November 24, 2020

Today, MDIC announced the formation of a working group focused on 5G-enabled healthcare technologies. The goal of this group, championed by FDA, is to bring key stakeholders and ideas from different sectors to improve the process for development and assessment of novel medical devices enabled by 5G wireless communication, while ensuring patient safety.

The working group stakeholders include subject matter experts and senior-level executives from medical device manufactures, 5G network operators, 5G chipset and network equipment manufacturers, wireless service providers, test laboratories and test equipment manufacturers, standard development organizations, academic research groups, as well as FDA.

It is expected that stakeholder conversations will help prioritize research questions that facilitate the integration of 5G wireless technologies into medical devices.

“Once we’ve established common understandings of the technical and operational requirements for 5G enabled devices, we can concentrate on the safety and effectiveness of the device,” said Ed Margerrison, Director, Office of Science and Engineering Laboratories (OSEL) at Center for Devices and Radiological Health (CDRH/FDA). He continued, “This will reduce the variables that we need to look at as a regulatory agency and accelerate patient access to this technology, which is one of the objectives here.”

“The working group – coordinated by MDIC through its public-private partnership platform in pre-competitive space – is uniquely positioned to identify the knowledge gaps, particularly in the regulatory science areas, and facilitate the integration of 5G technology in medical devices,” said Pamela Goldberg, MDIC President and CEO.

Topics and activities envisioned by this working group include:

  • Identifying medical device 5G use-cases and best 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

Organizations and individuals interested in taking part of this collaborative effort are encouraged to contact MDIC Data Science and Technology Program Director Jithesh Veetil for more information.