Wearing healthcare devices – evolution or revolution?

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Associated Press reporter Patrick Connolly, in Seattle, Wa., Dec. 18, 1986, adjusts the insulin pump he wears on his belt to keep his blood sugar near normal. Connolly, who has had diabetes for 27 years, receives a squirt of insulin through a slim tube into a small needle under the skin of his abdomen every few minutes from the one-pound pump. For Connolly the experimental device is more effective than 10,000 insulin shots he has had. (AP Photo)

The revolution is upon us

Wearable technology for healthcare applications is by no means new, in that devices such as insulin pumps have been available for years. Yet the opportunities for wearables in medical applications mean that the sector is about to undergo revolutionary change.

However, perhaps more than in any other industry, advances in healthcare wearables must provide clear benefits to the wearer/ patient or their healthcare professional/provider; they must also pass all the associated regulatory hurdles and be safe and secure from hackers, data thieves and “intruders”.

The forthcoming advances will allow us to diagnose and treat chronic and acute conditions, which at the moment remain untreatable, or at best are not treated very satisfactorily.   They will improve the quality of life for those with short and long-term medical conditions.

Passing muster

Technologies which “make it” in medical applications are no different from other industries in that they need to provide a benefit. For example, this could be a clinical, cosmetic, quality, convenience or financial benefit.

However, in contrast to other less regulated industries, in order to make “clinical claims” about the device and to commercialise it effectively, clinical efficacy, safety and increasingly financial efficiency need to be proven to the satisfaction of national regulatory agencies.

This necessitates a series of clinical trials, usability studies and health economics studies, which can be expensive and time consuming for the device developer to pursue. Therefore, it is no wonder that the first widespread smart wearables, have tended to be consumer devices which promote fitness, a general healthy lifestyle and wellbeing.   These latter devices can be developed unencumbered by Medical Device regulatory constraints.

Furthermore, since most devices will be “connected”, it is vitally important that they are safe from nefarious characters who want to remotely interfere with the device function or steal the secrets it may hold about its user.   This is a genuine threat. Former US Vice President Dick Cheney, indicated that he had the remote wireless access function on his heart pacemaker disabled, to avoid just such hazards.

There are three main areas where the rise of wearable technologies will significantly benefit the medical sector (i) monitoring & diagnostics, (ii) therapeutics and (iii) prosthetics:

Monitoring the healthy and diagnosing those with medical conditions

In the future, medical diagnostics could draw upon the technological approach which is already happening in some high performance sports. A Formula 1 car contains around 300 sensors. During a race the team will collect and transmit about 60 gigabytes of data from a single car.   McLaren Applied Technologies, sister company to the Formula 1 team, is active in applying its sensor and analytical technologies in wearable healthcare applications.

The average family car has 60-100 sensors which constantly monitor its condition. These are providing feedback to the engine and other automotive systems, relaying information to the driver and sending data to memory. Sensors are also used to detect driver inputs, for example, the position of the accelerator pedal and environmental factors such as external temperature.

Contrast this with a person who relies upon their natural sensors (e.g. pain) to detect problems. Of course this can be combined with medical diagnostic tests and diagnostic imaging. However, consider that even today, the advice for self-diagnosis for several types of cancer is essentially to regularly feel for a lump.

The ability of the healthcare professional to monitor the patient and intervene remotely has yet to be fully exploited, whether the patient in a hospital bed or going about their daily life. Such technologies are in development, for example Sensium Healthcare is developing low powered wireless vital signs sensors which stream data from the patient in a hospital bed to monitoring stations.

Once we start collecting data from body-worn sensors, there are of course still questions about communication of the collected data. To whom would it go and what the recipient will do with the data once it is collected.

 

The extent to which we can monitor the human condition with wearable sensors and act upon the results is just in its infancy, but it does provide an opportunity to transform healthcare provision, heralding the future for patient care.

