Tag Archives: FDA

What can you imagine?

What can you imagine? Does it show in what you do? Every company stands for something, and Bill Taylor, the founder of Fast Company, encourages business people to think of strategy as advocacy. Do you and your company stand for something compelling? Some companies truly do have a big and exciting vision and others can’t […]

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Realities for UDI and Beyond

The #1 concern that keeps medical device professionals awake at night is compliance with new regulations. The question is, how much work will medical device companies need to do to meet the FDA’s Unique Device Identifier (UDI) requirement? Most companies will need to do quite a lot that they haven’t until now. So is it […]

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Benefits beyond the “have to”

Nearly everyone has “have to” or “should in their vocabulary, and feels there are things that fall into those mandatory categories. For individuals that might be spending time with difficult family members, getting regular exercise, and paying taxes. For manufacturing companies, much of that is regulatory or customer compliance. We often feel these as major […]

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UDI: Medical Device Profits at Risk – Unnecessarily

How many companies’ profit margins will plummet because of the FDA’s Unique Device Identifier (UDI) requirements? Quite a few, I imagine. Don’t get me wrong. I am not opposed to the regulation. I think it makes sense, and that companies will comply. The question is: at what cost? I believe it is possible to comply […]

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FDA Pushing Simulation and Advanced Technologies at AdvaMed

I had the honor of speaking on a panel session with several very knowledgeable folks last week Monday October 1 at AdvaMed’s annual MedTech Conference.  The panel was titled Enabling Better and Faster Medical Device Development and Evaluation via Virtual Simulation, Collaboration and Regulatory Submissions. Our panel moderator was Jean Colombel, head of life sciences […]

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