Boyd Allin

Design Reviews in Medical Device Development

During the development of medical and consumer electronic devices there are scheduled design reviews held in order to comply with IEC 60601 and to ensure the best product is realized. These reviews are invaluable; however, a few common pitfalls are worth identification.


One tendency is to narrow the audience to a myopic group of the key designers. Frequently “external” staff is invited to the reviews but these additions are often other technical staff.  My experience has shown that augmenting the core design team with non-technical staff can provide extremely valuable and unorthodox design insights. In particular, the inclusion of industrial designers in technical design reviews has proven fruitful. The core technical design team in the later stages of design can become very entrenched in the design/architecture direction and somewhat blinded to radical deviations that may be superior embodiments. The unique and minimally constrained thinking that industrial designers bring to the review can literally lead to building the device inverted, or at least what the engineers had considered inverted.

The inclusion of a diverse review committee necessitates good preparation. Attendees who have little prior knowledge of the design will at best be apathetic bystanders and at best an inquisitive drag on the meeting. Preparing these participants prior to the review will unlock this potent addition to the review and ensure efficiency. Spend some time composing a design review brief and distribute to the team for consumption prior to the review.

As a consultancy, StarFish is tasked with designing devices for other companies who are often under tremendous resourcing pressure and or whose core competency is not design. Especially early in a design, another often omitted attendee is the client. This is often due to the aforementioned resourcing squeeze that was, in part, responsible for the outsourcing; they are simply too busy. In addition, the inclusion of the client in the design reviews can be daunting since it is at these reviews that issues and problems are identified, some of these are of course design errors. However, it is my experience that significant involvement of the client in the volatile early design reviews leads to superior designs, smoother relations and superior products even if we get a little egg on our face.

The high level design review, the subject of the first three pitfalls, is a powerful tool to address strategic aspects of a design; however, the formal design review should be followed by a detail oriented review. This detail oriented review is most effectively conducted by a systems engineer or other multi-disciplinary engineer who can, with the aid of the principal designer, go through the design with a high degree of resolution. The task is not to evaluate the design but more the implementation of the design. Identification of tolerance issues, wear related issues, fatigue concerns, kinematic concerns and other detail oriented technical considerations are the domain of this review step. The formal high level review is ill equipped to deal with these aspects of a proper review and failing to include this step in the review process can be costly.

There is little doubt design reviews are a potent tool for optimizing the design of products. Some keys to a good design review are preparing the audience in advance, inviting a diverse group and including the client in the early and often messy reviews. This combination of tactics enhances the potency of the high level review; however, the high level review needs to be augmented with an in depth review by a technical resource external to the team.  By implementing these ideas you will reap added benefit from your reviews and satisfy IEC 60601 at the same time.

Image: StarFish Medical

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