 

Therapeutics – improving life for those with a health issue to correct

Wearable devices have huge potential to treat chronic and acute conditions, covering several approaches:

  • Drug delivery – Wearables are already happening. The first connected devices, which help the user to take their therapy through convenience and the use of apps, are already on the market and in development. For example, Insulet Corp. (Billerica, Mass.) market the stick-on OmniPod® insulin pump. ChronoTheraputics (Hayward, CA) is developing a wearable nicotine delivery device to aid smoking cessation, which attaches to the body. It will have an associated smartphone app and website to support the patient in their desire to break their addiction to smoking.
  • Therapy regimen adherence – Wearables have huge opportunity in promoting adherence to the therapeutic regimen. For example, in many conditions 40 to 50% of patients do not take the medicine which they are prescribed.   Wearable technologies can help to detect when the drug has been taken and remind patients if they have forgotten to take their medicine. Proteus Digital Health (Redwood City, CA) is one such company active in this field).
  • Neuro-stimulation and neuro-modulation – Some of the most exciting advances are those where the wearable is directly stimulating or stimulated by the nervous system to correct, for example, sight problems, induce psychological effects or create a direct effect on the cellular immune system. A few notable companies in this area have made significant advances:
  • Second Sight’s retinal implant picks up a signal from a camera embedded in a pair of glasses worn by the patient, enabling blind people to get obtain partial vision.
  • Bioness’s body-worn neuro-stimulator enables people with partial paralysis to walk again.
  • SetPoint Medical’s device communicates with an implant which stimulates the vagus nerve and is in trials for treatment of autoimmune and inflammatory disorders. This therapy could potentially treat serious, intractable life-changing conditions.
  • Neurovalens is developing an electronic headset which stimulates the brain to suppress appetite and to induce a metabolic change within the body.

In the future we may just see that rather than taking recreational drugs people turn to neurostimulation devices to get their kicks.

Next generation prosthetics and robotics

 Advanced robotic prosthetics, such as replacement limbs, which are controlled directly by the patient, are already in use. These devices fix to the body and are controlled either by interfacing with the nervous system or by picking up muscle movements, which the user learns to control in order to make the prosthesis move.

We can expect to see great advances in this field where much of the innovation to-date has come from defence research, when veterans returning from combat with amputations have needed better prosthetics.

Future vision

Across the spectrum of healthcare, the advance in wearable technology is being driven and enabled by the evolution of technology:

  • miniaturisation
  • greater efficiency in power usage
  • improvements in sensing

Paradoxically, the key area which has to catch up is environmentally-friendly batteries since so many healthcare products are single use disposables, so a high-energy-density, green battery technology would be very valuable.

In such a heavily regulated market there will be many more such hurdles to overcome. However, with the pace of technological advance are we merely undergoing an evolutionary process or is this the beginning of an exciting healthcare revolution?

 

By Dr. Greg Berman, Head of Medical. Kinneir Dufort

Gregory Berman is a biochemist who helps medical companies large and small, to design, develop and introduce new products. Working from the earliest stages of product inception and planning the business benefits that they will deliver, through development and transfer-to-manufacture. He has three decades of experience in medical product development, initially at a start-up biotech company and then working in Design and Development Consulting.   His interests lie in using technology to improve human health in all its forms, whether it is researching the genetics of aging, health and disease, detecting and diagnosing disease earlier or therapy, for example by helping people to take their medications correctly.

Wearable, wireless devices have only just started to make an appearance in the medical arena. For example, the commercial and health promoting opportunity for diagnosis, monitoring and research generated by wearable sensors is immense. Consider that a single Formula 1 car is fitted with up to 300 sensors which, during a single race, will wirelessly transmit around 1.5 billion data samples. Things happen fast in a car revving at 15,000 rpm, however compare this with the average data collected from a patient, even if they are lying in the Intensive Care Unit. Much data collection is still reliant on a nurse making regular patient observations and interventions.

Greg is working with a range of companies to develop wearable medical technologies including diagnostic sensors, drug delivery devices and patient monitoring systems. He sees an exciting future in technology integration which is just starting.