When are gadgets not medical devices?

Neil Oliver, Technical Marketing Manager at Accutronics, explores the safe transition of medical equipment into the rapidly changing mobile space

There was a time when, for common ailments, no matter how big or small, most people would head to their local GP. If a sample of any kind was required, this would be sent away to a lab, often taking weeks to return and enlighten a potentially anxious patient.

They say necessity is the mother of invention, and the intervening years have certainly seen rapid development in testing and sample analysis. Further advancements have also been made in medical diagnosis technology. Part of this progress can be attributed to improvements in rechargeable Lithium-ion batteries, which have allowed medical devices to cross the chasm into the portable and wearable sector.

Doctors, emergency services and patients have benefitted and countless lives have been saved or improved, but a recent consumer trend, has raised concerns. Our pocket pal, the mobile phone, has experienced even faster product development lifecycles, with new iterations available every six to ten months.

This increased dependency on our smartphones has resulted in a wave of portable medical devices which can connect directly to the phone, with an app relaying an on the spot diagnosis. Heart rate and blood pressure monitors are already extensively used in tandem with mobiles and tablets. More complex devices for patients with chronic diseases, such as glucose meters for diabetics, pulse oximetry and kidney infection machines, as well as ultrasound wands and smart fitness monitors are all flooding the market.

Vital reliability

At first glance, this seems like a great innovation. However, on deeper inspection problems arise. In isolation, the emergence of new technologies empowers consumers with increased transparency in health monitoring. In reality however, the convergence of professional portable equipment used by doctors and cheap consumer devices used by hobbyists, poses the possibility of an unregulated self diagnosis society. We could see potentially unsafe and unreliable devices being used to self diagnose and self treat. Any trend in the consumer market would inevitably have a competitive knock on effect on professional use and the proliferation of subpar devices could put lives at risk.

At the heart of the issue lies the power supply. On a typical day a paramedic may report for a 24 hour shift, ensure the equipment is charged and ready to use before undertaking emergency calls. Throughout the day, a device may be turned on and off multiple times and withstand the bumps and knocks inherent in a pressurised urban environment.

The effect is multiplied for medical personnel in emerging and developing countries such as rural Malawi and Sudan. Roaming doctors use an eRanger portable trike to get from one village to the next. The supply of electricity is unreliable, the roads are underdeveloped and temperatures fluctuate rapidly, all placing extra strain on the battery's ability to power the device.

The consequences of a battery failing during medical use could, quite literally, be life threatening. A failing Lithium-ion battery may not be immediately noticeable but may become unreliable over time as overcharging and overheating could lead to a risk of failure or even combustion. This is relatively common in poorly tested, often consumer focussed, batteries but extremely unlikely in professionally designed smart batteries.

OEM battery solution

At Accutronics, we have taken a proactive stance, by introducing our Entellion range of highly tested, but off the shelf portable smart batteries. This includes a series of slim credit-card sized smart Li-ion batteries, boasting high gravimetric and volumetric energy density, which means longer run times, supported by intelligent monitoring.

In contrast to the short product life cycles of smartphones, medical devices can be expected to endure periods of up to a decade without redevelopment. The stark reality is that the cell technology used in such devices will become obsolete long before the product is discontinued. If we are to eliminate the medical risk, it is essential that battery solutions are designed into the product at the conceptual stages, rather than being relegated as an afterthought.

Manufacturers can work with Accutronics from concept to the design and production stages. Implementing a holistic development philosophy means that OEMs can benefit from application support and design advice to achieve shorter development times and better cost savings.

Accutronics' customers can also benefit from unique labelling and firmware support as well as application specific testing and regulatory approval. Manufacturers can rest assured that custom battery designs will not be changed, unlike mass produced, consumer batteries which quickly become obsolete.

The rise of portable medical devices also raises concerns within regulatory circles. There are strict testing requirements for Lithium ion batteries to ensure that they remain safe whilst being transported, stored, charged, discharged and even when electrically or mechanically abused. All of Accutronics’ Lithium ion batteries meet or exceed required standards which are set out by the IEC and UN.

Smartphone use isn't going to go away, and portable medical use is becoming an increasingly serious proposition, so why inhibit either? Rather, use the benefits of both and minimise the burdens and shortcomings of each.

An effective solution in which the two areas can co-exist, is using the smartphone to complement the medical technology, this could be to log and share data over our improving cellular networks. Similarly they could be used as a secondary monitor to give additional information, and utilise their increasingly powerful processors to perform non vital diagnoses, supporting medical staff.

So the next time your doctor starts playing with their mobile phone in an emergency don't panic! They are probably checking your vitals and not Facebook... probably.