Industry 4.0; Strengthening US Public Health Infrastructure
The FDA has recognised a need for speed, and it’s turning to smart technology and today’s deep tech to get it there. The mission is critical, to say the least, the risks are far too high to fall behind. As the rest of the world looks to adapt and find efficiencies, luckily, so does the FDA.
“At the start of this 21st year of the 21st Century, businesses, manufacturers, the FDA, and patients, are all adjusting to the changing times and adopting new trends. For the day-to-day work of the FDA, those changes are focused on advanced manufacturing technologies, digital industry and ‘Industry 4.0.’” says the FDA.
Over the past several years, the FDA has invested significantly in to support public health preparedness. The FDA looks to increase efficiencies and mitigate risks through digital manufacturing and advanced approaches such as continuous manufacturing, a continuous, uninterrupted, end-to-end production line that streamlines production. New technology, such as 3D printing, introduces the opportunity to produce patient-specific medical devices more efficiently.
However, Covid-19 has since compounded the need, bringing to light the vulnerabilities of supply chains and the need for more adaptive and responsive manufacturing systems to increase “time to market,” to borrow a phrase, on medical countermeasures.
MCMs, , are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency. Essentially, they’re a risk management plan, and can be used to diagnose, prevent, protect from, or treat conditions associated with chemical, biological, radiological, or nuclear (CBRN) threats, or emerging infectious diseases.
MCMs can include:
- Biologic products, such as vaccines, blood products and antibodies
- Drugs, such as antimicrobial or antiviral drugs
- Devices, including diagnostic tests to identify threat agents, and PPE, such as gloves, respirators (face masks), and ventilators
In its efforts to accelerate the adoption of advanced and smart manufacturing to strengthen the nation’s public health infrastructure, the FDA is “creating a new collaboration with the National Institute of Standards and Technology (NIST) through a memorandum of understanding (MOU). This MOU is intended to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products and medical devices by adopting 21st-century manufacturing technologies. These include smart technologies, such as artificial intelligence and machine learning, and emerging manufacturing processes.”
The FDA and NIST are looking to AI and computational modelling to monitor manufacturing lines, reduce downtime and increase efficiencies. Another strategy being investigated is “modularisation of unit operations “, which essentially standardises the manufacturing process, allowing for the same part to be used in different items, which could decrease cutover time in switching production from one product to another.
Gartner: Leaders Lack Skilled Smart Manufacturing Workers
With organisations rapidly adopting industry 4.0 capabilities to increase productivity, efficiency, transparency, and quality as well as reduce cost, manufacturers “are under pressure to bring their workforce into the 21st century,” says Gartner.
While more connected factory workers are leveraging digital tools and data management techniques to improve decision accuracy, increase knowledge and lessen variability, 57% of manufacturing leaders feel that their organisations lack the skilled workers needed to support their smart manufacturing digitalisation plans.
“Our survey revealed that manufacturers are currently going through a difficult phase in their digitisation journey toward smart manufacturing,” said Simon Jacobson, Vice President analyst, Gartner Supply Chain practice.
“They accept that changing from a break-fix mentality and culture to a data-driven workforce is a must. However, intuition, efficiency and engagement cannot be sacrificed. New workers might be tech-savvy but lack access to best practices and know-how — and tenured workers might have the knowledge, but not the digital skills. A truly connected factory worker in a smart manufacturing environment needs both.”
Surveying 439 respondents from North America, Western Europe and APAC, Gartner found that “organisational complexity, integration and process reengineering are the most prevalent challenges for executing smart manufacturing initiatives.” Combined they represent “the largest change management obstacle [for manufacturers],” adds Gartner.
“It’s interesting to see that leadership commitment is frequently cited as not being a challenge. Across all respondents, 83% agree that their leadership understands and accepts the need to invest in smart manufacturing. However, it does not reflect whether or not the majority of leaders understand the magnitude of change in front of them – regarding technology, as well as talent,” added Jacobson.
Technology and People
While the value and opportunities smart manufacturing can provide an organisation is being recognised, introducing technology alone isn’t enough. Gartner emphasises the importance of evolving factory workers alongside the technology, ensuring that they are on board in order for the change to be successful.
“The most immediate action is for organisations to realize that this is more than digitisation. It requires synchronising activities for capability building, capability enablement and empowering people. Taking a ‘how to improve a day in the life’ approach will increase engagement, continuous learning and ultimately foster a pull-based approach that will attract tenured workers. They are the best points of contact to identify the best starting points for automation and the required data and digital tools for better decision-making,” said Jacobson.
Long term, “it is important to establish a data-driven culture in manufacturing operations that is rooted in governance and training - without stifling employee creativity and ingenuity,” concluded Gartner.