While some industry processes take many years to evolve, it is known that wide-scale events may catalyze a rushed response. Though the benefits of Remote Care have been recognized through the last decades, it has been the outburst of Covid-19 in the late 2019, and the following couple of years, in which the pandemic affected over 200 million patients worldwide, that gave the HealthCare world a significant push towards transferring a vast portion of medical monitoring, and to some extent, even medical treatment, to be conducted at home, from afar, eliminating the need to physically arrive at hospitals and clinics.
In order to obtain this desired cause, the medical devices industry is nowadays undergoing a transformation, from stand-alone devices, with emphasis on usage in hospitals and clinics, to cloud connected medical devices intended for home use, and enabling Remote Patient monitoring, and remote treatment. The global market for IoMT (Internet of Medical Things) medical devices is already showing significant growth and is projected to more than triple itself in five years (From $26.5B in 2021 to $94.2B in 2026).
This journey obliges the device manufacturers to carefully examine medical device "cloudification" solutions with regards to several aspects, which we will look at in this blog.
IoMT vs. IoT
One might argue that there is no difference between IoMT to regular IoT (Internet of Things), however, even though the IoMT has evolved from the IoT domain as a subset, it definitely holds different attributes that have to be taken into consideration. While IoT is, by a significant portion, consumer oriented, consequently characterized with risk-taking differentiating design and user experience, the IoMT industry, by nature, being used for risk-averse medical purposes (either monitoring or treatment) needs to be much more robust & secured, meet much stricter regulatory demands, and is designed for a usage that includes professional medical workforce along-side patients who sometimes value efficiency (like big straight fonts) over hyped design.
As a domain that serves the medical care professionals, it is important for every IoMT solution to be able to support the data formats that are used by the relevant domain. Whereas gathered data may be mere numeric data (telemetry results), it may also be audio files, video files, online streaming, support of meta-data management (e.g., whereabouts of treatments, session management) and even specific protocols or formats such as DICOM for the imaging domain or FHIR.
It is important to analyze as well what would be the scale of data upload (for every transmission- what would be the size, what would be the frequency of transmissions) as those, along with the type of data and the method of storing and querying it highly effect cloud resources utilization, and therefore the derived cloud costs. In some cases the cloud cost to implement a feature may overshadow its benefits so careful analysis is a must.
Quality Regulatory Compliance
Any Connected Care medical devices solution need to meet stringent regulatory criteria by regulation bodies (Such as the FDA for the US, the CE mark for the EU, and more) if the manufacturer wishes to be allowed to sell their products in those huge markets.
An imminent part of meeting those criteria would be building the solution in consistence with relevant quality standards, such as ISO 13485 & ISO 14791.
Regulatory world is, in the parlance of speech, a ‘whole new ball game’ for companies that have yet to encounter it, and even for those who previously have, it would still be wise to remember that meeting the standards on your core domain expertise (achieved in ‘blood, sweat and tears’) is unlike meeting it for a freshly embarked-upon domain, such as cloud and IoMT connectivity.
Adding connectivity to medical devices, let alone integrating the gathered data and derived insights into EHR systems, opens a door for cyber security threats, as any connected end-device is a potential breach. Device manufacturers and health care bodies as their clientele must verify that those doors are well-locked and constantly monitored. As cyber security is an ever-evolving industry, this issue is not a one-off, and domain specific expertise is continuously required.
Privacy Regulatory Compliance
Medical devices, by nature, handle personal medical data (PHI). As such, the devices, and the completing solution of cloud connectivity has to meet strict regulation, whereas different target markets obey different regulations (e.g. HIPAA in US, GDPR in EU). As in the case of quality regulations, privacy regulations offer an ongoing challenge that requires specific expertise for handling, tracking the occasional requirements changes and accommodating for it.
Deriving Actionable Insights out of the Medical Device Data
IoMT can (and does) benefit much more on top of the standard medical devices’ functionality. Having data that previously had been manage separately per patient/device/care provider, securely gathered in a central accessible place (cloud) allows for Big Data benefits for both Health care bodies, device manufacturers, and medical research. As long as the infrastructure and the applicative platform can account for the cyber security and anonymization of the personal data, there is a whole new world of analytical tools that can be applied to datasets on previously unseen scales, and yield breaking through insights. Building those undoubtedly required abilities from scratch is a well worth noticing effort.
Making the leap from stand alone medical devices to connected devices, enabling remote care, is required, as the Healthcare world is already in the midst of this shift.
There are many aspects and challenges to consider when embarking upon this change.
We at BioT take pride at our no-code self-service medical device cloudification platform, designed to meet specifically the opportunities and challenges of the remote care world, based on underlying expertise gained by already connecting dozens of medical device companies to the cloud. We offer an amazing reduction of the time to build an IoMT system, without compromise on your data ownership, along with assuming liability for cyber threats and regulation compliance. And above all, a motivated team that continuously innovates and pushes the frontiers of remote medicine to the future.