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Improving FDA Reviews of Combination Products
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with…
Forget Winning; Think Improving
I recently had the great experience of speaking as part of a panel on the value of the Baldrige Excellence Framework, but what meant the most to me was the chance, I hope, to dispel some common misconceptions about what the Baldrige is actually all about. And, no, it’s not just an “excellence…
How to Create a Culture of Continuous Improvement
I have discussed steps to take to build a culture of continuous improvement in numerous posts on my Curious Cat Management Improvement blog. What it boils down to is building a system that supports that culture. Your culture is the result, not your aim. David Heinemeier Hansson put it well…
Gartner Announces Rankings of Its 2015 Healthcare Supply Chain Top 25
(Gartner: Stamford, CT) -- Gartner Inc. has released its seventh annual Healthcare Supply Chain Top 25 ranking. The 2015 ranking recognizes companies across the healthcare value chain that demonstrate leadership in improving patient care and lowering costs. "Alignment to patient outcomes, company…
Improving Public Alerts in Emergency Situations
(ISO: Geneva) -- People at risk, be it from natural disasters, terrorist attacks, or other incidents in daily life, need to be able to take appropriate safety actions based on a proper understanding of the level and nature of the emergency. Two recently published ISO standards will help…
Lazy Lean Guy
In 1987, shortly after I became a manufacturing manager, the shop foreman at the time warned me about a young assembler. “Watch out for Michael,” the foreman said. “He tends to bend the rules. You may need to talk to him.” In fact, I did watch Michael, and it did appear that he approached his…
So Why Is It Called ‘Regression,’ Anyway?
Did you ever wonder why statistical analyses and concepts often have such weird, cryptic names? One conspiracy theory points to the workings of a secret committee called the International Committee for Sadistic Statistical Nomenclature and Numerophobia (ICSSNN), which was formed solely to befuddle…
The CEO’s Role in Knowledge Management
I do not presume to preach to business leaders (CEOs and other senior managers). However, having helped a number of organizations and their leaders with knowledge management (KM), I’ve observed certain leaders who are able to achieve greater and more sustainable results from KM than others,…
Is Customer Experience Really Everyone’s Job?
Pundits and experts alike say that ensuring a good customer experience (CX) is everyone’s job. In fact, if you Google “customer experience is everyone’s job” or “customer service is everyone’s job,” you’ll find endless articles, blogs, and webinars with that very title. It’s true. Technically, it…
<em>Win the Customer</em>
(AMACOM: New York) -- Great companies distinguish themselves from the competition by providing their customers with something truly special, something beyond price point that can’t be duplicated: unique, outstanding customer service experiences. Win the Customer (AMACOM, 2015) cuts right to the…
FDA Eases Up a Bit on Enforcement Gas Pedal
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical device-related warning letters dipped to 121 during calendar year (CY) 2014, compared to 144 during the…
Ten Mistakes Great Leaders Avoid in Building Work Culture
Culture eats strategy for breakfast. It doesn’t matter how great your plans to introduce a new product to the market are if your culture weakens execution. Culture is how things get done around a company. Great leaders focus on the work culture their leadership helps create as much as they focus…
Fitness Test for Old Pipes
Thames Water is the United Kingdom’s largest water and wastewater services provider with more than 15 million customers. As part of its business, Thames Water delivers an average of 2,600 million liters of drinking water every day. The company’s cast-iron water mains in many areas of London and…
How Many Episodes Does It Take to Get Hooked on a TV Show?
I have two young children, and I work full-time, so my adult TV time is about as rare as finding a Kardashian-free tabloid. So I can’t commit to just any TV show. It better be a good one. I was therefore extremely excited when Netflix analyzed viewer data to find out at what point watchers get…
How to Prepare Your Team for Customer Service Training
You’re ready to send your team to customer service training. The big question is whether your team is ready. Chances are, they’re not. A 2010 McKinsey & Co. survey revealed that approximately 75 percent of training programs failed to measurably improve business performance. A lack of…
Six Secrets for Productive Meetings
“When I die, let it be in a meeting. The transition from life to death will be barely perceptible.” —Anonymous Today I’m going to share some ideas from an always-thoughtful newsletter written by Steve Harden of LifeWings—a company of pilots who use aviation ideas to create cultures of safety in…
On the Cowboy Trail: The 10-Percent Way to Get Buy-In
I’ve been fantasizing about going on a road trip next summer to Alberta to experience the majestic Canadian Rockies. While browsing possible itineraries, I keep noticing this advice: “Leave the beaten path and take the alternative route of....” If you’re trying to get new ideas considered at…
IBM Leverages ISO 14001 for Sustainable Business
A meaningful, systematic approach to environmental management has made IBM one of the world’s most environmentally conscious companies. The globally integrated IT company leverages ISO 14001 for a comprehensive corporate policy on environmental affairs. In a recent interview for ISOfocus,…
How Truly Great Companies Maintain Excellence
Businesses come and go. Even Fortune 500 companies get in trouble. There is at least one organization, however, that is setting a high bar for others. Do you know which one? Let me pose these questions: • What U.S. company is celebrating their centennial anniversary this year? • What company is…
Lean Accounting in a Nutshell
Companies that are seriously pursuing the lean journey soon find their accounting, control, and measurement systems need to change to support the new strategy. The principles and methods of lean thinking and practice are quite different from traditional business and therefore require different…
ZEISS DuraMax LTE CMM: Precision Measurement and Affordability
(ZEISS: Maple Grove, MN) -- ZEISS Industrial Metrology has introduced of the new DuraMax LTE coordinate measuring machine (CMM), providing uncompromising access to ZEISS scanning technology at an affordable price. Equipped with the same controller technology, software, and VAST sensor technology…
The Improvement <em>Kata</em> PDCA Cycles Record
Improvement kata describes a routine for continuous improvement through four major steps. Those steps provide a structured pattern to enable consistent practice of each kata routine until it becomes habit—until it’s a natural way of thinking and acting. This change in behavior makes it easier…
Call for Papers Opens for 2016 Coordinate Metrology Society Conference
(CMSC: Weatherford, TX) -- The Coordinate Metrology Society (CMS) has announced its call for papers for the 32nd annual Coordinate Metrology Society Conference (CMSC), to be held July 25–29, 2016, in Murfreesboro, Tennessee. The CMS is seeking original contributions from portable metrology…
API Launches vProbe, the Newest Accessory for Omnitrac 2
(API: Rockville, MD) -- Automated Precision Inc. (API) has released the vProbe, the newest accessory for the Omnitrac 2 (OT2) laser tracker. The vProbe’s wireless technology syncs perfectly with API’s Omnitrac 2 laser tracker. The vProbe is a six degree-of-freedom (6DoF) contact probing option.…
AICON Is a New Partner of Tube Innovation Days
(AICON 3D: Braunschweig, Germany) -- Since the summer of 2015, AICON 3D Systems has been a partner of Tube Innovation Days, a network of 11 top technology partners from the areas of tube manufacturing and tube processing. Regular in-house trade fairs offer visitors the chance to get detailed…

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