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3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers

E-data Preservation and Management
It is crucial to preserve electronically-stored information, such as emails and files, and have a process in place at your company for managing this.

Companies should also monitor the “e-trails” they leave, meaning when people within the company communicate via email, they could be used against the company (i.e.; emails containing information associated with the history of a product and its design, development, testing, quality control, inspections and post-market monitoring).

“One of the first questions attorneys will ask is, ‘Has this ever happened with this product in the past?’ ” Strasius says. “Have a responsible history. Then they ask, ‘Was the process followed?’ Use a good paper trail for your product. This involves approval, certifications, processes, inspections and post-market efforts. If the right standards and regulations have been followed, you’ll get favorable testimony and evidence in defending the product. The history of the product and the ability to prove that the company did the right thing at every opportunity is hugely important in defending these claims.”

Other trends and concerns on the horizon, according to Strasius, relate to nanotechnology and robotics.

His general advice for how to prevent and handle these potentially litigious situations is:

    • Have the right people, in the right place
    • Educate, and continue to educate
    • Use common sense
    • Seek outside consultants as necessary
    • Communicate

What do you see as the greatest concern for medical device companies in the digital age? Leave a comment below or email us.

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