The term “wireless” in Industry 4.0 is not limited to only wireless communication; it is backed up by modern technologies such as the Internet of Things (IoT) and Cloud Computing for effective and robust system functionality. In the health and medical domain, medical devices are labeled as wireless medical devices when the device itself, or a part of the device, fulfills a health service using wireless communication protocols. Indeed, since patient care and safety are the highest priorities, these devices should follow FDA safety guidelines before they are released in the market...

1. Wireless Medical Devices
By: Govind Yatnalkar
The term “wireless” in Industry 4.0 is not limited to only wireless communication; it is
backed up by modern technologies such as the Internet of Things (IoT) and Cloud Computing
for effective and robust system functionality. In the health and medical domain, medical devices
are labeled as wireless medical devices when the device itself, or a part of the device, fulfills a
health service using wireless communication protocols. Indeed, since patient care and safety are
the highest priorities, these devices should follow FDA safety guidelines before they are released
in the market.
There are myriad wireless communication protocols that can be integrated with medical
devices. Some of them include Wi-Fi, Radio Frequency Identification (RFID), Zigbee, Bluetooth,
Near Field Communication (NFC), or a simple cellular network. Irrespective of the protocol
selection, the major functionalities of wireless medical devices include either communicating or
sending data between systems, continuous remote monitoring of patients, and controlling
system components. For example, physicians canremotely access and monitor patient data
without knowing the actual patient location. Also, using IoT/Cloud, remote data access, and
modern analytical tools, remote intelligent systems can be deployed to deliver precise drug
levels based on the results provided by analytics. An example of such a system is Wi-fi or a
Cloud-based intelligent insulin delivery device. Also, patient records can be maintained using
RFIDs as the access points. In such cases, doctors can access the entire patient’s medical history
by scanning the uniquely associated RFID.1
As stated formerly, these wireless medical devices hold patient data while executing
functionalities such as data transfer and patient monitoring. This data drives future system
decisions and therefore the accuracy of this data is extremely vital. If manufacturers are
revamping their traditional systems with novel data communication protocols, they should
validate all functionality at every stage to identify any risks associated with the system. The
other major aspect of safety is security. Being a data network protocol, manufacturers should
utilize the latest network security frameworks to avoid any unauthorized access or malicious
attacks. Additionally, they should consider using security protocols which are also recognized by
the FDA which ensures the system is truly secure against a potential cyberattack. Ifthe FDA
finds that the wireless medical device follows their essential safety guidelines and reaches the
required levels of safety and efficacy, the FDA grants market clearance or approval.2
1 FDA (September 2018). Wireless Medical Devices. Retrieved on January 3rd from https://www.fda.gov/medical-devices/digital-
health -center-excellence/w ireless-m edical-dev ices.
2
Wan, S., Gu,Z.,& Ni, Q.(2020).Cognitive computing and wireless communications on the edge for healthcareservice
robots. Computer Communications, 1 49, 99-1 06.

2. To sum up, wireless medical devices are enhancing healthcare services by providing
sophisticated features such as continuous patient data monitoring and remote patient system
control or data access. Surely, manufacturers should take care that their medical device with
wireless protocol is well tested, documented, and most significantly, it is safe and secured
enough to be utilized in the market. Do you have a wireless medical device that needs FDA
approval? Our regulatory and software experts at EMMA International can help your wireless
medical device get FDA compliant. Contact us at 248-987-4497 or
info@emmainternational.com for additional information.