The FDA decided to explore with industry ways to
accelerate the adoption of advanced and Smart Manufacturing technologies to strengthen the nation’s public health infrastructure. The FDA-initiated research project sought to generate a deeper understanding of factors impacting a manufacturer’s decision to invest in and adopt digital technologies by illuminating perceived and demonstrated barriers from technical, business, and regulatory perspectives and related cybersecurity considerations. Under this project, subject matter experts from Manufacturing USA institute MxD and the
International Academy of Automation Engineering® (IAAE) were assembled to perform site-level evaluations of nine manufacturers (6 large and 3 mid-small) plus one corporate-level manufacturer and analysis of interview data from a representative sample of 31 manager/director level representatives.
This whitepaper summarizes the findings of the study, organized within structures that address Business Processes, Technology, and People assets.