The MedTech industry has never been more global. With demand for medical devices from emerging markets and an increasing drive for efficiency and quality, using global plants and external resources offer many benefits, but also some challenges.
As companies work within an ever-shrinking supply chain, unprecedented demand for a narrow set of products and less than optimum working conditions, we see how companies are banding together to meet the special needs of the current pandemic.
The urgency created by the Covid-19 outbreak made this even more clear, with the European Medical Device Regulation (MDR) being postponed for one year . “As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.”
The compliance to the MDR, now postponed till May 2021, is a new set of regulations governing the production and distribution of medical devices in Europe, with explicit requirements for manufacturers to establish, implement, and manage a quality management system (QMS), including the implementation of UDI (Unique Device Identifier) for tracking medical devices.
The risks that the MDR was trying to mitigate is the loss of control and visibility due to globalization and outsourcing. To optimize and ensure consistent quality, supervisors now need to be able to see beyond the plant shop floor, across multiple plants throughout the world. To maintain confidence in operations, they also need visibility of global partners and their facilities. If this is achieved the rewards can be very big indeed.
The Fourth Industrial Revolution
The Fourth Industrial Revolution—Industry 4.0—is fundamentally changing manufacturing around the world. Driving ‘smart manufacturing,’ it is revolutionizing the ways in which technology interacts with both society and even, to carry forward the MedTech reference, human bodies.
Whether it’s called Industry 4.0, Industrie4.0 or Smart Manufacturing, it is rapidly changing the face of manufacturing. It is a new paradigm for manufacturing world-wide, extending to MedTech companies and driving them to embark on a digital transformation journey.
Axendia president Daniel Matlis says it best: “Digital transformation is the foundation for Industry 4.0 for MedTech. Innovative medical device companies are embracing the Industry 4.0 paradigm for smart manufacturing to support outcome based models. They recognize that they cannot manufacture and market next generation, disruptive and personalized products with last generation processes and legacy systems.”
The Global View
The requirements of a Manufacturing Execution System (MES) are already changing to enable dynamic production of high-mix, highly sophisticated and customized product batches. This necessitates a system that enables dynamic production models, turning the manufacturing network into a ‘marketplace’ where using the Internet of Things (IoT) intelligent materials and products can find the services they need and most efficient paths though production.
The technology is already available to extend this dynamic shop floor marketplace into a global view of a completely smart supply network, incorporating global plants, suppliers, contract manufacturing organizations (CMOs) and even distribution partners.
A modular MES with decentralized logic offers a pathway to a smart factory (Industry 4.0), but with interoperable architecture, it also gives real time product and in-process data from any connected global facility. With such a solution, MedTech companies can analyze and track throughput across their operations and find the most efficient routes for production beyond the factory walls, without compromise on quality or traceability. Having complete situational awareness of the supply chain, such a solution offers huge potential to increase production efficiency and to save thousands of manufacturing hours.
A Call to Action: Controlling the World
OK, so we are not talking about controlling the whole world, but we are talking about giving the freedom for MedTech to make the best use of resources available, wherever they may be, while keeping excellent control over manufacturing processes and quality. Globalization and outsourcing are already a major part of driving production economy and reaching new marketplaces. With a future-ready MES that encompasses the globe, many benefits of an Industry 4.0, smart manufacturing production model can be achieved in a single, high efficiency, controlled and distributed manufacturing solution.
Digitization is not enough—merely digitizing legacy manufacturing practices in last generation systems will not achieve Industry 4.0 benefits.
The challenge many Medical Device companies face today result from antiquated technology solutions that were implemented to only support local and internal functional areas. With globalization and outsourcing, brand owners no longer generate or own the data within their four walls.
To read more about enabling Industry 4.0 across your global manufacturing network, read our white paper series: MedTech Needs Industry 4.0 to Thrive in the Outcome Economy