Citeline Podcasts
1,366 episodes - English - Latest episode: 3 days ago - ★★★★★ - 24 ratingsCiteline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.
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Episodes
Device Week, Aug. 10, 2018 – Cancer Center Steps Up To Pass Combo Product
August 10, 2018 17:11 - 7 minutes - 13.6 MBOn this week’s podcast, Medtech Insight’s Catherine Longworth and Ferdous Al-Faruque talk about surgical guidance company Endomag, which recently secured a landmark approval from US FDA for its combination breast cancer product Sentimag and Magtrace. Medtech Insight article addressing topics discussed in this episode: New Cancer Center Played Pivotal Role In Endomag's Success https://bit.ly/2MzCl6u
Endomag Combo Product Success Tied To New FDA Cancer Center
August 06, 2018 20:35 - 7 minutes - 13.4 MBUS FDA's new Oncology Center for Excellence brought in key experts to help review and approve Endomag's new Magtrace and Sentimag System combination product to help surgeons trace and remove breast tumors. The case highlights how disease-specific centers could change the way the agency reviews products.
Device Week, Aug. 1, 2018 – A Closer Look At Cancer Surgical Ablation
August 01, 2018 21:05 - 10 minutes - 18.6 MBDevice Week, Aug. 1, 2018 – A Closer Look At Cancer Surgical Ablation In this edition of Device Week, Medtech Insight’s Tina Tan chats to finds out more about the fast-growing market for surgical ablation devices to treat cancer. Marion Webb gives an insight into the speed at which the market is expanding and who are the emerging innovators. Catherine Longworth then discusses in more detail one of the more established players in this field, Medtronic, which has installed its Visualase syste...
Device Week, July 27, 2018 – Medicare And TAVR
July 27, 2018 17:20 - 9 minutes - 16.6 MBOn this week's podcast, Reed Miller talked about the Medicare Evidence Development & Coverage Advisory Committee's recent gathering to discuss transcatheter aortic valve replacement coverage policies and the debate over hospital and physician volume requirements. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Medicare Advisors Mo...
Tackling The AMR crisis
July 25, 2018 12:33 - 22 minutes - 50.7 MBThe issue of antimicrobial resistance (AMR) has been stalking global public health for a number of years - and governments, heath authorities and the international scientific community as a whole is finally starting to take action. In this podcast Mike Ward of Informa talks to Dr Peter Jackson, executive director of the AMR Centre, a public-private partnership, which is based at Alderley Park, Cheshire, and leads the UK response to the crisis.
Device Week, July 20, 2018 – VC Spending Up, M&A Down
July 20, 2018 01:08 - 9 minutes - 18.2 MBIn this edition of Device Week, Medtech Insight’s Tina Tan discusses trends in VC financing and M&A activity for medtech in 2018. Davide Filmore explains FDA’s latest approvals numbers, and Reed Miller gives an overview of the state of medical device approvals from outside the US. 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: VC Deals Analysis: Mega-Rounds Abound, As ...
Device Week, July 13, 2018 – Medtech’s Next Top Maturity Model, Part 3
July 13, 2018 17:27 - 11 minutes - 21.8 MBPart 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method. Medtech Insight articles addressing topics discussed in this episode: Boston Scientific, Edwards Lifesciences, Baxter...
Device Week, July 6, 2018–Clinical Data Presentations At ADA;Big Deals From GE, Novartis, Bio-Techne
July 05, 2018 17:30 - 10 minutes - 18.3 MBIn this edition of Device Week, Medtech Insight editor Marion Webb reports on the American Diabetes Association conference in Orlando and editor Reed Miller runs down the latest corporate restructuring news. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR m Medtech Insight articles addressing topics discussed in this episode: ADA2018: Insulet Reports Positive Clinical Results For Omnipod Horizon, Limited Market Release Of Dash https://bi...
