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.


Digital Twin Self-Assessment

BETA version released for widespread distribution to manufacturers

Digital transformation is now understood to occur in cycles of business transformation that leverage digital technology. Business value cycles involve repeating iterations of gaining insights, for example through digital twins, performing actions through business processes, and improving outcomes, either operational or financial or both. 

However, gaining consensus on what digital twins are particularly suitable for a specific context can be challenging, and very few organizations have a framework to follow in identifying and executing such projects.


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For this reason, a Digital Twin Self-Assessment framework and assessment tool was recently developed by the International Academy of Automation Engineering and MIT, along with other project partners including Manufacturing USA institute MxD and Horizon Controls Group. This was performed under U.S. CARES Act funding for the primary benefit of manufacturers within the U.S. Pharmaceutical Industry (including Medical Device manufacturers). 

This framework was designed for a specific industry deployment that has been ongoing but was developed with a view to being shared freely across industry for the benefit of the manufacturing base. The intent is that those who use this tool can better understand the typical steps recommended to design, implement, and test digital twin solutions, but also how to follow steps in a unique manufacturing context, starting and ending with the careful framing and measurement of business value.

If you find the framework and tool valuable, or have suggestions on how it can be improved for a second release later this year, please share your feedback using the survey link at the end of the PDF.

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.