Every day tens of thousands of Australians have to take a syringe, prick their skin with a needle and then inject themselves with insulin. Imagine if every one of those diabetes sufferers had a device fitted inside their body that measured their sugar levels and automatically released insulin as and when required.
That’s one of several projects on the go in a research partnership between the Australian Research Council Centre of Excellence for Electromaterials Science and Dublin City University in Ireland. Other initiatives include a Sweatch watch that measures levels of sodium ion in your sweat and a “smart tattoo” that tracks the status of dermatological diseases.
The medical possibilities for intelligent, internet-enabled medical devices is vast, with one recent estimate expecting the global market to be worth US$163bn by 2020. To date, the so-called wearables market (think Fitbit, Apple Watch and so forth) has made the most of the early running. But the scientific value – and potential commercial returns – for next-generation implantables represents a different level of magnitude.
“The possibility for harvesting real-time health data from an implantable device is huge,” says Aoife Morrin, principal investigator at Dublin City University’s National Centre for Sensor Research. “A wearable typically has access to the outer layers of skin whereas an implantable can potentially look into internal organs and deeper tissues inside the body.”
Breakthrough market
It’s not only medical researchers that are growing excited at the prospect of knowing more about our insides. Predictably, pharmaceutical firms have been quick to seize on the technology’s potential. Automated systems get around the problem of patients failing to take their medication or not replacing it (a habitual problem that hits Big Pharma’s sales hard). As importantly, ongoing real-time diagnostic data helps corroborate a drug’s effectiveness, thus increasing the likelihood of that drug being prescribed.
Consider Proteus Discover, the brainchild of the US healthcare firm Proteus Digital Health. Discover is a microscopic sensor contained within an ingestible pill. The sensor activates on contact with stomach acids and then starts relaying clinical health data to a replaceable patch worn on the patient’s torso. The technique is initially being used primarily for patients with cardiovascular and metabolic diseases, such as hypertension and Type 2 diabetes.
The patch also registers the time that the medication was taken and a patient’s subsequent behavioural patterns (sleep, exercise, etc). All this information is then loaded up wirelessly to an app on the patient’s smartphone and then to the Proteus Cloud.
“By turning the high frequency act of medication taking into a digital event, Proteus is directly integrating therapies with greater measurement, feedback and behaviour cues,” says Andrew Thompson, Proteus’ chief executive.
Healthcare investors appear to share his enthusiasm. In April, the biotech firm secured US$50m in its latest funding round, adding to the US$172m it raised in 2014.
Another company making inroads in the implantable market is Microchips Biotech. The US firm has created an electronic device that employs “micro-reservoir” technology first developed by the Massachusetts Institute of Technology to deliver therapeutic doses of a variety of drugs from within.
A physician can alter the pre-programmed frequency or quantity of the dose via wireless communications. Alternatively, sensors embedded in the device can release the drug automatically in response to physiological or metabolic changes. Last year, the Israeli drug firm Teva Pharmaceuticals invested US$35m as part of a partnership with Microchips.
Cultural barriers
For all the hype around new-generation implantable technology, the market remains in its infancy. Most ideas are still at prototype stage, if that. Even assuming the technology can be cracked and proven to be safe, several important hurdles still stand in the way of implantables revolutionising medical care.
The first is cultural. Wearing a watch that monitors your heart rate or a bracelet that measures your sleep is one thing; having an electromagnetic sensor inserted permanently inside you is quite another. That said, few think twice now about surgically implanted pacemakers or hearing aids, say, so maybe time will overcome the initial ick factor.
Less certain is the cultural aversion many have towards data privacy. The critical difference with a pacemaker or hearing aid, of course, is that implantables “talk” back. An endless supply of high personal data, always being generated, never stopping – and potentially going who knows where and for who knows what purpose. Device manufacturers, pharmaceutical firms and healthcare providers are naturally at pains to say patient data is protected by standard patient-physician confidentiality. Proteus, for instance, asserts that data is only passed on to healthcare providers with the patient’s explicit consent and with the sole purpose of “informing personalised treatment decisions”.
What about cybersecurity breaches, however? If hackers can infiltrate the medical records of sports stars such as British cyclist Bradley Wiggins and the US gymnast Simone Biles, what’s to say biometric information from your implantable might somehow find its way to your health insurance provider or to a tech company like Google (which is currently experimenting with a “smart” contact lens)?
While such fears are not without reason, Erin Byrne, the chief client officer at the US healthcare communications firm Grey Health Group, insists that “proactive” measures can ease patient concerns. “If companies follow the governance regulations that are in place and communicate truthfully, then I think people recognise the benefit to them and that data is a propeller of good health.”
There’s also the question around who will pay to have a new-generation implantable inserted. If current implantable devices are anything to go by, Australians could find themselves having to reach deeper into their own pockets. Last month, the health department removed 2,500 pacemakers, artificial hips and other implantable products from its official prostheses register. The move will reduce how much private insurance firms have to contribute towards the fitting of such devices in the future.
Joining the dots
The promise of better health – both for individual patients and, in the event their data is used for medical research, for the wider population – certainly serves as a powerful counterbalance to privacy concerns. But will implantables really deliver?
Therein lies the second big hurdle: efficacy. The main selling point for implantables is that they can create “more accurate, more timely” information quicker than ever before, says Adrian Downing, the director of healthcare at the UK advisory firm Concentra Analytics. “But that suggests that clinicians have time to look at the data and, if they do, that they trust it and understand its full context,” he says.
Implantables promise to usher in a patient-data led form of healthcare that discomfits many medical practitioners, which see it as a loss of their traditional control. Downing cites doctors’ reticence about allowing the development of a single database for patients’ medical information in the UK. The ill-fated scheme eventually got scrapped because of low uptake by the medical profession.
“The critical question governing implantables’ effectiveness is how the data is used within existing healthcare services,” Downing says. “Even now with wearables, none of the information is going to GPs [general practitioners]. The system is simply stopping it.”
Joanne Hackett concurs. As chief commercial officer at Precision Medicine Catapult, a UK firm promoting the commercialisation of data-driven medicine, she stresses the need for patient’s information to “follow them” through the health system.
She points to Sweden as a good example of a liberal, “linked-up” approach to patient data. The system stems for a very particular mentality, she adds. “Every patient is considered a research patient, so people don’t think twice about being included in a clinical trial.”
She also singles out Australia for its promotion of “person-controlled” electronic health records. Earlier this year, the Australian Health Association issued a revised policy statement that called for a “simple consent mechanism” that would allow doctors across the healthcare service to access patients’ records.
“All healthcare providers involved in providing clinical care to a patient should have access to the core clinical information, provided their registered health profession board has a policy on electronic health records covering conditions for such access by their members,” the AMA argues.
