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Should the MedTech industry care about Industry 4.0?

11 December 2017

Should the MedTech industry care about Industry 4.0 (I4.0)? While the simple answer is ‘Yes’, this article will attempt to explain just how important I4.0 is to the future of manufacturing of medical devices.

Not only should manufacturers of medical devices care about the impact I4.0 will have on their industry, they simply cannot afford to ignore it if they are going to keep pace with their competitors and market demands. I4.0 helps remove limitations on innovation due to manufacturing constraints, drives production to levels of efficiency never before seen, and changes the way quality (and also regulatory compliance) is built into products.

Let’s firstly understand what I4.0 is and why it will bring an industrial revolution. I4.0 merges physical and virtual worlds and is built upon technologies that are available today. It will enable the distribution of intelligence throughout the shop floor, creating an autonomous ‘smart factory’ that can make dynamic decisions about the most efficient production flow without operator intervention. This fundamentally changes the manufacturing model from a traditional linear series of process steps to a dynamic model where products/materials understand what processes they require and communicate directly with machines to find the most economical service provider for their needs. 

The smart factory relies on communication between all machines (the service providers or cyber-physical production systems - CPPS) and materials/products (service consumers or cyber-physical systems - CPS) within the Industrial Internet of Things (IIoT). This requires each device passing through the shop floor to have its own intelligence. This distributed intelligence creates a decentralised production model and huge volumes of data (Big Data) that will need to be handled and, to maximise efficiency, understood. 

So where do the benefits lie in having such a production system? The benefits are huge, which is why I4.0 is fast becoming a reality. The capabilities exist today and medical device manufacturers, especially those that rely on paper processes, now have the opportunity to leapfrog current technologies and benefit by future-proofing their business to keep pace with constant change.


One of the clearest benefits of I4.0 is the huge increase in production efficiency it brings with it. By removing the linearity of the production model, a marketplace is created whereby products and materials can seek out the fastest and most efficient routes to get what they need, and the lowest cost. So, rather than simply moving to the next production step in a process line, a product will know what process requirements it has and will communicate with machines throughout the shop floor and bid for the best service. To try and explain how this works, let’s look at an example where a product needs a process that could be provided by any one of three machines: Machine 1 may require calibration and not be able to provide service until this is complete. Machine 2 may be able to provide the process but require a different configuration which impacts time and cost. Machine 3 may be already set up, have necessary materials and be ready to complete the process at the lowest cost. The product, of course, routes itself to Machine 3.

Customisation and personalisation

The dynamic shop floor model with intelligence in each device also means that small batches, customisation or personalisation of a product can be easily achieved within normal manufacturing parameters. When the customer order is received, this is loaded into the CPS and they are able to negotiate with CPPS machines to get the processing steps they need specific to the order. Of course the marketplace need not be limited to the factory. With horizontal integration, products could also seek service provision from the wider supply chain, maintaining full traceability.

Easy customisation makes the production of innovations such as patient-specific devices more cost effective, helps reduce development cycles with rapid prototyping and gets new products to market more quickly. Ultimately the autonomous production process creates a model that is self-organising, predictable, economical and highly efficient for the production of completely customised devices.


The de-centralised production model creates large volumes of data. Correct handling and analysis of this data can lead to better control of quality as actions to correct or improve can be triggered much more rapidly. In effect, this means that quality is no longer inspected at the end of the production process, but becomes part of each production step in a process that is continually improving and optimising. Minimal operator intervention further helps to minimise risks of human errors occurring during manufacture and operators take on more of a proactive supervisory role.


The bi-directional communication capability of products and materials passing through the line, plant and extended supply chain gives inherent traceability throughout with complete contextualised data immediately available for rapid investigation and disposition. This can extend to the supply chain and to production batches that are split or merged.

Regulatory compliance is part of I4.0

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.

Planning for I4.0

Although there are clearly a great deal of benefits to I4.0, there are a number of areas that need to be considered before implementing a complete smart factory and this is where a new generation of Manufacturing Execution System (MES) can help. The future-ready MES delivers a backbone to build an I4.0 environment on. In Industry 4.0 the MES solution must be truly modular and interoperable so that all functions or services can be consumed by smart materials, smart equipment or any other shop-floor entity. To do this it cannot be in the form of the traditional centralised MES platform, but be configured to logically handle the masses of decentralised data. 

The next generation of MES aggregates and adds context to the masses of data collected, turning it into useful information on which to base operational decisions. Vertical and horizontal integration ensures that business-wide controls are not bypassed; enforcing areas such as product specification, process control, operator certification and proactive quality control to make sure processes are operating within precise limits, while also controlling the maintenance and calibration of equipment to meet regulatory and quality demands.

A future MES is an essential part of the pathway to I4.0 as it will enable traditional production methods to run alongside the new, dynamic ones. It will enable the different technologies incorporated within I4.0 to be implemented at a pace that matches business goals and strategy, enabling manufacturers to manage risks and consolidate existing business with plans that will give them competitive edge in the future. 

I4.0 is not a minor enhancement or evolution of how we manufacture products: it is a complete revolution. The benefits and opportunities it delivers to the production of medical devices are enormous. 

I4.0 opens a whole new world of possibilities for what medical devices can achieve. It removes previous constraints of efficiency and economy and adds instead a pathway for superior quality, highly sophisticated medical solutions at viable pricing levels. The limits are no longer defined by the practicalities of production, but more by the limits of the imagination of innovative companies that are re-defining the future of medicine. So should the MedTech industry care about I4.0? Yes!

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