Device Week, June 29, 2018 – Updates From US Congress And The Courts
June 29, 2018 18:32 - 9 minutes - 17.5 MBOn this week's podcast, we discuss medtech matters that US lawmakers have on their radars, and issues that are coming up in the courts. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Learn more about the Medtech Insight Awards and enter nominations: https://bit.ly/2tMcQYD. Medtech Insight articles addressing topics discussed in this episode: bioMérieux America CEO Talks Dx Reform Progress, Antibiotic Resistance: https://bit.ly/2yQBBHQ Servi...
Generics Bulletin Editor Discusses Industry Trends
June 28, 2018 14:36 - 11 minutes - 15.8 MBInforma Pharma Intelligence’s head of content Mike Ward and Generics Bulletin editor Aidan Fry discuss how US market pressures are making life tough for the generics industry.
Device Week, June 22, 2018 FDA Guidance And The MTI Awards
June 22, 2018 20:13 - 7 minutes - 13.4 MBOn this week's podcast, we provide a roundup of recent guidance documents issued by US FDA on topics including humanitarian use devices to off-label communications. We also discuss the Medtech Insight Awards. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Learn more about the Medtech Insight Awards and enter to win: https://bit.ly/2HqAuxv Medtech Insight articles addressing topics discussed in this episode: US FDA Tackles HDE 'Probable Bene...
Global Generics Podcast 2018
June 20, 2018 10:09 - 4 minutes - 7.58 MBListen to this podcast with Generics bulletin editor Aidan Fry and deputy editor David Wallace to find out: · Tips to write a nomination that gets noticed · How else you can be involved in the awards including complementary tickets · The benefits of sponsoring
Device Week, June 14, 2017 – Money Matters: Medtech M&A And VC Deal Trends
June 14, 2018 13:40 - 8 minutes - 15.3 MBIn this edition of Device Week, Medtech Insight’s Tina Tan and Catherine Longworth discusses the trends in M&A and venture fundraising activity seen this year so far. They touch on what areas are getting the most interest from investors and strategic buyers, and the most recent deals worth noting. 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: VC Deals Analysis: Posi...
Device Week, June 7, 2018 – Digital Health, Cybersecurity And Standards Conformance
June 07, 2018 18:46 - 8 minutes - 15.7 MBIn this week's podcast, we discuss the upcoming Medtech Insight Awards, digital health learnings, an uptick in Homeland Security alerts on device cybersecurity and a nascent US FDA program to improve use of standards in pre-market submissions. Listen to the podcast via the player below Links and Medtech Insight articles addressing topics discussed in this episode: Medtech Insight Awards https://bit.ly/2HqAuxv (Deadline for entries is June 22) Medtech Design In The Age Of Digital Health: Min...
Device Week for May 30, 2018 FINAL MP3
May 31, 2018 17:33 - 5 minutes - 10.2 MBHere’s the latest device week podcast.
Scrip Awards 2018 Preview with Alex Shimmings & Mike Ward
May 25, 2018 09:00 - 8.31 MBMike 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 tr...
Scrip Awards 2018 Preview with Alex Shimmings & Mike Ward
May 25, 2018 09:00Mike 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 tr...
Device Week, May 24, 2018 – Medtech’s Next Top Maturity Model, Part 2
May 24, 2018 20:25 - 22.6 MBIn 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...
Podcast: New MDIC CEO Talks Priorities, Vision
May 24, 2018 19:37 - 30.6 MBTwo 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.
Device Week, May 18, 2018 – Medtech’s Next Top Maturity Model, Part 1
May 18, 2018 19:18 - 26.2 MBOn 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 ...
Device Week, May 11, 2018 – Exoskeleton Report, BioTrinity Conference
May 10, 2018 20:22 - 19.2 MBOn 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.
New Accel Chair Talks Medtech Tax, Reimbursement, Women In Leadership
May 09, 2018 20:25 - 45.5 MBAdvaMed 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.
NSF's Trautman Talks MDSAP, Swapping FDA's QSR For ISO 13485, Regulatory Convergence, And More
May 09, 2018 16:05 - 62.4 MBFormer 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 nee...
Device Week, May 4, 2018 – Gottlieb At MDMA
May 04, 2018 19:36 - 11.1 MBOn 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.
