Blurred Lines: What is a medical device?

We used to have a clear cut concept of what constituted a medical device. However, with the increased use of technology via smart devices for example, the idea of what is and isn’t a medical device is becoming less straightforward

The use of smart watches, chips and even apps have burgeoned in use and where we once we thought of a medical device as something that was found on a hospital ward, these days their shape and form have shifted to become increasingly complex pieces of technology.

The rise in illnesses such as diabetes has fuelled the change in device design. New ways of treatment and drug formulations mean that more patients are able to manage their own treatment at home out of a hospital setting - so new devices have had to accommodate medical advances.

Devices are becoming smaller and are often not able to even be seen, offering a new wave of product design. Implants containing microchips are on the rise. Whether we’re talking cochlear implants, pacemakers or contraception that releases drugs via a wireless signal, the market for implantable devices is strong.

So if we are happy to implant a chip under our skin and call it a device, are we happy to think of our smart phone in the same way? Recently Blackberry was reported to be producing a bacteria-free device for use in hospitals suggesting that this is a potential key market for mobile manufacturers.

In a recent article for MPN, Neil Oliver, Accutronic commented: “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.”

In an article in The Wall Street Journal, Eric Topol also highlights the way that over the last decade smartphones have changed everything from shopping to entertainment, and medicine is about to follow suit.

He writes: “Medicine is next. With innovative digital technologies, cloud computing and machine learning, the medicalised smartphone is going to

upend every aspect of health care. And the end result will be that you, the patient, are about to take centre stage for the first time.

“With the smartphone revolution, an increasingly powerful new set of tools—from attachments that can diagnose an ear infection or track heart rhythms to an app that can monitor mental health—can reduce our use of doctors, cut costs, speed up the pace of care and give more power to patients.”

It will be interesting to see how this new wave of medical devices pans out and affects future manufacture of products. Whether we’re talking materials, coatings or the microchip technology, new device design is demanding a re-think to meet the needs of a changing healthcare sector.