After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug Administration (FDA) is now directing its attention to the medical device industry.

On Feb. 18, the FDA held a day-long meeting to address the 510(k) system, which it has used for more than three decades to review and clear medical devices to be sold in the United States. The 510(k) refers to the section of the Federal Food, Drug and Cosmetic Act that requires manufacturers of medical devices to notify the FDA of their intent to market a medical device at least 90 days in advance. Also known as premarket notification, the 510(k) process is intended to be applied to devices that are similar to products currently on the market.

Therein lies the crux of the issue—as ever-more sophisticated and complicated medical devices are being created, more and more “high risk” devices (those that are life-sustaining and/or implanted in the body) are slipping through the cracks and being approved under the 510(k) process, even though they may share only a trivial similarity with a device already being sold.

A management system is the framework of processes and procedures used to ensure that an organization can fulfill all tasks required to achieve its objectives. A lean management system consists of the discipline, daily practices, and tools that you need to establish and maintain a persistent, intensive focus on process. It is this process focus that sustains and extends lean implementations.

Peter M. Senge, is an influential systems thinker from Massachusetts Institute of Technology. He is the author of the book The Fifth Discipline: The Art & Practice of the Learning Organization published in 1990 and a revised edition published by Broadway Business in 2006. In Chapter 4, “The Laws of the Fifth Discipline,” Senge suggests 11 systems laws that help us understand systems better. The laws are:

The following words of an anonymous poet as he (or she) immortalized the lessons from Deming’s funnel experiment.

“Tamper, tamper is the game, try to make all the same. Squeak and tweak it every day, off we go to the Milky Way.” 

—Anonymous 

I offer a corollary that may help understand the underlying problem:

 
“We love to tamper with our processes. We cannot help it. We are hard-wired to tamper with our processes!”

For many years, I have examined in-house and customer-generated specifications. Often, I have seen something curious called “action limits.” Action limits always fall somewhere between the target value and upper and lower specification limits.

The following is an example:  

A mechanical engineering firm was contracted to install new cooling equipment in a municipal ice rink’s mechanical room. The challenge was to design the equipment installation without tearing out the old equipment first, and to install some elements and piping that housed the refrigerant around the current equipment configuration to limit downtime of the facility when the cooling unit was actually disconnected.

The challenge

As an incentive, the municipality offered the engineering firm a bonus for every day they finished ahead of  schedule, or a penalty for every day the rink was out of commission past the projected timeline.

“Our corporate mission is to deliver the ‘Best Value in Energy and Related Services,’” according to a large Midwestern electric and gas utility company. This is a mission statement, which after a minor modification (just change the industry), could be posted on any boardroom wall and inserted into any number of CEO speeches. But this company actually put its mission statement into practice and reaped the rewards by becoming a superior value provider. Six Sigma marketing was the tool the company used.

Six Sigma marketing is a fact-based, disciplined approach for growing market share and top line revenues in targeted product/markets by providing superior value. It uses a modified define, measure, analyze, improve, control (DMAIC) process, similar to the one employed by traditional Six Sigma, to focus on people, products, and processes to enhance or improve value.

Define

The company began by focusing on the key markets or segments that it was serving and the products that these segments use. The intersection of a product and market is the competitive arena in which organizations compete for revenues and market share.

This utility served a number of different markets with electricity and gas:

The cross-functional team at Piedmont Newnan was made up of employees that deal with the process daily. For this process improvement project, they focused on case carts, which are used for pulling together all supplies needed for surgical procedures.

Pam Murphy, a registered nurse and director of surgical services at Piedmont Newnan Hospital, has seen it all in her 23 years of employment at the hospital.

In 2007, when the Newnan, Georgia-based hospital was chosen as a pilot site for a lean implementation for the Piedmont Healthcare System, she knew that participation from the hospital’s staff would be critical. She also knew there would be a concern that lean—a methodology that aims to eliminate waste—would mean doing more with less.

Aerospace and other manufacturing industries have accelerated outsourcing of manufacturing operations to increase efficiencies and reduce costs. However, moving some of the operations outside of the traditional four walls of the factory has created “dark areas” in the manufacturing visibility process. As a supplier to the world’s largest manufacturers, such as Boeing, Hobart was looking for ways to address these issues and become a better supplier by providing real-time production visibility to their customers in order to alleviate the fear of missing mission-critical deadlines. Hobart needed to track work orders through the different stages of manufacturing, and send real-time notifications on jobs that affect the quality or delivery schedule. Hobart needed these notifications automated as manual tracking is laborious, costly, and error-prone.

Requirements

To provide end-to-end, real-time visibility to its customers and internal operations, Hobart Machined Products needed to:

• Streamline receiving, inventory, shipping, and returns of raw material, parts, and finished products

• Simplify the creation of customer orders and shop-floor work orders

• Automate the kitting process based on bill of materials and parts inventory

The AS9100C standard (also referred to as AS9100:2009 and AS9100 Rev C) has been published since January 2009. You are not alone if you are confused about the delay in being audited to this standard. Like you, most companies seeking registration to AS9100 are in the process of trying to figure out how and when to roll out this standard within their organization and the following information should bring clarity to this subject.

If the standard is published, why can’t I get certified now?

Before any company can be certified to the AS9100C standard, the aerospace industry must complete these milestones:

• The AS9104-1 standard must be published (expected spring 2010).

• The AS9101D standard (checklist) must be published (expected spring 2010).

• The AS9100C/AS9101D training course for certification body auditors (the registrar’s auditors) must be developed, vetted, and made available for use by certification bodies (expected by April 30, 2010).

On July 20, 1969, astronaut Neil Armstrong landed on the moon, signaling the attainment of President John F. Kennedy’s vision to put a man on the moon and return him safely to earth. The accomplishment required nearly a decade of research and experimentation by NASA as it worked to overcome one technical challenge after another: the ability to dock two ships together in space, the design of the Lunar Excursion Module, and the inherent difficulties of manned space travel. Each of these breakthroughs not only made the Apollo moon missions possible, but also enabled many other excursions to outer space.

But what if President Kennedy had been less ambitious? What if his vision had been to send an unmanned “rover” to the moon, or what if he hadn’t even thought it possible to reach the moon? How many of these breakthroughs would exist today? Of course, it’s difficult to say with certainty, but one thing is for sure—if mankind had never set a goal to land on the moon, we never would have gotten there.

The science of harnessing customer loyalty and satisfaction is getting very trendy in business. And perhaps nothing has been more responsible for driving excitement than Net Promoter.

Developed by Fred Reichheld, Net Promoter is a loyalty metric and a discipline for using customer feedback to support business growth and profitability. You’re probably familiar with the ubiquitous Net Promoter question, “On a scale of zero to 10, how likely is it that you would recommend our company to a friend or colleague?”

The basic idea is that you can use that question to segment your customers into three core groups: Promoters (scoring 9–10), Passives (7–8), and Detractors (0–6). You derive your Net Promoter Score (NPS) by subtracting the percentage of Detractors from the percentage of Promoters. The higher the score the better.

While the model has stirred some controversy, NPS proponents—including many prominent business leaders—claim this is a simple and effective framework to measure company performance, customer satisfaction, and loyalty. It’s gritty and actionable for frontline employees across business divisions, while insightful and predictive for management.