Many people fear change, and this is even more pronounced in regulated medical product industries. One of the major reasons for this is the law of unintended consequences. The danger is real and those of us whose job it is to develop improved products and manufacturing processes should pay this law special attention.
The idea is not new. John Locke and Adam Smith wrote about its effect in economic policy. In the 20th century sociologist Robert K Merton popularized the idea. Unintended consequences fall into three broad categories.
Unexpected benefits, such as the usefulness of potential blood pressure sildenafil (trademark Viagra) as a treatment for erectile dysfunction.
Unexpected drawbacks, such as the law in Australian State, Victoria, requiring wearing of bicycle helmets. This law massively reduced the number of juvenile cyclists who considered wearing the helmets uncool and was counterproductive to overall health.
And worst of all are perverse results, when an action results in the opposite of what was intended. Two great examples of this are the Streisand effect and cobra effect.
Prior to taking an action to remove an aerial photograph of her home from the internet, the picture of singer Barbara Streisand’s Malibu home had been downloaded six times, two of which were by her lawyers. After her lawsuit failed 420,000 downloaded the picture.
A law in British India paying a bounty for each dead cobra resulted in enterprising individuals breeding the venomous snakes. When the authorities realized what was happening they ceased paying the bounty. The breeders then released their now worthless snakes back into the wild causing an overall increase in the cobra population.
Merton listed fives causes of Unintended consequences – 1. Ignorance – it is difficult to anticipate everything, 2. Errors in analysis, 3. Immediate interests overriding long-term interests, 4. Basic values requiring less favorable actions, 5. Self-defeating prophesy.
Errors in analysis are often the result of groupthink, where incomplete analysis is carried out of potential drawbacks because of the reluctance of team members to find any problems with the team’s big idea.
While it is impossible to think of every possible outcome of a decision, it is critical to serious think about all possible consequences, intended and unintended, of any action, especially if they are drawbacks or perverse results. Will your new process to reduce one category of defects result in a greater occurrence of another? Will your new product to improve the appearance of skin result in increased incidence of skin cancer? Such potential results need to be investigated, even if it means that the project gets killed.
It is important to properly brainstorm all possible outcomes of your change. Use of the pre-mortem described in an earlier column is a good method. Do not fear the process. Usually you will identify minor drawbacks, not serious enough to derail the project and much better to know about in advance to avoid surprise.
You will also identify unintended benefits that will help you sell the overall project, especially if they cause improved quality or safety.
Realize that every change you make will have unintended consequences, bad, good, and neutral. It is better not to be surprised so strive to identify all in advance.