Planning for obsolescence in medical devices
Out with the old and in with the new. For most of us, this is just another cliché that we’ve heard a million times before, however in the manufacturing industry this is very much the reality.
In the past, the Medical Device Directive (MDD) was used to harmonise the laws relating to medical devices within the European Union. Products that conformed with the MDD were labelled with a CE mark. The intent of this mark was to provide a certification of quality and reliability that could be trusted. However, things did not always go to plan.
A combination of problems, stemming from diverging interpretations of the MDD and high-profile scandals involving medical devices, highlighted the weaknesses of the laws in place.
So, what went wrong?
In the past, problems have arisen with medical devices holding CE marks caused by parts failing during the expected lifespan of the device and there then being a difficulty to replace the part in question. These issues, among others, highlighted the need for the regulations in place to be updated to include regular testing of equipment regardless of whether it is certified with a CE mark.
Now, the MDD has been updated and replaced with the new Medical Devices Regulation (MDR). Unlike with the MDD, the MDR is a regulation and not a directive. This means that it is directly applicable in all EU member states and is not open to different interpretations.
The MDR has introduced several changes to the laws surrounding medical devices in Europe compared to its predecessor. One of the changes introduced is making manufacturers responsible for the lifecycle of a device.
The role of obsolescence management
When a device is not performing as it should, it could be just one component letting the whole thing down. In cases such as these, it makes far more sense to replace the part that isn’t working correctly instead of the whole device. However, sourcing spare parts could prove difficult if the component in question is no longer produced by the original equipment manufacturer (OEM) and is therefore obsolete. An obsolete industrial parts supplier, like EU Automation, can help source like-for-like replacement parts however you don’t want to have an over reliance on this when manufacturing your devices.
While it isn’t impossible to find replacement parts, it’s much easier if obsolescence management is considered from the outset. When manufacturing a medical device, it’s important to consider the lifespan of all the components individually.
For example, if manufacturers face a choice between two options for a component where the first is cheaper but facing obsolescence in the near future and the second is a bit more expensive but has a longer production lifespan then it is worth investing in the part with greater longevity so that the overall device life is not threatened by the future obsolescence of one component.
With the rate at which components face obsolescence growing all the time with new technological advances, good obsolescence management is more important now than ever before. Failing to carry out this practice could cost companies millions in unnecessary replacements of devices, money which could have been saved with good obsolescence management from manufacturers.