TEAM INSIGHTS

MEDICAL COMMERCIALIZATION IS HARD – SOME INSIGHT TO HELP OTHERS
A Few Thoughts about Medical Device Design Control

Everyone that works in product development knows the dreaded words, “design control.” If we set the Wayback machine for 1985 we would find that design controls, as the ISO and FDA expressed them in their first attempts, were developed based on that absurdly inane academic development model called the “cascade” model. I love academics for a lot of […]

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Getting from objectives to executing the strategy

To empower a product development team for success, the definition of objectives depend on clear thinking by the responsible executives. To help clarify objectives, we have a few questions that are helpful (and this is by no means an exhaustive list). Are we selecting technologies that expand our capabilities or ones that draw on current strengths? If moving […]

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The key role of executive leadership in product development

We are all familiar with the idea that a short time to market is one of the keys to profitability. I own at least five books on fast product development, and there are common themes: tight integration of design, engineering, marketing, and manufacturing; clear communications in a flat structure; and of course, good direction. To pull that off, […]

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