The Case for Wireless Medical Devices

Wireless medical devices represent one of the fastest-growing niches of the IoT market. Here’s how and why you should get in on the humanity-improving movement.

For the Love of Life

To paraphrase the famous movie line... Medicine, engineering, business are all noble pursuits necessary to sustain life, but love is what we stay alive for. The most enduring of our motives, love drives us to innovate.

The application of IoT in healthcare is also driven by our need to deliver good medical management to the people we love - improving their quality of life and providing peace of mind for those of us at the periphery of their ailments and upset.

Such is this universal and hardwired motivation that the WHO launched its Triple Billion vision, which aims to see by the end of next year one billion more people enjoying better health and wellbeing, one billion receiving the health services they need without experiencing financial hardship, and one billion more people better protected from health emergencies.

Sadly, the COVID-19 pandemic has threatened to reverse much of the progress made in recent years to achieve this noble goal, revealing huge disparities in the levels of care made available to suffering communities across the world.

The WHO’s 2021 World Health Statistics report says ‘Regionally, health workers who deliver essential services are at their lowest density in the places where the highest burden of disease was measured. Even when national densities are sizable, inequalities persist between rural, remote and hard-to-reach areas compared to capital cities and urban centres.’

And according to their latest available data, density of health workers is the lowest in the WHO African Region, with just three doctors and 10 nursing personnel per 10 000 population. In most OECD countries, there too are concerns about an undersupply of doctors in remote regions. These issues have been exacerbated by the aging of general practitioners and an inability to keep pace with total population growth.

The WHO’s report also reveals that, among the major non-communicable diseases, age-standardised rates for diabetes are on the rise, increasing globally by 3% in the last year alone. It is estimated that 700 million adults worldwide will have diabetes by 2045 causing significant epidemiological and financial burden on healthcare systems.

At Silicon Labs, we lead with a strong belief in the transformative power of IoT to bring about significant societal and environmental benefits. These eye-opening reports present us with great opportunities to rapidly scale up the adoption of smart technologies to support the provision of healthcare – addressing challenges related to overload in the capacity of health services, the enablement of data aggregation for effective diagnostics and remote treatments - ultimately improving the way we and our loved ones live our daily lives.

Cash in Connected Care

Interest in and demand for remote medical services has taken off since the pandemic set in. In the United Kingdom, for example, the proportion of remote primary care consultations increased threefold between February and June 2020. This is a movement on which the Medtech world is looking to capitalize. A recent McKinsey report suggests that on average 10 percent of Medtech companies’ pre-corona revenue was based on digital health solutions, but they expect that figure to exceed 50 percent within five years.

Exploiting advances in wireless technology, wearable health tech helps with remote disease management, allowing for the monitoring of patients while empowering them to receive ongoing care with minimal disruption. While this technological evolution is giving rise to new legal, regulatory and commercial considerations under review by governmental bodies, the market for portable medical devices is set to boom: Incumbent tech players and newbie startups all recognize the untapped opportunities in connected devices for disease prevention and healthcare provision such that the worldwide wireless medical device market is projected to grow at a CAGR of 12% until 2025, adding an estimated US $17 billion in addressable revenue for IoT device makers.

There has already been significant innovation in the field of connected diabetes devices. The major evolution being the transition away from spot-measurements performed with Blood Glucose Monitoring devices to 24/7 operations performed by Continuous Glucose Monitoring. Handheld readers are being replaced by smart phones, where sophisticated management apps are offering automated data logging, reporting and secure identification. Insulin pumps controlled wirelessly by separate devices are getting miniaturized to ultimately become fully disposable. This miniaturization is fuelling the need for tiny electronic packages - spurring the semiconductor world to deliver and unlock a lucrative industry for device makers.

The Power of Portable

Connectivity for portable medical products is today centered around Bluetooth® Low Energy. There are a few products, which run Wi-Fi or other proprietary communication protocols (such as CPAP machines, which are grid-connected and therefore much less sensitive to low-power consumption need), but Bluetooth Low Energy is very much the dominating solution for the vast majority of the products. According to various reports more than 5 billion Bluetooth Low Energy technology-enabled devices were shipped in 2021, up 40% from 2015.

Because Bluetooth Low Energy operates in the 2.4GHz band and typically features a bandwidth of 1Mbps with a range of 15-20 meters, a connected device can safely hook up to a smart phone and embed itself in this immensely powerful human interface. Bluetooth Low Energy also enables new functionalities such as reporting of data and raising of alarms in the event of improper usage by the user. And power consumption is so low that medical devices can run for multiple years on a standard coin-cell battery.

