What are Medical Devices?
Unlike the defence or aerospace industries, we are more likely to come into contact with medical devices in our everyday lives. The medical industry relies heavily on technology to deliver critical services, from diagnostic equipment to life-support machines. These are high-value products and are expected by their customers, Hospital Administrators or purchasing departments and Health Authorities to have a long shelf life. They also need to be durable and be able to continue working in a mix of environments and undergo a heavy workload.
Why do Medical devices need a long shelf life?
Medical devices need a long shelf life partly because of the time taken to develop a new product and get it certified and due to the cost that is quite often from the public purse. Purchasers need to take these into account and expect them to last a long time.
With a proper obsolescence plan in place, most devices can be updated or legacy products can be reworked and repaired. However, this becomes particularly difficult when manufacturers end production of key components and the product needs to be kept going. In order for the product to remain functional, compliant and safe the owner will have to source, replace or redesign parts.
How big is the Med Tech sector in the UK?
According to Statista, the projected market volume of Medical Devices in the Medical Technology Market in the United Kingdom is US$18.21bn in 2024. The market is forecasted to continue growing as the need for better technology to treat an ageing population comes to the fore.
Lifecycle Management of Medical Devices
There are a few options available to manufacturers and end users when it comes to ensuring the long-life cycle of a product, each of which brings its own challenges. You can go in-house, but your team might lack the expertise across a wide spectrum of disciplines or outsource your solution to a team like the one we have here at Force Technologies who can take care of the Semiconductor side of the project.
Obsolescence can lead to several issues for medical device companies, including increased costs, supply chain disruptions, and the risk of non-compliance with regulatory standards. For instance, when a specific integrated circuit (IC) used in a piece of diagnostic equipment is no longer produced, the manufacturer must find a replacement that meets the original specifications without compromising the device’s performance or safety.
Some strategies that should be considered to mitigate obsolescence in Medical Devices include:
Long Term Storage – The long-term storage of critical components in advance that will ensure the extended life of a product. Read about our recent expansion into Long Term Storage.
Monitoring of Manufacturers product lifecycle announcements – Keeping up to date with all changes announced by the Original Manufacturer and creating a strategy that enables you to mitigate the end of production before it happens.
Relationships with Suppliers – Build relationships with suppliers and distributors to secure your access to hard-to-find components.
Obsolescence Mitigation Strategies for Medical Devices
When a medical device is not performing as required, it can sometimes be a case of replacing a single part will fix the issue and this solution is a much more cost-effective way of dealing with it. The alternative is to purchase a whole new machine that may cost hundreds of thousands of pounds. Sourcing spare parts can be difficult especially if the part is no longer manufactured so you might want to think about your options for sourcing replacement components. This is called an obsolescence strategy and some of the options you might want to consider include:
Taking advantage of Last Time Buy announcements – ensuring you buy enough components to support the device’s expected long-term lifecycle.
Redesign and retrofitting – If no exact replacements are available you could get a manufacturer to custom redesign the device to accommodate new components.
Alternative Sourcing – Identifying and qualifying alternative components or suppliers, including considering aftermarket or third-party options.
In Conclusion
All stakeholders in MED Tech need to understand the issues around semiconductor obsolescence and implement strategies that will enhance the lifecycle of their products. Obsolescence poses a significant challenge for the industry but with a proactive lifecycle management strategy, the effects of obsolescence can be avoided.
It is important to understand the risks, anticipate changes and secure the right amount of critical components to ensure the long life cycle of your products. Done right, you can ensure that medical products remain reliable, safe and compliant and deliver the best outcomes for patients everywhere.
If you need help with your medical product lifecycle or obsolescence strategy please get in touch with us here at Force Technologies Sales@forcetechnologies.co.uk