Lean Medical Device Manufacturing in 3-D

If you’ve ever been cloaked in darkness for an extended period of time, you know how painful it can be when suddenly exposed to a bright light. Without the right glasses on to minimize the discomfort, the natural reaction is to quickly squeeze your eyes shut, reverting to a more comfortable blindness.

Transitioning from a conventional medical device manufacturing process to a Lean Toyota Production System (TPS) can provoke a similar response in a company’s associates. If a culture’s behaviors and mentalities (the glasses filtering their reality) aren’t acclimated to Lean thinking before TPS tools are introduced, the relationship between the changes and the benefits will be obscured.

Additionally, when TPS developments expose uncomfortable issues in the medical device company’s processes and structures, the inclination of some associates is to return to working as they were accustomed to—even if it’s inefficient and unproductive.

This is why so many companies across a variety of industries have struggled to sustain Lean initiatives. Their “tools first, people second” approach may offer short-term gains, but doesn’t cultivate a culture that consistently brings problems and wasteful activities to light and works collaboratively to solve them.

By focusing on three critical dimensions within an organization—the Mindsets and Behaviors, the Management Infrastructure and the Operating System (see Figure 1)—a medical device manufacturer strengthens its ability to effectively implement the Toyota Production System, transform into a customer-focused, waste-eliminating enterprise, and sustain a business model of continuous improvement.

1. Mindsets and Behaviors

In a company, people are the engines that drive progress. Making Lean improvements without first preparing and empowering the people within the organization is like applying a new paint job and adding shiny new rims to a car with a seized motor. As nice and new as the car might look, it won’t go very far down the highway without a rebuilt engine.

However, if the time and effort is put in to aligning an organization’s mindsets and behaviors with delivering customer satisfaction, and making the connection to why Toyota Production System initiatives are in everyone’s best interest, they are more inclined to sustain and kaizen (the process of continuous, incremental improvement of an activity to create more value and less waste).

Once a medical device company has explained to its production team what the Toyota Production System is, a constructive way to convey why it’s relevant to their manufacturing process is to get them thinking about “value” from a customer’s perspective and how that translates into what is important to them.

For example, ask the operators to consider a large-ticket item that they’ve personally purchased, what they looked for, and why they chose one product over another. By putting them in the customers’ perspective, it empowers them to see what their own medical device customers consider to be valuable. They start to recognize how their production efforts can affect whether or not a customer decides to purchase products from their company and understand that doing what’s right for the customer is also in their best interest.

Instead of commanding the team to follow TPS initiatives, the Lean approach is to engage them about their ideas for what can be done to improve the production process to help deliver value to the customer. As mindsets start to shift toward this kind of lean thinking, people are more willing to disclose problems, contribute to solving them, and continuously improve the value stream.

Cultural Support

In conventional manufacturing organizations, the cultural mindset is that problems are bad and exposing them is even worse. Unfortunately, this does nothing to solve the problems, much less lead to manufacturing excellence. Making the shift from concealing problems to digging them up like buried treasure, requires an adjustment to an organization’s cultural mindsets.

The traditional command-and-control manufacturing culture looks like a pyramid (as shown in Figure 2), with upper management at the top, management and support in the middle, and subordinate team members and customers settling at the bottom.

The predominant mindset is that, as long as quotas are met, problems are best ignored. Team members resign themselves to certain problems because it’s understood that management doesn’t want to hear about them.

In the event that a problem becomes too pervasive, a specialist is brought in to fix it because the production team isn’t perceived as having the wherewithal to come up with a viable solution. Unfortunately, these cultural mindsets often result in relaxed standards, longer lead-times, decreased morale, and dissatisfied customers.

When an organization’s cultural mindset emphasizes kaizen (continuous improvement), as it does in the Toyota Production System, the pyramid is inverted (see Figure 3). Management sees themselves as “servant leaders” who are dedicated to providing resources and support to help team members solve problems and continuously improve processes in order to satisfy the customer.

In this type of culture, managers are frequently on the production floor listening to feedback from the team, seeing problems first-hand, and helping remove obstacles to improvements.

Team members are encouraged to expose problems so that they can be resolved quickly and collaboratively. As a result, people feel respected for their ideas, the organization fosters a learning environment, work is performed with greater efficiency and less waste, and customers get the value they want, when they want it.

2. Management Infrastructure

If an organization’s culture doesn’t embrace the notion that everyone’s job is to find and resolve problems and support the team members’ efforts to satisfy the customer, then essential redesigns to the management structure will be counterproductive. This is another reason why it’s so important to acclimate people’s behaviors and mindsets to lean thinking before making changes to the management infrastructure and operating systems.

In traditional manufacturing organizations, managers oversee departments of workers making different products by using batch-and-queue processes. Alternatively, what’s needed in a Lean organization, asserts James Womack and Daniel Jones, authors of the book “Lean Thinking: Banish Waste and Create Wealth in Your Corporation,” are “teams that manage whole value streams for specific goods and services.”

An effective TPS management redesign that aligns with this perspective is a structure with a dedicated team leader supporting a product-focused team of five to seven members.

The team identifies all the specific steps and time required to get a job done. Standardized work is then created so that the job can be completed in a timeframe that matches customer demand, using the appropriate number of processes and the minimum inventory. Working cohesively, the team problem solve to address any work imbalance or interruptions to continuous flow of the value stream.

