How to Scale Design and Manufacturing Services for Bluetooth Medical Device Makers
Medical device manufacturing is one of the most demanding businesses. The technical complexities required to transform biometric signals into actionable data, the increasingly miniaturized nature of devices, and ramping global production are just some of the obstacles facing medical device makers. Add to these years of development, testing, and qualifying for numerous regulations, certifications, and standards, and you get to an extremely challenging business equation that only few device makers can solve without original device manufacturers (ODMs).
The ODMs have a critical role in designing and building devices, absorbing the CAPEX, and mitigating the risks for the device makers. However, the competition is fierce and ODMs succeed only if they can build innovative products quickly and cost-efficiently in global scale.
Silicon Labs is the wireless connectivity partner that helps ODMs to deliver high-quality solutions quickly and efficiently to their medical device maker customers worldwide.
With Silicon Labs, ODMs have a single Bluetooth portfolio and toolset to scale their medical device business – addressing all medical device segments, improving CAPEX efficiency, and accelerating time-to-market. Our best-in-class wireless performance, ultra-low power consumption, robust security, and medical-optimized capabilities allow you to design and build innovative, high-quality products, increasing your competitiveness in the ODM market.
Continue reading to learn more about our medical-optimized Bluetooth Low Energy (LE) solutions.
A Single Bluetooth Portfolio for All Medical Devices
Silicon Labs provides medical ODMs a single, unified Bluetooth LE portfolio with optimized solutions for all types of devices, ranging from thin medical patches to connected garments, wrist bands, and portable bedside monitors.
The same portfolio scales from the tiniest CSP packages to RF-certified SiP modules and from basic connectivity solutions to advanced AI/ML-accelerated wireless MCUs. The same Bluetooth SDK works across the entire hardware portfolio.
With the unified Bluetooth portfolio, medical ODMs can efficiently serve their entire customer base, addressing all medical device types with minimal customer-specific platform modifications.
Easier Platform Integration
Our field-proven Bluetooth stack provides ODMs mature and stable APIs while also supporting the main OS variants such as bare metal, FreeRTOS, and Zephyr. This simplifies interface abstraction and integration to minimize platform modifications in the long-term.
Faster Customer Launch
Faster product launch for the device maker means faster time-to-revenue for the ODM. With Silicon Labs, you can shortcut development time in three stages:
- Hardware reference designs and software examples for various Bluetooth medical devices, including CGM and ECG quick-start product development
- Using Silicon Labs’ Bluetooth stack, you inherit our Bluetooth SIG certifications, avoiding time-consuming testing for end-product qualification
- RF regulatory certified modules come with an integrated antenna and worldwide regulatory certifications, cutting months from the product launch and accelerating time-to-revenue.
Security and Regulations Compliance for Bluetooth Medical Devices
Connected medical devices are heavily regulated and standardized, requiring end-device makers to pass countless time-consuming certifications. Silicon Labs Bluetooth solutions are readily supporting the primary medical requirements, accelerating time-to-revenue for ODMs:
- Supporting the FDA requirements on IoT devices, HIPAA, IEEE 2621, and others
- Up to PSA Level 3 security certifications, including the SESIP L3 with DT Sec PP and PSA
Secure Programming
Silicon Labs provides ODMs a secure provisioning platform, Custom Part Manufacturing Service (CPMS) that enhances provisioning from the typical programming to e.g., unique device identifier, cryptographic key injection, secure boot setup, encryption services, and package marking while using hardware security modules (HSMs) for key protection.
Integrated Medical Functions
Many medical-optimized functions are readily integrated into Silicon Labs' Bluetooth solutions, reducing BoM and development costs for device makers—DC-DC, Coulomb Counter, ADC, DAC, ACMP, crystal, Realtime Clock (RTC), AI/ML, MCU, RAM, and flash.
Miniaturization without Compromises
Our small CSP packages enable adding Bluetooth connectivity to extremely compact and challenging medical device form factors – such as smart patches, and Continuous Glucose Monitors – without compromising wireless performance, compute, and security.
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Wireless Performance and Ultra-Low Power
The human body is one of the most complex design challenges for medical device makers. It absorbs and reflects radio signals and disturbs antenna resonance, especially for wearables imposed to strict specific absorption rate (SAR) limits. Silicon Labs Bluetooth solutions are renowned for their best-in-class radio (RX) sensitivity, which is the most important performance factor in wearable applications. This, together with multiple power amplifiers, dynamically adjusted transmit (TX) power, and 0dBm TX optimization save device energy and battery.
A Proven Track-Record of Helping Drive Bluetooth Medical Device Innovation
Several medical device makers have built their medical devices on Silicon Labs Bluetooth, including CGM, pulse-ox, tooth implant, insulin pump patch, cardiac monitor, epilepsy management, and more.
Scale Bluetooth Medical Device Design with Silicon Labs
Silicon Labs provides medical ODMs a single, unified, and medical-optimized Bluetooth portfolio that allows you to address the entire medical device space efficiently, minimizing CAPEX and platform modifications while bringing you the most competitive Bluetooth LE capability set to take over the medical device business. To learn more about how we can help accelerate your development, contact Silicon Labs to learn about our wireless solutions for medical ODMs.
