Medical devices are increasingly wireless, supporting patient care, monitoring and diagnostics through technologies like 4G LTE/5G cellular, Wi-Fi and Bluetooth®. When defining their products, medical companies invariably encounter a key integration option: should they embed wireless functions using a proprietary chip-on-board (CoB) design or rely on a pre-certified module from a third-party provider? The decision can directly influence product development costs and timelines, regulatory testing loads and final product performance.

This foundational design decision is becoming more important as the medical community strives to meet demand for wearable monitors and diagnostic devices and expands use cases for in-home remote health management and rural locales where hospital access may be difficult. The differences between these approaches have a direct bearing on how manufacturers design, certify and test their devices as they prepare them for volume manufacturing. And as demand grows, many medical companies find that their “make vs. buy” decisions are informed by the degree to which they have access to in-house RF engineering expertise.

Balancing Flexibility and Simplicity During Product Development

For space-constrained or highly customized devices, chip-on-board affords designers tighter control over integration and device operation. This enables more flexibility when it comes to product form factor and performance features. However, CoB also requires significant RF engineering knowledge; it depends on close – and often time-intensive – collaboration with chipset vendors, and demands extensive debug cycles during development.

Source: Ezurio

Modules simplify the path to integration. These off-the-shelf components are pre-tested and pre-certified, reducing the burden on device manufacturers. They enable faster development cycles and are often preferable for medical companies that prioritize clinical function over RF customization. The trade-off is cost – modules are typically more expensive – but they reduce engineering time, complexity and risk.

A common hybrid approach involves combining both: for instance, using a 5G module due to regulatory complexity and CoB for Wi-Fi to save space or cost.

How Manufacturing Affects Test Time and Scalability

Testing is critical in wireless device production. CoB designs require more comprehensive RF test coverage, including direct chipset control and access to factory test modes. While this enables extensive validation, it also increases test time and demands more from manufacturing teams.

Modules, on the other hand, have limited access to internal test modes. Testing is often conducted through AT (attention) commands with reduced test coverage. This results in shorter test times and easier scalability for high-volume production.

Both approaches scale similarly in terms of physical factory setup; it’s test throughput per unit that differs. LitePoint supports both scenarios with test automation solutions and multi-device testing platforms that optimizes units-per-hour (UPH) even with expanded test coverage.

Juggling the Variabilities of Compliance and Final Product Testing

CoB-based designs place the full regulatory burden on the OEM, including FCC wireless compliance in the United States and international certifications such as EU-mandated conformity assessment (CE) testing. This includes emissions, coexistence and RF exposure tests. Modules alleviate much of this by offering pre-certification, especially for complex technologies like 5G, which operate in licensed spectrum.

However, assuming a module requires no further testing is a common mistake. Even pre-certified modules must undergo final product validation, as antenna placement, housing materials and PCB layout can affect wireless performance. LitePoint emphasizes the need for end-to-end testing, ensuring the assembled product performs to specification – especially for mission-critical medical applications.

Each wireless protocol – Bluetooth, Wi-Fi, 5G – has unique test cases. Bluetooth Low Energy and Bluetooth Classic, for example, differ in respect to the modulation scheme, limits on frequency deviation, sensitivity, etc. When products support multiple radios, coexistence testing is essential to ensure technologies like Wi-Fi and Bluetooth operating at 2.4 GHz do not interfere with each other.

Why LitePoint is the Right Test Partner

LitePoint’s value extends beyond test equipment. We provide the RF expertise, support and turnkey automation that medical OEMs need, in addition to the industry’s largest installed base of more than 350 wireless chipsets. For companies unfamiliar with RF or constrained by timelines, LitePoint’s controlled test environment offers:

• Out-of-the-box automation software tailored for chipsets and modules
• Test coverage for several wireless technologies including but not limited to 4G/5G, Wi-Fi 6/6E/7, Bluetooth Classic and Bluetooth Low Energy
• Scalable solutions, including over-the-air and multi-device testing
• Testing that extends beyond Pass/Fail to deliver insights on transmit quality analysis
• Industry-leading customer support that shortens debug and validation cycle

LitePoint enables medical device companies to focus on clinical performance while ensuring wireless quality and compliance. Whether choosing CoB, module integration or a mix of both, LitePoint simplifies testing and accelerates time to market by delivering faster testing speeds to expedite production throughput and reduces test errors to improve yields.

The choice between chip-on-board and modules in medical electronics isn’t binary. It depends on form factor, engineering bandwidth, time-to-market goals and regulatory obligations. What is consistent, however, is the need for reliable, robust, flexible and scalable testing.