In this management structure, each team member has a clear understanding of his or her responsibilities for building in quality and doing so on time. If an issue arises that inhibits their ability achieve this, the team leader is able to step in and assist, problem solve or escalate the problem so that the issue can be resolved quickly.

See to Believe

Even though a TPS management structure is designed to provide better support to the production team so they can do their job to their best ability, it tends to challenge conventional thinking about how to do work and how to work together.

Many operators are accustomed to a system where each worker has a set of hard-earned skills, works at their own pace, and are left alone—as long as they meet their quotas. Proposing a new system where operators work in small, product-focused groups with a dedicated team leader might initially be perceived as unnecessary oversight.

Additionally, the process of transitioning away from siloed, batch-and-queue processes and toward single-piece flow is likely to bring a variety of long submerged problems to the surface. If there’s inadequate preparation to deal with the many problems and education of what to expect beforehand, this discomfort is likely to be perceived as management pushing another ineffective “improvement” concept, and a reason for why workers should return to their conventional production processes.

One strategy to help minimize contention is to first demonstrate success in a limited area. Instead of drastically overhauling the management structure, regrouping the production team and rearranging machines, start a small “test lab” with a “test team.” The “test team” would be structured according to the proposed support organization redesign and apply TPS practices to a specific activity that’s been performing poorly (e.g., kaizen and rebalance of work to produce Product A).

Once the TPS “test team” has stabilized and substantiated the improvement, the rest of the organization can witness first-hand how the new team structure would work to build in quality, do it on time, problem solve and eliminate waste. This type of “test lab” can be essential to establishing the psychological sense of support, mitigate the sense of risk, and requires fewer resources in order to prove the viability of new Lean processes.

Not only will the rest of the production team see that the TPS management system won’t negatively affect their job, many will be grateful for the waste, inefficiencies and obstacles that TPS will remove from their work.

Whatever the management restructure, when implementing the Toyota Product System, it’s important that there’s an understanding for the necessary cadence of when new mindsets, behaviors, structures, processes and systems should be introduced. A successful redesign of departments and work functions requires, first and foremost, speaking to the real needs of employees at every point along the value stream so it is in their interest to make value flow, according to Womack and Jones.

3. Operating Systems

Once the organization—from upper management to the production floor—has been properly trained on the Toyota Production System, the culture supports and promotes continuous improvement, and management has been restructured to capably address and deal with issues, powerful TPS tools can be implemented to dramatically improve work flow and optimize manufacturing performance.

One TPS tool that engages the expertise of the production team, and empowers them to find and solve problems, is value stream mapping. Once product-focused teams have laterally assessed the value stream (steps and processes from point of order through final delivery) for waste, they identify stagnation of material or information negatively affecting lead time and adding unnecessary cost.

This straightforward process helps bring problematic areas of stagnation and wasteful activities to light. From there, the team can discuss opportunities for improvement and develop a plan to deliver better value to their customers.

Value-stream mapping usually reveals imbalance between processes, with potential disparity between demand and what is being produced. This margin provides ample opportunities to increase capacity. Kaizen and rebalance can self-fund the restructured support positions, alleviating the concern that workers will “Lean themselves out of a job.”

As Pascal Dennis explains in his book, “Getting the Right Things Done,” Lean thinking is about eliminating waste, not people. “If we involve them [workers], they’ll help eliminate it—but only if we’re committed to employment stability,” Dennis writes.

Instead of being released, if team members are reallocated to new value-creating work, a symbiotic cycle develops where involvement creates improvement, and improvement creates involvement, according to Dennis.

Illuminate Problems

Another impactful TPS tool is something called an “andon.” The andon is a visual device in the production area (typically a light at the process and a lighted overhead display that shows the current status of the production system. This alerts the team leader and support departments when there is a problem, or something needs attention.

Instead of hiding problems, manufacturers use the andon to make them very visible so resources can be quickly applied to solve them. For example, in a medical device manufacturing facility, a four-light andon system might be installed along the production floor, with each light representing a different issue.

One light might represent that the die on a forging press is not available in time, so the operator would use the andon to illuminate the issue and call their team leader for assistance to solve the problem.

If changeover of the dies is taking longer than expected, the operator would use a different colored light to alert the team leader for support so that the problem could be solved and be prevented from recurring.

Another light might signal to maintenance that the operator needs assistance with the equipment, and a fourth light could distinguish that support is needed because the operator doesn’t have the materials or incorrect materials were delivered.

Value-stream mapping and the andon are only two of the many renowned TPS tools that help the team work together to promptly implement continuous improvements. But, regardless of the TPS tool, if the why behind the tool is not understood, its value will be obscured.

The Depth of Lean

“The greatest wastes are unused talents and untried ideas.”
~ Source unknown

What separates a legitimately Lean company from one that simply labels themselves “lean” is the holistic approach to the Toyota Production System.

A distinctly lean environment aligns, focuses, and engages team members at every point along the value stream and empowers them to redefine work functions, contribute their ideas for improvements and make value-creating steps flow.

In addition to careful planning and execution, getting to the point where the Toyota Production System is the core operating principle of the organization requires an understanding that people, not processes, systems or tools, are what deliver real value to the customer.

Matt Burba is the executive vice president of Implant Manufacturing and Lani Watson is the corporate Lean leader at Orchid Orthopedic Solutions, a Holt, Mich.-based contract designer and manufacturer of implants, instruments and innovative technologies for the orthopedic, dental and cardiovascular markets. Orchid Orthopedic Solutions has implemented the Toyota Production System since 2007.