Where’s the Clinical Value in Digital Health Devices?

The COVID-19 pandemic, and the resulting global stay-at-home orders, demonstrated the enormous role that technology had to play—from keeping us in contact with our loved ones to connecting us with doctors via our devices through rapidly-deployed telehealth solutions. According to McKinsey, telehealth has surged under COVID-19.

As the heightened risk became clear for those with certain pre-existing conditions—including obesity, high blood pressure, asthma and diabetes—it has also been a wake-up call for many to take greater care of themselves.

Wellness vs healthcare devices

I don’t doubt that this lead many to dig in their bedside cabinets for discarded fitness wearables and other wellness devices in an effort to reclaim agency over their health. But while such devices are fantastic tools in providing reassurance and enabling the tracking of gains over time, there is a very significant distinction to be made between wellness devices and digital health devices with the certified accuracy required to collect clinically interesting data.

When it comes to monitoring their health, consumers don’t need another fitness tracker—they need a digital health device they can use to monitor their health in the knowledge that the data being recorded is medically sound.

Sadly, building a medically sound digital health device is not as easy as it sounds—and much of the inherent complexity comes down to two interwoven factors: stringent regulatory standards and proprietary technology.

It’s traditionally been a whole lot easier to build a wellness device than it is to build a certifiable digital health device suitable for use in both home and professional healthcare environments.

Stringent standards and proprietary technology impede innovation

Within the healthcare industry, any instrument, machine, implant and in vitro diagnostic product (IVD) used in the diagnosis, prevention and treatment of diseases or other medical conditions is held to the most stringent standards. That applies to hospital-based digital health devices but also to any digital health device intended for home use provided to a patient by a medical professional. 

The approvals process to take a medical-grade digital health device into the mass market presents a high barrier and approvals are also region-specific which adds to complexity and costs.

A key issue with many digital health devices is that the way they communicate to the cloud and present their data to the clinician is often proprietary. To date, many digital health solutions on the market use proprietary software in the device, cloud and app.

As a result, they rarely interface into clinical medical records or provide triage of normal and abnormal readings. Those that can be implemented on a technology level may still present an unnecessary learning curve. Telehealth may have become much more commonplace this year, but the fact remains that should a doctor wish to use data collected by a digital health device during a consultation, they would need to learn whatever proprietary interface that device comes with.

Furthermore, digital health devices may use any combination of Bluetooth, Wi-Fi and cellular to deliver data. These communication interfaces create sufficient complexity in communications, security and file systems. In many cases, digital health device manufacturers lack confidence when adding such connectivity to products due to data and security areas they are unfamiliar with. 

The solution? A platform approach

The key issue here is that digital health devices are still being built from the ground up using proprietary technology, with software instructions executed directly on hardware—what we call bare-metal programming. This leaves little to no room for standardisation between devices.

By enabling device manufacturers to move from bare-metal programming to building upon established embedded platforms and operating systems such as Arm Mbed, we can ensure that the devices they build are inherently trusted, secure and unified in their communication of data.

Arm has been part of the mobile phone industry for 30 years, where platforms, standards and architectural choice has fuelled innovation and driven down costs. The consumer medical industry is now adopting the same approach, ensuring that new digital health devices are far more easily implemented into both a home and professional healthcare environment.

A platform approach means it’s also far easier, quicker and cheaper to build a digital health device—be it a consumer wearable or something designed only for clinical use. But it’s also vital in expediting the approvals processes associated with enabling new digital health devices and their data to be used by medical professionals.

Jumping the regulation hurdle with cloud

Companies such as Cambridge-based L2S2 are working with Arm to offer compliant reference hardware and firmware designs based on Arm Mbed. These enable device manufacturers to build digital health devices that are compliant with L2S2’s Managed Medical Device Cloud (MMDC), a cloud data platform that aggregates medical data from a range of home digital health devices without the need for those devices to have been certified or accredited by each medical facility.

It’s this kind of joined-up thinking that will enable a new wave of digital health devices. By choosing the right OS, device management solution and health data platform, digital health device manufacturers can enable rapid development and integration.

Perhaps the world of digital health technology is finally getting close to the holy grail of consumer-friendly and digitally-enabled medical devices in which patient data is more secure, no longer siloed and innovation can keep pace with patient needs and outperform the highest regulatory challenges. It’s that which we need if we want to see real benefit in fighting viruses such as COVID-19 using home digital health devices.