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Why I Dislike Target Costing

‘Target costing’ is arguably one of the single greatest contributors to the poor quality of products in the marketplace today.

3 Lean and Agile Methods the TSA Used to Improve Performance

At O’Hare, the wait “fell from 105 minutes in early May to just nine minutes in the two weeks before the Fourth of July.” Learn more

Human Factors – Changes You Should Know and Why You Should Care

The FDA issued a new guidance, Applying Human Factors and Usability Engineering to Medical Devices in early Feb 2016.  On April 3, 2016, it will replace Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management issued in 2000.  This lengthy document (49 pages) contains some very specific language on how human factors should be…
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What Can We Learn from the Theranos Experience?

Theranos, a blood testing laboratory, has been the subject of media scrutiny after a number of articles were published in the Wall Street Journal. Since clinical testing laboratories are not usually regulated by the FDA, this article will provide a short history of what has happened and some lessons learned to consider for the future….
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Design Controls: Just Good Design Practices

In the world of medical device product development, we often hear complaints about the burden of design controls.  However, when you examine the elements of design controls, you see they actually represent good design and engineering practices.  The goal of these practices is to show that you can manufacture products of the required quality as…
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Exploratory PD: An Adaptive Approach to Product Development

Exploratory product development is a fundamental redesign of the product development process. ExPD is an adaptive approach that responds quickly to internal and external factors. Read more

Designing Medical Devices for All Users

Who is the user of your medical device?  We often design our products with either the end user or the major skilled user (such as a physician) in mind. Medical devices are often touched by someone in addition to the final intended user.  As medical device designers, we need to consider all the different users…
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What Does a Pretotype Have to Do With My Medical Device?

What is a pretotype Have you heard of pretotyping?  It means to test the initial appeal and actual usage of a potential new product by simulating its core experience with the smallest possible investment of time and money.  In other words, “Make sure you are building the right IT before you build it right.”  The…
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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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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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