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How to Identify and Manage Project Risk

Project risks come in many different forms, from those the project team anticipates to the ones they discover when an unexpected problem crops up. In product development, there are many sources because you interact with so many parts of the organization in order to commercialize the product. However, there are some simple steps you can…
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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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Why Usability Testing Matters for Medical Devices

Some medical device product development teams skip usability testing when developing new products.  Reasons include, ‘it takes too long’ or ‘we already know how the product is going to be used’ or ‘we’ll test usability during design validation’.  User feedback is frequently collected by showing mock-ups or through structured data collection, as opposed to usability…
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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 Devices Undergo Extensive Safety Testing; Is This Really Necessary?

As part of ongoing efforts to encourage more physical activity among children, McDonald’s added the “Step it” fitness tracker to Happy Meals.  After only a few days, following reports of skin irritation caused by the wrist worn fitness tracker, McDonald’s decided to remove the fitness tracker from Happy Meals. In July, 2016, the FDA released…
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3 Lean and Agile Methods the TSA Used to Improve Performance

Why TSA Security Lines Aren’t as Bad as You’d Feared”, covered recent changes that have been made in order to address the long lines and the amount of time spent to clear airport screening.  The results they quoted were staggering and much better than I expected.  At O’Hare, the wait “fell from 105 minutes in…
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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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