Personal health medical devices are broadly classified into four applications ̶ diagnostics, monitoring, therapeutic, and treatment adherence devices. The Grand View Research report says that the portable medical device market size is expected to reach USD 85.3 billion by 2025 at a CAGR of 8.7%. The major contributor to this surge is the increasing adoption of smart wearables and portable therapeutic, monitoring, and diagnostics devices.
The ‘Diagnostics’ devices help patients to diagnose various illnesses at home, including fever, cold, diabetes, blood pressure, and other infections, without having to go to a clinic.
The ‘Continuous monitoring’ devices and wearables monitor body vitals like body glucose, ECG, EEG, temperature, and SpO2. They capture, store, send, and process data to alert the patient for any critical situations. The ‘Therapeutic’ devices include various home treatment devices such as auto-injectors, insulin pens, asthma inhalers, infusion pumps, pain management, CPAP (Continuous Positive Airway Pressure) therapy, and respiratory devices. The ‘Treatment adherence’ devices are used to remind, notify, and inform the users about taking their medications. These include medication management kits, smart pill bottles, smart medicine boxes, and patient-centric mobile applications.
Digital evolution has led to a significant increase in the development of personal health devices. Being portable and consumer-centric, these devices must be easy to use, provide quick diagnostics and results, protect patient data, and comply with the local medical standards. Global Original Equipment Manufacturers (OEMs) and start-ups encounter a slew of complexities and challenges while designing a revolutionary solution from their ideas.
Let us look at a few key challenges that these device developers face.
Miniaturization and Manufacturing
The users must either wear the continuous monitoring device or always keep it with them for therapy or medication. For this purpose, these devices must be portable. With advancements in semiconductor, sensor, and imaging technology, it is now possible to design smaller footprint devices with effective functionality. The medical OEMs today leverage miniaturization technologies to improve the existing products’ efficacy and build new ones. Any device with a reduced form factor requires smaller components, more efficient component placement, and a complex multi-layer Printed Circuit Board (PCB) design.
The challenges include integrating the components and sensors in the smaller footprint design, effective power utilization of the handheld/wearable devices, and mass manufacturing with enhanced accuracy. It is now possible to reduce the device’s size through advancements in the electronics design technologies like the multi-layer PCB design using blind and buried vias, effective power management Integrated Circuits (ICs), and integrated wireless connectivity modules.
Miniaturization significantly challenges the traditional method of mass production. It necessitates proper material handling, testing, and process automation because manual assembly and alignment are not viable with smaller form factors. It is important to involve the manufacturing experts early on during the product design process to ensure alignment of the manufacturing strategy with the product design. Various unique capabilities are needed, including micro-moulding and additive manufacturing, to meet these requirements.
Multiple Sensors Integration in a Portable Formfactor
With the COVID-19 pandemic, remote patient monitoring and telemedicine applications have drastically increased. The home diagnostic and portable health assessment kit has multiple sensors to measure the ECG, heart rate, respiratory rate, temperature, blood glucose, and SpO2. Some telehealth devices even have cameras to capture high-resolution videos and images for real-time patient diagnosis.
The challenge here is to integrate multiple sensor platforms in portable devices with optimized accuracy, sensitivity, and higher reliability. Accuracy is crucial because the device must precisely process the diagnostics data captured by the sensor. The added difficulty for the camera-enabled devices is effective image tuning for an improved display of the high-resolution images to the physicians for diagnosis.
Low Power Consumption
Personal health devices operate on battery power and most of these devices are either wearables or connected therapeutic devices. They operate on the battery for a longer period. Continuous Glucose Monitor (CGM) measures the patient’s glucose continuously for an entire day without being removed from the body. The medical device developers are trying to bring down the device’s cost and size by reducing the discrete design components for efficient power consumption.
The heart of a portable device is the microprocessor or the microcontroller. The low-powered mixed-signal MCUs or the ARM Cortex M/A processors and the analog integrated circuits are the best options for minimum power requirements. The device requires the complex processors of Qualcomm Snapdragon or Nvidia to run complicated algorithms at the edge to analyze the sensor data or for an intuitive Human-Machine Interface (HMI). Component placement is vital in a smaller form factor for heat dissipation and heatsink design. To save power, the firmware application should be designed to send the sensor data to the mobile app or the cloud regularly.
Wireless Connectivity Options
Personal health devices now have several wireless connectivity options to send patient data to the cloud for storage and analysis. This historical or real-time data helps to create charts and reports that the patients and the practitioners can review. The auto-injectors and the smart insulin pens send the patient’s health information data to the mobile application via Bluetooth Low Energy (BLE) including the injection time, injection duration, the drug temperature, and the drug viscosity, etc.
The next-generation patient monitors also have LTE connectivity for sending real-time data to the cloud. The major challenge for the device developers is to incorporate all the wireless connectivity modules including Wi-Fi, Bluetooth, and LTE into a portable form factor for seamless communication. They also struggle to achieve reliable communication with very little power. BLE is energy efficient, accurate, durable, and a low-cost option to enable near-field wireless communication in the device.
Another challenge is to connect a larger footprint of devices to the cloud and to manage the cloud infrastructure seamlessly as they scale up. To keep the device ecosystem up and running,
it is necessary to manage the device lifecycle remotely including discovery, provisioning, troubleshooting, and automatic Firmware Over-The-Air (FOTA) updates.
Security is pivotal in designing portable medical devices that capture, store, and transmit the personal health data of an individual. These devices are used in a home or public network environment that is highly insecure and prone to cyber-attacks. The device makers need to consider security in every element of the connected devices, right from the device layer to connectivity to the cloud layers. Chip level security with a secure boot process using the root of trust and a safe boot loader along with secure OTA updates should be enabled for full-proof security.
The proliferation of personal health devices is transforming the healthcare industry and enabling consumers to diagnose and monitor vital signs of their health at home or on the go. Innovative device developers require end-to-end capabilities from devices to the cloud to managed services for resolving these challenges. With our 25+ years of product engineering service experience, we are the preferred design partners for global MedTech customers and innovative start-ups to design, develop, manufacture, and manage ultra-low power, portable personal health devices. We have an in-depth understanding of stringent medical device development processes adhering to ISO 13485 and IEC 62304 standards and extensive development experience of FDA Class 2 and 3 devices. With our recent partnership with NuCurrent, we are also designing innovative wireless charging solutions for personal health and consumer devices.
Contact our experts today to know more about our medical device design services.