Part 1 of a 5 Part Blog Series on | "Advancing Public Health with Wearables; Strategic Development of IoMT Biosensing Lifestyle Devices"

Home healthcare is an industry that has seen rapid growth in the past decade, with consumers taking more interest now than ever in understanding, maintaining, and improving their health and wellbeing. More recently, the outbreak and response to COVID-19 generated an outpouring of demand for telemedicine and telediagnostic solutions for simpler, faster, lower-risk medical treatment. Internet of Medical Things (IoMT) technology has opened endless opportunities for serving these needs, with Wearable IoMT Biosensing Lifestyle Devices now allowing critical biometric data to be collected in real-time, even outside medical facilities. Networked with smartphone and cloud-based apps, these physiological and bio-sensing smart devices continuously measure and record essential metrics and essential contextual information, all of which are then made easily accessible to users and medical providers. 

These devices have proven to be of great value as a class, and their prevalence continues to grow, with many developers now looking to commercialize wearables of their own. Yet, due to their unique components and related intricacies, actually doing so may prove more complicated than with your average medical product. Achieving success requires a clear understanding of these devices, their intended uses, and the processes necessary to make them both safe and maximally beneficial to users.

Use Cases and Benefits

Due to their versatile functionality, IoMT wearables are well-suited to serve a diverse range of medical purposes. For example, they are regularly used to manage chronic diseases and, more generally, cases that require ongoing monitoring of health metrics such as heart rate, blood pressure, temperature, and blood oxygenation, even when away from medical facilities. In the management of diabetes, they may be used to perform Continuous Glucose Monitoring (CGM), triggering insulin injections via pump when necessary. For patients with Parkinson's disease, constant data collection regarding symptom severity and progression can prevent extended hospital stays previously required for observation. Wearables may also be deployed to treat conditions such as depression, with the collection and analysis of data such as heart rate and blood pressure allowing for inferences towards the patient's mental state.

Beyond disease management, pharmaceutical companies may utilize wearable devices during clinical trials to more thoroughly and accurately assess the impact of medications on patients, both supporting a more personalized approach to medicine while also accelerating clinical testing periods. They are also employed in the performance of remote diagnostics, i.e., telediagnostics, increasingly so with the advent of COVID-19.

As these examples illustrate, IoMT wearables can be found across the medical industry and produce both immediate and long-term benefits for concerned stakeholders of all classes, providing service-centric solutions that address patient, provider, and payer needs while improving quality of treatment and expanding opportunities in data collection and analysis. These devices create new avenues of engaging and empowering patients, supporting personalized medical care that accelerates recovery times, prevents re-hospitalization, and improves outcomes overall. In treatment scenarios, continuous monitoring through an IoMT wearable can accelerate feedback loops and mitigate latency and gaps between measurement and treatment that often occur when the interaction is done exclusively in the office. Meanwhile, they offer the ability to gather diagnostics outside of clinical settings and do so while still receiving clinical-grade results.

Over time, these diagnostics create longitudinal datasets paired with previously unavailable contextual information to uncover critical insights and support enhanced, more informed decision-making with the mining, management, and analysis of a population of patient data de-identified per HIPAA standards.

FDA-Defined Categories of Medical Wearables

With technology continuing to advance, potential applications are increasing, and device designs improving, IoMT wearables are seeing widespread and growing adoption within strict clinical frameworks and outside of them. You are likely already familiar with a device or two that offers collection and analysis of biometric data without providing medical advice or being tied to a healthcare provider. This points to the first nuance of understanding wearables; within the class, devices may fall into two general subcategories from a regulatory perspective. When looking to create and commercialize a wearable device, developers first and foremost must be able to identify whether their device should be classified under the first category, Consumer Health Wearables, or the second, Clinical Grade Wearables. Doing so will determine whether or not the device will be subject to regulatory standards and significantly shift how commercialization is approached from a technical perspective.

Consumer Health Wearables, or Wellness Devices, and their related apps are used to manage general wellness and fitness, such as smartwatches, sports bands, and activity trackers. They do not offer clinical determinations of health and typically are not used in collaboration with a medical professional. Instead, they provide data for users to stay informed and self-direct towards enhancing the quality of life and achieving wellness goals. These devices are not subject to FDA regulation.

Meanwhile, Clinical Grade Wearables and their related apps are devices used in conjunction with expert advice from healthcare professionals. Unlike the former category, these do aid in making clinical determinations of health by completing all necessary data available to the provider, who may then make evaluations and prescribe treatments. These must be certified or approved for use by regulatory agencies like the FDA or ISO.

To address the rapidly expanding consumer medical market, the FDA issued a guidance document in July of 2016 entitled "General Wellness: Policy for Low-Risk Devices" to clearly outline the features that classify wellness devices and how they should be handled from a regulatory perspective. Within this document, the FDA defines General Wellness Products as those meeting two criteria:

1) It is intended for general wellness use only.

2) Presents a low risk to the safety of users and other individuals.

It goes on to delineate accepted intended uses, of which there are two:

1) Use relating to maintaining or encouraging a general state of health or healthy activity.

2) Use relating to the role of a healthy lifestyle in reducing the risks associated with certain chronic diseases and conditions.

This document also clarifies that the FDA will not regulate general wellness products like consumer health wearables— so long as these devices and their distributors do not make claims concerning disease prevention, treatment, mitigation, or cure. All claims must relate to sustaining or improving general wellbeing rather than specific medical conditions.

Heading Towards Commercialization

With such initial concerns addressed, moving into development itself is a question of understanding and selecting the parts that will provide a device with its desired capabilities. In the case of wearable devices, the chosen sensor technology will heavily influence their eventual functionality. Narrowing down and eventually selecting the proper sensor modality requires an understanding of time-related to clinical decision making. More simply, developers must determine whether the data provided by a device will be most helpful to providers if delivered short-term (daily/weekly), mid-term (monthly/quarterly), or long-term (yearly/lifetime). 

In short-term delivery, physiological sensors are most often used, acquiring data in real-time, continuously, and non-intrusively. Meanwhile, mid-term applications typically employ biosensors, which collect data periodically to detect biomarkers in biological body samples. Some devices do so with minimally invasive techniques, while others are entirely non-invasive. In these cases, discrete periodic measurement of data is the preferred mode.

Despite their rapid surge in popularity, medical solutions tied to mobile and cloud-based applications are still relatively recent and underexplored, bringing with them a set of intricacies unseen in other classes. Because of this, the path to commercializing a wearable IoMT biosensing lifestyle device can be both daunting and challenging for those inexperienced in their development. Fortunately, MIDI's Innovation Roadmap™ provides a clear guide to bringing these devices to market utilizing the DevelopmentDNA™ approach, in which MIDI's team of engineers and usability experts tied to industrial designers work with clients to address the functional, lifestyle, cost-to-manufacturer, safety, and business requirements that must be met to produce the best device possible. This "golden standard approach" (as termed by CEO Christopher Montalbano) is then followed up with execution performed in a rapid, AGILE product development fashion under the MIDI Quality-First™ umbrella, carrying wearable devices from the drawing board and into the hands of patients and providers in need.

Stay tuned for the next part of this MIDI Innovation Roadmap™ series, in which we will further explore the nuance of wearable development, examining biosensors and physiological sensors and defining the characteristics which distinguish them.