Over the last decade, lean manufacturing has been prescribed as a cure-all in a wide variety of industries. Most success stories have centered around the automotive and consumer goods industries. Medical device manufacturers have been slower to adopt lean principles.
While some companies, such as DJO LLC and Medtronic Inc., have been recognized for their lean initiatives with the prestigious Shingo Prize, many other firms are far behind. Traditionally, because of high profit margins, there’s been less incentive for manufacturers of syringes, cannulas, pacemakers and other products to go lean.
“The medical device industry is still fairly early in its lean journey compared with other industries,” says Art Smalley, president of the Art of Lean Inc. and a former Toyota Motor Corp. engineer. “Some of the price-cost squeeze that has long been going on in other industries is now affecting medical device manufacturers.
“Whenever there starts to be increased pressure and competition in any industry, lean starts to draw attention,” adds Smalley. “Companies that felt pressure earlier [typically] started their lean journey sooner.”
Some medical device manufacturers are protected by patents or boast strong profit margins that insulate them from the need to pursue lean initiatives. “However, as competition heightens and margins come under pressure, or customers simply demand more, then attitudes will change,” predicts Smalley, who has worked with a handful of medical device manufacturers.
“Up until five years ago, many medical device manufacturers were not motivated to change [their production practices],” notes Drew Locher, managing director of Change Management Associates. “Sometimes, they would ‘hide’ behind regula-tions as a reason why change could not happen.”
“The intense regulatory environment that surrounds the medical device industry is usually perceived to be a limitation to going lean,” adds Jamie Flinchbaugh, a