Counterfeit Medical Device Parts

In another “Medical Development Insights” interview, I spoke with Rich Nadeau and Al Cruz about counterfeit medical device parts. They had prepared some interesting thoughts for the FDA-MDG conference on October 30, 2014. Rich is the Founder and president of eComp-Electronic Components Inc, a 14 year old company focused on specialty distribution and counterfeit product detection. Al is a Senior Product Quality Engineer III, at Hologic, where he develops, modifies, applies and maintains quality plans and protocols for processing materials and products. They met when Al went to Rich with a concern about failure rates in one of the products he was testing.

Counterfeit medical products cause risks to consumers’ health and well-being, adversely affecting companies by loss of sale and loss of reputation when counterfeit parts fail. With the ease of access that the Internet provides to procurement offices, the medical dangers of counterfeit parts have grown.

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About Edward Dolan

My expertise is in improving project success for bio-medical technology companies. I consult, train and coach decision makers, both executives and employees to: • Recognize the real, underlying problems that stymie further progress. • Change what is undermining their success. • Develop systems that will reinforce, sustain and build upon their achievements.

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