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, Minnesota, 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 re-work, 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.

Removing Waste while Meeting Regulations

“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. 

The term “waste” in the Lean world has a special meaning – in this case, 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 more difficult.

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, a senior consultant from Kaizen Institute supporting Lean efforts at Heraeus. “The thing I learned very early is that it’s ‘do what you say, and say what you do’. ISO doesn’t mind, 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 by the business 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. 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-level Value Stream Map, I picked a particular product line,” says St. Louis, “because it would help us focus on some tangibles, but also we 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.”

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 on a daily basis to improve their processes after over 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 Kaizen Institute team, the organization implemented the SMED system (Single Minute Exchange of Dies), a Lean method developed at Toyota to reduce changeover times.  “The approach is to look at the changeovers from when you have the last good piece from the first run, to the first good piece of the next run,” says Wroblewski. The key is preparing in advance for the shutdown of the machine so that work can occur as rapidly as possible during that period.  Dies, tools, and fixtures are arranged accordingly.  “The question you ask,” says Wroblewski, “is ‘what are the things that can be done when the machine’s still running versus things that have to be done when the machine’s stopped?’”

The use of 5S, a series of procedures for establishing visual order in a working environment, was another Lean tool that produced quick and dramatic results. The process helped workers establish logical and easily visible placement for tools and parts, improved sightlines, and reduced 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. 

“We went down the path of cleaning it up,” says St. Louis, “and that lead to some very impressive results. Some customers actually thought that the machine shop was an ISO class clean room operation - that they would have to gown up before going in there. That’s how much they took to the 5S. You wouldn’t have even recognized what it looked like before, and these improvements had tangible benefits to us in that they reduced our operating costs.”

The 5S process also fits well with compliance strategies within medical devices industry because it can be considered to be part of the Good Manufacturing Practices (GMPs) for the FDA.

Success Factors

Lean is demanding on organizations because it requires many people to adopt a new way of thinking about processes that they may have followed for years.  At Heraeus, senior management sponsorship and strong alignment with strategic plans were essential.

“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 think one of the worst mistakes I could have made coming in would have been thinking that I have ‘X’ years of experience working with Lean, I’ve got all the answers, and if they don’t see it my way they’re wrong.  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.”

The dialogue, however, isn’t just for managers – workers on the shop floor are depended upon to not only cooperate, but to play a key role in designing and implementing improvements. “The key thing is empowering the workers and always keeping them aware of why you’re doing it, and where you’re going, and why it’s important, and involving them,” says St. Louis, “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.”

We have to manage differently,” says Wroblewski. “That’s a struggle for a lot of people who have been successful for 20 or 30 years with a certain way of managing.  We have to allow people on the line level to solve the problems, and then move forward, and teach and coach and mentor.  Most corporations don’t have that now. "