Industry 4.0: Redefining manufacturing of future Medical Devices



This feature’s guest author is Francisco Almada Lobo, CEO, Critical Manufacturing

Advances in technology mean that the production of medical devices is posed for a complete revolution. Technologies that form part of the Industry 4.0 (I4.0) manufacturing concept, such as the Internet of Things (IoT), Big Data, cloud computing, mobile technology, microelectronics, and low cost sensors, are leading this industry to new levels of efficiency and making the production of new, innovative devices a reality

More than any other industry, the production of medical devices demands the highest quality levels. Creating customised solutions such as patient-specific devices adds complexity and cost. The new ‘digital’ factory gives producers a way to meet a changing market and regulatory demands with easy customisation, reduced cost levels and highest quality results. It will enable them to more efficiently meet burdensome documentation requirements and produce higher volumes at lower costs.

Industry 4.0 Technology Enablers

I4.0 is Smart Manufacturing. It is a vision that will bring a fourth industrial revolution to manufacturing sectors. Although the advantages it offers means that this step change will happen, however, the transition will not be overnight. This presents companies with the opportunity to plan their strategy and plot a workable pathway not just to an evolution in technology but to support this manufacturing revolution.

Some of the core technologies that bring the Industry 4.0 vision to life include the mobilisation of computing power, the power to handle and analyse masses of data, electronics that are shrinking both in cost and size, and the ability to access data from anywhere in the world. The availability of miniature, low cost electronics means that intelligence and sensors can now be included within many products and materials throughout the shop floor and into the wider supply chain. Products can communicate directly with process machines and machines can communicate with other machines, opening up whole new ways in how devices and products are coordinated throughout one or multiple plants. With bi-directional communication capability, products and services can also be connected to systems from anywhere. This removes the geographic limitations of scheduling, controlling, and tracking products through the manufacturing process and enables the use of multiple plants and wider supply chain assets to minimize cost and maximize production efficiency.

Connecting more and more smart materials, products, and assets generates masses of data from many locations. Cloud computing gives both the storage and the ‘anytime, anywhere’ ability to handle this data – making it freely available for the advanced analytics required by Industry 4.0. Advanced analytics is another vital part of the change in the way we manufacture as it transforms huge volumes of structured and unstructured data into intelligent, structured strategic information. This provides knowledge about costs and processes that facilitate decisions and actions to remove bottlenecks, optimize efficiency, maximize production capacity, and eradicate processing errors. Powerful analytical software with huge volumes of data to feed also opens up the possibility of predicting scenarios for even more effective production strategies and decision making.

Cyber-physical Systems

Within the Industry 4.0 model are cyber-physical systems (CPS) and cyber-physical production systems (CPPS). Merging real and virtual worlds, these systems enable smart products, as part of the CPS, and software-enhanced machines, as part of the CPPS, to leverage the data from sensors and actuators and self-manage the production process. Both products and machines will know their own state, capacity, and configuration options so that decisions can be made to optimize production efficiency without operator intervention.

With the CPS as consumers and CPPS as service providers, a fully communicating, decentralized organization is formed that takes away the need for linear production flows. This creates an intelligent, highly flexible production model with benefits including robustness, autonomy, self-organization, self-maintenance, self-repair, predictability, new levels of efficiency and interoperability, and global tracking and tracing with UDIs.

As well as driving down current production costs by making most efficient use of materials and machines, one of the biggest benefits of Industry 4.0 is that it enables easy and efficient manufacture of more sophisticated product lines and the ability to easily customize and individualize products to specific customer requirements. For the medical devices industry this is a new level of agility to compete and respond to rapidly changing markets and a practical way to meet increasing demands for a wider range of sophisticated mobile and personalized solutions such as contact lenses that can detect glucose levels, next generation inhalers, bioelectronic medicines, and ‘lab on a chip’ electronic based testing.

A dynamic production model

Current models for customization take a linear approach. Starting with a generic product, standard processing routes are followed with specialist steps added, usually at the end, to meet custom specifications. Using Industry 4.0, however, the product has its own intelligence and can be programmed with requirements of a customer order before it steps through the processes required for the final product. It no longer needs to move linearly through the factory floor but can interface with machines requesting the processes it needs. This creates a marketplace whereby machines (CPPS service providers) can bid to provide the product (CPS) with the service it needs.

