Citeline Podcasts

Here’s the latest device week podcast.

Alexandra Shimmings, Executive Editor (Europe, Commercial) for Scrip, Pink Sheet and In Vivo. Joins Mike Ward, Chief Content Officer at Datamonitor Healthcare & Scrip Intelligence to deliver a preview of the 14th Annual Scrip Awards.

Entries are now open for the 14th Annual Scrip Awards. Since they began, the Scrip Awards has sought to applaud the essential role that the pharmaceutical, biotech and other allied industries play in improving healthcare. Its trophies span the entire range of industry activities, from new drug launches and clinical trials, to innovative deals, outsourcing and fundraising.

This year, we have introduced a new category – Best Use of Real-World Evidence – to reflect the growing importance of real-world evidence to the sector in understanding the value of drugs in the market and not just the highly controlled environment of the clinical trial.

Over the past 13 years, The Scrip Awards has carved out a unique place in the industry calendar, with around 500 attendees coming from around the world to the prestigious ceremony, which this year will take place in the London Hilton on Park Lane in Mayfair on 28 November.

Enter Here: https://pharmaintelligence.informa.com/events/awards/scrip-awards-2018

Mike Ward, the Global Head of Content at Informa, Pharma Intelligence Insights and Alex Shimmings, Executive Editor (Europe, Commercial) for Scrip, Pink Sheet and In Vivo. Present a preview of the the 14th Annual Scrip Awards.

This year, we have introduced a new category – Best Use of Real-World Evidence – to reflect the growing importance of real-world evidence to the sector in understanding the value of drugs in the market and not just the highly controlled environment of the clinical trial.

Over the past 13 years, The Scrip Awards has carved out a unique place in the industry calendar, with around 500 attendees coming from around the world to the prestigious ceremony, which this year will take place in the London Hilton on Park Lane in Mayfair on 28 November.

The deadline for entries is June 1. Now is the time to prepare your entry and make sure you take your place among the best.

ENTER HERE: https://pharmaintelligence.informa.com/events/awards/scrip-awards-2018

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In this week’s podcast, part 2 of our multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed. Author Shawn M. Schmitt explains what happens when a device-maker is appraised using the Capability Maturity Model Integration (CMMI) model and method, from the first intake calls to the last day of the assessment, when the final appraisal results are given to a firm.

Medtech Insight articles addressing topics discussed in this episode:

• 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

Two months into the job, MDIC CEO Pamela Goldberg talks about the organizations work running the NEST Coordinating Center, early feasibility studies and its work with US FDA on Case for Quality.

On this week's podcast, Shawn M. Schmitt talks about his first story in a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. An ongoing US FDA pilot program – which uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method – is discussed.

Medtech Insight articles addressing topics discussed in this episode:

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

• 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

On this week’s podcast, Marion Webb reports on emerging exoskeleton technology to help patients recovering from spinal cord injuries or stroke, and Catherine Longworth reports on BioTrinity 2018 in London, a gathering of investors and medtech innovators.

AdvaMed Accel's Martha Shadan and Ashley Wittorf sat down with Medtech Insight to talk about their lobbying priorities for medtech start-ups and small businesses.

Former longtime US FDA official Kim Trautman, now with NSF International, sat down with Medtech Insight at MedCon 2018 for a podcast interview to discuss an array of industry issues, including the burgeoning Medical Device Single Audit Program, international regulatory convergence, FDA's percolating plan to replace the Quality System Regulation with ISO 13485, what keeps her up at night (hint: it's EU's new Medical Device and IVD Regulations), and other important issues that device-makers need to keep a sharp eye on.

On this week's podcast, Sue Darcey talks about some key takeaways from FDA Commissioner Scott Gottlieb's appearance at the Medical Device Manufacturers Association conference in Washington, DC, including some assurances on combination-product and pain-control-device reviews.