Design verification testing: quality and reliability in product development
Published: September 2023
Scott Salter, Design Consultant
Test, refine, test, refine, test, refine.
During medical device design and development, precision and reliability are absolutely key. These devices are not just products, they are lifelines for patients and healthcare professionals (HCPs). Patient health and our clients’ success depend on the delivery of high-quality products.
That’s why we prioritise Design Verification Testing (DVT) as a crucial part of our design and development process, all underpinned by our ISO 13485 accreditation.
In this article, we will shed light on the importance of DVT, its benefits, and the capabilities we offer to our customers in this vital aspect of medical device development.
What is design verification testing?
Put simply, DVT provides objective evidence to confirm that design outputs (the product) meet the design inputs (design specification and product requirements).
Our engineering team uses quantifiable and evidence-based test methods in order to do this. Our test facility includes highly accurate force analysis technology, environmental chambers, optical and video measurement as well as a range of smaller precision-calibrated instruments. They can also create highly detailed, production representative prototypes to facilitate tests.
Benefits of design verification testing
DVT is an essential phase in the product development cycle for several reasons. Firstly, it helps to identify and mitigate potential risks and hazards associated with a device to ensure patient safety, but it also identifies design flaws and deviations early in the development process. So, it reduces both device and product development risk, ultimately saving costs and reducing the time it takes to get a device to market.
For regulatory bodies such as the FDA and EMA requiring rigorous testing to approve medical devices, DVT provides the necessary data to meet these regulatory requirements.
A thoroughly tested and validated medical device instils confidence in patients and HCPs, and so, enhancing its market competitiveness.
How verification testing fits in to Shore’s medical design and development
Our design and development process consists of six main phases. This structure addresses the systematic flow of all main project stages from the initial Phase 0 customer communication/feasibility/planning through to the final released Phase 5 production activities (if applicable).
Phases 1 to 4 contain the main design concept, engineering development, verification, and validation activities.
We typically conduct formal verification as part of Phase 4 of our design process (see diagram below) where it forms a vital element of new product introduction (NPI). This is usually conducted as part of a pilot build – the final, small-scale sample run, prior to mass manufacture.
At the project’s outset, we thoroughly review your data, identifying key phases and documenting necessary input and output deliverables for each development stage. These phases include lower-level detailed tasks and processes for product definition, verification, risk assessments, validation, traceability of design outputs to inputs and when applicable transfer to manufacture.
Six phases of Shore’s medical device design and development
We take pride in our comprehensive capabilities in DVT. Our team of experienced engineers employs state-of-the-art tools and methodologies to ensure the highest level of quality and reliability for medical devices. Here are some key aspects of our DVT services:
We typically create project-specific protocols to ensure that tests are performed in a consistent manner and any sources or variations are minimised. Protocols detail the method, equipment, date, the individual performing the test and are reviewed, verified, and approved before being conducted.
Many tests are standardised in nature, derived from a common ISO or ASTM design requirement, such as a drop test or shipping test.
Our dedicated test lab is equipped with an array of fully calibrated instruments to support testing needs. Some examples of which are pictured in our test facility below:
Shore’s in-house test lab
Reporting and ISO 13485 compliance
Individual verification test results for each requirement are meticulously recorded and stored.
In addition to individual test reports, Shore produces a Design Verification & Validation Report which forms an executive summary of the design validation & verification test results. Successful completion of the testing demonstrates that the product satisfactorily meets the design inputs and is suitable to start production and product launch.
Our verification testing process adheres to Appendix C – ISO 13485:2016, Clause 8.3.4, which covers design and development controls.
Design verification testing in action
DVT testing is an essential part of our design process. It ensures quality assurance, reduces time to market, increases product reliability, is cost-effective, and enhances customer satisfaction.
As a device progresses through Shore’s development process, we conduct small-scale Engineering Confidence Testing. The purpose of this test is to ensure that requirements are on track and that any necessary adjustments and improvements can be made early in the design cycle.
A great example of this is the Spravato nasal drug delivery trainer, which Shore successfully developed and delivered for our client, Janssen. This trainer features a user-triggered actuation, which was required to mimic the actuation force of the nasal inhalation parent device. A robust set of engineering confidence testing during prototyping and early tool trials allowed for minor improvements to be made, ensuring the forces matched the requirements. Therefore, when the larger scale and volume verification testing was performed, we had a high degree of confidence that the results would be successful – which proved to be the case.
Spravato nasal drug delivery trainer
How design verification testing has evolved here at Shore
Writing this is especially timely, given that this year marks 10 years since I joined Shore. In that time, I’ve seen first-hand the investment and advances Shore have made in our inhouse testing capabilities.
Shore’s first test facility was a small, dedicated test room, and investment in a state-of-the-art Universal Test Machine (UTM) and environmental chamber. Such was the benefit of these facilities to Shore’s active project work, that the test room was expanded into a specialised laboratory space as part of an extensive office refurbishment in 2017.
This improved area allowed the company the additional capacity to add more high-end instruments; a video measurement system, viscometer, syringe pump and an upgraded UTM. These upgrades are ongoing, and very much driven by our clients’ requirements for a full engineering understanding of the products we deliver, allied by a desire for a high level of accuracy in our day-to-day investigation, not just verification testing.
Expansion of the office test lab triggered a further expansion at our dedicated, off-site workshop space – where a section of the large industrial area has been converted to a build and test facility. This fresh space allows Shore a dedicated area to undertake large volume build, assembly and testing, which is often necessary during pilot build, prior to mass manufacture, and other volume builds.
Looking at Shore’s testing capabilities from a personal development angle, the company has given me a chance to dive into a role focused on specialising our testing capabilities. This reflects how Shore really supports its staff’s development and fits perfectly with the employee ownership model that makes working here so enjoyable.
At Shore, we believe in delivering high-quality products that meet your needs, and verification testing is one of the ways we ensure that we achieve this goal.
Contact us to learn more about how we can work with you.