Architecting an Internet-of-Things (IoT)
The Internet of Things (IoT) is one of the major technological developments in recent years. IoT helps to connect people to people, people to physical objects and physical objects to other physical objects. Given the explosion of the number of “things” that need to connect to the internet (and perform complex functions); IoT architecture requires a three-tier approach, utilizing a “gateway”.
Incorporating Sustainable Design in Medical Device Development
As the majority of hospitals incorporate sustainability into their purchasing decisions and countries regulate sustainable design (e.g. Brazil), it’s prudent for medical device manufacturers to consider sustainable design in their medical device development.
The Design Requirements and Agency Expectations for Connected Devices
The design of wireless medical devices needs to include aspects of system design which are not always obvious. The FDA document Guidance for Industry and Food and Drug Administration Staff Document issued on August 14, 2013, is an excellent starting point for identifying design aspects of a wireless system that must operate and ‘co-exist’ with other diverse devices as well as multiple instances of itself.
The FDA Agile Practices In Medical Device Development Under IEC 62304
Agile methods are state-of-the-art for software developers and they can be adapted to IEC62304 in the highly regulated medical device field. The Association for the Advancement of Medical Instrumentation (AAMI) has issued a Technical Information Report, TIR45 Guidance on the use of AGILE practices in the development of medical device software
The FDA, Cybersecurity and Coexistence for Bluetooth and Wi-Fi Enabled Devices
Integrating wireless technology into medical devices has numerous benefits that positively impact patient outcomes both by allowing caregivers real time access to patient data and by providing the ability to remotely program these devices.