The Recall Impact Part 4 – Prevention is Key - EngiLifeSciences
Medical Device Industry

The Recall Impact Part 4 – Prevention is Key

By March 23, 2016 No Comments

When a company voluntarily or involuntarily recalls a product, the opportunity cost can be great. A survey released by EMERGO in January 2015 showed that, of three main challenges facing medical device companies, product development was the top issue acknowledged. (The two other challenges were problems with financing and changes in regulations)[1]. Recalls demand that companies invest in communication, litigation, product disposal, and logistics.

The time, effort and finances would be much more efficient if they were used to research and develop products with effectiveness and compliance being front of mind, delivering a competitive advantage. The excessive cost accompanying recalls combined with damages to a company’s image could mean the opportunities to implement these changes can never be realized.

It is true that completely avoiding future recalls is unlikely, but strong emphases on developing integrated high-quality procedures will assist in slowing the wave of recalls, even if globalization, complexity, and the acceleration of the industry continues.

Successful firms in the Life Sciences industry are committed to continual process improvements, efficient procedures, proper information distribution, and streamlined product research and development. At EngiLifeSciences, our compliance and engineering experts remove the burden of regulatory and quality assurance from our clients so they can focus on achieving their business-critical goals. Our clients receive help from our experts to streamline their Life Sciences R&D/Product development processes, while also building in controls to ensure regulatory compliance.


[1] “Outlook for the Medical Device Industry in 2015.” January 5, 2015. EMERGO. Web. April 2015.
Additional Source:
Medical Tracking Solutions, MTS Blog: The Big, Bad, and Ugly Costs of Medical Device Recalls

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