The tremendous potential for new applications of wireless-enabled medical devices has spurred significant innovation of late. Combining medical assistance with power of broadband can improve healthcare for everyone throughout the world. Yet, those in the U.S. tend to think first about designing to address FDA and FCC regulations. That’s complicated enough.
But as you consider your market opportunities, remember that the population of the United States is approximately 318 million. When compared, however, to the world’s population – 7.2 Billion – the US is less than 5% of the market. Consider that when you consider designing products for helping people live better lives.
The promise of innovation and the potential to change medicine is a global concern – and the market is a global market. The convergence of communications technology and medical devices is evolving quickly. It takes a team dedicated to keeping up with not just technology changes, but market and government regulation changes, too. And when we say government, we mean governments – plural.
During our upcoming webinar on Global Markets for Wireless Medical Devices, we’ve partnered with the US Department of Commerce US Commercial Service to bring you expert advice on how to be sure you’re designing – and testing – for the world. Some of the topics discussed will include global understanding of:
• “Intended-Use” – this is critical terminology with global definitions
• On-body, In-body, Near-body – and the differences in testing requirements
• Range of operation, battery life, performance optimization – implicated in regulatory approval
• Selection of wireless technology appropriate for the application – to help you design efficiently
• Quality of service – both from a device and an operations perspective
• Coexistence with other devices (interoperability) – especially critical for low-range frequencies
• Security of data transfer – this varies slightly
• Electromagnetic Compatibility (EMC)
Regulatory commissions that will impact approval of the above include – but aren’t limited to – the following agencies:
US: FCC Federal Communications Commission
CA: IC Industry Canada
EU: ETSI European Telecommunications Standards Institute
Japan: MIC Ministry of Internal Affairs and Communications
Korea: KC Korean Certification
Israel: MoC Ministry of Communications
So, you have a great idea. You’ve begun development. You’re looking at FDA approval concerns. But if you’re not sure your design will meet global specification requirements, don’t let this opportunity go by, as it is sure to advance your product’s success. Learn from the professionals in regulation, trade, and antenna research, all from one webinar.
Join us June 5, 2014 – sign up here by June 4th to assure your spot.
Click here for information on the presenter, Dr. Gerard Hayes.