We live in a fast-changing world that is delivering rapid advances in technology and greater consumer expectations. Along with changing healthcare reimbursement models, which are moving to support improved patient outcomes, there is increasing demand for personalized products and precision medicines requiring increased complexity in medical devices. This is spawning a new era of digital and mobile medical devices and healthcare techniques, which are using the Internet of Medical Things (IoMT) to connect technology, people, and processes. These include innovations such as lab on a chip and remote monitoring of patient testing devices. One company has even introduced the concept of cloth-based diagnostic monitoring technology; using undergarments to remotely monitor cardiac performance. To respond to these modern demands and to survive in the future marketplace, medical device manufacturers need to be more agile, innovate more quickly, and adapt to remain competitive.

Encroaching Technologies

The medical device market is further being disrupted as historically nonmedical technical devices begin to encroach on the market. Companies such as Apple, Samsung, IBM, and Verily (formerly Google Life Sciences) are producing a new generation of smart, consumer-friendly products that help users manage conditions and achieve personal health targets. Using the IoMT, medical device companies are collaborating with these technology companies to develop and market devices that can track and manage chronic and lifestyle associated diseases, offer real-world evidence in support of postmarket surveillance, and ultimately improve patient outcomes.

Another area that is taking the medical device industry by storm is 3D printing. The 3D printing of patient-matched medical devices, medications, and even human tissues is likely to revolutionize areas of the industry. Other innovations include robotic-assisted surgical devices and using the IoMT to broaden access to testing services and provide faster test results. These are just a few examples. What can (and must) the medical device industry do to keep pace with this almost exponential rate of change in technology?

Industry 4.0: The New Generation of Manufacturing

In parallel with changing market demands, advancing technology and smart manufacturing techniques are revolutionizing how medical devices are being produced. Commonly termed as “Industry 4.0,” this new model for manufacturing is a fourth industrial revolution. It will reduce product costs, increase production efficiency, enhance product quality, accelerate innovation, and speed up the release of new and disruptive technologies into the market.

So, what is it about the Industry 4.0 manufacturing model that means it will so quickly overtake last generation processes and systems? Firstly, we need to be clear that this leap forward in manufacturing techniques is based on technology that exists today, and it is already being widely implemented in many high-tech industries. The change is coming, and businesses cannot risk simply ignoring it or they will be quickly overtaken by their competitors.

Industry 4.0 offers immense improvements in efficiency. Using distributed intelligence and real-time information throughout the shop floor, it enables cost-effective, high-quality production of patient-specific/personalized devices with dynamic production lines. Traditional production lines have a linear form. A product simply moves from one processing stage to the next and any bottlenecks, routine maintenance such as calibration, or faults heavily impact the lead time on a product. Increased product complexity requires greater testing and inspection to maintain quality, and any product customization requires significant manual intervention.

As the backbone of a smart factory, the MES will improve visibility, control, and collaboration across the supply network or manufacturing marketplace.

Industry 4.0 is different because the production model is no longer a “line,” but rather a dynamic series of processes. Adding intelligence to materials, products, and machines means they know what processes they need and what services they can provide. A product (or cyber-physical system, CPS) can, therefore, “negotiate” its way through the shop floor, communicating with machines (cyber-physical process systems, CPPS) to find the most efficient and expedient way to get the processes its needs.

In Industry 4.0, by integrating internal systems and extending the sharing of information to outside suppliers, the shop floor (and wider supply chain) becomes a smart marketplace where CPS request the services they need and the CPPS bid for the services they can offer.

Understanding the Role of the New MES

Traditional manufacturing execution systems (MESs) have long been used by the medical device industry to control manufacturing processes for often-sophisticated products. Their aim has been to reduce processing errors and help maintain quality throughout the production line as well as help with reactive activities to comply with regulations.

A future MES is an essential part of the pathway to Industry 4.0 because it will enable traditional production methods to run alongside new, dynamic ones while smart manufacturing technology is implemented at a pace that matches business goals and strategy. Acting as the backbone of a smart factory, the MES will improve visibility, control, and collaboration across the supply network or manufacturing marketplace. To achieve this, it needs to be smarter than its predecessors, based on decentralized logic to accommodate distributed intelligence throughout the plant, and efficiently handle the vast quantities of data the shop floor produces.

To support Industry 4.0, there are numerous advances in technology that the MES need to sustain. Firstly, as the manufacturing environment relies heavily on sharing information, it needs to gather and share data not only across the enterprise, but to suppliers, contract manufacturing organizations, and distribution partners to support product and operational quality. A cloud-based MES provides a globally accessible, globally transparent system acting as a single source of truth for manufacturing data and processes.