FDA’s Patel Discusses Pre-Cert Working Model
April 26, 2018 21:19 - 19.2 MBUS FDA released a working model for their digital health pre-certification program as part of a broader Digital Health Action Plan. FDA's Bakul Patel spoke to Medtech Insight about what the agency is hoping to achieve with the new model.
Device Week, April 26, 2018 – On Patent Rulings And New Reimbursement Rates
April 26, 2018 15:48 - 6.75 MBIn this edition of Device Week, Tina Tan chats to Elizabeth Orr on recent patent rulings, one related to an ongoing battle between TAVR rivals Boston Scientific and Edwards Lifesciences and another related to the broader area of challenging patent judgements. She also speaks to David Filmore to find out more details about CMS’s annual hospital inpatient proposal which it has just issued and how the new reimbursement rates would impact industry. For more information on Medtech Insight and to...
Device Week, April 19, 2018 – FDA Safety Plan, Cybersecurity, Pivotal Clinical Trial
April 19, 2018 19:40 - 18.5 MBIn this week’s Medtech Insight podcast, we discuss US FDA Commissioner Scott Gottlieb’s big plan to boost medical device safety and quality, important news regarding cybersecurity, and the latest on a Medtronic clinical trial.
Device Week, April 11, 2018 – Israel's Digital Health Goal;A New Reality For Surgery Kicks In
April 11, 2018 13:09 - 17.8 MBIn this edition of Device Week, Tina Tan speaks to Catherine Longworth on Israel's push to become a global leader in digital health and Marion Webb on how science fiction is becoming reality in the operating room as surgeons take up technologies such as virtual, augmented and mixed reality to bring real benefits to patients. 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 episo...
What FDA Learned From BGMS Panel
April 03, 2018 20:38 - 10.3 MBAfter a meeting of FDA experts convened to talk about capillary blood glucose meters used in hospitals, Courtney Lias, division director of Chemistry and Toxicology Devices spoke to Medtech Insight about her takeaways.
Device Week, April 3, 2018 – US FDA Warning Letters Spotlight
April 03, 2018 20:31 - 15.5 MBOn this week's podcast, Shawn Schmitt discussed his recent reporting on US FDA warning letter trends, including a record-low letter count last year and what might be contributing. Medtech Insight articles addressing topics discussed in this episode: FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack https://bit.ly/2q39s8M
It's NTAP Season!
March 26, 2018 21:47 - 38.4 MBDuring the wait between the CMS NTAP town hall in February and the proposed rule on which products will receive an add-on payment, expected in April, Prevision Policy analysts Laura Helbling and Ramsey Baghdadi share their thoughts on drugs seeking NTAPs, recommendations by BIO and the Alliance for Regenerative Medicines to modify NTAP for regenerative medicines, and FDA’s stance that its Breakthrough and RMAT designations don’t mean the agency has determined a drug is an improvement over exi...
Device Week, March 22, 2018 – Brexit, And Where Things Stand For Medtech
March 22, 2018 18:24 - 42.1 MBOn this week's podcast, we discuss Brexit. UK and EU leaders announced some progress on Brexit this week, establishing a conditional transition period after the UK exits the Union in 2019. But that does not resolve many questions and concerns in the medtech space of what's to come. Here is a deep dive into where things stand. 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: B...
The Sarepta Precedent: The Good, The Bad, and The Ugly
March 16, 2018 17:48 - 33 MBA podcast discussion of three broader precedents stemming from the original Exondys 51 approval.
Device Week, March 13, 2018 - Israeli Medtech Industry, Glaucoma Week, February VC Deals Update
March 15, 2018 19:29 - 17.7 MBOn this week's Device Week podcast, we discuss the medtech scene in Israel, the state of the glaucoma-therapy field, and the latest venture capital investments in medtech.
Podcast: Accelerating Cancer Drug Development - From Target to Patients
March 12, 2018 16:11 - 29.3 MBAlderley Park, one of the UK's leading bio and life science campuses, has just hosted a new conference, Accelerating Cancer Drug Development - From Target to Patients. At the event Mike Ward spoke to two of SMEs based at the site in Cheshire about the challenges of growing a business in the oncology supply chain.
