Q&A: Avoiding the “Planned Failure” of Medical Devices
In medical devices, “planned failure” should not be an option.
“Batteries that are built to die” may sound like a ridiculous or counterintuitive concept. However, many consumer electronics manufacturers (OEMs) have built eventual obsolescence into their devices as a way to increase profits.
Think of your smart phone. Most phone batteries don’t last more than one day per charge—given the demand for smaller, thinner, and lighter batteries in consumer electronic devices, and how the smart phone battery is expected to provide continuous, often high-discharge power for all of the phone’s components. To maximize financial gain, most consumer electronics OEMs opt for more hardware updates and shorter product development lifecycles (PDLCs) of one year or less over longer PDLCs and devices that cannot be updated so quickly. This would be a disastrous move for medical device OEMs, however, as patients rely on the components in their portable and implantable medical devices to keep them healthy and safe, i.e. not give out on them when it’s time for an update.
Rob Phillips, sales and marketing director of the battery manufacturer Accutronics, described this phenomenon in a recent informational article for Accutronics’ blog, “Don’t Plan to Fail: Managing Component Obsolescence in Medical Devices.” He took the idea one step further: OEMs need to take a long, hard look at component obsolescence management and come up with a different, better strategy for their consumers, who have drastically different needs than the consumers of Apple products, for example.
“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,” Phillips wrote. “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.”
Phillips went on to describe how battery cell manufacturers must be involved in the early stages of the product’s design, adding that good cell selection means the battery will be available for the life of a device, while a poor choice of battery could mean successive redesigns throughout the product lifecycle.
Obsolescence is inevitable to some degree, Phillips conceded, as technology is constantly changing and improving. But as the development of healthcare devices is becoming increasingly holistic and no longer operating in silos, component obsolescence has a much deeper impact; the entire system must be taken into consideration when replacing a part to ensure that requirements and regulations continue to be met. Thus, great care and caution must remain paramount, for the safety of the product and, by extension, the patient.
“Planned obsolescence management doesn’t have to mean you plan to fail,” Phillips wrote. “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 programmes.”
appliance DESIGN followed up with Phillips to find out how batteries for medical devices can deliver optimum performances over a long PDLC, how these batteries can be tailored to fit the devices of specific OEMs, and if predictive maintenance of medical device components would yield more risk than reward.
appliance DESIGN: Planned large-scale failure of medical devices is obviously unacceptable, though obsolescence often begins with a battery that’s not made to last. How can batteries for medical devices demonstrate upmost efficiency, safety, and reliability over time?
Rob Phillips: Medical device batteries are now expected to last anywhere between five and 25 years and be safe throughout installation and use. They must provide accurate state-of-charge information, be highly reliable with predictable discharge profiles and use battery chemistry that is suitable for the application.
Smart features, like those in [Accutronics’] CMX series of Lithium-ion smart batteries, ensure that a device can deliver optimum performance in a variety of situations. Smart features include active and passive protection circuits that prevent over-temperature, over and under-voltage, overload and short circuit. Forming an essential part of medical device operation, smart power management means the battery only requests charge when needed and shuts down when not being used.
How are the batteries tailored to fit the needs of medical device OEMs?
Despite [smart] features, it is important to remember that a battery is a consumable part that will degrade over time. This is why choosing the right battery chemistry is vital and why it pays to involve battery OEMs early in the product design process.
In fact, involving OEMs earlier in the product development life cycle can be critical to device success. It is often the case that battery design is left as an afterthought and, as a result, is a major cause of medical device failure. Poor mechanical design, along with bacterial contamination, lack of rigorous compliance testing and software issues, are the most common reasons for device recalls.
At Accutronics, we’ve developed a holistic process to help medical device OEMs consider battery design at the concept stages of the product development process. Aspects such as cell selection and choice of chemistry boast a range of benefits to devices, from high energy density to outstanding cycle life; but they can be difficult for OEMs to make sense of without consulting battery manufacturers.
Predictive maintenance, i.e. fixing issues before they arise, is already making headway in the large-scale manufacturing sphere. Is this the future of designing medical devices as well? The rewards are clear, but what are the risks?
While concepts such as predictive maintenance are becoming increasingly popular in numerous manufacturing sectors, the use of predictive analytics poses a cybersecurity risk for medical devices. We have already seen that as the medtech industry embraces the Internet of Things (IoT) and increases the uptake of portable and wearable medical devices, more opportunities for cybercrime present themselves.
The best preemptive measure a medical OEM can take is ensuring device components are secure and fit for use. Security means more than just protecting your device from external sabotage; it is a promise of performance and reliability for your most vital asset—your patients.