August 6, 2010
By Michelle Wu, Director of Quality Services
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. I originally began reflecting on this idea after reading a forum post on LinkedIn, where people were debating the potential moral hazards brought on by the design review process. Their main argument suggested that the design review process encourages device designers to not fully assess potential risk on their own, because they might assume that the responsibility has been shifted to a committee. Here, I will elaborate. I have always stood by the idea that the quality of the design review is significant in and of itself. 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 (i.e., the corporation).
Subsequently, ensuring that the design reviews are effective in the first place will help avoid the mentalies that “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 okay.” The expectations, rigor and tone should be set by management and the individuals of the design review committee. Design review members should ask probing questions and expect to discuss details, and not just be satisfied that all documents on a checklist were completed. The design team should anticipate questions in areas not considered, and anticipate that it may lead to additional design work and testing.
Design reviews can vary greatly depending on the level of care that is encouraged by management. For example, a flippant design review might simply involve checking 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.
In a more conscientious design review, the team engages in critical discussion after checking that all required documents have been released. Questions are raised to ensure 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’ overlooked? While this type of review clearly requires more time and effort, it ultimately results in the safest and most effective device, which in turn benefits the user and company alike.
Members of a design review team must avoid the tendency for groupthink, a pattern of thought characterized by self-deception and mindless conformity to group values and ethics. With groupthink, team members may only adhere to the minimum acceptable levels of rigor and risk, thus avoiding independent probing and questioning. Sometimes this is manifested in a “he/she is okay with it, and I trust that individual, so I’m okay with it” type of mentality, which deludes the individual into thinking his/her opinion will add no value to the conversation. It is important that all individuals participating in a design review bring their expertise and critically evaluate the design.
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 lays out a rigorous process for the review team, while all committee members are committed to the goals of usability and patient safety and 2) watch out for groupthink – again, with management setting the tone.