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Medical Devices

7 Steps to Integrate Medical Device and Lean Product Development

Here are some steps to get started implementing lean product development in your organization. The goal is to identify and remove…

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…

Regulatory Requirements Do Not Prevent Integration of Lean and Agile Methods into Medical Device Product Development

Lean and agile are frequently used terms in product development.  The advantages of these techniques to improve time to market…

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…

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…

Balancing Medical Device Innovation and Clinical Trial Obligations

Product development is about delivering products to the customer, which contain the features and quality that they are willing to…

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…

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…

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…

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