Device Week, March 8, 2018 – CMS Reorg, FTC Contact Lenses, Aneurysm Devices And Patents
March 09, 2018 21:12 - 15.2 MBOn this week's podcast, we discuss medtech policy developments at several federal agencies, including the US Centers for Medicare and Medicaid Services, the Federal Trade Commission, FDA and the US Patent and Trademark Office. For more information on Medtech Insight and to start a free trial, click here: bit.ly/2w7LnlR Medtech Insight articles addressing topics discussed in this episode: US CMS Coverage Office Reorganizes In Effort To Improve Efficiency http://bit.ly/2FvGtAY Contact Lens ...
Grading Gottlieb
March 06, 2018 21:52 - 44.8 MBFDA Commissioner Scott Gottlieb has been most effective, room for improvement, and what would make for a second successful year.
Medtronic Exec Talks About Neuro Panel Recommendations
March 02, 2018 20:30 - 10.5 MBMedtronic's Stacey Pugh talked to Medtech Insight after FDA's Neurological Devices Advisory Panel met to talk about how intracranial aneurysm devices should be evalauted in clinical trials. While she didn't find anything surprising about the panel's recommendations, she says it gives industry more clarity and consistency about the direction they need to take.
Device Week, Mar. 2, 2018 – Medtech Tackles Rheumatoid Arthritis And Trial Starts & Stops
March 02, 2018 18:28 - 18.2 MBIn this edition of Device Week, Medtech Insight’s Reed Miller and Marion Webb discuss what medtech’s role is in combatting rheumatoid arthritis and highlights some of the recent clinical trial initiations and completions. 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: Bioelectronics, Imaging Fortify Medtech's Defense Against Rheumatoid Arthritis Starts & Stops: Abbot...
Device Week, Feb. 23, 2018 - Down Patent Hole With Alice
February 23, 2018 20:05 - 7.95 MBFollowing a major Supreme Court patent case in 2014 that set a test for what is and is not patentable subject matter, medical device companies struggling to protect their software that is often considered not patentable. In this podcast we discuss the legal hurdles and what companies can do to push back.
Compliance 360° Part 13: Navigating The Quicksand Of Device/Drug Combo Products (2 of 2)
February 16, 2018 19:56 - 35.6 MBThis is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 13th installment – the second 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 podcast, Chase digs deep into design control, design changes, human factors studies and biocompatibility concerns for combo products. She also discusses some pre- and post-marke...
Device Week, Feb. 15, 2018 – New Advances In Neurostimulation And Investments In Innovation
February 15, 2018 10:04 - 15 MBIn this edition of Device Week, Medtech Insight’s Reed Miller chats to Marion Webb about the most interesting presentations by the key spinal cord stimulation players at this year’s NANS meeting in Las Vegas, and also finds out from Tina Tan how the venture financing climate has been for start-ups in January. 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: NANS 2018: P...
Compliance 360° Part 12: Navigating The Quicksand Of Device/Drug Combo Products (1 of 2)
February 12, 2018 20:23 - 24 MBThis 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 d...
Device Week, Feb. 9, 2018 – Last Night In Congress, And Digital-Health Discourse
February 09, 2018 19:07 - 17.2 MBOn 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 Fut...
MDMA’s Mark Leahey Talks Device Tax, Year Ahead
February 07, 2018 22:40 - 50.8 MBIn 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.
Exclusive: Patel Talks Pre-Cert Workshop
February 05, 2018 22:06 - 45.8 MBUS 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.
Device Week, Feb. 1, 2018 – Court wranglings over medtech patents and False Claims Act enforcement
February 01, 2018 13:13 - 11.1 MBIn 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 Il...
MDIC CEO Talks Long-term CMS Collaboration
January 29, 2018 23:08 - 26.1 MBThe 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.
Device Week, Jan. 25, 2017 – Strategic Priorities For US FDA Device
January 25, 2018 20:06 - 13.9 MBOn 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 Pla...
From Device Recalls To FDA Inspectional Changes, QA/RA Experts Must Leap Hurdles In 2018
January 19, 2018 15:25 - 21.2 MBDevice-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.