Obsolescence vs. Medical Devices: The Healthcare Bogeyman

Obsolescence vs. Medical Devices: The Healthcare Bogeyman

One of the most common fears that people have is that of spiders, according to BBC’S Science Focus. Spindly insects with long legs and dozens of eyes either come in at number one on many top ten fears lists or a close second. Snakes, heights, and public speaking are prevalent fears among people. Medical technology manufacturers also have a common fear, but it’s not of needles, closed spaces, or germs.  

It’s electronic component obsolescence.  

Obsolescence in technology is not uncommon. The tech industry is one of the fastest developing sectors in the world. In the past ten years alone there has been unprecedented change and evolution in consumer electronics. 2022’s outlook on technology innovation is no different. Cloud services and hybrid work models keep the top position this year on the innovation list. This means component manufacturers are building newer, faster, smaller, and better components. 

Consumer electronics–products like smartphones, laptops, home appliances, and others–do not have a long shelf life. Many consumer electronics have lifecycles of 18 months. Why? Innovation in the tech industry moves at lightspeed. Apple, for example, releases a new phone model every year. One that’s slimmer and faster with new software applications and improved camera quality. Apple isn’t the only tech company releasing a new model each year either.  

Electronic components are becoming obsolete faster as manufacturers keep up with consumer demands. So, why is obsolescence a dreaded word in healthcare? The solution to this problem is as complex as the reason behind it. It’s easy to upgrade to a new phone every year. It’s not easy to do the same with a pacemaker.  

What is Obsolescence and Why is it So Bad for Medical Devices? 

What is obsolescence in electronics? Obsolescence occurs when a manufacturer ceases to sell, support, or develop a product or component. In electronics, obsolescence can have a huge effect on a number of various industries—everything from automotive to energy to the healthcare sector.  

The reason is that an electronic component can be used within a myriad of different technologies to support varying products. Obsolescence is considered a supply chain threat, according to an article from 2018 by SourceToday which included a survey on component obsolescence. 

When a component reaches obsolescence, most manufacturers and other industries have a choice: the procurement of another component that does the same job as the obsolete component or redesign around it. If a substitute is not found, a complete redesign is necessary. If a redesign is impossible, a massive purchase of soon-to-be obsolete components needs to be made. These issues plague all industries regarding component obsolescence. It is not a problem specific to healthcare alone.  

Healthcare, however, does not have the same option that consumer electronics have.  

Medical devices cannot substitute a component with ease the same way another industry might. For a medical device to be put on the market, it must go through rigorous testing. These tests are military-standard strict and, once finished, require FDA approval to go out to market. The FDA doesn’t just certify the device either. It must certify every component used to create the appliance.  

If a component becomes obsolete, medical device manufacturers cannot substitute another component. If they do, they must go through the same process once again for FDA approval. That means long wait times, expensive certification costs, and overall risk to patient health. Medical devices do not have the same shelf-life as consumer electronics either.  

Medical devices are expected to have a product lifecycle of upwards of 10 years. According to a 2021 article by SourceToday, it’s not uncommon for large medical devices to have a concept-to-end-of-life lifecycle of 20 years. Medical devices are also expected to work without fail when needed under “abnormal” circumstances.  

Most consumer electronics like smartphones or coffeemakers, are only expected to perform when “on.” Medical devices, such as a defibrillator, may sit dormant for long periods of time. The moment the device is needed it must be ready to start up and perform perfectly when needed. Some devices, like implantable and wearables–a pacemaker for example–are expected to operate continuously for years, if not decades.   

With component life spans getting shorter and shorter obsolescence must be considered at the start. What can medical device manufacturers do to combat the myriad of issues that come with it? 

How Do You Manage Obsolescence?  

There are steps you can take to be better equipped for eventual component obsolescence. Since obsolescence is the future for devices, from consumer to medical, it’s best to prepare for it as early as the design stages. One such step is, upon learning of a component entering obsolescence, making a large last-time buy of finished components.   

The only complication with that is buyers must have safe, long-term storage of these components, often semiconductors. Normally, most buyers do so with the aid of a third party. These parties often have access to long-term storage facilities with proper handling and conditions. This is one of the main ways of managing obsolescence. It often works. 

Then Covid-19 happened. Component stocks were quickly depleted to build necessary medical devices to support the overwhelming number of patients. Full product redesign? Alternative component sources? Forget it, the re-qualification time it would have taken for the FDA to formally approve was far too long a wait.  

The world is still grappling with the effects of the semiconductor shortage. Many companies no longer have that same buffer stock to keep them safe. While things are slowly, but surely, returning to normal the problem Covid-19 exposed persists.   

So, what other steps can you take? As it turns out, plenty.   

Always Plan Ahead 

Planning in advance is key to most obsolescent solutions. It is better to gather the maximum number of cross-references from the design phase onward. That way you can prepare for component purchases far in advance, knowing what can and will be needed. Covid-19 taught us that having a 40-day supply buffer might still not be enough. So, if a device requires a certain component that is prone to shortage risk, buy more.  

The most important step one can take, above all else, is consistently monitoring lead times and emerging market trends. While Covid-19 came as a surprise to many, the effects of lockdowns and the rise of the work-from-home model were not. The lesson was hard to learn but invaluable. This information must always be monitored so that you understand possible arising supply chain risks.  

What’s better than that? Partnering with a distributor that can help you manage future obsolescence issues and cover all possible eventualities.  

A Trusted Distributor Will See You Through 

Obsolescence doesn’t have to be a frightening future endeavor. With the help of an authorized and independent distributor, obsolescence management becomes stress-free. Area51 Electronics, as this type of distributor, can meet all supply chain needs. With an extensive portfolio of original equipment manufacturers (OEMs) and a vast, collaborative network of suppliers, obsolescence becomes predictable.  

As a proponent of collaboration, something we offer in our unique approach called collaborative advantage, our network of suppliers will help you overcome formidable obstacles. Preparing for end-of-life components doesn’t have to be complicated and expensive. Area51 Electronics will take care of the complex issues so you continue building better equipment to save more lives.  

We’re all in this together. We’ll watch your back knowing you have ours.   

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