The next industrial revolution is on its way. It is bringing innovative technologies that are available and proven and placing them in the modern manufacturing plants. The cloud, the Internet of Things, mobile computing technology, embedded computing, advanced analytical software, and 3D printing all have a part to play in the future of manufacturing. Known as Industry 4.0, this revolution will change the way we manufacture devices by enabling much greater levels of distributed intelligence for greater production autonomy, flexibility, and economy.

What then could this mean for manufacturers of medical devices? When looking at the medical industry, there are many more intricacies involved in ensuring and enforcing compliance with its many regulations. These regulations are an essential part of patient safety and, although they may make the adoption of Industry 4.0 a bit slower in maturing and stabilizing, this revolution will be embraced. Like previous industrial revolutions, Industry 4.0 fundamentally offers manufacturers so many benefits, it simply cannot be ignored.

One area of medical manufacturing that will gain tremendous advantages from Industry 4.0 is the customization of patient-specific devices. The need for high-quality, high-mix products lends itself perfectly to the Industry 4.0 model. Based on cyber-physical systems (CPS) that integrate computational networks with the surrounding physical world and its process, this change to the manufacturing architecture brings with it much higher levels of intelligence and plant automation. Physical objects passing through production processes will incorporate their own embedded software and computing power to interact with more intelligent machines, cyber-physical production systems (CPPS), on the plant floor.

Products (the service consumers: CPS) and software-enhanced equipment (the service providers: CPPS) will exchange intelligent information to enable self-management and optimization of the production line. Products will know what process steps they need and machines will know their own state, capacity, and configuration options. This decentralized model of manufacturing means that production decisions can be made without the need for operator intervention. It offers robustness, autonomy, self-organization, self-maintenance, self-repair, and predictability. In such a way, the automatic production of completely customized products to exact patient needs becomes not only practical but highly efficient and economical.

Handling Big Data and Meeting Regulations

The use of tablets to connect to machines eliminates the need for multiple logins or different interfaces. Relevant information to carry out necessary works can load onto workers’ tablet interface as they approach a machine and their whereabouts will also be part of the plant information.

Of course this decentralized control of manufacturing execution creates a huge amount of data that needs to be analyzed and acted upon. Technologies including the Industrial Internet of Things (IIoT), big data analytics, and the cloud all help for this to be handled and used efficiently, but the shop floor context is still needed to make sense of the information collected. While some data can be stored locally in the CPS, information relevant to higher systems can be sent to big data structures and, with the correct vertical integration, to enhanced manufacturing execution systems (MES). Correct handling and filtering of this information will lead to supply chain optimization and better control of quality because actions to correct or improve can be triggered much more rapidly.

To work efficiently, the smart shop-floor also requires service-oriented ways of alerting the rest of the information system to the information available. However, that is not likely to all come from the CPS and CPPS directly. In Industry 4.0, the MES solution must be truly modular and interoperable so that all functions or services can be consumed by CPS smart materials, CPPS smart equipment, or any other shop-floor entity.

The decentralization of the control systems inherent to Industry 4.0 brings with it many opportunities, but also specific challenges to the medical industry. Having materials, products, and machines that make autonomous decisions challenges the traditional approach to imposing corporate quality guidelines. An MES that can aggregate the vast quantities of data and put them into context will add a level of factory control that is vital to compliance with the requirements of medical regulatory bodies. Careful vertical integration of the MES is needed to ensure equipment is properly maintained and calibrated, to check that processing recipes are correctly applied, and to confirm that processes are operating within acceptable control tolerances.

Using tablets or smartphones with appropriate security and control, many areas where personnel need to connect with the plant can be made more efficient.

