Medical device design, design controls, prototyping, user-centered design, and innovation; medical device manufacturing, process controls, and continuous improvement.

Use design controls for innovation

In the movie Wolf of Wall Street, Leonardo DeCaprio challenged his team to “sell me this pen,” implying that a good salesperson could sell anything.

This article helps teams “design a pen” using design controls in a way that sparks innovation. I wrote it for the biotech or medical device industries but the concepts apply to any company that must share work among a team. We go from defining user needs to transferring design into manufacturing.

Medical Device Design Controls

This article provides an overview of FDA design controls and lists resources to help understand and apply them.
This is in a “dry” format, necessary for repeating definitions. See my blog for versions that use case-studies or are related to pop culture.

5 minute read.

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Design Control: learn from my mistakes

Innovation, efficiency, and safety can coexist when a team uses effective design controls. In this article, I apply modern design controls to a product I co-invented and commercialized in 2004 using lessons learned in 15 years.
I describe that product in another article. This article helps you learn from my mistakes.

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Make state of the art medical devices

7 minute read.

The new European Union Medical Device Regulation will protect patient safety by requiring healthcare companies to make products that are “state of the art,” a term that’s easily misunderstood. This law is best explained with an example from cars,  comparing today’s state of the art with to the 1980’s television series Knight Rider, where David Hasselhoff fought crime in a talking, self-driving car.

Van Halen, Brown M&Ms, and Quality Assurance

6 minute read.

In the 1980’s, the rock-band Van Halen caused $85,000 damage to their dressing room after finding brown M&M’s in their bowl of “munchies” before a concert. The facts behind that story can help medical-device companies become more efficient and pass any FDA or ISO Quality-System audit. This article shows you how, with the lead singer of Van Halen, David Lee Roth, as your guide.

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