Wearable Medical Device

A Wearable Medical Device is a wearable device that is a medical device.

• AKA: Wearable Biosensor.
• Context:
  • It can support Remote Patient Monitoring.
  • It can range from being a Consumer-Grade Wearable Medical Device to being a Clinical-Grade Wearable Device.
  • ...
• Example(s):
  • a Personal Fitness Tracker.
  • a Brain-Sensing Headband.
  • a Medical Skin Patch.
  • a Smartphone (that is mostly carried on the body).
  • a wearable Heart Rate Sensor such as: a CardioMem Heart Sensor.
  • a wearable Glucose Sensor such as: a Dexcom Glucose Monitor.
  • a wearable Blood Pressure Sensor such as: a iHealth Blood Pressure Monitor.
  • ...
• Counter-Example(s):
  • a Portable Medical Device, such as a Portable Blood Pressure Monitor.
  • a Laptop Computer.
• See: Decentralized Clinical Trial, Telemedicine, Digital Medicine, mHealth, Telehealth.

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References

2021a

• (Bayoumy et al., 2021) ⇒ Karim Bayoumy, Mohammed Gaber, Abdallah Elshafeey, Omar Mhaimeed, Elizabeth H. Dineen, Francoise A. Marvel, Seth S. Martin, Evan D. Muse, Mintu P. Turakhia, Khaldoun G. Tarakji, Mohamed B. Elshazly (2021). "Smart wearable devices in cardiovascular care: where we are and how to move forward". In: Nature Reviews Cardiology, 18.
  • QUOTE: Technological innovations reach deeply into our daily lives and an emerging trend supports the use of commercial smart wearable devices to manage health. In the era of remote, decentralized and increasingly personalized patient care, catalysed by the COVID-19 pandemic, the cardiovascular community must familiarize itself with the wearable technologies on the market and their wide range of clinical applications

2021b

• (FDA, 2021) ⇒ Remote or Wearable Patient Monitoring Devices EUAs. Last Updated: 07/15/2021
  • QUOTE: Remote or wearable patient monitoring devices include (1) non-invasive remote monitoring devices that measure or detect common physiological parameters and, (2) non-invasive monitoring devices that wirelessly transmit patient information to their health care provider or other monitoring entity. The FDA has issued EUAs for certain remote or wearable patient monitoring devices to help increase the availability of monitoring and treatment of patients and to help address reduction of healthcare provider exposure to SARS-CoV-2 during the COVID-19 pandemic.

2018a

• (Byrom et al., 2018) ⇒ Bill Byrom, Marie McCarthy, Peter Schueler, and Willie Muehlhausen (2018). "Brain Monitoring Devices in Neuroscience Clinical Research: The Potential of Remote Monitoring Using Sensors, Wearables, and Mobile Devices". In: ASCPT - Clinical Pharmacology & Therapeutics, 104(1), 59-71.
  • QUOTE: A sensor is a device or device component that detects and measures physical or chemical information from a surrounding physical environment, and translates this into an electrical output signal. Microsensors are miniature sensors that have electrical and mechanical operation components, also termed microelectromechanical systems (MEMS). These are usually produced by integrated circuit manufacturing from silicon or similar materials. A wearable device contains one or more sensors that are integrated into clothing or other accessories that can be worn on the body, such as on a wrist band, belt, headband, adhesive patch, contact lens, or glasses. In the context of brain monitoring, a wearable device may be, for example, a forehead headband containing sensors able to measure EEG signals associated with the frontal cortex. The use of reliable, high-performance microsensors in the area of medicine is of growing importance for patient health monitoring, personal wellness, and clinical research.

2018b

• (Noah, 2018) ⇒ Benjamin Noah, Michelle S. Keller, Sasan Mosadeghi, Libby Stein, Sunny Johl, Sean Delshad, Vartan C. Tashjian, Daniel Lew, James T. Kwan, Alma Jusufagic, and Brennan M. R. Spiegel (2018). "Impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials". In: npj Digital Medicine. DOI:h10.1038/s41746-017-0002-4.
  • QUOTE: Wearable biosensors are non-invasive devices used to acquire, transmit, process, store, and retrieve health-related data (Andreu-Perez et al., 2015). Biosensors have been integrated into a variety of platforms, including watches, wristbands, skin patches, shoes, belts, textiles, and smartphones (Ajami & Teimouri, 2015; Steinhubl et al.,2016). Patients have the option to share data obtained by biosensors with their providers or social networks to support clinical treatment decisions and disease self-management (Pevnick et al., 2016).

2018c

• (Yetisen et al., 2018) ⇒ Ali K. Yetisen, Juan Leonardo Martinez-Hurtado, Baris Unal, Ali Khademhosseini, and Haider Butt (2018). "Wearables in Medicine". In: Advanced Materials, 30(33), 1706910. DOI: 10.1002/adma.201706910
  • QUOTE: In combination with value-based healthcare systems through telehealth, wearable devices can enable monitoring at risk patients, intervening diseases at an earlier stage, and reducing healthcare expenditures by means of prediction and prevention of disease. These wearable technologies include smartwatches, wristbands, hearing aids, electronic/optical tattoos, head-mounted displays, subcutaneous sensors, electronic footwear, and electronic textiles (Figure 1a). They can be conformably placed on the epidermis, inserted through the skin or body orifices for measuring electrophysiological or biochemical signals, and delivering drugs. Such technologies when incorporated in garments, accessories, or epidermal surface to provide electronic alerts, sense physical and biochemical information, or deliver drugs are broadly called medical wearables.

