May, 2006

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Article Index

Another Minnesota Medical Device Success Story
Article by: Justin Dorsey
You’ve had a heart attack. Your ICU physicians need to determine—fast—the extent of the damage and, if possible, the cause. They use angiography, the science of administering a “contrast” through a catheter to see where and what the damage is. Traditionally, contrast was administered manually through a cumbersome manifold whose different ports would allow pushing and then pulling. Precious time was used in moving from port to port, and reading flow-rates was imprecise because of the manual pressure. Today, doctors can more accurately and quickly assess the damage from your heart attack—thanks to Acist Medical’s pressure-sensitive automated delivery system for contrast.
Leading in Lean
Article by: Manufacturers Alliance
Starkey Labs, the world leader in custom hearing aids, has begun their lean journey by implementing Visual management through 5S techniques coupled with Kaizen events. Leading the way in the lean transformation process is Bruce Shamla, Director of North American Manufacturing and Scott Gustin, Process Engineering Manager.
COMPLIANCE NEWS NOTES
Article by: Vija Kelly
Recent OSHA Inspections
When Should Leaders Apologize–
Article by: Lynn Moline & Mike Braun
“I’m sorry.” The words are simple, but they are highly charged when they are—or aren’t—said by leaders.
Managing Chaos, Complexity, and Change in Product Development
Article by: Rod Greder
In the television show “Get Smart” from the late 1960s, the forces of good, symbolized by the organization CONTROL, were constantly battling the evil group KAOS. Today, this battle between control and chaos occurs inside most organizations trying to innovate today, especially during product development. Examples include morphing customer requirements, technology shifts, corporate reorganizations, mergers and acquisitions, “new-and-improved” systems and processes, budget cuts, and external factors such as regulatory, political, legal, and international.
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Another Minnesota Medical Device Success Story
You’ve had a heart attack. Your ICU physicians need to determine—fast—the extent of the damage and, if possible, the cause. They use angiography, the science of administering a “contrast” through a catheter to see where and what the damage is. Traditionally, contrast was administered manually through a cumbersome manifold whose different ports would allow pushing and then pulling. Precious time was used in moving from port to port, and reading flow-rates was imprecise because of the manual pressure. Today, doctors can more accurately and quickly assess the damage from your heart attack—thanks to Acist Medical’s pressure-sensitive automated delivery system for contrast.

The “heart” of Acist’s system is a sterile, single-handed, precise control mechanism connected to a precise pump and monitor. Its automation made it possible for doctors to accurately track flow rates, volume, pressure, and cumulative patient dose calculations—as well as programmable limits—on a computerized screen. Moreover, its precision has made it applicable to not just cardiac procedures but also peripheral ones. In short, it was a medical-device breakthrough. And, it has now been used in over three million procedures worldwide.

As is always the case, manufacturing has posed challenges and brought successes. Ed Miller, VP of technology has been with Acist since 1996, shortly after Acist’s first commercial application. He says that back then, it took five days to assemble each machine. Today, it takes an average of 4 1/2 hrs. But Ed knows that to stand still is to stagnate in manufacturing. So, he and Manufacturing Manager Sergio Bulask have initiated a company-wide training program in continuous improvement Six Sigma. Their mantra is “DMAIC” (Define, Measure, Analyze, Improve, Control).

For both Ed and Sergio, the Manufacturers Alliance is a natural partner. “I can’t imagine why a manufacturer wouldn’t belong to the Manufacturers Alliance,” Sergio says. “To have them as a local resource is huge. Being able to send our folks from different parts of the company to their programs is something that we just couldn’t and wouldn’t pass up.”

Ed and Sergio also explains that not just floor-operators have something to learn from the Manufacturer’s Alliance. “Right now our constraints aren’t on the manufacturing floor. Instead, we’re grappling with the good ‘bad news’ of skyrocketing growth. Just last year, we added 30 employees, which for us is a 30 percent increase. Acclimating them to our culture takes time and energy. We have the same issues with our international operations. Japan is our core Asian distributor, and 40 percent of our business is now overseas. While growth is obviously good, it also heightens the need to have stringent and efficient manufacturing procedures. I agree with Sergio that it is great to have the Manufacturers Alliance as a local resource.”

Acist was recently purchased by the Italian base company Bracco. Bracco has given Acist an established marketing reach into Europe, which expands its growth prospects. At the moment, Acist’s patented delivery system has no direct competitors. Nevertheless, it is developing additional lines of products to offset the inevitable. And, when asked about the “China” factor, Ed says, “We’re not ruling out the possibility of manufacturing in China. But, frankly, China holds more opportunity for us with regards to sales than manufacturing savings. You might even see us as a bellwether for economic growth in that area. We have certainly seen an increased interest from patients and doctors in Asia for our procedures. And we know that our Minnesota medical-device peers have experienced the same sort of increased interest.”

So, that’s the way it’s supposed to be: Minnesota manufacturing jobs stay here, and finished goods are exported overseas. Given the skyrocketing and unsustainable domestic health-care costs, it is also reassuring that sales of these high-tech medical devices are not entirely dependent on U.S. consumption. In short, Acist’s is a true success story!

