Since Lean Thinking became popular in 1990s many industries have applied its practical cost saving methods. This includes the medical device industries. Many engineers who had worked with the lean methods in other industries salivated at the savings that could be made. Many of the savings they saw looked more like windfalls than low-hanging fruit!
Many organizations established lean departments to work on the ideas. Teams that included Lean Engineers as well experienced operations staff including managers, technicians, and product builders. And one or two minor quick wins were achieved, typically in non-core support functions like stationary supply.
But the challenges to make real meaningful changes soon became apparent. The key tool in the lean thinking arsenal is kaizen, the process of review and making small changes, especially Just-Do-It changes. Every lean expert knows that all these little improvements soon result in a very robust and efficient process.
However, this approach is often at odds with the change control systems required by medical device manufacture certification. It soon becomes apparent than many of even the smallest changes proposed have potential effects on the certification of the device when the FMEAs are examined by diligent quality engineers. It is difficult to say with 100% certainty that the change will have no effect on one or other key performance measure.
This slows the process down to a pace that defeats the purpose. It also adds to the cost of making the change. Many small changes that would be cost savings in other industries, will cost more to implement in the medical device industry than the change is worth.
So how can we make process changes? One way is by grouping small changes into one change notice. This will save on cost, albeit, at a slower pace. A risk here is that several small changes can together look like a big change, which regulatory affairs might want to take a longer look at.
In practice kaizen in medical device manufacture often becomes kaikaku. The best approach in practice is to bunch as many changes together, big and small, and implement together in one or more change notices. Ideally, try and group the kaizen changes with a necessary quality control change.
It will always be a challenge to convince the quality incident change notice owners to include your minor changes in their notice because they will view any differences as a threat to the approval of the main change. This is a good test of management commitment to lean process improvement. If management supports the lean team, they will support the grouping of kaizen changes with other necessary business changes.
However, many management teams will worry about any risk of a delay to the quality change and will not give the necessary support. You may find that the only lean idea embraced by senior management is 5S. They often think that by enforcing a tidy desk policy they are improving efficiency and reducing cost. While this can be a useful introductory exercise, without fully embracing the other ideals of lean thinking it may have a negative effect.
How committed is your management to lean thinking? While management like the idea of continuous improvement and elimination of waste, proper implementation of lean ideas is painful. It involves disruption, loss of jobs and changes to the way things are done. In regulated industries with fat protected profit margins, lean thinking is often not necessary for short term survival and, therefore, difficult to get buy-in for.
But without embracing the ideas there is a strong chance that at some time in the future, after patents expire, or another company has a better product in your space, it will be too late to make the changes that could have been.