Four aspects to consider when challenging your medical device design

30 Nov 2021 4min read

In the process of developing your medical device, as your design progresses, so should your understanding of its functional strengths and limitations. To assess whether your device will work in the hands of your users, ‘build and test’ activities are essential during product development to explore the capability of the design across a variety of configurations and test conditions.

Let’s look at some key aspects to consider when carrying out a build and test programme so that data and learnings generated from testing are both meaningful and actionable.

What to consider in your medical device design process

1. Traceability

Traceability during testing activities is paramount. First and foremost, acknowledge the importance of the data that will be generated by your tests. As you start to lean on your findings to make strategic tooling decisions, for example, it’s important that the foundations they stand on are rock solid.

Take the time to set up a robust process for tracking builds, preconditioning and environmental conditions at the start of your medical device development. This will help to remove doubt and caveats later down the line. Remember that both success and failure should be anticipated at all stages of a device’s design and therefore, your process can support you when things go right and when they go wrong.

documentation record for medical device assembly

2. Reliability

Your testing methods need to be reliable to effectively assess the capability of your design and identify new issues to be solved. Reliability in your testing builds confidence that any data trends and variations are inherent to the medical device design, not the way you built and tested it.

Consider investing time into robust assembly jigs and fixtures. A few weeks spent improving and documenting critical assembly steps will mitigate the need for reconciliation work at the end of the testing programme.

Similarly, it’s often possible to get sufficient confidence in your test methods with just a few days’ work. At Team Consulting, we frequently create ‘challenge’ devices to mimic the operation of the real medical device in a highly repeatable way. This allows us to quickly understand and minimise variation inherent to the test methods.


3. Adaptability

Comprehensive planning is a prerequisite for the successful execution of a medical device testing programme. The nature of research and development, however, makes an element of adaptability equally as important.

Consider adding milestones and decision gates into your test plan. If the objectives of a testing phase aren’t met due to an unexpected design or testing issue, resources can then be reallocated towards its resolution.

Getting the balance between rigour and pragmatism is crucial here. Relaxing the control over testing may accelerate issue resolution timelines, but be mindful to maintain a level of traceability to ensure your results remain valid.

4. Efficiency

The benefits of comprehensive build and test facilities are quickly realised once testing activities get underway, especially if issues with the design are identified mid-programme. Team’s engineering expertise, combined with our extensive laboratory capability, significantly increases programme efficiency. Our approach reduces the time between results analysis, decisions on next steps and implementation of the changes for the next build. In many cases, this timeframe can be reduced from days to hours and the rate of knowledge gained increased accordingly.


If you’re looking for support to design your next medical device or carry out testing, our experts can help. We support you to get a compliant and effective medical device to market thanks to our comprehensive range of services, including testing capabilities. If you’d like to tell us more about your testing requirements, get in touch.

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