483s, you'd know that many of these cases touch on testing – a critical aspect of ensuring medical device safety and effectiveness. But that's just the tip of the iceberg.
Complaints, often the initial data source for analyzing potential field issues, took a prominent place, with 86% of warning letters addressing inadequate processes in this area. And that's not all; concerns related to processes, documentation, manufacturing, validations, and design controls often boiled down to problems with requirements, verification, and validation.
Becoming a V&V Virtuoso
Whatever testing model you’re following (waterfall or v-model), here are basic yet game-changing tips to conduct your V&V as smoothly as possible.
Document Your Work
“If it has not been documented, it didn't happen.” Maintain impeccable records of all V&V escapades, from testing strategies to outcomes. A comprehensive test report should include:
1. Test performed
2. Objective of the test
3. Description of test methods
4. Pass/Fail criteria
5. Data analysis plan
6. Test results
7. Discussion/Conclusions
8. Your test protocol
The Importance of the Team Involved in the Process
It’s important to get the right folks around the table to discuss various aspects, adjusting your focus based on the product's complexity, especially for new projects. In MedTech Design & Development, if you don’t have eight to ten people talking about your product, you’re probably missing out on someone.
Who are they? A regulatory guy, a quality person, someone in the design control space, another one dealing with documentation. Let’s add two to three engineers, maybe someone focusing on testing and a project manager.
Precision in Product Requirement Identification
In design verification, the road to success begins with a comprehensive understanding of your product's unique requirements. While safety and efficacy are always paramount, it's essential to recognize that product requirements can vary significantly based on the specific product type.
Let's take the example of screws within the medical device domain. Whether it's an orthopedic screw, a bone screw designed to secure a plate, a bioresorbable spinal screw, or even a state-of-the-art 3D-printed screw, each has its distinct prerequisites.
For spinal implants, meticulous attention is needed to assess factors such as screw compatibility with the plate, insertion angles, and the intricacies of the locking mechanism. In contrast, when dealing with bioresorbable screws, the focus shifts toward the material composition.
Despite all these variations, what remains constant is the need for a tailored approach to requirement identification. So, while the core product may be a screw, the journey to design verification success demands that each variation is meticulously addressed according to its unique requirements.
Manufacturing Process Validation: A Cornerstone of V&V
Amidst the rigorous V&V journey, manufacturing process, and good manufacturing practices (GMPs), validation often stands as the unsung hero. Product design verification and validation are important, but how the product will be manufactured is equally important.
Manufacturing Process Validation is the critical step that bridges the gap between product design and commercial production. It ensures that the manufacturing process consistently makes products that meet predefined quality standards. Potential risks and deviations can be identified and addressed early in the development cycle. This proactive approach minimizes the chances of defects or non-conformities, reducing the risk of costly recalls or post-market issues. In collaboration with Contract Development and Manufacturing Organizations (CDMOs) or Contract Manufacturing Organizations (CMOs), validating the manufacturing process becomes even more critical, ensuring that the external entity can consistently deliver products that meet your specifications and quality standards.
Typical Types of Failure Identified: Forewarned is Forearmed
If your product development team can avoid these common mistakes, you stand a much better chance of successfully launching your new medical device.
1. Design Deficiencies: These include discrepancies between the product's intended design and its actual specifications, such as size, shape, or material composition.
2. Performance Issues: These failures pertain to a product's inability to meet required performance standards. For instance, a diagnostic tool may yield inaccurate results.
3. Software Errors: In the digital age, software-related failures are common. Bugs, glitches, or programming errors can impede a device's functionality.
4. Compatibility Problems: It could be related to different types of materials or tolerant stack-up issues. Failures arise when a medical device is incompatible with other devices, software, or systems it must interact with for proper operation.
5. Usability and User Interface Problems: Failures in this category involve device operating difficulties, confusing interfaces, or inadequate user guidance.
6. Safety Hazards: These failures encompass any feature or function that risks patients or users, including sharp edges, electrical malfunctions, or radiation exposure.
7. Inadequate Reliability or Durability: A device's reliability over time is critical. Failures may occur if a device malfunctions prematurely or deteriorates faster than expected.
8. Regulatory Compliance Issues: Non-compliance with regulatory standards can lead to legal and market access problems. Failures may involve improper labeling, inadequate testing, or missing documentation.
9. Incomplete or Inaccurate Documentation: Comprehensive documentation is essential for traceability and quality control. Failures here include missing records, incomplete test reports, or inaccurate data.
10. Insufficient Labeling or Instructions: Proper labeling and clear instructions are essential for safe device use. Failures involve labeling errors, ambiguous instructions, or missing warnings.
Understanding and mastering Verification and Validation…
is the key to success in medical device development. In fact, V&V wields unparalleled influence over the fate of your product development journey, as evidenced by insights gleaned from past FDA 483 letters. It can seem overwhelming. However, if approached strategically and systematically, it doesn't have to be an insurmountable challenge.
To excel in V&V, document your work, assemble the right team, and identify product requirements meticulously. Make sure to validate the manufacturing process and the product design, especially in collaborations with external entities.
V&V isn't just a formality; it's your path to crafting groundbreaking devices that reshape healthcare. Concise Engineering has a track record of helping organizations achieve FDA compliance and optimize their development processes. Let us assist your team in mastering V&V and driving innovation in healthcare.
Justin Bushko
President, Concise Engineering
Next Steps
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