by John Dzelme, Global Chief Operating Officer with Seabrook.
The landscape of medical device manufacturing has shifted immensely in recent years. One of the most significant developments has been the endorsement by regulatory bodies, including the Food and Drug Administration (FDA), of the total life cycle production concept. With this, Product Lifecycle Management (PLM) systems have fast become the barometer for medical device manufacturing, because of their ability to manage the entire process, from conception and design, through to production and on to continuous monitoring once the device has left the shop floor and is with the consumer. In this blog, I make a case for PLM in the medical device and life sciences industries by answering some questions I’m frequently asked about PLM.
What is PLM?
Siemens has a very succinct and clearly defined description of PLM, which it says is an information management system that can integrate data, processes, business systems and ultimately people in an extended enterprise. PLM allows you to manage this information throughout the entire life-cycle of a product – efficiently and cost-effectively.
How can PLM enhance medical device manufacturing?
Quality and product safety is paramount for medical devices, which are nowadays often implanted into the body. In order to create a truly quality product that adheres to the strictest of safety regulations, manufacturers need to employ automated systems that govern the entire process in a more holistic and complete way. To truly understand how PLM can benefit medical device manufacturers, it needs to be thought of as a strategic business approach – rather than a piece of software or a collection of technologies.
PLM promotes the production of safe and quality products because:
- It facilitates greater levels of integration between each component part of the process, e.g. conception, design, engineering, manufacture.
- It ensures that all the relevant information is contained in a centralized structure, allowing those working on each stage of the process to have immediate access to all the relevant information.
- PLM allows for streamlined communication between all departments involved and encourages collaboration, communication and cooperation.
- With PLM, there will be a progressive move away from departments working in isolation from each other, and the creation of an interactive environment that ensures greater innovation.
As the concept of total life cycle production gathers pace and increasingly becomes the norm, medical device manufacturers must embrace advanced technologies such as PLM in order to compete. The benefits are considerable – not only for the manufacturer but also for the consumer.
To learn more about PLM, join me John Dzelme, Seabrook’s Global Chief Operating Officer, at Seabrook’s first Irish Manufacturing Excellence Forum in Dublin on Monday, April 25 2016. For more information, or to enquire about a place at the forum, see seabrook.ie/preparing-for-industry-4-0