FDA Awards Funds for Smart Medical Manufacturing Project

Chicago-based MxD has been awarded funding from the Food and Drug Administration (FDA) Office of Counterterrorism and Emerging Threats (OCET) to identify the unique barriers and advantages of digital transformation in regulated medical product manufacturing.

Even prior to the pandemic’s disruptive effects, manufacturers of medical products were under increasing pressure to improve output, quality, and efficiency. While all organizations face challenges in adopting new technologies, those that operate within the framework of FDA regulation have unique constraints — and opportunities.

Now, accelerating the adoption of these new technologies is more critical than ever to address the need to rapidly respond to novel threats and become more resilient.

“All companies face an imperative to use technology to better respond to the unique demands of the time,” said Chandra Brown, CEO of MxD. “Reaping the benefits of advanced analytics, digital twins, proactive simulation, and other emerging tools will require navigating this landscape while maintaining the highest standards for safety and efficacy. Partnering with the FDA will allow MxD to identify the ideal path to digital transformation for critical subsectors including medical device, PPE, therapeutic, diagnostic, and medical product supply chain.”

Through this project, MxD, supported by its member, non-profit industry partner International Academy of Automation Engineering (IAAE), will offer the FDA OCET a deeper understanding of the dynamics and conditions that impact a manufacturer’s decision and subsequent strategy to invest in and adopt digital technologies in their production by illuminating both perceived and demonstrated barriers from technical, business, and regulatory perspectives, and related cybersecurity considerations.

Opportunity to Participate

To do so, MxD and IAAE are seeking participation from companies in this industry and request interested companies to contact MxD at the email below. Responses will contribute to an analysis of advantages and barriers to the adoption of smart manufacturing in the life sciences field and help drive the future technology and regulatory landscape towards more efficient and effective technology uptake.

All data and responses will be anonymized before inclusion to a final analysis report to provide the FDA OCET insight into how to accelerate these critical technologies to better prepare for the next crisis. Participants will receive an individual evaluation report giving a snapshot of where their companies stand in the world of digital manufacturing, providing a foundation to build a digital adoption roadmap.

Contact [email protected] to learn more and participate. Responses are encouraged by December 18, 2020, to maximize partnership opportunities.