Drugs, devices and digital media

As the first line of the blues song might now have it, I went down to the Boots audiology specialist. An elderly aunt had suffered a dramatic loss of hearing just after buying a pair of removable Phonak hearing aids made by Switzerland’s Sonova. Cost: a cool £3000.

Had she broken the hearing aids, were their batteries at fault, or was she just losing her auditory marbles? She certainly had some sleepless nights of anxiety.

Given demographic trends in much of the developed world, designers need to know about such problems. Yet it turned out that Boots had not explained enough that, when it first fits hearing aids, it warms them up to only 65 per cent of their potential performance. That way, hearers get used to them. Well: despite my aunt’s advancing years, her brain had adjusted so fast to this first, 65 per cent performance that she’d had a kind of hearing relapse. Still, Boots merely had to ramp up the device to 98 per cent of its potential for my aunt’s hearing and her nerves to be much improved.

In fact, the every-six-months adjustment of digital medical devices at the UK retail chain by a 30-something with a Manchester University MSc in audiology is part of a wider trend toward the convergence of more-or-less conventional medical devices with the digital domain. Indeed for designers the Phonak Naida V hearing aid hints at what the medical branch of wearable media will be doing a lot more in years to come. Using GPS, it reports on the user’s geographical position. It also works up that data to determine perhaps seven different typical hearing environments encountered by the user – from blabbermouth dinner party to Hollywood soundtrack at the TV or cinema. Then the Naida V tunes its response to those environments, and displays improvements as frequency charts on the Boots audiologist’s desk.

Now, medical devices can be big or small: they stretch from orthopedic and surgical instruments, diagnostic apparatus and equipment for blood transfusions and intravenous work down to pacemakers, stents, catheters, syringes and needles. Yet tomorrow’s healthcare won’t just see convergence between established, often American makers of such devices (Johnson & Johnson, General Electric, Medtronic, Baxter International and several thousand SMEs) and the new mobile IT. A third, much larger force will also be involved: the pharmaceutical industry. For while digital specialists now ride in to improve medical devices, many companies making medical devices first grew up around the delivery of drugs.

It’s true that key US trials with simple heart pacemakers began in 1960, and that these important devices did not dispense drugs. But from 1966 America’s Food and Drug Administration (FDA) began to regulate the labeling of all medical devices. Fifty years on, sensors have been designed into not just pacemakers, but also drug-device combination products: into inhalers, insulin pumps, transdermal patches used in smoking cessation. They have also come to pills themselves.

Nebulisers, coated stents, implantable and ambulatory pumps, pre-filled syringes and auto-injectors – designers of all these will now itch to make them more digital. Meanwhile, pills with ingestible sensors look like they will now come quite fast: in September 2015 the FDA agreed  to test the antipsychotic Abilify tablet (made by Japan’s Otsuka) in conjunction with a sensor and app developed for it by California’s Proteus Digital Health.

If the US medical scene is anything to go by, however, the three-way convergence between Drugs, Devices and Digital Media will prove different from the marriage of the first two in the 1960s. Then, regulation of drugs and devices was just beginning, and the post-war boom was still on. Today, much of the DDD convergence outlined above will involve a struggle to go reducing costs as much as one devoted to improving patient benefits. Expect, therefore, to see plenty of devices designed to get patients to save healthcare systems money through their digitally-assisted adherence to the medication regimens recommended by doctors.

Straitened times, like regulation and the growing field of the bioethics of surgical implants, could slow the design and development of truly ambitious digital medical devices. Yet there will be progress. In June, at The Royal London Hospital, the Barts Blood Pressure Clinic inserted implantable pulse generators little bigger than £2 coins into the chests of two NHS patients so as to control their drug-resistant hypertension electronically. In the branch of implants known as advanced prosthetics, sensors, power systems, actuators, lightweight materials and brain-prosthetic interfaces are set to bring energy and sophistication to artificial body parts. Last, 3D printing will help bring both medical and consumer electronics into that cast you’re wearing now you’ve broken your leg.