Increasing Agility, Digital Integration in FDA-Regulated Manufacturers

Digital integration is ubiquitous in our lives — our earbuds connect automatically to our phones and using an app on our smartphone to order lunch makes it more likely that we’ll actually get the extra pickles/no mayo we want on our favorite sandwich.

But as the complexity of the processes and amount of data involved grow, so does the difficulty of actually achieving digital integration. The costs of failing to integrate grow too. The COVID-19 pandemic has highlighted the need for the efficiencies related to smart manufacturing technologies, in everything from production of masks to automobiles.

Regulatory oversight tends to add complexity to processes. The early shortages of personal protective equipment (PPE) in the COVID-19 pandemic led to an effort to prevent similar problems in the future and to examine how digital technology can be used to do so.

If digital technology can improve how we respond in such situations, why isn’t it more widely used?

In order to help the FDA understand how and why the companies that they regulate are making decisions to implement digital technology in their operations, the agency contracted with digital manufacturing institute MxD on a study that was completed in July 2021.

The FDA Office of Counterterrorism and Emerging Threats (OCET) sought to highlight the real and perceived barriers that come with adopting technology. Ultimately, the FDA was looking for ways to take a role in accelerating the uptake of new technology and to increase regulated industries’ agility during future emergencies.

To conduct the study, MxD partnered with the International Academy of Automation Engineering (IAAE). The team set out to establish a baseline understanding of the factors that affect a manufacturer’s decision whether or not to invest in digital technologies.

Insights and perspectives were combined with BioPhorum’s Digital Plant Maturity Model (DPMM) to provide a holistic view of each production facility’s progress along its digital transformation journey. By using the DPMM as a basis for the assessment, the MxD team was able to measure a manufacturing plant against five maturity levels and provide a neutral report on the current state of the plant and facilitate a discussion of what the future state should be.

The study partners surveyed nine manufacturers across varied fields to gauge their digital journey. Each manufacturer produces FDA-regulated products including medical devices, biologics, personal protective equipment, and pharmaceuticals. Multiple representatives at each manufacturing site were surveyed about perceived and real barriers to technology adoption from technical, business, and regulatory perspectives, and related cybersecurity concerns.

Each manufacturer got an individualized consultancy report, benchmarking their implementation and strategy against the rest of the industry and highlighting areas where they could improve.

One team took the report back to their executive team. Its discovery that the company had a quite fragmented approach to their digital transformation resulted in the creation of a new internal department to consolidate all digital transformation in one house.

MxD is a neutral collaboration space, able to gather anonymized data from companies and synthesize it for the FDA. From its work with the manufacturers, the MxD team was able to identify common themes and a list of requests for clarity, guidance, and assistance from the FDA.

Since no manufacturer wants to admit challenges and problems to their regulator, MxD played a crucial role in getting unvarnished and direct feedback.

The DPMM study results showed that the “majority of manufacturers assessed are only starting to emerge into levels with islands of automation combined with manual processes, and many are still highly reliant on paper-centric processes.”

Among the top factors identified as standing in the way of digital transformation were legacy systems, insufficient funding, competing priorities of senior executives, and organizational silos.

From the study, the FDA established a number of ways that manufacturers can accelerate digital transformation by removing ambiguity both at the FDA and at the companies so they know more clearly what they’re allowed to do in different contexts.

The FDA also can use the study to better advise regulated organizations and improve the regulatory/review process of smart manufacturing tech.

All of this means that FDA-regulated companies will hopefully be able to adopt new digital technology with lower risk and less confusion, better preparing the United States for the next emergency.


Collaborations like this help our partners solve problems too big for any one organization to solve on their own. Join an MxD-funded project.

The analyses upon which this publication is based were performed under Contract Number [FDA Order No. 75F40120P00303; Subaward No. Project 20-19-01], entitled, “[Analysis of the Advantages of and Barriers to Adoption of Smart Manufacturing for Medical Products],” sponsored by the Food and Drug Administration, Department of Health and Human Services.