As the Bluetooth Low Energy protocol is fast becoming the de-facto communication standard, the technical requirements for security and data privacy are rapidly increasing. Left unaddressed, security apprehensions can risk dialing back progress and hinder consumer buy-in. The US Congress passed a first bill in December 2020 that mandates minimum security to all companies selling IoT products to the US government. Legislation like the California Consumer Privacy Act (§ SB-327) requires ‘reasonable security features’ for all connected devices to protect user data.

At Silicon Labs we are working very closely with standard bodies like DTSec who are tasked with developing a protection profile for all connected diabetes devices. We are part of the IEEE P2621 committee looking at security standards for all diabetes and all wearable medical devices moving forward. Entities such as the NIST and the FDA are joining forces to develop new standards that help protect portable medical products against well-known remote and local cyberattacks by ratifying safeguards for the secure commissioning of new products, the authentication of software prior to its execution, and the life-time management of already deployed products.

There’s Work to be Done

Moore’s Law continues to have a direct impact on progress, seeing extremely cheap, miniature Bluetooth Low Energy-connected chips opening the door to disposable data collection in real time. Size shrinkage, larger Flash/RAM options, improved Radio Frequency performance and power consumption will see the market for portable medical tech expand into new consumer segments and applications: Wirelessly connected transdermal patches for controlled drug delivery, smart inhalers, connected weight scales and much more. These will be standing on the shoulders of pioneers like BD Medical, Shanghai Berry, Nonin who are today pathing the way.

The transformative potential of IoT, which brings with it significant societal and environmental benefits, cannot be fully realized until we successfully address trust-related concerns for device makers and end users, alike. The products being taken to market must assure the safe delivery of accurate measurements with precision and speed, through robust wireless connectivity and backed up with enduring, ultra-low power operation. We then need to reduce the complexity and cost of a device and its production. After a product is launched, its software must be continually improved, tested, and distributed across the installed base throughout the product lifecycle. To make connected products as commonplace as the phone in your pocket, we need to guarantee the effortless and seamless integration of devices to minimize user burden.

Big Data Up Close & Personal

As the use of remote healthcare ramps up (and the cost decreases), soon portable medical devices will drastically reduce premature death from non-communicable diseases such as diabetes adding years to individual life expectancy. Low-cost, everyday, disposable connected devices that constantly monitor your health will be able to identify what is going on within your flesh and bones and recommend bespoke prophylactic measures to prevent the onset of disease. The human body itself will become a medium for communication and the days of reactive medicine will be bygone.

Portable medical devices will liberate users from the constraints of cost, accessibility, and privilege on the proviso that you are comfortable sharing your data on the radio waves.

Then we will find a way to collect a critical mass of data so that advanced diagnostics and aggregated data can provide timelier medical intervention in poorer nations too, where resources are scarce. Our collective data will become fodder for AI-powered machines that will rapidly process it all to deliver highly accurate predictions and treatments. Together, we could radically reshape healthcare; hailing the dawn of proactive medicine for all.

Healthcare will increasingly become accessible to billions of people who today lack the access to adequate medical services. Together, we could smash the WHO’s Triple Billion targets and see that everyone lives longer and prospers.

Now there is a great reason to get into the wireless medical device game!

Quick Start your Wireless Medical Device Development

There are three fundamental engineering challenges related to developing wireless medical devices. You must:

• Guarantee the delivery of accurate measurements with precision and speed
• Supercharge your Bluetooth medical device’s wireless security with robust technology
• Maximize your battery life by design and low power consumption set up

Silicon Labs offers the most low-power and secure Bluetooth Low Energy portfolio. Our Series-2 SoCs provide excellent low-power, analog performance, and total system integration. Our Bluetooth Low Energy software stack is shipped in millions of products and goes through a rigorous robustness testing with dozens of Android and iOS smartphones. We have extensive system understanding having initially started with Connected Diabetes Devices and extending applications to cover Blood Glucose Monitoring, Continuous Glucose Monitoring, Insulin Pumps and Pulse Oximeters. We have introduced a comprehensive Secure Vault technology, which ensures physical and digital protection, satisfying US and EU regulations, and supporting the latest NIST and FDA security requirements.

For a lowdown on our offering and reasons for you to consider their deployment in your next project check out visit our Portable Medical Devices page.