Although vertical integration within the Industry 4.0 model for the medical industry probably needs to be deeper and more carefully engineered than for any other industry, there is also a significant advantage of this approach. Having the IIoT means that all necessary records for compliance can be stored; covering every piece of information needed to meet FDA and other regulatory body requirements. This includes unique device identifiers (UDI), electronic signatures, and certification of any operators that manually interact with the process. Exceptions and full electronic device history records (eDHR) can be stored in the device itself as it is built in real time. This means that the full, readable history of the product is readily available at any time for review by customers, auditors, or any other interested party.

Traceability throughout the Supply Chain

As individual products passing through the production process have bidirectional communication capability, they can be connected to systems from anywhere and tracked throughout production — even outside of the plant floor into the wider supply chain. This end-to-end track-and-trace capability makes the supply chain itself highly integrated, transparent, more reliable, and agile.

Increased Mobility Adds Efficiency

Having elements throughout the manufacturing plant that are autonomous with distributed computing and communication capability, it no longer makes sense to have fixed workstations for operators to interact with the plant. The advance of mobile computing technology provides an ideal opportunity to drive further efficiency into how a plant operates. Using tablets or smartphones with appropriate security and control, many areas where personnel need to connect with the plant can be made more efficient. For example, if maintenance technicians can use tablets to connect to machines as they need to, they do not need to battle with multiple logins or different interfaces. Relevant information to carry out necessary works can load onto their interface as they approach a machine and their whereabouts will also be part of the plant information. Combined with the CPPS advising its status and needs, the efficiency of both planned and unplanned maintenance can see substantial increases.

Of course, having information about products, equipment and personnel throughout the plant floor also opens up the possibility of using virtual reality to further help plant efficiency and productivity. The complete status of the shop floor can be visualized in real time in 3D maps, making it easy to identify inefficiencies or problem areas and implement corrective actions. Augmented reality scenarios also become a possibility to help operators and technicians with their work and to reduce the risk of human error.

The Efficiency of Autonomy

With products and machines making decisions about the most expedient route to a finished product, Industry 4.0 significantly changes the manufacturing outlook. Alongside the ease with which each individual product can be customized without the need for a person to cradle it through a different production process, the whole concept of the smart factory opens up other possibilities for efficiency drives. If people are not needed on the shop floor, there is the potential for reducing energy overheads with cold and/or dark factories.

The use of CPPS and a smart supply chain make inventory management leaner as well. There are also billions of potential savings in scrap or wasted materials as the whole production process is optimized. Using the powerful software available for advanced data analysis and the huge streams of realtime data from the shop floor, production scenarios may also be predicted rather than just reacted to, which further maximizes productivity and improves business decision making.


Alongside realizing truly efficient production of patient-specific devices and other high-mix production batches, the Industry 4.0 model will give a level of efficiency that will significantly accelerate general manufacturing processes. This increase in productivity will reduce production costs and enable faster time to market. Intelligent operation and data analysis will give complete visibility of an operation; enabling smarter strategic decisions and further enhancement to processes.

Industry 4.0 will not happen overnight. There will be a transition and, particularly in medical applications, time will be required to prove quality systems. As autonomous smart materials, products, and production systems (CPS and CPPS) become a marketplace on the plant floor, a traditional centralized UI-focused MES will not be effective — not even for compliance, optimization, and monitoring. To enable the transition to Industry 4.0, MES for the future must address the challenges of a logical decentralization to support highly automated CPS with operations dispersed across different systems. They need to provide appropriate connectivity, mobile computing capability, use of the IIoT and cloud, and advanced analytical services. Careful vertical integration is especially important to ensure compliance with medical industry regulations.

For the medical device industry, the idea of decentralized, autonomous production capability is not just a want but a need to track the future of medical science. As medical device products become smarter as part of CPS, they have communication with monitoring systems and remote physicians. These are evolving into part of an Internet of Services (IoS), which is opening up new possibilities for providers. Healthcare will eventually be connected via CPS into an IoS — and the requirements for medical device manufacturing must support it.

This article was written by Francisco Almada Lobo, CEO, Critical Manufacturing, Moreira da Maia, Portugal. For more information, Click Here .