Exploring the convergence of consumer and professional medical devices

Neil Oliver explores the use of portable medical devices in home healthcare and patient's expectations

The past few years have seen considerable efforts by consumer electronics companies to enter the wearable and portable medical technology sector, including the launch of development platforms such as Apple's HealthKit and Samsung's S Health.

Many experts are concerned about the result of mixing commercial short-termism with traditional long-term medical device development.

Think of a medical device and you'll immediately think of a large, AC mains-powered machine like a ventilator, anaesthesia machine or medical imaging equipment such as an MRI, PET or CT scanner.

However, dig a little deeper and you'll realise you're probably carrying one in your pocket.

A typical smartphone now carries the computing power historically limited to process intensive industries such as space exploration missions.

It is this ambiguity which is blurring the line between a consumer electronic device, such as a smartphone or smartwatch, and a fully fledged professional medical device.

Designed for portable use to monitor, diagnose and inform long term treatment plans, the functions performed by professional medical devices, such as pulse oximetry, blood pressure monitoring, kidney diagnosis and glucose meters, have opened the market to consumer manufacturers and third-party app developers, putting patient health at risk.

Design traits typical of consumer devices are defining the normally expected characteristics of portable medical devices.

As consumers we have come to expect lightweight and thin devices with often embedded batteries that last up to 12 hours and products that are replaced with new versions every 12 months.

Because product development lifecycles (PDLCs) for medical devices are typically longer, around ten years, removable rather than embedded batteries are the norm.

This allows back-up batteries to be used in the field, effectively extending battery life on the fly as well as meaning that users can easily replace batteries at the end of their life. It's normal for Lithium-ion (Li-ion) batteries to provide 300-500 charge cycles before the battery life drops to an unacceptable level.

Excessively reducing weight and thickness for aesthetic purposes can also have a knock on impact on battery life and quality. Less space means the battery's volumetric and gravimetric density will be limited, affecting its total lifespan.

Home healthcare

The innovation in portable and wearable devices has largely been the result of an ageing population all over the world.

As more and more developing countries reach a median stage in their demographic transition model, life expectancies continue to rise at the same time that birth rates decline.

This trend has led to the rise in age-related, long term health conditions.

The most common chronic conditions are high blood pressure, Alzheimer's, heart disease, depression, arthritis, osteoporosis, diabetes, cancer and stroke. It's no surprise then that this trend is proving challenging for an already over burdened hospital and inpatient infrastructure.

Research by the US Food and Drug Administration (FDA) has shown that: "As patients move to the use of home health care services for recuperation or long-term care, the medical devices necessary for their care have followed them. In fact, according to results of the 2000 National Home and Hospice Care Survey approximately 1,355,300 patients were receiving home health care services from 7,200 agencies. In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually."

However, the medical devices designed for use in hospitals by trained professionals were never intended for use by patients in the home.

As a result, many patients, especially those who do not have the regular assistance of a dedicated home healthcare professional, struggle to operate, understand, maintain and troubleshoot devices. This has spurred third-party manufacturers to cater for patients looking to fill the void with pseudo-medical devices that feature familiar ergonomics and heuristics.

Industry collaboration

To embrace this latest innovation in wearable and portable devices used predominantly in a home healthcare environment, Accutronics' innovation philosophy embodies an ethos of a holistic product development process.

Although it's important to take a holistic approach when designing batteries for hospital based medical devices, it's absolutely vital when designing portable products for use in home healthcare.

The smaller size and lower mechanical tolerances mean that if battery design is left as an afterthought, as it so often is, it could lead to the commercial failure of the product.

At Accutronics we advocate a widespread industry collaboration between numerous stakeholders, including design engineers, manufacturers, healthcare professionals and healthcare organisations as well as regulatory and accreditation bodies.

Reducing the fragmentation so prevalent in the industry currently, will create a culture of sustainable product development, one that's required to face the challenges posed by the paradigm shift towards home healthcare.

Our range of credit-card batteries have been designed to overcome these problems by incorporating a powerful Lithium-ion battery with smart protection circuits that prevent overcharging, over discharging and overheating, all packaged in a credit-card sized unit. As well as this, algorithmic software security prevents fake batteries being used in these health-sensitive portable and handheld devices.

The yellow card system used by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is a great example of how patients can report the adverse effects of medicines and incidents occurring from the use of medical devices.

Raising awareness of methods like these will ensure that the right feedback is given to manufacturers to improve their products, undergoing any clinical testing where necessary.

So, as companies like Samsung and Apple enter into the wearable medical space, a concerted effort by all stakeholders will ensure that commercial short-termism can be turned into sustainable long term improvements in our health and, more importantly, in our quality of life.

Neil Oliver is technical marketing manager at Accutronics

Recent Issues