Managing component obsolescence in medical devices
Regulations & Standards
The consumer electronics industry has embraced obsolescence as a way of increasing profits. Smartphones, laptops, and media players are designed to fail, central to this is the rechargeable battery. Many manufacturers now seal the battery into the device, so rather than simply swapping the lithium-ion (Li-ion) battery when it reaches its end of life, users are strong-armed into buying a new product. However, when it comes to medical devices obsolescence on such a large scale is unacceptable.
The consumer market seems to have accepted that planned obsolescence, or planned failure, is simply a fact of modern life. In the field of medical technology, however, the idea of having to replace a costly device because the battery, for example, is suddenly obsolete after less than two years would cause uproar.
Obsolescence is inevitable to some degree, especially as technology is constantly changing
Of course, obsolescence is inevitable to some degree, especially as technology is constantly changing and adapting to consumer expectations and medical innovations. Battery technology in particular is constantly in the headlines as cell manufacturers attempt to keep pace with the needs of consumer devices leaving medical device OEMs with limited options.
The development of healthcare devices is becoming increasingly holistic and system-led, no longer operating in silos. This means that component obsolescence has a much deeper impact, as the entire system has to be taken into consideration when replacing a part to ensure stringent requirements and regulations continue to be met. The demand for these smarter devices, that still need to provide a return on investment (ROI) with a long product development lifecycle (PDLC), is forcing medical device original equipment manufacturers (OEMs) to take a long hard look at component obsolescence management.
Where do OEMs invest their time and expertise?
This raises a quandary, where do OEMs invest their time and expertise? Should they take engineers away from research and development of revolutionary devices to focus on obsolescence solutions? It’s not an easy choice to make.
Medical technology (medtech) OEMs are having to focus on maintaining devices rather than replacing them, and so being aware of when and where issues may arise during a device’s lifespan is vital unlike, for example, a smartphone. Reliance on a supply chain that was primarily developed for an industry that changes more rapidly than the relatively slow-paced medical sector will cause problems.
Battery cell manufacturers can often fall into this category. International, commercial cell manufacturers often design battery cells with their own consumer device divisions in mind. When these devices evolve and place different demands on batteries, the cells will be discontinued and replaced with different models. Medical devices need to be able to rely on a continuous supply of the same battery type for an average lifespan of around ten years, so they need to be able to count on their supplier.
Good cell selection means the battery will be available for the life of the device
Involvement by a battery integrator in the early stages of a device’s design allows the battery to be tailored to meet the electronic device’s specific requirements. This can also ensure the battery includes cells which are available from multiple vendors, have longevity and meet all regulatory safety requirements. Good cell selection means the battery will be available for the life of the device whilst a poor choice can mean successive redesigns throughout the product lifecycle.
Planned obsolescence management doesn’t have to mean you plan to fail. Working with component providers that are committed to helping manage future obsolescence will allow medical device OEMs to focus on developing new technology rather than investing valuable resources on extensive obsolescence programs.