Taking Predictive Medicine to the Next Level Using Wearables

Author : Steven Daenen, Product Marketing Director for Health IoT at NXP Semiconductors

29 September 2023

Figure 1: Functional block diagrams of the NXP NHS52S04 and NHS52S14 wireless SoCs
Figure 1: Functional block diagrams of the NXP NHS52S04 and NHS52S14 wireless SoCs

Throughout the world, chronic non-communicable diseases (NCDs) are putting significant strain on healthcare resources. Aging populations and varied lifestyle choices have driven growth in cardiovascular disease, diabetes, various forms of cancer, plus serious respiratory complaints - such as asthma or chronic obstructive pulmonary disease (COPD).

According to the World Health Organisation (WHO), NCDs cause 41 million deaths each year. That’s 74% of all deaths globally.  gives his views on what can be done to reduce such figures, and explores the challenges that medical OEMs face.
 
With the deepening global skilled worker shortage in healthcare, IoT products designed specifically for the medical market are gaining increasing prevalence - thereby helping to reduce the need for healthcare practitioner intervention. These medical technologies are enabling novel ways for better leveraging healthcare system budgets, as well as increasing therapy efficacy and improving patient comfort. For example, a patient’s condition may be monitored through devices like on-body wireless patches or rapid diagnostic tests. Patients can also be prompted or guided to better adhere to their prescribed therapy through mechanisms that monitor the time and dose of therapy delivery. Healthcare devices can also ease therapy delivery via on-body delivery system (OBDS) usage. Larger dose sizes or higher viscosities can thus be administered, while minimising patient discomfort.

The availability of accurate and reliable data for monitoring and precise control is crucial for optimising therapy effectiveness. As these intelligent devices may increasingly carry out medical decision making and actions, maintaining high standards of data quality, authenticity, privacy and reliability all become paramount. 

Smart connected medical device growth 
The general approach to keeping our aging population well is to encourage healthy lifestyle choices. Wearable devices, such as fitness trackers, have gained popularity among consumers - due to their ability to provide real-time data and personalised insights into health and wellbeing. The integration of advanced sensors and data analytics enables users to track their daily activity levels, monitor vital signs, check sleep patterns, etc. 

Wearables even have connectivity features that typically synchronise with a smartphone or computer, thereby allowing users to view their data, set goals and receive notifications related to activity (such as reminders to move or track workouts). Despite this, there is strong growth in the pervasiveness of NCDs - thus presenting significant potential for medical devices to make a positive impact on global healthcare issues.

Challenges of regulatory approval
The main difference between a simple fitness tracker and a wearable medical device lies in their intended purpose, plus the level of health monitoring and the interventions they provide. While there may be some overlap in fitness-focused features, medical wearable devices offer data with much greater accuracy for diagnosis and treatment management. Furthermore, secure wireless connectivity enables healthcare professionals to monitor medical conditions remotely. 

Smart connected medical devices need to comply with strict standards and regulations, such as clearance by the European Medicines Agency (EMA) over here or the Food & Drug Administration (FDA) in the US. This ensures patient safety, data security and the exactitude of the collected information. The lengthy and complex process of obtaining regulatory approval can significantly delay time-to-market, requiring extensive documentation, clinical trials and rigorous testing. The evolving nature of technology also makes it challenging to keep up with the constantly altering regulatory landscape - as regulatory bodies strive to adapt their guidelines to accommodate rapid advancements in the field. OEMs need to navigate these hurdles effectively to bring their innovative healthcare devices to market while ensuring compliance with the necessary regulations.

Figure 2: NHS52Sx4 SoCs feature Arm Cortex-M33 chips with TrustZone security
Figure 2: NHS52Sx4 SoCs feature Arm Cortex-M33 chips with TrustZone security

Miniaturisation and moving towards transparent usage of connected medical devices
Although it has already been shown that smart and intelligent medical devices can help both patients and medical professionals to manage chronic health conditions, it is also true that the electronic components for such devices need to be small and lightweight. This miniaturisation is key to extend the wear-ability from a few days to several weeks. For instance, use of silver-oxide battery technology can reduce battery size and weight by a factor of 5 compared to standard Li-Ion coin cells. 