Of course, with increased connectivity through products, machines, and wireless sensors; the amount of realtime data snowballs. New MESs need to support advanced analytics to turn this data into real, actionable information that will enable rapid decision making, improve quality, and provide complete visibility of real-time product and process data across internal and external steps.

The new MES also needs to integrate wider production and logistic processes. Deep vertical integration is needed to ensure compliance with medical industry regulations and company-wide procedures. It needs to certify that 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. Horizontal integration is required to encompass wider services and functions from global facilities and trading partners through a smart supply chain.

Industry 4.0 is inherently decentralized with intelligence distributed throughout the plant. The next generation of MES needs to support this logical decentralization across the manufacturing facility, other factories, suppliers, and contract manufacturing, and it needs to allow this to happen in a phased manner so businesses can plan a pathway to the smart manufacturing paradigm. In such a way, the MES enables integration of the complete supply chain and intrinsically provides complete genealogy and traceability, encompassing raw materials through to finished product. With careful vertical integration, all information will exist within the MES, enabling manufacturers to move away from the burden and restriction of paper systems.

Industry 4.0 is spawning a new era of digital and mobile medical devices.

To enhance efficiency, the MES should also measure and improve overall equipment effectiveness, yield, cycle time, and delivery fulfilment. For complete integrity, all stakeholders must have access to readily available, accurate, and integrated data, and the system further needs to comply with regulations including 21 CFR Part 820, EU Medical Device Directives, ISO 13485, and 21 CFR Part 11, Annex 11.

The New MES Puts Paper in the History Books

Using paper-based and manual processes is slow and expensive and limits proactive and predictive capabilities to enhance quality. The Industry 4.0 model with a future-ready MES as its backbone can replace this outdated approach. Using real-time data and advanced analytics, information can be used for continuous process improvements and, with real-time analysis of process performance, quality can be built into all steps of the production line. With its “Case for Quality,” FDA is encouraging businesses to use electronic systems and move away from a focus on compliance to concentrate on improving the ability to prevent errors before they occur; thereby improving product quality and patient outcomes.

As medical devices become more complex, more testing is required to prevent defects from leaving the factory. To achieve elevated levels of product quality, using manual processes becomes costly and inefficient. By analyzing the continuous stream of processing data, the MES can identify the source of any process variability and enable corrections to be implemented during processing instead of products requiring rework or defects leaving the shop floor, which lead to issues in the field, regulatory action, or even a recall. Research into FDA data suggests that 54 percent of recalls over the last three years could have been prevented by an MES. 1

Strategic Pathway to Industry 4.0

MESs have long been recognized by medical device manufacturers as a strategic tool to control manufacturing processes, reduce opportunities for error, and build in product quality throughout production. These systems have helped companies to move away from reactive compliance activities with reduced processing errors and increased product quality. However, few companies have implemented an MES throughout all their production facilities or implemented full MES functionality. Instead of being a value-add tool, this scenario has led to legacy MES within the medical device industry becoming a hindrance to progress. While this is currently a negative to businesses, it also presents an opportunity.

Having fewer layers of integrated legacy technology offers a potentially easier route to implementing modern MES technology and more readily capturing the huge benefits of a smart manufacturing model. By changing to a new MES system that is designed to support Industry 4.0, manufacturers will increase their agility in reacting to market demands while future-proofing and error-proofing their business. This will significantly reduce risks to their business model, increase their competitiveness, and provide greater freedom to innovate.


Ultimately, the next generation of disruptive and personalized medical products cannot be efficiently produced using outdated process systems. If medical device companies want to compete in the future, reduce costs, increase quality, and handle highly customized or personalized products efficiently; they need a strategic plan to migrate to smart manufacturing techniques. New MESs offer a pathway to realizing the benefits of Industry 4.0 while supporting legacy production in a phased, structured transfer. They are an essential backbone for the industry to integrate wider systems, realize the full benefits of Industry 4.0, and ensure compliance of their system with industry regulations.

The new MES needs to be flexible to adapt to changing business needs, be built on a cloud aware platform, support big data with advanced analytical capability, and be based on decentralized logic to support the distribution of intelligence throughout the shop floor. They require modular functionality to provide current information on the dynamic state of a manufacturing ecosystem in a secure and in-context format that other systems can accept. Implementing such a system provides real-time product and process data that can be used to ensure consistent product quality, drive down costs, and enable faster rates of production of even the most complex products.

This article was written by Chris Parsons, Vice President of Marketing, Critical Manufacturing, Austin, TX. For more information, visit here .