Medical Electronics
Manufacturing meets Industry 4.0 for MedTech
Advances in technology are enabling the production of more and more sophisticated medical devices. These include patient-specific equipment, mobile connectivity and remote diagnostics and bioelectronic medicines. Wearable devices that monitor fitness and health targets are also becoming a common part of daily lives. Francisco Almada Lobo, CEO and co-founder of Critical Manufacturing tells us more
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his increased level of sophistication and use of electronics in the MedTech marketplace requires a change in manufacturing techniques for products to be viable and competitive. The next industrial revolution, termed Industry 4.0 (I4.0), takes production away from a linear process, where products have to follow the same step-by-step route through a plant, to one that is dynamic in nature. It merges real and virtual worlds to create a manufacturing model that will increase business agility, give the ability to economically meet individual customer requirements, lower overall production costs, enhance product quality and increase production efficiency.
This new manufacturing philosophy has been bought about by technology enablers such as Big Data, the Industrial Internet of Things (IIoT), low cost, miniature electronics and sensors, mobile computing technology, and the Cloud. Together these enable a ‘smart manufacturing’ model where intelligence resides in materials and products in such a way that they can make their own decisions on the best and most efficient way to get the process steps they need by communicating directly with smart machines. This not only reduces manufacturing time and costs but also enables the economic production of ‘personalised’ custom products that can truly advance the ways in which patients are treated.
Of course distributing intelligence throughout a manufacturing plant means
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that the production model moves away from a centralised to an inherently decentralised one. It also results in masses of data being produced that needs to be stored, given context and correctly analysed to ensure smooth, efficient operations. By having a continuous stream of real time data about production, any issues can be quickly identified and handled, and quality is built into the product rather than inspected in at the end. All materials are also fully traceable and the pathway to regulatory compliance much less painful and time consuming.
Manufacturing execution systems in I4.0
Manufacturing execution systems (MES) have long been used as a centralised production conduit to control operations ‘below’ on the shop floor. So are these systems no longer required with the autonomous decentralised smart factory? The answer is yes and no: traditional MES based on a centralised production model are not designed to handle the masses of decentralised data produced by the smart manufacturing model. However, the data still needs to be given context or it cannot be transformed into useful intelligence on which to make production decisions. A system also needs to be in place to ensure that rules and best practices from the wider business model are not bypassed. So, I4.0 requires a new modern MES. Although the new MES does not need to be physically decentralised it does need
logical decentralisation. It needs to be able to aggregate the masses of data produced and put them into context. It also needs to vertically integrate production systems so that automated materials and machines cannot avoid corporate processes. This includes compliance, logistics, engineering, sales and operations, all of which have components within the production model and beyond into the wider supply chain.
Clear benefits of I4.0 for MedTech Assured quality, consistency and reliability are critical aspects of producing medical devices, to ensure good patient outcomes. For some time now, the FDA has been making a ‘Case for Quality’ to change the main focus of MedTech manufacturers away from compliance activities to product quality, based on continuous processing improvements to ensure quality is built into products rather than inspected in. Instead of documented actions to correct processing problems, the MES can use the data created by the shop floor to identify potential issues and take steps to eliminate errors before they arise. Such enhanced quality levels offer the reward of reduced on-site audits and less interruption to business operations. The Big Data produced within the smart factory means the MES contains complete materials and products traceability. All necessary records for compliance can be stored electronically and be made readily available wherever and whenever needed. This includes every piece of information needed to meet FDA and other regulatory body requirements such as 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), stored in the MES provide a complete, fully searchable ‘as built’ record of every device that is readily available at any time for review by customers, auditors or any other interested party.
The volume of data provided by sensors,
products and equipment will also make it possible to view the complete status of a
production floor and equipment, in real- time, using 3D visualisation. Along with the use of mobile devices, new virtual reality (VR) and augmented reality (AR) scenarios will become possible. Operators will be able to use their own, personalised mobile interfaces to interact with the processes on the shop floor. This also opens up other areas of efficiency improvement such as maintenance activities where smart equipment provides an approaching technician an augmented reality view of scheduled maintenance or parts that need to be replaced, based on performance metrics.
The pathway to the future of MedTech manufacturing The changes involved in the full vision of I4.0 means that this industrial revolution will not happen overnight. The benefits offered through its implementation, however, mean it certainly will happen and this gives the opportunity for businesses to plan a strategic pathway that will protect the future of the business. A future-ready MES, based on decentralised logic, provides the backbone needed to create a smart factory at a pace that suits other business goals. It needs to be scalable to meet current and future business needs and, alongside the traditional MES functionality in handling operations, offer the levels of production flexibility and agility, connectivity, mobile application and advanced analytics that are necessary to realise the benefits of I4.0 Ultimately, the potential of the smart factory means that increasingly sophisticated medical devices can be matched by efficient, cost effective production with inherent quality that produces safer, reliable products which ultimately reduces risk for the patient and the manufacturer. I4.0 opens up the possibility of accelerated innovation and competitive advantage in this area, leading to even more step changes and advances in the way patients are treated.
www.criticalmanufacturing.com Components in Electronics October 2017 27
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