July 1, 2010
By Michelle Wu, Director of Quality Services
I recently came across an intriguing discussion thread on the medical device engineers network on LinkedIn. Someone asked whether the design review—a required element in FDA regulations on design control—creates a moral hazard in the device development process. The discussion was sparked by an essay written by technologist Les Bogdanowicz, and can be found on his LinkedIn profile. In the discussion, commentators deliberated the obvious increase in medical device recalls over the past few years. The FDA design review process was originally intented to decrease the number of product recalls, but sometimes what seems like a good solution can in fact have unintended consequences. The Wikipedia entry for moral hazard defines the term as:
...the prospect that a party insulated from risk may behave differently from the way it would behave if it were fully exposed to the risk. A moral hazard rises because an individual or institution does not bear the full consequences of its actions, and therefore has a tendency to act less carefully than it otherwise would, leaving another party to bear some responsibility for the consequences of those actions. For example, an individual with insurance against automobile theft may be less vigilant about locking his/her car, because the negative consequences of automobile theft are (partially) borne by the insurance company.
In the case of the design review, the claim posed is that the design review has diluted the accountability of a design flaw from a single designer to the multiple people serving on the design review committee. Thus, as no one individual bears the direct responsibility or accountability of the consequences of the design flaw, a flaw may go through the design process unidentified and the risk passed along to the user. It is sort of a “diffusion of responsibility” type of situation, perhaps exacerbated by pressure to speed a product to market.
The commentator who initially started the discussion on LinkedIn mentioned that he has seen engineers “whip up a design with the mentality that as long as it passes the design review it is okay.” However, a couple of the subsequent posts generally expressed that it was not their experience to see responsibility of maintaining device integrity transferred because of design reviews. Because I am someone who is regularly responsible for design reviews in my company, the entire discussion made me stop and reflect. We strive to ensure that all device reviews are thorough and effective, and the last thing we want is a design flaw in our clients’ products. In my next column, I will explain why and how I think that this moral hazard can be effectively addressed by a responsible design review committee.