Citeline Podcasts

On this week's podcasts, David Filmore talks to Sue Darcey about the opioids bill enacted in the US this week, including an expansion of "sunshine" payment reporting requirements for device-makers. And Elizabeth Orr discusses some recently launched 510(k)-process pilot programs and questions industry has about them. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

Medtech Insight articles on topics addressed in this episode:

President Signs Opioids Bill Calling For Alternative Tech, More Pain-Control Research” https://bit.ly/2OPJpkX

Proposed 510(k) Changes Elicit Some Industry Skepticism: https://bit.ly/2CJIWtk

Expanded Sunshine Provisions Will Burden Industry, Yield Little, Attorneys Say: https://bit.ly/2ELuGmj

In this edition of Device Week, Medtech Insight’s Marion Webb gives an overview of her new Market Intelligence article on innovative digital technologies applied to cardiology and Catherine Longworth reports on a Hermarina – a company in Brittany helping to build France’s ‘blue economy’ based on marine resources – which has developed several products, including a blood-replacement therapy, from a certain type of sandworm.

For more information on Medtech Insight and to start a free-trial, click here.

https://bit.ly/2BbtrcT

Medtech Insight articles on topics addressed in this episode:

Minister's 'Upfront' Approach On Brexit Can Be Blueprint For Wider UK Industry Engagement

https://bit.ly/2BbtrcT

Apple And Zimmer Biomet To Study Patient Experience With Joint Replacement Surgery

https://medtech.pharmaintelligence.informa.com/MT123436/Apple-And-Zimmer-Biomet-To-Study-Patient-Experience-With-Joint-Replacement-Surgery

US FDA Commish Defends Approach To Apple Approvals

https://medtech.pharmaintelligence.informa.com/MT123353/US-FDA-Commish-Defends-Approach-To-Apple-Approvals

Medtech Insight senior reporters Ferdous Al-Faruque and Sue Darcey talk about how the upcoming US midterm elections could shake things up for the medical device industry in this week’s podcast.

Medtech Insight articles addressing topics discussed in this episode:

• Lots of Oversight But Little Legislation Expected If Dems Take House https://bit.ly/2QL6bqs

• Device Industry Champion Erik Paulsen In Tough Election Fight To Retain House Seat https://bit.ly/2yvmCj2

In this edition of Device Week, Medtech Insight’s Reed Miller and Catherine Longworth discuss the efforts of national, regional, and local governments to bring in medtech investment, discussing examples from Lithuania, Ireland, and Texas.

Brexit Trade Deal Must Wait, But UK Medtech Sector Finds Reasons To Be Cheerful

https://bit.ly/2xZ6Uxt

UK Device Manufacturers Must Contingency Plan For A Hard Brexit

https://bit.ly/2yl82IO

Innovation Driving Ireland's Transition From Medtech Supplier To Strategic Partner

https://bit.ly/2xyBU4U

Coinciding with Cybersecurity Awareness Month in October, FDA’s Suzanne Schwartz talked to Medtech Insight about a slew of related initiatives to bolster connected security on medical devices but argues however the agency needs more resources to be effective.

On this week's podcast, we discussed some key takeaways from this week's MedTech Conference, including a significant focus on the need for device companies to become data companies and establish new ways to directly engage patients to compete in the new digital reality. Also, some FDA digital health updates, and discussion of the China tariffs. 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:

The Medtech Conference: Industry Is Falling Short In Digital Investments https://bit.ly/2OpfP4M

Jeff Shuren Talks Breakthrough Bonanza, TPLC And Innovating Safety https://bit.ly/2Qa2iLx

AdvaMed Chair Nadim Yared Talks Challenges, Priorities https://bit.ly/2IpWZoy

Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must jump to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.

Medtech Insight articles addressing topics discussed in this episode:

• Assessing A Device-Maker's Manufacturing Capability Is Serious Business For These 2 Longtime CMMI Appraisers. Here’s Their Story https://bit.ly/2pnSFNR

• FDA Staffers, Device Firm Employees Are Training As Appraisal Team Members For CMMI Maturity Model Pilot https://bit.ly/2MR6D40

• Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience https://bit.ly/2K69U34

• Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised https://bit.ly/2K6TWRV

• Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites https://bit.ly/2jGPlL1

After announcing his departure from AdvaMed, JC Scott, the long running chief advocacy officer, and his successor Greg Crist, the current top public affairs officer, talked to Medtech Insight about their legislative agenda and future priorities.

In this edition of Device Week, Medtech Insight’s Reed Miller talks to editor David Filmore about the latest good news for LivaNova and London-based reporter Catherine Longworth provides and update on Creavo Medical, a UK-based company using an old technology for a new kind of cardiac diagnostic that could save hospitals a lot of money in the treatment of patients suspected of having a heart attack.

For more information on Medtech Insight and to start a free trial

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Start-Up Spotlight: Creavo Medical, Diagnosing Myocardial Ischaemia With MCG

NICE Endorses Sutureless Aortic Valves While LivaNova Reaches Study Milestone

TRD Societal Cost Can Sway US Payer On VNS Coverage Decision

CDRH Director Jeff Shuren spoke to Medtech Insight at the MDIC Annual Forum about a risk-benefit uncertainty guidance US FDA released that day. He says he hopes the guidance will provide clarity to industry about the circumstances when FDA will accept different levels of uncertainty.