Author: Daniel Pyne
By connecting our senses to sensors, wearable technology has made a quantum leap, unlocking numerous opportunities across multiple industry verticals.
Continuing evolution in wearable technology is paving the way for the emergence of advanced devices in the field of communication and navigation. Perhaps, the greatest potential of wearable technology exists in the healthcare sector. Wearable healthcare technology is gaining widespread popularity, primarily owing to its ease of use and flexibility.
People have turned to wearable devices that effectively monitor the functioning of their vitals, helping them avoid daily visits to their physician.
Improving the Medical “Root Cause Analysis”
Traditionally, body-borne computing devices are apt for medical diagnostic purposes. Conventional ways of checking blood pressure and blood sugar required complex, invasive procedures, the results of which were not available instantly. Popular medical wearables available in today’s market have replaced these procedures to an extent as end-users show a marked affinity towards non-invasive procedures and real-time results.
As they reduce the need for physically visiting doctors for common diagnostic procedures, medical wearables will also witness higher adoption at diagnostic centers, specialty clinics, and pathology labs. Wearables designed for improving self-management abilities are also becoming key diagnostic instruments for physicians. Recorded data from such devices is transferred electronically, and the doctor can assess important incidences.
The device and its mobile app may show data on erratic changes in body temperatures during a specific time – and this data can help physicians detect the root cause of such recurring instabilities. Patients can reveal activities they engage in, or the foods they consumed during this period, which could further help the doctor to recommend some prohibitions. Traditional measures to detect the cause of temperature fluxes failed to identify incidences that triggered such fluctuations, but real-time monitoring in wearable medical devices has eliminated this hindrance altogether.
Wearable sensors for remote healthcare monitoring systems are being developed to improve the accuracy of clinical assessment. Wearables equipped with electrocardiograph (EKG) sensors can monitor the patient’s heart activity by sensing multiple physiological signals. Similar to the EKG sensors, manufacturers of wearable medical devices are also focusing towards the development of breathing sensors to monitor respiration and blood pressure (BP) sensors to register critical changes in blood pressure. Some devices are also equipped with complex sensors such as the electromyogram (EMG) sensor that records muscle activity or the electroencephalogram (EEG) sensor that monitors electrical stimulations within the user’s brain.
Wearable medical devices that can offer such critical monitoring procedures effectively can put an end to a wide range of existing medical monitoring systems and products. In addition, the adoption of these medical wearables will further supplement a physician’s ability to denote the health monitoring of a remotely located user. Connectivity functions are preloaded in every wearable medical device available in the market.
Some advanced medical wearables also facilitate cloud connectivity. This means that any crucial irregularities in the user’s health will be informed to all concerned medical practitioners treating the user, and will also update existing electronic medical records through cloud-based accessibility. Eventually, doctors will be comforted by growing accuracy of remote monitoring offered through wearable medical devices and will formulate their therapy by thoroughly relying on the data recorded through these devices.
Healthcare Wearables – the Regulatory Perspective
The transformative potential of wearable medical devices is no longer restrained to medical treatments and healthcare services as these devices are managing to swiftly navigate the interlaced and intricate regulatory approval framework of the FDA. The administrating body’s announcement of smart regulation that directs more oversight towards high-risk technologies is a promising development in the advantage of large players who want to develop a universal platform for wearable medical technology.
Wearable technology is also crossing the boundary from consumer electronics devices to regulated medical devices. A clinically-focused evolution of healthcare wearables, however, is irking the FDA authorities who are concerned more about the potential problems caused to consumers, rather than the security of these wearable devices.
Wearable medical devices associated with fitness apps, diabetes management or similar medical intentions are steering clear of the FDA crossroads, while the ones that record critical data for medical treatment are being meticulously reviewed. Abbott Diabetes Care Inc. developed the FreeStyle Libre Flash Glucose Monitoring System, a wearable arm patch for diabetes self-management. Initially, the product was distributed in certain regions of Europe, awaiting approval from the FDA. Later, the U.S.-based administrative body reviewed the product’s premarketing approval application, and gave the approval, albeit, with some conditions for beginning commercial distribution in the U.S. and other parts of the world.
From a medical standpoint, wearable technology offers promising transformation for the healthcare industry, particularly as patient care devices.
In the long run, healthcare wearables will be observed as an evolving product segment in the global industry of medical devices, which is presently on the cusp of rapid innovation. Cost of regulatory compliance may get lowered, creating a stable ground for manufacturers of wearable medical devices.
These product developers, along with regulators and healthcare service providers, must embrace the potential of wearable technology in improving the conveyance of care to patients.
About the Author
Sabysachi Ghosh is Senior Consultant – Healthcare & Medical Devices at Future Market Insights. He is the author of the report Wearable Medical Devices Market: Global Industry Analysis and Opportunity Assessment, 2016-2026.