It seems we live in an era that favors progress over perfection, the aim is to push vanilla products fast to market. For those of us that work in critical processes such as medical device packaging, we must be careful about adopting this mindset. Perfection is the enemy of progress” said Winston Churchill, but perhaps he should have said “The poorly managed aim of perfection is the enemy of progress” often we get stuck in this “either-or” myth of progress, as we believe we have but only one choice. Often we are asked by our vendors “Do you want it fast or do you want it right? In our industry the answer is quite clear; we require it to be right and yes, we need it fast.
As the world population expands to nearly 10 billion people the requirement of production will continue to be heavy and growing. This however does not mean we are off the hook in terms of developing products that not only meet spec but also exceed core product requirements. In medical device packaging, there is a tug-of-war that takes place daily in corner offices at medical device manufacturing companies. Production and management want a steady flow of product out the door each day, and well they should as this is what pays the bills. Unfortunately, quality engineers have had to become the Grim Reaper’s as they must repeatedly deliver the message that the production must slow in order to meet product quality. This happens often in medical device packaging as it is seen as a solid candidate for process tweaks.
Both camps with their dissimilar goals need to be empathetic and work together in order to find better ways to deliver on the new zeitgeist of “Perfect and Fast”. Here is an example of how this plays out in medical device packaging. In order to create strong repeatable seals on medical device pouches, engineers must develop a design of experiment that narrows down to nominal sealing machine settings. Sometimes these settings require a three to four-second process time to accurately and repeatedly seal a medical pouch. This often gets production scratching their heads and asking what if we were to cut in half the speed of this event in order to double production. They might suggest increasing the temperature and dropping the contact time for the medical pouch sealer but just like baking a cake you cannot double the temperature and half the time and expect good results. Many processes are slow by the constraints of physics and biology, the maturation of fine wine, or the undeveloped mind of a child simply take what they take.
The solution in my view is to begin the process in medical device manufacturing and packaging by focusing in on perfection as a value of the project, by doing so the regulatory layers nearly take care of themselves. Built on a baseplate of quality you can now find the waste with old chestnuts like Muri Mura and Muda as well as Man, Machine, Method analysis. It is far more difficult to make a fast system perfect than a perfect system fast in my experience. So, stand your ground quality engineers, safe sterile efficacious devices happen on your watch, but always be thoughtful of the grand reality the companies can only exist with a balance sheet that must serve costs and of course the most difficult to manage axis, Time.