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  5. Analysis of the Advantages of and Barriers to Adoption of Smart Manufacturing for Medical Products
  1. Innovative Technologies

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

Performer: MXD (The Digital Manufacturing and Cybersecurity Institute)
Project leader: Daniel Reed 
Contract value: $478,871
Project dates: July 2020 - June 2021

FDA and industry each play a role in ensuring the nation has access to safe and effective medical products even during pandemics and public health emergencies. The COVID-19 pandemic reinforced the need to adopt and accelerate the implementation of ways to increase critical supplies and supply chain resilience. Advanced and smart manufacturing technologies have been identified as potential ways to meet these needs. 

This FDA-funded study (PDF, 2.2 MB), conducted by MxD and IAAE, aimed to increase the agency’s understanding of factors that impact a manufacturer’s decision to invest in and adopt digital technologies by identifying both perceived and demonstrated barriers. The project team performed evaluations of nine manufacturers, interviewed representatives, collated the responses, and created a perspective that will allow the agency to assess areas where it can foster greater manufacturing resilience.

This project was funded by the OCET Advanced Manufacturing Program.

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