Citeline Podcasts

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 12th installment – the first of two parts – former FDA investigations branch director Ricki Chase brings you the latest insights into the complexity surrounding combination device/drug products. In this first podcast, Chase reviews regulations and guidance documents related to combo products. She also highlights the varying types of combo products, definitions unique to device design, and how combo product manufacturers differ from the typical medical device or drug firm.

On this week's podcast, we discuss US Congress' last-minute budget deal that included several Medicare provisions relevant to the medtech sector. And we also talked about US FDA's recent two-day workshop on its Pre-Cert Pilot Program for digital health.

Medtech Insight articles addressing topics discussed in this episode:

• Medtech Provisions Approved In US Budget Agreement: http://bit.ly/2H2dWEh

• Coming Together On Pre-Cert: Digital Health World Engages With FDA To Hash Out Regulatory Future: http://bit.ly/2Et48F0

• DC Reflections: Mark Leahey On MDMA's 2018 Priorities And The Medtech Landscape: http://bit.ly/2EbSLls

In a phone interview with Medtech Insight, MDMA CEO Mark Leahey talked about the industry group's ongoing efforts to fully repeal the medical device tax, 2018 priorities, the emerging digital health sector and more.

US FDA, industry and other stakeholders huddled at NIH for a two-day workshop at the end of January that resulted in deep discussions around how the agency should implement its Pre-Cert Program for software as medical devices. In an exclusive with Medtech Insight, CDRH's Bakul Patel explained the purpose of the confab was to understand how companies realistically operate so they can build the program with those considerations in mind.

In this edition of Device Week, Medtech Insight’s Tina Tan chats to Elizabeth Orr about court developments in False Claim Act enforcement and its impact on the medical device sectors, as well as ongoing patent battles among industry players.

For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

Medtech Insight articles addressing topics discussed in this episode:

'Escobar' Conundrum: 2017's Biggest Story In Medtech False-Claims Enforcement

Illumina Awarded $26.7m In Patent Row

The outgoing MDIC CEO Bill Murray says even though he's leaving the organization, he's excited about a number of long-term projects including one that could help better understand the evidence requirements sponsors should consider in the pre-market trials to satisfy CMS requirements.

On this week's podcast, Ferdous Al-Faruque and David Filmore discuss the three-year strategic priorities for FDA's device center a recent interview with center director Jeff Shuren. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

Medtech Insight articles addressing topics discussed in this episode:

• FDA's US-First Strategy: Device Center Sets Three-Year Goals

• Podcast Exclusive: Jeff Shuren Discusses FDA's Device Strategic Priorities

The Place To Be At FDA In 2018? Office Of Product Evaluation and Quality

Device-makers could be in for a change to how they handle product recalls now that US FDA is reevaluating its processes for market withdrawals. That's according to longtime device industry expert Steve Niedelman, who also points out other hot topics that quality and regulatory professionals need to keep a sharp eye on this year – such as the device center's "Total Product Life Cycle" approach and next moves in its "program alignment" inspection scheme – in this Medtech Insight podcast.

In this edition of Device Week, Medtech Insight’s Reed Miller, David Filmore and Catherine Longworth look back at the past year and the key trends in US and international product approvals, as well as in M&A activity. They also give their perspectives on what to look forward to in 2018.

For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

Medtech Insight articles addressing topics discussed in this episode:

M&A Analysis: M&A Rises In 2017 As Market Set To Bounce Back In 2018 - https://medtech.pharmaintelligence.informa.com/MT121985/MampA-Analysis-MampA-Rises-In-2017-As-Market-Set-To-Bounce-Back-In-2018

US Approvals Analysis: Hits Just Keep On Coming. Can It Last? - https://medtech.pharmaintelligence.informa.com/articles/2018/01/17/us-approvals-analysis-hits-just-keep-on-coming-can-it-last

Global Approvals Analysis: Emerging Markets Drive Volume Of OUS Approvals - https://medtech.pharmaintelligence.informa.com/MT122053/Global-Approvals-Analysis-Emerging-Markets-Drive-Volume-Of-OUS-Approvals

CDRH Director Jeff Shuren sat with Medtech Insight in an exclusive interview to talk about his latest strategic priorities for the center over the next three years. They include improving employee engagement, creating more collaborative communities and streamlining the device center’s core processes.