Applied-Knowledge Center

Here you will find research and information that will help you stay current.  Resources include relevant research and thought-provoking content, inspiring the kind of creativity that drives innovation and new economies.


Analysis of the Advantages of and Barriers to Adoption of Smart Manufacturing for Medical Products

This infographic provides an overview of the learnings from the FDA study about what factors stand in the way of successful adoption of automation technologies in manufacturing.

Here you will gain relevant insights about the types of actual and perceived barriers companies report when seeking to leverage the opportunities from digital transformation.

Executive Summary

This document provides a more in-depth treatise of FDA study presented in the above infographic

Here you will gain full access to detailed charts and graphs that provide valuable information about business process, technology, regulatory, and people factors that can impede manufactures’  adoption of digital technologies.

You will also learn about different levels of digital mastery present in the industry and be introduced to specific best practices that can be applied in any manufacturing setting.

Executive Summary

Seeking Agility Through Smart Manufacturing

The SARS-CoV-2 pandemic revealed that existing U.S. manufacturing frameworks characterized by few facilities and lengthy and complex supply chains are fragile and strained from elevated business risks and shortages. Further, the gaps identified in the U.S. Manufacturing supply chain reinforced the need to improve supply chain resilience, reduce time to market, and increase manufacturing capacity for medical diagnostics, therapies, and vaccines.

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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.