Landscape Analysis of Adoption of Advanced Manufacturing in Non-Medical Industries
An ORES Advanced Manufacturing Project
Performer: Booz Allen Hamilton
Contract Value: $961,120.56
Project Dates: February 2023 - October 2023
The FDA ORES Landscape Analysis Project, conducted by Booz Allen Hamilton, was designed to evaluate the adoption of advanced manufacturing technologies across various non-medical industries from February 2023 to October 2023. The project aimed to provide insights that would guide the FDA in shaping regulatory approaches for products manufactured using innovative technologies.
Research and Analysis
During the research phase, the team conducted an extensive review including 17 interview sessions with 36 individuals representing 15 organizations along with a comprehensive review of 6,000 sourced documents that were narrowed down to 2,400 that were most relevant. The analysis contributed to the diverse perspectives and expert opinions reflected in the final report.
Key Findings
The final report, structured into six themes and 19 subthemes, identified 24 challenges and 43 best practices within the advanced manufacturing landscape. It also highlighted nine influencing factors and nine indicators of current usage and future growth, offering a comprehensive overview of the evolving technology environment. The project emphasized the importance of collaborating and engagement within the industry. For example, the research found that participation in workshops, trainings, and conferences is essential for building trusted partnerships and creating opportunities for information sharing. Leveraging international partnerships is also recognized as crucial for addressing emerging public health concerns and informing robust regulatory policies.
Other significant findings include encouraging data sharing within the industry. For example, reflecting on how data models impact quality and providing training on the consequences of partial or unavailable data can lead to better decision-making. Also, the development of additional regulatory science metrics or tools is key to enhancing the evaluation of advanced manufacturing technologies. From an economic standpoint, the project found that sharing best practices between industry and government could reduce economic risk associated with adopting new technologies while maintaining a focus on safety and performance. The project emphasized the need for a unified advanced manufacturing strategy to broaden the industry’s innovation horizon and prepare staff for effective regulatory oversight as new technologies continue to emerge.
Booz Allen Hamilton Report
Landscape Analysis of Adoption of Advanced Manufacturing in Non-Medical Industries