Figure 1: Wearables devices for medical applications. a) Wearable devices (in vitro) have loose or conformal contact with the skin, or worn/inserted through body orifices. The most common interface is loose skin contact wearables, which measure electrophysiological signal via optics and electrodes. b) Information transfer from wearables. The data collected from wearable devices can be transmitted to the Internet or other devices via a body area network, Bluetooth, Wi-Fi, LTE, 3G, 4G, or 5G connection. The medical data can be sent to a healthcare provider to receive therapeutic feedback or acted upon automatically by other devices in the network.

2017

• (Izmailova et al., 2017) ⇒ Elena S. Izmailova, John A. Wagner, and Eric D. Perakslis (2017) . "Wearable Devices in Clinical Trials: Hype and Hypothesis". DOI: 10.1002/cpt.966. In: ASCPT - Clinical Pharmology & Therapeutics.
  • QUOTE: For remote monitoring of cardiovascular parameters, activity (including gait, balance, and many other forms of motion measurement), body temperature, galvanic skin response, blood oxygen saturation, and multisensor/multisystem monitoring (Majumder et al., 2017), advanced wearable device research and development is continuously improving. Common form factors include wearable watches/bracelets, patches, textiles, and garments (Table 1). All of these sensor devices are being built with the ability to monitor continuously and communicate data in real time or intermittently. While maturity, promise, and quality all vary greatly at the moment, clearly these sensors and devices have the potential to become an integral part of the future of healthcare and biopharmaceutical development.

Table 1: Examples of wearable sensors.

Device type	Data collected	Examples
Wrist worn	Actigraphy, HR (Heart Rate), BP (Blood Pressure), EDA (Electrodermal activity)	Actiwatch Spectrum by Phillips, ActiGraph Link by ActiGraph, E4 by Empatica, ViSi Mobile by Sotera Wireless
Skin patch	ECG (Electrocardiography), actigraphy, skin temperature	BioStampRC by MC10, HealthPatch by Vital Connect, BodyGuardian by Preventice
Cuffs	BP, HR	Intellisense Digital BP Monitor by Omron Healthcare
Finger worn	HR, SpO2	iSpO2 Pulse Oximeter by Massimo
Clothing embedded sensors	HR, HRV (Heart Rate Variability), ECG, Breathing Rate, actigraphy	Smart shirts by Hexoskin
Headbands	EEG (Electroencephalogram), EMG (Electromyography)	EMOTIV EPOC by Emotiv, 4D FORCE by 4D FORCE

2016

• (Steinhubl et al., 2016) ⇒ Steven R. Steinhubl, Evan D. Muse, and Eric J. Topo (2016). "The Emerging Field of Mobile Health". In: Science Translational Medicine, 7(283).
  • QUOTE: These extraordinary advancements in mobile computer technology and connectivity have already transformed nearly every aspect of our lives: finance, travel, entertainment, education, and, of course, communications. However, only now are mobile health (mHealth) technologies making initial inroads into health care and, in so doing, are providing the foundation to radically transform the practice and reach of medical research and care. Through progressively miniaturized and increasingly powerful mobile computing capabilities, individuals are becoming increasingly capable of monitoring, tracking, and transmitting health metrics continuously and in real time. This metamorphosis has provided the potential for acute disease diagnosis and chronic condition management to take place outside the standard doctor’s office or hospital (Fig. 1).

2015a

• (Ajami & Teimouri, 2015) ⇒ Sima Ajami, and Fotooheh Teimouri (2015). "Features and Application of Wearable Biosensors in Medical Care". In: Journal of Research in Medical Sciences.
  • QUOTE: Wearable technology may provide an integral part of the solution for providing health care to a growing world population that will be strained by a ballooning aging population. By providing a means to conduct telemedicine — the monitoring, recording, and transmission of physiological signals from outside of the hospital — wearable technology solutions could ease the burden on healthcare personnel and use hospital space for more emergent or responsive care. In addition, employing wearable technology in professions where workers are exposed to dangers or hazards could help save their lives and protect health care personnel.

2015b

• (Andreu-Perez et al., 2015) ⇒ Javier Andreu-Perez, Daniel R. Leff, H. M. D. Ip, and Guang-Zhong Yang (2015)." From Wearable Sensors to Smart Implants--Toward Pervasive and Personalized Healthcare. In: IEEE Transactions on Biomedical Engineering (Volume: 62, Issue: 12). DOI: 10.1109/TBME.2015.2422751.
  • QUOTE: This paper discusses the evolution of pervasive healthcare from its inception for activity recognition using wearable sensors to the future of sensing implant deployment and data processing.

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