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Process

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…

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…

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…

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…

Why Product Development Needs to be Done Differently

Exploratory product development is a fundamental redesign of the product development process. ExPD is an adaptive approach that responds quickly…

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…

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…

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…

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…

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