The phrase “it can’t work here” is one that Robert St. Louis has heard many times. As vice president of operations at Heraeus Medical Components in St. Paul, MN, St. Louis has championed the adoption of Lean methods in an industry where such efforts raise questions, if not downright opposition.

As global markets become more competitive, medical components has joined a growing number of sectors, including manufacturing, government services, and healthcare, in turning to Lean. The success stories are compelling. Companies find they are able to significantly improve lead and cycle times, reduce defects and rework, and control costs.

Lean is generally met with skepticism, even in the automotive industry where it originated—the idea that a set of simple tools can be applied to complex processes is “counter-intuitive,” says St. Louis. Then there’s the issue of regulation.

“In the medical industry, there’s a heightened sensitivity to changing things because of different regulations and requirements,” says St. Louis. “You’ll hear every reason why you can’t do something—this regulation doesn’t allow you to do this, or this customer doesn’t allow you to move this, or that’s considered a process change.”

While caution is understandable, dismissing Lean for these reasons reflects a basic misunderstanding of how Lean works. In truth, Lean helps rather than hinders both regulatory compliance and quality while delivering substantial improvements to the bottom line.

“Lean is different than what people think,” says Kevin Klump, a South Carolina-based Lean consultant with Kaizen Institute Lean Advisors. Klump has worked with several large providers in the medical components industry, “because Lean is a way to enhance the existing quality programs of medical device companies by truly identifying the actual steps that take place, and reducing waste.”

The term “waste” in the Lean world refers to all efforts or outlays that don’t add value to an end product. Typical examples are unjustified amounts of work-in-progress (WIP) and product inventory, duplicated procedures, excessive walking due to inefficient layout, delays in finding parts due to a disorderly environment, or errors due to poor communication.

Waste is costly – measurements in this industry show cycle times, product development times, and delivery times to be double or even triple what they should be, significantly harming the company’s competitive position. Also, because waste clutters and complicates processes, it makes compliance difficult.

“Waste in any medical device adds variation, unnecessary steps, or potential mistakes,” says Klump. “The more forms of waste you add into a process the harder it is for you to control that process.” This creates a sort of vicious circle. “You keep having to add more and more steps, which in reality usually leads to longer lead times and more mistakes, and in a lot of cases more recalls because the complications of the process have gotten to a point where you can’t control them.”

Conversely, Lean processes, when applied properly, work in conjunction, not in opposition, to compliance efforts. “The regulations require you to have some sort of system, and you need to have some control of that system going forward,” says Mike Wroblewski, whose company, Gemba Consulting, a Kaizen Institute Consulting Group Company, provides Lean consulting services to Heraeus. “The thing I learned very early is that it’s do what you say, and say what you do. ISO doesn’t mind, or the FDA doesn’t mind if you change processes as long as they’re documented, and you are showing that you’re controlling that change going forward.”

Starting the journey

A Lean method called Value Stream Mapping typically provides the watershed moment in every Lean journey because it builds a clear consensus on which activities in a process are deemed of value, and which are viewed as wasteful. Unlike process mapping, Value Stream Mapping encompasses all the steps designed to create a particular end result for the customer. This might entail the supply of an implantable device such as a pacemaker, a measurement instrument for the consumer market, or a hospital bed. In each case, the value stream includes the design, prototyping, parts sourcing, assembly, packaging, and distribution of the product.

Getting people together from these diverse processes is a defining moment in the Lean journey because it is here that workers learn about the interdependencies that ultimately determine the value that they are able to create. “One thing that’s very powerful about Value Stream Mapping in the medical device industry,” says Klump, “is that it gives people a window into their processes, which are otherwise hard to grasp because they are so complicated. Value Stream Mapping looks at the flow through these processes, and what is value and is nonvalue added. It helps people see the processes in a way that allows them to build better quality into the process.”

The outcome of Value Stream Mapping is the generation of current state and future state maps, the latter of which serves as a master plan for improvement activities.

Mapping strategies vary; companies can select value streams that are very general or quite specific. At Heraeus, St. Louis chose the latter approach.

“Rather than doing an Enterprise Value Stream Map, I picked a particular product line,” says St. Louis, “because it would help us focus on some tangibles, but we also could deliver from that. And I thought if I did an enterprise, it would just be too nebulous, and the right activity wouldn’t happen.”

Once people saw the concept working, the ideas started to spread within the company. “I think the most significant result we got,” says St. Louis, “was not only did we achieve the objective that we had put on the future state map in the timeframe that we wanted to, but also people started opening their eyes and saying ‘I want to learn more about this.’ So that to me was the most significant win, and that that has spread globally beyond just our doors is extremely powerful.”

Klump took a more general approach when working with another global medical equipment vendor. “They needed their senior leadership to truly understand how Lean could work for them,” says Klump. “We provided macro Value Stream Mapping so they could see the operation from a less silo-like perspective, as opposed to from each process step. We helped them see the flow of the process from a value stream at a high level, and this allowed them to select their first value stream.”

Making improvements

Using the future state map as a guide, organizations apply a series of Lean process tools to attack specific areas of waste in the value stream. The improvement process is perpetual–Toyota still strives daily to improve their processes after more than 50 years of Lean.

Initially, one of the burning issues at Heraeus turned out to be delays stemming from changeover processes in their value streams. Working with the GEMBA team, the organization implemented Single-Minute Exchange of Dies (SMED), a Lean method developed at Toyota to reduce changeover times 5S, an acronym for a series of procedures for establishing visual order in a working environment, is another Lean tool that often produces quick and dramatic results. The process helps workers establish logical and easily visible placement for tools and parts, improves sightlines, and reduces clutter, making the environment more efficient. In one instance, St. Louis used 5S to apply order to a machining operation of a competitor that Heraeus had recently acquired.

The process also fits well with compliance strategies. “5S is a perfect tool for the medical device industry because it can be considered part of the Good Manufacturing Practices (GMPs) for the FDA,” says Klump. “It fits in there perfectly because if you read the GMPs you could be reading the 5S requirements.”

Finding the right fit

A key to success with Lean is adapting it to the business environment where it is being applied.

“You’ve got to have the ability to be flexible,” says St. Louis, “and I think this is really key, not only with your processes, but with your thinking as a manager. I really need to bring together that whole team to make it work for this particular business, and ensure that it aligns with the strategic objectives of that business.”

Worker involvement is an essential part of the adoption process. “The key thing is empowering the workers,” says St. Louis, “and always keeping them aware of why you’re doing it, and where you’re going, and why it’s important, and involving them. because if you involve them they’ll understand. If you don’t tell them what you’re doing and why you’re doing it then it becomes autocratic, and it creates barriers and resistance.”