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What Does Airline Capacity Have To Do With Lean?

Observation on Lack of Capacity A recent article in the Wall Street Journal (The Reason Southwest Stopped Overbooking), which contained excerpts from an interview with Southwest Airlines’ CEO Gary Kelly, brought out the need to address airline capacity issues on the ground and in the air. Responding to a question on the impact of lack…
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Does Your Product Development Process Make you Anxious?

Is your product development process keeping you up at night? Has it become heavy, taking too much time? Are you sacrificing speed and innovation because it is too hard to get through the process? Current Problem In today’s business world, we frequently see larger or established companies buying new or smaller companies (fast growing) in…
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Launching Your Medical Device Product Doesn’t Have to Be Complicated

Question: Introducing medical devices to the market seems more complicated than product launches I’ve done in other industries. Why is that? Answer: Medical device product launches have some ……
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7 Steps to Integrate Medical Device and Lean Product Development

In a previous blog, we covered why medical device companies often don’t use lean product development with their product development.  You’ve thought about it and made the decision to try using lean product development.  The objections from Quality and Regulatory are many.  You know there must be a way, but you just need some help…
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Medical Device Companies: Ten Tips on Nailing Down Your Requirements Early

Medical device product development teams often think they need to have all the customer requirements and design inputs defined when they enter design controls. In this posting, I’ll explain to you why it isn’t necessary to have them completely defined upfront and ways to add more detail over time.  In our experience, we find teams …
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How Many Design Reviews Do I Need for Medical Device Product Development

Question: How many design reviews are required during medical device product development? Answer: There are many factors that go into determining the number of design reviews needed.  21 CFR Part 820 and ISO 13485 both require design reviews (Additional information is also found in FDA Design Control Guidance for Medical Device Manufacturers and in ISO/TR…
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Integrating Business and Design Controls in Medical Device Product Development

Product development is a necessary function to grow your company.  However, medical device product development often focuses solely on following design controls.  The business needs of the project are done by ‘someone else’ in marketing.  The lack of closely aligned processes and information for a project affect the final product.  It becomes easy to develop…
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I Don’t Have TIME to Plan

If you fail to plan, you are planning to fail (Benjamin Franklin) There is a lot of truth in this statement, especially when developing products.  In this posting, we will demonstrate the 1) Value of planning and 2) How to document the plan. 1) Value of Planning Let’s compare a project to taking a trip…
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Act Like A Chef When Developing Products

In product development, as in a professional kitchen, experimentation and exploration are integral to creating a new recipe. It’s hard to predict what will happen so the product development process has to adapt….
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Why You Should Use Prototypes

Why Use Prototypes Why do you use prototypes? To better understand the customer? To determine whether the technology works? To see whether your product concept is manufacturable? All of these are valid reasons to use prototypes during product development.  However, sometimes companies wait until late in development to collect feedback.  They often think the prototype…
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