Acist Medical
www.acistmedical.com
Justin Dorsey, Director of Sales & Marketing, Advanced Capital Group located at 50 South Sixth Street, #975 Minneapolis, MN 55402. call (612) 230-3009, email jdorsey@acgbiz.com, or visit www.acgbiz.com.

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Leading in Lean
Starkey Labs, the world leader in custom hearing aids, has begun their lean journey by implementing Visual management through 5S techniques coupled with Kaizen events. Leading the way in the lean transformation process is Bruce Shamla, Director of North American Manufacturing and Scott Gustin, Process Engineering Manager.

The company has seen a number of improvements because of a team effort to be a lean manufacturer. Order progression and rejection rate has decreased while their service level has increased significantly. They measure their service level by the percentage of orders shipped in 4 days or less. In one instance it took 30 hours of overtime to take 1,200 units from stage 1 to stage 3 in a process. After a Kaizen event, they eliminated the need for overtime and were actually overstaffed. Two improvements directly related to implementing 5S were the ease of use of the production area, measured on a pass fail basis, and the test bench area where a kanban system was implemented

Where Starkey Laboratories is headed with lean.

Starkey laboratories plans on using process maps, incorporating more visual management & 5S techniques, having a fully trained workforce by 2007 and achieving the goal of a 100% service level. They will be doing 40 - 50 Kaizen events in 2006 with one event per cycle per production area. Hats off for a great start to Bruce Shamla, Scott Gustin, and the team they work with.
The mission of the Manufacturers Alliance is to provide peer-to-peer training, education, and resources which inspire manufacturing companies to continuously grow, improve, and stay competitive.

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COMPLIANCE NEWS NOTES
Recent OSHA Inspections
Case 1

We were just called in to consult after a follow-up inspection by OSHA at a metal-working job shop. The OSHA inspector was unhappy with the lockout/tagout procedures. Although the written lockout/tagout program described the scope, authorization, application, purpose, and exceptions to the lockout procedures—there was a separate procedure for each piece of equipment—the inspector wanted the scope and authorization, etc., on each individual procedure. This was make-work. Nevertheless, you might want to review your lockout/tagout procedures to make sure that they are complete and address all energies that must be brought to a zero state before maintenance or service is done on the equipment.

Case 2
Another metal-working client had an OSHA inspector tell the company to throw out its Bloodborne Exposure Control Plan because they didn’t need it.

The OSHA inspector was off base. Most metal-working shops have a lot of nuisance cuts and scrapes. Bloody rags, paper towels, and bandages are commonplace. If employees are not informed of the risks of blood-carried diseases and they treat their potentially infectious wastes casually, the company could end up with a liability for disease that could have been prevented by employee education and proper handling of potentially infectious wastes.

Hepatitis B and C are a serious concern. Hepatitis B, for example, is 100 times more infectious than AIDS. And, it is far more prevalent.

Educating workers is critical. We have encountered workplace situations where blood-contaminated towels and bandages are thrown ¬at—not even in—the wastebasket. Sinks are left with blood visible on them. Other employees should not be exposed to the risks of such practices.

Moreover, the next OSHA inspector that walks through will probably want to see the Bloodborne Exposure Control Plan.
<img src="http://www.mfrall.com/newsletter/authorpics/vijakelly.jpg"align="left">Hazard Management is a consulting and training firm specializing in occupational safety and hazardous waste management. Call Vija Kelly at 651-697-0422 for more information.

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When Should Leaders Apologize–
“I’m sorry.” The words are simple, but they are highly charged when they are—or aren’t—said by leaders.

An apology is a mark of civil society and human decency. When someone wrongs someone else, a sincere apology goes a long way toward making amends, preserving a relationship, and forestalling further negative consequences. In fact, most of us are taught to own up to our mistakes and to have empathy for others.

The concept is similar in business, but it can have much deeper implications depending on the subject of the apology and who is making it.

On an interpersonal level, most agree that strong, ethical leaders should and do apologize for their transgressions against other individuals and admit to errors, at least inside their organizations. When an executive misunderstands a message from a colleague or when a manager reprimands an employee before getting all the facts, an apology is probably in order. In apologizing, the leader admits the adverse impact of his or her action and takes responsibility for it. In the end, trust is built and the work moves forward.

However, some transgressions come with the potential for litigation or damaging publicity. Fortunately, most Manufacturers Alliance members rarely, if ever, find themselves in the precarious position of having to make public apologies. But when it happens, at what point can an apology be construed as an admission of guilt– When does an apology needlessly spread awareness of an issue that only a few people would have known or cared about– On the other hand, when does failure to apologize incite animosity that could trigger a lawsuit–

We’ve witnessed many significant apologies in the past few years, some of which produced the intended results and some of which backfired. The president of the major hospital that transplanted the wrong organs into a 17-year-old girl apologized, although only after a flood of bad publicity, but his candid demeanor and pledge to create a research endowment in honor of the victim resolved the crisis. By contrast, Exxon offered only a tepid and very late apology for the Valdez oil spill and the company’s reputation still suffers today, 17 years later. However, when the president of a major university apologized repeatedly for his remarks last year about women’s aptitudes for science and engineering, he lost his job anyway.

