In my last post, I promised to follow up with an explanation as to why I believe that a Design Review need not be seen as a Moral Hazard.  My thoughts here are my response to a long discussion on a LinkedIn group debating whether the Design Review process encourages device designers to not fully assess potential risk on their own, as they might assume that the responsibility has been shifted to a committee.  Here, I will elaborate.

I personally am more persuaded by the argument that the “quality of the design review is significant.”  The purpose of conducting design reviews is to ensure that the design satisfies the design input requirements for the intended use of the device and the needs of the user, which is independent of who has the ultimate responsibility and liability for the product (the corporation).  

More important is ensuring that the design reviews are effective, and avoiding the “all documents are complete, thus there are no issues,” “design reviews are just a formality,” or “I (the engineer) just need to pass DR and then it is ok” mentalities that can occur.  The expectation, rigor and tone should be set by management and the individuals of the design review committee.  The review members should ask probing questions and expect to discuss details, and not just be satisfied that all documents on a checklist were completed.  Design team members should anticipate questions in areas not considered, and anticipate that it may lead to additional design work and testing.  

One can imagine the difference in design reviews at the extreme ends of the scale with regards to the level of detail.  For example, in one type of design review, it could mainly be a check that “all documents are complete.”  Questions might focus on whether the design inputs, risk analysis, output drawings, etc. have all been released.  Given that a multi-functional team review and approval is generally required to release those documents, the assumption would be that if the team is okay with it, then no discussion is needed.    At another type of design review, there would be a check that all required documents are released, and in addition, there would also be some detailed discussion.  Questions would be posted to ensure the team applied the appropriate level of rigor and that the team, while focused on the details, has not missed something overall:  Were enough samples used for creating design input specs?  How were the test parameters chosen?  What are the top risks that were identified?  How were they mitigated- through design if possible?  Was anything in the ‘big picture’ missed?   While obviously more work may be associated with the second type of review, it helps to ensure the safest and most effective device, which benefits the business and user alike.  

It is also important to be on the lookout for groupthink, a pattern of thought characterized by self-deception, forced manufacture of consent, and conformity to group values and ethics, according to a popular definition.  Members of a design review may have established a certain acceptable level of rigor and risk, and thus avoid independent probing and questioning.  Sometimes this is manifested in a “The fill in individual here (Engineer/Independent Reviewer/Quality/VP/respected person) is okay with it, and I trust that individual, so I’m okay with it and my own analysis won’t add value” type of thoughts.  It is important that all individuals participating in a design review bring their expertise and critically evaluate the design individually.

So, if your device is subject to the design review process, I think the best way to ensure that no moral hazard exists is to: 1) ensure that management sets appropriate expectations and a rigorous process in place for the review team, while all committee members should commit to the goals of usability and patient safety and 2) watch out for groupthink – again, with management setting the tone.