When it comes to technology adoption, the healthcare industry is historically risk averse. Despite strict regulations protecting patient data and concerns over medical outcomes, a new report from Mordor Intelligence reports that the global market for wireless portable medical devices is expected to exceed $31.4 billion this year. 1 The same report projects 12.14 percent compound annual growth through 2030 to meet the demands of a burgeoning geriatric population for wearable and implantable devices and in-home vital signs monitoring.
The primary role of many portable wireless medical devices is to perform essential clinical functions, such as patient monitoring, infusion, or diagnosis (see Figure 1). While medical device manufacturers excel at designing solutions to meet these critical healthcare needs, their skills may not inherently include wireless technology. Adding wireless components — Wi-Fi or Bluetooth, for instance — to transmit patient data securely and reliably in real time to nursing stations or electronic health records systems is a complex task.
The wireless connectivity knowledge gap can create a blind spot in which medtech companies may inadvertently neglect to adequately test their devices as they graduate from a concept in the lab to the volume production line. This oversight can lead to device underperformance in which patients may experience poor connections and delays in clinical notifications. In the worst cases, devices may fail, which for manufacturers can trigger product recalls, compliance violations, and an erosion of customer trust.
With adoption rates rising, the wireless technology landscape is increasingly complicated to manage as it moves from discrete and comparatively simplistic electronic components to highly integrated modules housing multiple wireless protocols such as 5G cellular, Wi-Fi, and Bluetooth Low Energy (see Figure 2).
This article presents seven critical questions that medical device designers should be asking as they build the next generation of wireless products to improve quality of life for millions of patients.
Top Questions for Wireless Medical Device Testing
Which wireless technology is best suited to my product? Whether Wi-Fi, Bluetooth, or cellular, the choice depends on how much data needs to be transferred, how swiftly, and over what distance. Medical devices carrying large data volumes that require reliable, always-on connections may be better suited to Wi-Fi.
These include insulin pumps and devices for monitoring blood pressure and heart rate. Others, like blood glucose monitors and pulse oximeters, transmit small amounts of data just a few times a day and may be better candidates for Bluetooth.
Cost is another important consideration, with Bluetooth modules generally adding less to bill of materials budgets than Wi-Fi or cellular modules. Designers should also familiarize themselves with compliance and regulatory requirements that may influence their connectivity decisions.
What are the different stages of wireless test and how do they differ? Typically, during R&D and design verification testing, the focus is on validating fundamental RF parameters (e.g., power output, receive sensitivity, and error vector magnitude) across different frequency bands of operation.
During quality and assurance testing, the focus shifts to the user experience. This includes validating performance across real-world use cases and conducting coexistence and over-the-air (OTA) interference testing to determine whether the product will perform well in the field. It’s important to test full parametric performance and not just rely on go/no-go tests that only indicate whether the device is functional.
Production testing requires an optimum balance of quality and cost economics. That means checking the device’s bare minimum functional performance and then testing multiple devices simultaneously to reduce the cost of test and expedite time to market.
There are two common denominators that cut across these different test stages. The first is hardware test equipment that is capable of scaling from lab to manufacturing. The second is a user-friendly yet advanced automated software tool that reduces RF testing overhead to minimize test-suite development and design and execution times.
What is the best way to comprehensively test wireless performance? As you progress through the product development cycle, what you test and the way you test will vary. When designing a product from scratch, for example, it’s important to measure the performance of the RF transceiver in isolation to ensure that it meets design specifications.
Once the device is validated, it must be tested in its entirety. Real-world scenario testing entails attaching the device antenna and casing to ensure that the final hardware and software are not impacting wireless performance.
Can testing help ensure patient data accuracy? Hospitals and home environments can be crowded RF spaces, with multiple devices operating at similar frequencies. Interference can lead to dropped signals, corrupt data, or incomplete transmissions. Even a small percentage of lost or distorted data can undermine the reliability of clinical decisions.
Interference testing that measures device sensitivity, packet error rate (PER), and bit error rate (BER) can indicate how often transmissions are corrupted under different conditions. Some throughput tests can also identify design flaws by measuring data transfer rates between devices on a wireless network.
Should I use an off-the-shelf RF module or design in a chipset technology? When you buy off the shelf, you typically don’t have access to the wireless chipset and controls for testing. That means you need to use the command provided by the module vendor, write your own software, or rely on a test vendor like LitePoint, which has a test methodology setup to quickly validate performance.
The choice is contingent on two factors: Time to market and form factor.
Time to market: Off-the-shelf modules can be expensive but often reduce development time, as they come precertified and precalibrated. Generally, that eliminates time spent working with regulatory labs for compliance testing. On the other hand, commissioning a chipset design means working extensively with the chipset supplier to ensure seamless integration into your product. This can be a complicated, time-consuming process and can add overhead to the design process.
Form factor: Chipset-based designs offer better control over the end-device form factor by accommodating smaller, compact designs compared to off-the-shelf modules.
Whether you design your chipset or buy an off-the-shelf module, LitePoint, for example, provides automation software through the IQfact+ tool that supports the gamut of chipset-specific test packages and can be used out of the box.
Are there additional test considerations when I move into high-volume device production? Many medical devices sell in the hundreds of thousands or even millions of units, so the ability to scale testing is an important step for accurately determining device yield. Just as importantly, designers want to make sure they aren’t incorrectly failing good units and/or passing bad units. An inaccurate test is as harmful as no test at all.
How can I better manage test costs? If manufacturing volumes are high and test costs are rising, you should consider a cost-of-test analysis, which includes single-test and multi-test options. This can help manufacturers reduce costs and expedite time to market by determining how much time it takes to test one device as a percentage of overall capital equipment costs compared to how long it takes to test multiple devices in parallel (see Figure 3).
As many in the medical community are discovering, portable wireless medical device technology is a game — and life — changer. Accurate, repeatable, scalable testing is a key step in delivering the highest levels of care.
This article was written by Khushboo Kalyani, Product Manager, LitePoint, San Jose, CA. For more information, visit here .
Reference
- Wireless Medical Devices Market Size & Share Analysis — Growth Trends & Forecasts (2025–2030), Mordor Intelligence.