For example, Product A may require Process X for its next stage of manufacture. It communicates with machines in the plant (and beyond) letting them know about its needs. Machine 1 may respond and let the product know that it can provide the service but that it needs reconfiguring and more material to complete the task. It indicates the cost for the process would be $50. Machine 2 has maintenance scheduled and cannot meet the service request. Machine 3 already has the correct configuration and material and is available to provide the service at a cost of $30. The product selects Machine 3. Once completed it reaches out to the shop floor marketplace again to request its next process step and, once again, selects the most efficient route available. In this way, products can find the quickest and lowest cost path through the necessary process steps and make best use of assets available on the shop floor. With the IoT, this is not limited by location and with higher cost devices the most economic route through production may involve multiple plants.

Where MES fits in

Manufacturing Execution Systems (MES) have, for a long time, been used to control flows through the shop floor. As the products being produced and machines around them have their own intelligence, is there any need for an MES in the future at all? Yes, a future-ready MES is possibly an even more critical part of the plant structure for the smart factory. It forms the backbone of I4.0 but, unlike the traditional MES centralized systems, the next generation of MES needs to be based on a decentralized logic to provide the associated agility and flexibility.

Based on decentralized logic and providing the agility and flexibility needed, a next generation MES is the backbone of the smart factory. It brings together and manages areas such as compliance, quality, statistical process control (SPC), scheduling, engineering, and maintenance systems to keep operations running smoothly. The fully integrated MES brings all parts of the plant together where information is readily and easily exchanged to best optimize machine capacity, equipment availability and order scheduling. It combines data from the CPS and CPPS and puts them into context for the wider plant to ensure the autonomous actions of the systems below stay within the rules and best practices for the business. It further provides operators with a single, intuitive view of the plant floor where concepts such as 3D modelling can be utilized to clearly see the status of all machines, processes and product batches.

The MES must be designed to handle the huge volumes and diversity of data created by the smart plant. It needs to be able to aggregate this information, which may come from multiple sites, and turn it into usable intelligence for strategic decision making. Advanced offline analytics and real-time analysis within the MES enable rapid triggering of plant responses to respond to manufacturing issues. For high value products, it may also make sense to use advanced techniques such as “in-memory” and complex event processing to further drive operational efficiency.

Regulatory compliance

Regulatory compliance is a major part of providing solutions to the medical industry. I4.0 changes the approach to meeting requirements for traceability and quality. Instead of inspecting quality into a process with documented actions to correct any problems found, the data available from the smart factory means that the MES can work to proactively eliminate errors before they occur. This shifts the focus of the plant from being a more compliant based structure to one that is focussed on product quality with compliance a natural by-product of the enhanced quality levels. This reduces the risk of product recalls and, in line with the FDA’s ‘Case for Quality’, opens up the possibility of reduced on-site audits.

Using the masses of data from the smart factory, the MES holds the necessary data and contextual information for complete product and material traceability. Eliminating paper records, this real-time information can be used to eradicate product and process errors; building inherent quality into product lines that are trustworthy, reliable, and enhance brand reputation.


With a future-ready MES, the I4.0 production model provides complete visibility of manufacturing processes; ensures easy, comprehensive traceability, and enables continuous process improvements using the ‘big data’ collected throughout production lines. It enables the manufacture of increasingly sophisticated devices while driving down costs, increasing production flexibility, improving efficiency, and enhancing overall business agility. It replaces the historical use of paper documents with electronic records and advanced analytics that will turn data into valuable business knowledge.

For the medical devices industry, this means lower overall production costs; efficient production of small quantity, highly customized products; continuous process improvements with products that have quality built-in, and easier regulatory compliance in line with the FDA’s ‘Case for Quality’.

Ultimately Industry 4.0 cannot be achieved without an MES. Bringing all parts of the production process together, the next generation of MES also offers Med-tech companies a pathway to combine old and new systems and move towards Industry 4.0 in a way that suits their particular business model.