Fast and responsive wireless communication enabled through 5G networks will change the way medical evaluation and treatment are conducted through improvements in telemedicine, implementation of new wearable sensors, personalizing medicine, and enabling advanced activities such as telesurgery. In the last few years, rapid advances in wireless communication continued to provide novel medical products with regulatory challenges in research, development, manufacturing and assessment.
5G-enabled Medical Device Workgroup:
MDIC is establishing a 5G-enabled medical device workgroup, that gathers key stakeholders and ideas, will facilitate the future development of novel medical device technology based on 5G telecommunication networks, while ensuring patient safety.
Proposed Deliverables:
Coordinated by MDIC, the workgroup will work on a 5G implementation roadmap specifying open regulatory research questions and knowledge gaps that should be addressed to facilitate the integration of 5G technology in medical devices and accelerate 5G-enabled device availability to patients. Examples of topics to be considered:
• Identifying medical device 5G use-cases and practical recommended practices for 5G integration.
• Outlining evaluation methods for the safe and effective use of 5G in medical devices.
• Incorporating telecommunication technology suppliers in the medical device supply chain.
• Managing the relationship between the device manufacturer, network operator, and the end user throughout the pre-market and post-market cycle.
Stakeholders for this workgroup include:
• FDA
• Medical device manufactures
• Medical device industry groups
• Large scale 5G network operators
• Small scale private 5G network operators
• 5G chipset manufacturers
• 5G network equipment manufacturers
• Test laboratories
• Test equipment manufacturers
• Standard development organizations (SDOs)
• Academic research groups
If you would like to join this collaborative effort, please contact MDIC program director Jithesh Veetil, jveetil@mdic.org
Current as of October 27, 2020
