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Best Practices for Medical Device Design Reviews Cheat Sheet (DRAFT) by [deleted]

Best practices for designing medical devices

This is a draft cheat sheet. It is a work in progress and is not finished yet.

Introd­uction

A number methods and attributes of effective design reviews that help produce a superior product; eight are listed below. There is no single method, process or venue that is the “proper” way of conducting a design review. On the contrary, there are a great many ways to conduct a fruitful design review.

Hold Many Reviews

Many Reviews: Hold impromptu one-on-one reviews as often as possible. These short discus­sions may not even appear to be reviews but the constant collab­oration gives rise to less hiccups when disparate systems come together and can provide a designer with the kick to get out of a design rut. If you have only formal reviews that demand rigorous docume­ntation you may find your team resists reviews.

Vary the Review Structure

Varied – The structure of the reviews should be varied to suit the situation and state of the design. Large group struct­ured, large group free flowing, small group and one-on-one reviews are all potent in certain areas and restri­cting oneself to only one type invites missed opport­unities to improve a design or avoid an error.

Structure Review Checklist

Structured – When employing a formal review it is a great idea to use a checklist of areas to think about and discuss. This list need not be product specific; e.g., CTE (thermal expansion) issues, creep issues, common fasteners, corrosion issues, fatigue concerns etcetera are generic areas that should be consid­ered. The use of a checklist helps a group to consider aspects that may not initially have been considered or that were not relevant initially but due to changes during design become relevant.

Free Flowing Explor­ations

Free Flowing: Portions of the review often benefit from free flowing explor­ation of questi­oning thought lines. This can be thought of as brains­torming for problems or possible failures, virtual device torture. If the discussion goes too deep for a wider audience, off-line this as a one-on-one review between the relevant parties and revisit as an action item.
 

Exploded assemblies

The design­er(s) are intimately familiar with the intric­acies of the design and it is often possible for them to imagine the assembly order in their head. This is not true for ancillary team members or indepe­ndent reviewers. The generation of exploded assemblies is worth the time and effort ten-fold. Exploded assemblies allow the group to walk through the assembly and interr­ogate the designer in a meaningful way on assembly order and identify jigs and fixtures that will be required or advant­ageous.

Cabling

Spend the time to model the wires! In my best practices from years ago, this edict used to be model the fasteners; however, with the ease of finding CAD models of fasteners online this is now commonly done. The modeling of wiring, even with add-in packages to assist, still time consuming and tempting to omit. Modeling the wiring and paying attention to bend radii, service loops and tie downs can save a great deal of time and rework in early engine­ering protot­ypes.

Bring the Client

Inviting the client to attend a review can be an effective way to keep them informed on design decisions and avoid potential misund­ers­tan­dings. In addition, the client often will have expert knowledge in a certain area and can bring that to the table.

Model the Kinematics

If anything moves, take the time to model this motion and confirm clearances and intended range of motion.