Ultra-low power consumption for all aspects of the product design is pivotal in enabling miniaturisation. NXP’s NHS52Sx4 wireless SoC family supports various battery types, with its integrated ultra-low-power radio and flash helping to extend battery lifetime.

Sharing information with family/caregivers via Bluetooth LE 
Consumers and medical professionals alike also want to be reassured that their medical devices are safe, reliable and secure. Use of Bluetooth LE is a key component in the progression of electronic healthcare devices that will help designers meet these demands. A constant stream of accurate and reliable data for monitoring or precise control is crucial, so making medical devices smaller and more lightweight can allow important information to be transmitted wirelessly with minimal disruption to users’ daily activities.

Putting patient safety and privacy first
Developing medical devices for patients requires a holistic approach that integrates safety and privacy considerations from the outset - especially given that bodies like the FDA stipulate these factors as essential for approval. For example, when it comes to continuous glucose monitoring patches for people with Type 1 diabetes, the glucose level readings generated by the patch need to be completely reliable and accurate for the user to know how much insulin they should inject. Any anomaly in the read accuracy has the potential to cause serious harm or even result in death.
 
Data privacy is essential for smart medical devices, so as to ensure the accuracy and integrity of collected health data while safeguarding sensitive patient information. Privacy protections keep such information confidential, building trust between patients, providers and OEMs.

Establishing the unique identity and authenticity of each device is vital for smart medical devices, so as to make sure of its integrity and prevent unauthorised tampering. In addition, strong security measures must be implemented to protect against remote cyber-attacks over the standard Bluetooth LE link (such as encryption, authentication protocols and regular security updates) and thus safeguard patient data.

Making design processes easier for medical OEMs 
Use of Arm TrustZone security technology enables the isolation of all the software processes within the NHS52Sx4 SoC into dedicated ‘virtual’ hardware processors, ensuring protection against attacks over Bluetooth. Connectivity, security, and sensor processing functions are also isolated in trusted software execution on dedicated hardware peripherals. 

Figure 3: The NHS52Sx4EVK evaluation kit aids prototyping of hardware based on Bluetooth LE connectivity
Figure 3: The NHS52Sx4EVK evaluation kit aids prototyping of hardware based on Bluetooth LE connectivity

With the MCUXpresso tooling suite, OEMs have the flexibility in application development. A reference ‘sandbox’ application illustrates the processor’s modular software architecture, facilitating reuse and modification. The NHS52Sx4EVK evaluation board features flexible interfaces and an integrated USB debug port for simple connection during software development. Example source code is available to help accelerate matters.

Case in point
Through IoT technology, advanced medically-approved devices are emerging that can improve patient quality of life by addressing chronic conditions, such as Type 1 diabetes, more effectively. For instance, continuous glucose monitoring (CGM) patches can automatically track blood sugar levels via a user’s smartphone. For diabetes patients needing multiple daily injections, these CGMs can communicate directly with an on-body drug delivery pump. The system can then assess the data every 5 minutes to predict blood sugar levels for the next 60 minutes and adjust insulin doses or pause delivery accordingly - helping to free the user from the daily rituals of regular testing and injecting.

Future prospects for healthcare
Medical device technologies will bring many benefits to society, such as reduced demands on healthcare practitioners, improved therapy efficacy, enhanced patient comfort, etc. Although getting rid of cables and bulky hardware is a giant step forward for the health sector, strict regulations around medical device development poses considerable challenges for innovative OEMs wanting to break into this new market. Of course, regulations are there for good reason. Operational failure, security breaches or data inaccuracy would not simply cause minor functional inconveniences - device risks could seriously jeopardise patient welfare.

The many challenges of developing IoT devices for the medical market can only be surmounted through a focus on miniaturisation, enhanced connectivity and extended battery life, as well as a proactive approach to meeting regulatory requirements. By correctly addressing these concerns, OEMs can bring innovative new healthcare solutions to market quickly and safely.


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