The wireless trend in healthcare can't be ignored. But there are risks to adding such a capability to legacy devices. Here's what you need to know.
The wireless trend in healthcare these days has become as ubiquitous as the air we breathe.
Consumerization of healthcare, coupled with advances in technology, have propelled this phenomenon, and many device makers are looking to add wireless capability to legacy devices.
But it's not just a matter of throwing a radio in and thinking it's done, according to Nicholas Abbondante, chief engineer for EMC, Intertek.
"There are a lot of benefits to going wireless, but there is a downside, too," Abbondante says. "You are adding complexity to your device. If you are transferring medical records, you have to think about security. What if your infusion pump controlled wirelessly by a remote controller is turned off? So, there is additional risk that needs to be considered."
There are also a whole host of tests that need to be performed, including what is known as wireless coexistence testing, Abbondante notes. In other words: Is your wireless-capable device affected when it is in the vicinity of other technologies, such as cell phones, WiFi, Bluetooth-enabled devices, or even the leaky microwave. The difficult thing is that there are no standards for this kind of testing, and it's up to the discretion of FDA as to whether the device's performance won't be compromised.
FDA aside, there are three things that Abbondant recommends keeping in mind when adding wireless capability to a legacy device:
1) Preapproved modules should be considered instead of going out and developing your own radio. This approach cuts down the development cycle and reduces expenditure needed to hire a design team.
2) Modifications of the module should be avoided. "Often, marketing wants to change something because they don't like the antenna," or something along those lines, Abbondante says. "Well, don't [change on a whim] because that will require the module to get reapproved and you lose the benefit of getting a module."
3) Watch out for global reglatory approvals; there is no standard, harmonized global approach to radio approval. "You are pretty much down to talking to each spectrum regulator in each country and see what they require," he says. "Maybe they'll accept reports from the EU, maybe they'll accept reports from the FCC. [But] some of them require in-country testing. Some of them require documentation translated in their language and submitted. It varies by country regarding what you have to do."
Abbondante will discuss the ramifications of transforming legacy devices more broadly at the two-day BIOMEDevice Boston Conference in Boston on March 27.
[Photo Credit: iStockphoto.com user seruvenci]