Citeline Podcasts

In this week’s podcast, Medtech Insight's US Commercial manager Reed Miller provides an overview of Medtronic’s “refreshed brand” on environmental, social and governance targets. Managing editor Marion Webb highlights her deep-dive pieces on CEO post-pandemic perspectives while UK-based reporter Barnaby Pickering provides an analyst perspective on price targets following poor SPAC reception.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

CEO Perspectives: COVID Impacts On Supply Chain, Digital, At-Home Care, And Medtech’s Place In ‘Food Chain’

Leading Medtech CEOs Say Health Equity, Environmental Work Will Outlast Pandemic

Analyst Insight: Justifying A Price Target Following Poor SPAC Reception

Medtronic ‘Refreshes Brand,’ Announces New Environmental, Social, and Governance Targets

Leading Medtech CEOs Say Health Equity, Environmental Work Will Outlast Pandemic

In this episode of Speaking Of Medtech we talk about arguably one of the biggest regulatory changes to come down the pike in decades: the ongoing harmonization of the US FDA’s QSR, which is going to broadly change the way the agency handles medical device quality oversight.

Medtech Insight articles addressing topics discussed in this episode:

• QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg

• QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo

• FDA’s Draft QSR: ‘Lucy’ Pulled The Football Away. Again

Scrip’s Five Must-Know Things – 1 November 2021 by Citeline

On this week’s podcast: The US FDA put some teeth to its regulation of the implants by issuing several new mandates, including a requirement that surgeons warn patients about the risks of the devices prior to surgery. Also this week the agency released its annual list of priority guidance documents.

Medtech Insight articles addressing topics discussed in this episode:

• FDA Strengthens Safety Requirements For Breast Implants

https://medtech.pharmaintelligence.informa.com/MT144648/FDA-Strengthens-Safety-Requirements-For-Breast-Implants

• FDA Guidance Priorities For FY 2022 Include Transitioning EUAs; List Includes CDS Software Again

https://medtech.pharmaintelligence.informa.com/MT144629/FDA-Guidance-Priorities-For-FY-2022-Include-Transitioning-EUAs-List-Includes-CDS-Software-Again

Pink Sheet reporters and editors discuss the issues that could arise when the COVID-19 vaccines are given to children age 5 to 11, Merck’s agreement to share the license for its proposed oral COVID-19 treatment, and problems for a sponsor blocked by an accelerated approval conversion to full approval.

Boehringer Ingelheim India Chief On Strategy, Jardiance Challenge, Gender Balance In Pharma by Citeline

Scrip’s Five Must-Know Things – 26 October 2021 by Citeline

Following the publication of its Self-Care Readiness Index, HBW Insight's David Ridley speaks to Global Self-Care Federation chair Heiko Schipper about what it takes to build a worldwide movement for self-care. We also discuss how industry players like Bayer Consumer Health - which Schipper heads up as division president - can contribute, for example as 'truth leaders' in an age of misinformation and public mistrust and as partners for community pharmacy, which still has an important role to play in the 21st century.

In this edition of Device Week, Medtech Insight’s Reed Miller discusses some important news from Medtronic and Marion Webb reviews the first of two feature articles on the impact of the pandemic on the medtech industry around the world.

Listen to the podcast via the player below:

The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider.

Medtech Insight articles addressing topics discussed in this episode:

https://medtech.pharmaintelligence.informa.com/MT144610/Market-Intel-Lessons-Learned-From-COVID-19-A-Global-Perspective-On-Digital-Health-Transformation

https://medtech.pharmaintelligence.informa.com/MT144592/Medtronic-Pushes-Completion-Of-Pivotal-Renal-Denervation-Trial-To-Late-2022

https://medtech.pharmaintelligence.informa.com/MT144582/Medtronic-Refreshes-Brand-Announces-New-Environmental-Social-and-Governance-Targets

In this episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more.

Medtech Insight articles addressing topics discussed in this episode:

• Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark US/UK Clinical Trials

https://medtech.pharmaintelligence.informa.com/MT123493/Breathing-Easy-ALung-CEO-Talks-Novel-Hemolung-Device-FDAs-Breakthrough-Pathway-Landmark-USUK-Clinical-Trials

• US Breakthrough Devices Tracker

https://medtech.pharmaintelligence.informa.com/datasets/us-breakthrough-devices