What are the challenges facing companies developing wearable technologies?
A wearable medical device is a piece of equipment that is attached to the body that detects and monitors changes in specific physiological or biochemical measurables. We are seeing rapid growth in the wearables marketplace and this excitement is spurring application development across the breadth of industry and most noticeably in the medical technology market.
There are many considerations to take into account when entering this market including technology advancement, integration and consumer (or patient) adoption.
How do you categorise a wearable medical device?
Wearable medical devices can be divided into two categories; Diagnostic and Therapeutic. Diagnostic devices include vital signs monitors, foetal and obstetric devices and neuro-monitoring. Therapeutic devices include those developed for pain management, glucose/insulin monitoring, respiratory therapy, sports and fitness applications, remote patient monitoring and home healthcare. All these devices are designed to monitor and collect real-time health information by monitoring changes in biometrics in order to predict the state of health, monitor wellbeing or even prevent injury and illness.
Devices can be invasive (penetrating the skin/body) or non-invasive (attached to the skin using sensors or sufficiently local to the biometric to be measured); both come with complications and both must comply with strict medical regulations.
What software will you need for wearable technologies and what are the challenges
Developers face a number of challenges. A common aim of designing wearable devices is to make the device as small as possible. This tends to lead to highly integrated ‘system-on-chip’ solutions and it can be challenging to develop such systems for products with modest sales volumes rather than the high sales volumes of the mobile phone market.
The hardware and software need to operate at a consistently high standard; this is a critical issue if the user’s health is dependent on the device for real-time monitoring of a medical condition. Although healthcare ‘apps’ are now beginning to emerge for the standard mobile platforms (iOS, Android, Windows) there is little standardisation for application programming interfaces. For higher risk devices that monitor and control vital physiological functions real-time operating system are available but may come with a much higher development cost.
Finally, you also need to consider the sensitivity of the data that these devices will be creating, developers must tackle crucial issues such as security and privacy.
Does your solution need to be wireless
Wireless enables freedom for the user in a number of ways. Firstly it enables reporting of results to a smartphone or base station, and that in turn enables remote data gathering and/or decision making. Secondly, powering or charging wearable technology is key to making it seamlessly integrate with lifestyle. Emerging wireless technology could allow contactless charging for wearable devices as opposed to the inconvenience of removing the device and charging in a stationary power source. Energy harvesting through movement or thermal energy would also remove this inconvenience, however this is dependent on the type of application, the power requirements for the device and the capability of the user.
What materials should you consider?
The interface between the wearable and the human skin is an important challenge to overcome during the early product development stages and not at the last minute pre-manufacture. Considering aspects such as common skin allergens and irritants when selecting materials, and therefore selecting only materials of high quality or medical grade, is key. Additionally early consideration of practical usability factors will give the best outcome, such as shape and size, how to ensure that the skin in contact with the device remains healthy, which elements should be disposable and which cleanable and attachment / reattachment practice. Furthermore devices that must operate on wet and dry skin and in wet conditions will require the correct IP rating. Ensuring that these things are taken into consideration early in development will reduce risk within the programme and maximise the chances of successful adoption in the market place.
Adhering to regulatory bodies.
The single largest challenge facing wearable medical device development is compliance with regulatory guidelines. There are well established guidelines for bringing medical devices to market (the MDD). Non-invasive devices that are classed as medical wearable technology (with, of course, clear medical claims) must be approved by the appropriate regulatory authority in the same way that all medical devices must comply.