Exactly how courts view apologies seems to be changing. Since 2003, 20 states (though not Minnesota or any bordering states) have enacted laws that declare apologies to be inadmissible evidence in courts. These laws were mostly in reaction to medical cases, but they are considered to be applicable to other situations. The laws arose in part because of the growing recognition that medical errors won’t be prevented if they are not admitted. But they also arose because studies here and abroad indicate that people are less likely to sue or are more amenable to settlement when they have received explanations and apologies.

Clearly, the decision about whether and how to apologize in business is situational and must be made with full knowledge of the circumstances, some solid legal advice, and careful consideration of consequences.

However, a few generalities seem to apply to apologies. First, timing matters. Public relations experts say that once a leader has the facts, the longer the wait, the worse the consequences. The experts also advise that the apology should focus on the impact on those who were transgressed, not on the company’s actions. It’s one thing to say, “We apologize that this incident caused difficulties for our customers,” but quite another to say, “We made a mistake when we shipped the faulty parts to the customer.” The former apologizes for impact; the latter may come needlessly close to an admission of guilt. Finally, any apology must be sincere.
Lynn Moline, owner of Lynn Moline Associates, Inc., is a consultant and trainer who specializes in executive development, executive team alignment, and planning. Mike Braun is a partner at CLG, a company that provides behavior-based strategy execution and performance improvement services.

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Managing Chaos, Complexity, and Change in Product Development
In the television show “Get Smart” from the late 1960s, the forces of good, symbolized by the organization CONTROL, were constantly battling the evil group KAOS. Today, this battle between control and chaos occurs inside most organizations trying to innovate today, especially during product development. Examples include morphing customer requirements, technology shifts, corporate reorganizations, mergers and acquisitions, “new-and-improved” systems and processes, budget cuts, and external factors such as regulatory, political, legal, and international.

Suppliers, partners, and employees come and go. Stuff happens. While these changes may not be evil, like KAOS, they do tend to cause disruption and lead to loss of control and effectiveness.

Change creates uncertainty in setting product development goals, causes organizational inefficiency, and increases personal stress. Change also creates explosive opportunities for the nimble and well-informed.

Successful innovation occurs in the interface between disciplines, technologies, and industries. This frontier is chaotic, difficult to describe, and unpredictable. “Chaord” is a term coined by Dee Hock, founder of VISA, to describe a system that is simultaneously chaotic and ordered. A chaordic system is open and is constantly learning in order to adapt. Successful product development organizations must be chaordic.

Numerous best practices exist for dealing with chaos in product development. One is recursive communication, which seeks to maintain continuity of context and purpose. It involves questions, answers, and statements that are continuously repeated. Recursive communication helps a product development team focus on corporate strategy and values and balance them against external factors. For example, during daily 15-minute meetings, a product development team can maintain control by answering three questions:

  1. What did you do yesterday–

  2. What will you do today–

  3. What obstacles are in your way–


The benefit of such meetings is that the entire team sees the whole picture every day, and peer pressure helps team members to do what they say they’ll do. This in turn helps prevent schedule slippage. Projects get to be a year late one day at a time, so it pays to monitor progress on a daily basis.

The old saying “It’s darkest before the dawn” might accurately describe the product development journey. If you use the right tools and processes, you can increase the odds that the light of day and even the bright lights of success will shine on your project. The following list describes additional best practice items for your toolkit.

Tools/Processes, (CONTROL Agent Maxwell Smart’s shoe phone!)

  • Checklists/scorecards/metrics (Don’t leave key activities and their outcomes to chance.)

  • Product data management software (Information should be transparent, real time, and accurate.)

  • Agile project management principles (Open, highly visible, inclusive, iterative, and focused on continuos learning.)



People/Teams

  • Experienced, trained, empowered cross-functional teams

  • Skilled and experienced project leaders (Agent Smart often wins, but does so in spite of himself.)

  • Recursive vs. discursive communication

  • Wisdom of crowds (Expand your network, and get diverse internal and external input to avoid surprises.)


Mindsets (Agent Smart said he loved danger.)

  • Tolerate ambiguity. (Allow breakthrough ideas to emerge. They can’t be forced.)

  • Be keenly aware of context and reality.

  • Be flexible and adaptable. (If you can’t plan accurately, then plan often.)


Finally, tools are important, but people are a bigger driver of success. As much as the world’s leading innovative organizations value the latest processes and tools, they value having the right individuals in the right roles and fostering meaningful interactions between them just as much. Although CONTROL was able to defeat KAOS with an individual (Agent Smart, who was anything but smart), today’s companies who are fighting to innovate and compete need every useful process, every best-practices tool, and every talented individual they can assemble.

Learn DFSS "best-practice tools" when selecting a design for a new product by attending the Selecting a Design Solution Concept workshop on June 28. For details visit www.mfrall.com
Rod Greder, Ph.D. founded Breakthrough Forum, an innovation dialogue and accountability group, for product developers and marketers to tap the collective intelligence of their peers who have been there and done that. rgreder@improveproducts.com, (763)443-1531.

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