Global issues stir debate at the 2018 MedTech Conference

Global issues stir debate at the 2018 MedTech Conference
by Donald Johnston
Senior Marketing Communication Director, Life Sciences, Clarivate Analytics
Life Sciences Connect

News from the global stage resonated throughout the MedTech Conference as the industry gathered in Philadelphia for AdvaMed’s annual meeting.  Among the liveliest sessions were those focused on the future of the clinical trials landscape in the U.K. as a result of Brexit, the impact of trade wars on the industry, and Jeff Shuren, the FDA’s CDRH director, weighing in on the Medical Device Single Review Program and many other key regulatory issues.

This article features excerpts from a collection of recent regulatory updates from BioWorld MedTech, the daily medical device and diagnostics news service from Clarivate Analytics.

 

Specter of no-deal Brexit looms over session

Questions about running clinical trials in the U.K. and Horizon 2020 took center stage at the MedTech Conference in late September, with one audience member expressing doubt that a no-deal Brexit is unlikely. “It isn’t nothing, but equally it’s not everything,” said Lord James Richard O’Shaughnessy, Parliamentary Under Secretary of State at the Department of Health, in a session that sought to emphasize that the U.K. will remain open for business, irrespective of Brexit. He attempted to explain what to expect ahead of the March 29, 2019, Brexit date.

“I spent a huge amount of time with my EU colleagues – health ministers, people with the commission – and I think there’s actually very deep understanding about what’s at stake, particularly in health care because of the benefits that the EU and U.K. working together bring,” he noted. He highlighted manufacturing, research and regulations as examples. He added that there is uncertainty, which affects investing and purchasing decisions, “and we want to get beyond that point.”

I spent a huge amount of time with my EU colleagues – health ministers, people with the commission – and I think there’s actually very deep understanding about what’s at stake, particularly in health care because of the benefits that the EU and U.K. working together bring.”
– Lord James Richard O’Shaughnessy, Parliamentary Under Secretary of State at the Department of Health

To read the full article, download our October 2018 MedTech update here.

 

Panel sees few good options for dealing with China on trade

The question of U.S. trade with China is front and center in the Trump administration’s policy agenda, and a panel discussion at this year’s MedTech Conference concluded that Beijing does indeed abuse its trade privileges. Most of the levers available to Washington may have a middling effect at best on China’s high baseline tariffs and rampant intellectual property theft, leaving device makers doing business with this Asian colossus with a massive overhang of uncertainty.

To read the full article, download our October 2018 MedTech update here.

 

Shuren unveils progress on IMDRF docs, cybersecurity

Fresh off the International Medical Device Regulators Forum (IMDRF) management committee meeting in Beijing, CDRH Director Jeff Shuren provided an overview of what the group decided at its latest get together, unveiling a new working group and detailing other initiatives.

“I’m going to tell you what the management committee decided. This is not out publicly yet,” Shuren told the session’s audience at the MedTech Conference, adding that the body will increase the number of its current working groups from seven to eight.

To read the full article, download our October 2018 MedTech update here.

 

Shuren says IMDRF still out on single review; FDA moving ahead

The FDA town hall at the various med-tech meetings usually offers at least an update on recent developments, and Shuren advised attendees at the MedTech Conference that the IMDRF is still not quite sold on the Medical Device Single Review Program (MDSRP). Still, Shuren said, the FDA’s device center is “already moving unilaterally to make some changes to get us there” on MDSRP.

Shuren addressed an audience on the last day of this year’s conference, and tackled a range of topics, including the ongoing effort to realign the operations at the CDRH. He noted that even though the IMDRF has not formally signed on to the single review concept, the building blocks of that program are nonetheless going into place.

 

Read the October MedTech update here.

 

This article was excerpted from a new compilation of regulatory updates written by BioWorld MedTech Staff Writer Liz Hollis and BioWorld MedTech Regulatory Editor Mark McCarty, who are both based in the U.S. BioWorld MedTech is the global news service providing med-tech updates and analysis from Clarivate Analytics. To access the full report, please click here.

For more information about BioWorld MedTech and to learn how you can subscribe today, visit: Clarivate.com/products/bioworld-medtech.

For more information about how you can better track the latest in medical device global regulations, visit: https://clarivate.com/products/cortellis/cortellis-regulatory-intelligence/

Speak to our team

Want to learn more about our range of products?

Contact us

Clarivate

Accelerating innovation