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The Joy of Requirements: A Tool to Develop the Right Product

At the end of any medical device development, you are going to need to do two very important things: verify that your device functions correctly, and validate that your device meets the needs of its intended users.

These two activities are fundamental to developing medical devices under Design Control sections 7.3 and 7.4 of ISO 13485:2016 and items ‘f’ and ‘g’ in FDA 21CRF820.30. Too often, however, they are treated as ‘tick box’ exercises at the end of the development, and insufficient thought is given to their implications at the beginning of the design and development pathway.

So how do you get a feel for late-stage verification and validation (V&V) activities at the beginning of your development process? How do you lower the risk of finding any surprises during V&V which could derail your product launch? The first step is to define your requirements.

What Are the Requirements?

The design control process requires design inputs to be defined, which is typically achieved by developing two key documents: the User Requirements Specification (URS) and the Product Requirements Specification (PRS). Your product will then be designed and developed to meet these specifications, with the design outputs (e.g., engineering drawings and material specifications) verified to meet the PRS and validated to meet the URS. Verifying and validating that design outputs meet design inputs is the core to design control. Hence, when drafting the URS and PRS at the outset, it is important to keep in mind their implications for end stage V&V.

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Oliver Sowerby is a Mechanical Engineering Consultant at Team Consulting, a medical device development consultancy in Cambridge, UK. He specialises in producing novel product concepts and developing them into robust medical devices that are ready to transfer to manufacture. Oliver has 11 years’ experience working in start-to-finish product development, having worked on the design of LED lights, automated labelling machinery, chemical reactors, and award-winning medical devices. He is a Chartered Engineer with a first-class degree in Product Design Technology and is the named inventor on several patents.
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Oliver Sowerby
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