The Human Side of Medical Device Asssembly

June 27, 2008
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Two Shingo Prize winners talk about how a strong workforce can pave the way to profitability.



Medical device manufacturers need to be especially flexible to accommodate the particular needs of their customers. In this cell, operators are assembling custom knee braces. Photo courtesy DJO Inc.

Medical devices are among the most sophisticated and highly regulated products manufactured today. Not only must they be extremely precise in terms of their performance, they must be completely and utterly reliable. Medical devices are also often manufactured in high volume. This, in turn, requires a high degree of automation in one’s assembly process to ensure profitability. Clean rooms, rock-solid inline functional testing, highly repeatable assembly processes-medical device manufacturers are often on the cutting edge of assembly, and for good reason.

That having been said, all the technology in the world isn’t going to do you much good if you don’t a talented and dedicated workforce to employ it. On the one hand, the high-tech equipment employed in manufacturing medical devices requires a good deal of skill to operate. On the other, the nature of the healthcare sector is such that a single facility will often find itself producing a mix of products, or maybe even creating products on a semi-custom basis. Manual assembly is still widespread. A one-size-fits-all approach simply isn’t possible when dealing with things like implants or splints. Operators need to think as opposed to just pushing buttons. An engaged and enthusiastic workforce can have a huge impact on the bottom line.

Illustrative of this point has been the experience of DJO Inc. (Vista, CA) and Aspect Medical Systems (Norwood, MA). Founded in 1978 as DonJoy Inc., DJO manufactures the Defiance line of knee braces-popular with college football players, among others-and the DonJoy CMF line of bone growth stimulation devices. The company also manufactures a device it calls the Venaflow, which helps prevent blood clots. Aspect Medical produces the BIS line of patient monitoring devices, which allows anesthesiologists to more carefully monitor a patient under sedation by measuring actual brain activity via something called Bispectral Index Technology.

In addition to meeting with tremendous success in the marketplace, both companies recently received the Shingo Prize for their efforts in lean manufacturing. Named for pioneering industrial engineer Dr. Shigeo Shingo, the Shingo Prize has been called the “Nobel Prize” of manufacturing, because of the world-class caliber of its recipients.

In the case of Aspect Medical, lean manufacturing allowed the company to reduce product cost by more than 50 percent, improve inventory turns by 180 percent and reduce manufacturing cycle times by 100 percent. In the case of DJO, getting lean increased employee productivity by 50 percent, doubled the rate of both inventory and finished goods inventory turns, and reduced order to shipment lead times by approximately 66 percent.

In both cases, worker participation and initiative have proved critical to the company’s success.

“Even though we have automated and semiautomated equipment, it won’t run for very long without proper care and maintenance,” says DJO’s vice president of lean and enterprise excellence, Jerry M. Wright, P.E. “Our operators practice VTPM, or Visual Total Productive Maintenance, which allows them to have greater ownership of their equipment and processes…. All of our products are made in workcells by self-directed work teams. Our teams vary in size from two people to 30 people per shift on our large custom brace cell. Each cell monitors customer orders, or demand, and builds what is needed for that hour or day. Each cell is able to switch from one model or product type to the next within seconds or at most a few minutes…. We continually [kaizen] blitz our processes, [and] our work teams are involved each time on how their cell is designed, how it is replenished with raw materials and how it is operated. It is fair to say that they play a significant role.”

In this same vein, Aspect Medical vice president of manufacturing John Coolidge says, “It’s all about the people. We have solid values associated with respect, ethics and teamwork. We are really fair with all employees. We have a solid track record of doing the right thing by all our employees. Our president and CEO, Nassib Chamoun, and all leaders in the company have a lot to do with this. It comes from the top…. We get a lot of success from a balanced approach to blending soft side human element needs with hard side operational execution and performance to plan needs. People know what needs to be done and how we want it done…. At the same time, they know we care and will do the right thing.”

According to Coolidge, his company’s workforce has been especially effective at carrying out continuous improvement activities, which have served to solve problems and production bottlenecks both large and small. In one instance, a test technician substantially reduced the number of stations in one of the company’s functional test areas, thereby cutting overall testing times in half. In another, a kaizen team figured out how to save $57,000 annually by extending the life of a critical consumable item used in a die-cutting process for disposable electrodes.

Coolidge says Aspect Medical’s “great ideas” program has been particularly effective in letting line workers provide input into the company’s production processes. For example, Aspect Medical uses the “visual factory” approach to improve material flow to its production cells, and operators often play a role in deciding exactly how a bin should be positioned for maximum efficiency. Operators also play a critical role in creating their own workstations, so that they can perform their jobs with as little wasted motion as possible.

“Ninety percent of [continuous improvement] is little things,” Coolidge says. “With workcells, for example, rarely do you get it 100 percent right the first time. That’s where continuous improvement comes in…. If an individual in production who’s doing the job day in and day out recognizes a better way of doing it, they have a vehicle where they can get that idea implemented. They put it in place so it isn’t just going off to some kind of project list for someone else to do.”

Write notes that DJO has also made a serious commitment to continuous improvement in its efforts to create and sustain an efficient work environment. In fact, the company has completed over 300 formal kaizen blitzes in the past seven years with results that have been nothing short of ”amazing.”

That having been said, Wright emphasizes that DJO didn’t just become a lean company overnight. Instead, it took a good three years of hard work on the part of company leaders before the idea of lean manufacturing could be said to have really taken root.

“As with any change, there are always those who ‘wait and see,’ and even some who are openly resistant,” Wright says. “The key we have used to make sure that everyone is onboard is…the kaizen blitz approach. We create a cross-functional team that includes process experts, the process owner from the process being ‘blitzed’ and process outsiders who don’t know much about the process. Our certified DJO kaizen blitz facilitators then take the team through the improvement event with only three limitations: no safety is compromised, no negative quality or regulatory impacts, work must be completed in the blitz timeframe. When the people who do the work every day see that they can change how they do it, the skepticism is gone. And, of course, they tell others about it immediately. Quite soon, you have other people asking for a kaizen blitz in their area!”

Finally, there is the question of worker retention. Few things have as direct an impact on productivity as absenteeism and high employee turnover. Many employers also worry that by training their workers they make it that much easier for them to leave for another company. However, the experience at DJO and Aspect Medical has been that the more empowered workers become, the more that they want to stick around.

“Our employee satisfaction survey results consistently exceed benchmarks by over 10 percent to 20 percent across the board,” Coolidge says. “[Since receiving the Shingo Prize] we’ve had a lot of companies come in for a tour. Initially, I had this fear that they were going to poach some of our great people. We let it all out there and explain what we’re going. There’s lots of interaction on the shop floor. But we haven’t lost anybody yet…. In the end, the openness and trust that you build pays you back.”

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