There are many areas of life where advances in technology have created opportunities.
Wearable healthcare technology is one area which is still emerging, but which has promising outcomes for patient-led care. Consumer electronics like smartphone apps, smart watches and Fitbits are paving the way for continual monitoring of daily activities to prevent health problems - but how does technology like this shift from being about wellness to having certified medical device status?
The rise of smart devices
In 2018, Accenture reported an increase in the use of wearable medical devices from 9% to 33% over the course of four years.  This figure is expected to keep growing, with Research and Markets predicting that sales of these devices will surpass $60 billion in five years’ time.  There are numerous potential functions these devices can perform, from monitoring the number of steps taken in a day to measure heart rate, sleeping patterns and blood pressure.
The benefit of these wearable devices is that it allows healthcare professionals to continually measure patient’s vitals and collect ongoing accurate data to provide greater insight into their condition. This is particularly useful for patients who live remotely or who are less mobile.
The potential within healthcare
The availability of this kind of technology provides a huge amount of potential for the future of healthcare. This is particularly prevalent in the present day when the healthcare sector faces numerous challenges such as high costs, greater demand and an increasing number of chronic illnesses. Not to mention juggling these ongoing challenges with the presence of the COVID-19 pandemic, a highly contagious disease which at present has no vaccine yet. 
Under these circumstances, having wearable devices available helps to navigate ongoing patient care and might reduce the number of check up appointments needed, allowing the patients to take more control over their own care. While this is an exciting step forward, there are limitations to consider - a crucial one being developing a device which is user friendly.
This goes beyond making it a pleasant user experience - as there are many factors that need to be considered here. The first being ensuring that the device is accessible and usable for patients who might not be digitally proficient. Device developers need to ensure that clear instructions are given to users or that sufficient help is provided to guide them through using their wearable device properly. Patient buy-in is also crucial to the success of these devices, as doctors and healthcare professionals cannot get quality data if the patient isn’t using the device.
In order for this type of technology to make a real difference, these devices need to bridge the gap between consumer electronics to regulated medical devices.
Regulatory compliance for wearable devices
At the moment, you can easily purchase an Apple Watch, Fitbit or install a health app onto your smartphone and use it as and when you please. While these devices and apps are useful from a wellness perspective, they don’t fall under the same scrutiny as a certified medical device.
In order to be certified as a medical device, a wearable device would need to conform to FDA (Food and Drug Administration) and EMA (European Medicines Agency) regulations. This includes adhering to the relevant industry standards such as:
- FDA’s 21 CFR 820 and Part 11
- ISO 13485
- ISO 14971
- EU MDR (replacing the Medical Device Directive (MDD) in May 2021)
A big part of fulfilling the requirements of these standards is having an established quality management system in place.
Quality management software
Quality management software provides an efficient, centralised system for compliance and quality activities. It goes beyond acting as a box ticking exercise and encourages continual improvement of your organisational processes, ensuring quality is at the forefront of everything you do. This is crucial in the development of medical devices as it helps to manage risk activities and pinpoint any potential problems early in the process.
Our quality management software, Q-Pulse, is a staple of over 200 life science organisation’s processes. It reduces the time spent on compliance activities and centralises key business data to make day to day tasks easier.
 Accucentre, ‘Accenture Study Finds Growing Demand for Digital Health Services Revolutionizing Delivery Models: Patients, Doctors + Machines’: https://newsroom.accenture.com/news/accenture-study-finds-growing-demand-for-digital-health-services-revolutionizing-delivery-models-patients-doctors-machines.htm
 Cision, ‘World Market for Wearable Devices, Set to Reach $62.82 Billion by 2025 - Increasing Penetration of IoT & Related Devices Drives Market Growth’: https://www.prnewswire.com/news-releases/world-market-for-wearable-devices-set-to-reach-62-82-billion-by-2025---increasing-penetration-of-iot--related-devices-drives-market-growth-300974593.html
 Research Gate, ‘Wearable Healthcare Technology - The Regulatory Perspective’: https://www.researchgate.net/publication/307476439_Wearable_Healthcare_Technology_-_The_Regulatory_Perspective