How to navigate testing for devices that use wireless technology
Some hikes are simple, others aren’t as easy, and some are downright complicated. Testing medical products that use wireless technology can be very similar: You can take a simple, moderate or complicated path, contingent on the design of your product.
The path you choose for integrating wireless technology into your medical product will help determine your complexity. The key to succeeding is to first define which path you need to take, instead of walking up the wrong one and needing to walk back down to start over.
In this article, we will explore different paths, assuming the design has wireless technology in it. We will also focus on the Federal Communications Commission’s (FCC) certification standpoint, in lieu of the FDA’s because the FDA’s review and approval is another process. (While overlaps exist, my purview is within the FCC certification process.)
Also, keep in mind that there are variations from country to country, and although FCC test results are widely accepted in other countries, always communicate to your test lab the countries where your product will be distributed. Your test lab will help you ensure your product goes through all the correct testing and document review for those respective geographies.
Selecting the right testing partner
It’s important to understand what to look for in a wireless medical device testing partner. Some of the fundamentals of this stage involve considerations such as your potential partner lab’s abilities to test for the geographies where you want to import your product. A potentially lifesaving device cannot proceed from a concept to a product unless it can pass regulatory tests to get to market. Another consideration is whether the potential lab partner has the right capabilities and proficiencies to test your product.
The three paths
The “easiest” path is using a modular certification. One example of this could be a Bluetooth Low-Energy (BLE) module integrated into a pulse oximeter. In this example, wireless certification is handled at the module level, and the end product (the oximeter) will only need simple emissions testing as well as some basic host-specific module integration transmitter testing. Under this path, no filing with the FCC is required, and a test report can be kept on hand for reference, if requested.
The “moderately difficult” path involves implementing a certified module, but with an antenna different than what accompanies the module’s grant of authorization. Let’s assume the pulse oximeter has an off-board PCB trace antenna that wasn’t certified with the module originally. First, the medical device manufacturer will require a “Change of ID” from the module manufacturer. This will transfer the test data and information about the module’s certification from the module manufacturer to the manufacturer of the medical device. Second, the medical device manufacturer needs to perform some additional testing using the new antenna. Third, the new grant owner will take the new antenna test data and file it using the “Class II Permissive Change” process, adding the new antenna to the medical device manufacturer’s new grant.
The “hardest” path is certifying a chip-down design. This could be a pulse oximeter with a complete on-board Bluetooth low-energy design. Chip-down design testing is the most complex because all testing has to be completed on the product design, and then certified from scratch. Whereas the easy and moderate paths involve using pre-certified modules, only requiring simple updates and integration testing of the host, a chip-down design requires full radio testing and filing with the FCC. The customer will be required to have all of the specific test modes, perform all of the certification testing, and manage their own certification filing documentation.
Medical devices are heavily scrutinized by several regulatory agencies, and for good reason: They must perform their intended task without interfering with other devices, as well as prevent doing any harm to human lives. Ensuring you’re following the right product certification path can be a challenge but understanding how the standards apply and how your design is affected by them, can make compliance a much smoother journey.
Colin Halladay is the strategic business development manager of test services at Laird Connectivity, a provider of wireless technologies, embedded, pre-certified wireless modules and design services.
From：medical design and outsourcing