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Archives for May 2016

How and Why We Must Challenge FDA

Veteran device CEO Joseph Gulfo says, “The FDA must be challenged (when appropriate) because it operates in a highly political environment and has strayed from its original mandate.”

The original mandate, according to Section 1003 of the Federal Food, Drug, and Cosmetic Act, is to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner [and that] there is reasonable assurance of the safety and effectiveness of devices intended for human use.”

But today’s FDA does much more than that – and that’s the problem.

Here’s his paper, “The Proper Role of the FDA for the 21st Century.”

And here you can email Dr. Joseph Gulfo directly to see how you can help on this important crusade.


Click for Joe’s slides and transcript. »

Best Time to Sell Your Medical Device Company

Deborah Douglas spoke at our fourth 10x Medical Device Conference in May 2016.

A main takeaway for me seems obvious but those who go-it-alone probably ignore it: Multiple bidders make for higher prices. Deb said, “For an average seller, our firm will talk to 300-400 buyers.”

Watch her full presentation below and click through for the slides and transcript.

A must read for any seller. »