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The internet of things (IoT) is a blanket term used to describe the billions of connected objects and devices around the world that exchange information with other objects, devices, and systems via the internet.
Under this broad canopy resides a rapidly growing subset of IoT—the internet of medical things (IoMT). The internet of medical things includes all the IoT devices used in healthcare, and its application is already widespread within the healthcare industry. One study from Deloitte predicts that the IoMT market will reach $158 billion by 2022.
Given it’s ubiquity in healthcare settings, it’s worthwhile for anyone working in the medical device industry to understand the uses, benefits, and challenges of IoMT today.
The internet of medical things is a network of medical devices, software as or in medical devices, and hardware infrastructure, all of which are connected and can communicate via the internet.
In practice, this often means the monitoring and sharing of patient data to improve healthcare outcomes. By transmitting data over a secure network, IoMT devices can connect patients and providers in real time, offering remote monitoring of conditions and more information for physicians to use in diagnosis and treatment.
Though IoMT includes a diverse array of medical devices, it’s possible to place them in four broad categories:
Let’s examine each these four IoMT categories in more detail:
Wearable IoMT encompasses two segments of devices, consumer health wearables and clinical-grade wearables.
Consumer health wearables (a type of wearable technology) include fitness trackers and bands like the Apple Watch, Whoop, and Fitbit. These devices are not generally regulated by FDA, but studies have shown that they can be used for specific healthcare applications like detecting irregular heartbeats.
Clinical-grade wearables, on the other hand, are regulated devices and support systems that have been approved for specific health applications. For example, the Sparrow System is a wearable device used to mitigate the symptoms of opioid withdrawal, and must be prescribed by a doctor.
The use of IoMT within hospitals is often related to logistics and management. Applications in this area include:
Asset management (such as wheelchairs, infusion pumps, and other high-demand assets)
Patient flow management
Environmental management (e.g. monitoring and adjusting temperature, humidity, and lighting to optimize conditions in different rooms)
IoMT devices intended for use within a patient’s home are generally used for remote patient monitoring (RPM) of chronic conditions, personal emergency response, or telehealth visits. The applications of in-home IoMT here are enormous, as they have the potential to improve the management of chronic conditions, cut costs for patients and providers, and prevent unnecessary travel and hospitalizations.
Community IoMT refers to a network of devices and systems exchanging information throughout a specific geographic area, such as a city or county.
Some of the uses for IoMT in this setting are tracking and monitoring of patients while in emergency vehicles, managing the transport and supply of medical equipment, and enabling remote patient services in field hospitals or drug-dispensing kiosks.
One of the most promising aspects of IoMT is remote patient monitoring. Patients with chronic illnesses, or those at risk of acute conditions, often have little insight into the status of their condition.
A trip to the doctor’s office or hospital can provide an update, but these are relatively rare moments in time that offer only single data points. Even worse, easy access to healthcare providers is not a given for socioeconomically disadvantaged people.
The IoMT creates a regular, often continuous, flow of data from patients to providers that helps lead to better outcomes, such as:
Earlier interventions - Chronic health conditions like diabetes and heart disease account for the majority of healthcare spending in the US. Early diagnoses and treatments—before conditions require hospitalization, for instance—help patients by avoiding poor outcomes and higher healthcare expenses.
More accurate diagnoses - A data set that extends over the course of weeks can be invaluable to healthcare providers. It’s easier to detect and analyze patterns with a full data set than to use information from a handful of visits over the course of the past year, for instance. With more and better data, doctors can diagnose conditions faster and prescribe the best available treatment plan for that patient.
Reduced healthcare burden - Patients aren’t the only ones who benefit from early intervention. There are a finite number of doctors, nurses, and hospital beds in any healthcare system. Studies have found that RPM technology can dramatically reduce hospitalizations, easing the burden on the healthcare system in a community.
However, none of these benefits come without significant challenges. The successful implementation of IoMT is dependent on facing and overcoming critical issues surrounding cybersecurity.
Healthcare is one of the most targeted industries for cyberattacks, and the results can be devastating. When Britain’s National Health Service was hit by a ransomware attack in 2017, procedures were canceled, care was delayed, and some records were impossible to access.
This points to the critical issue facing IoMT: currently, there is a tradeoff between security and accessibility. And security issues are coming not just from the new wave of connected devices hitting the market, but older, more vulnerable medical devices that were not built with the security features they need to be protected in today’s digital age.
All of this creates an atmosphere of uncertainty for medical device manufacturers. What sort of liability do they face if their connected devices are compromised by bad actors? What responsibility do they have when it comes to interoperable devices and the software that runs them?
The answers are still being developed by regulatory bodies and legislatures around the world, but the best place to start is with the guidance FDA has issued for premarket and postmarket cybersecurity.
While these documents are technically guidance—rather than requirements—they offer the FDA’s current interpretation of its medical device quality system regulations in light of cybersecurity concerns.
Medical device manufacturers looking to build the safest, most effective interoperable devices will need to continuously monitor the issue of regulatory and legal requirements and follow all cybersecurity best practices regarding IoMT as they develop.
The internet of medical things is growing at a rapid pace. The regulations surrounding security, accessibility, and the design, development, and postmarket monitoring of these devices will certainly be updated in the coming years.
At Greenlight Guru, we built our QMS software specifically for medical device companies because we know how complex this industry is. Our eQMS has the latest ISO and FDA best practices built into every feature, and we continually update it as new regulations and guidance are issued.
Get peace of mind knowing that you’re taking a proactive approach to quality and compliance with Greenlight Guru. Get your free demo of our QMS software today.
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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...