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, Jan. 18, 2018 – Approvals And M&A: Looking At The Past and Into The Future
January 18, 2018 07:01 - 20 MBIn 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 ...
Exclusive: CDRH’s Shuren Talks New Strategic Priorities With Medtech Insight
January 17, 2018 17:57 - 27.8 MBCDRH 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.
Device Week, Jan. 12, 2018 – Tracking Unfinished Medtech Business In The US Congress
January 12, 2018 17:21 - 14.7 MBStory referenced in this podcast: Medtech's Unfinished Business For Congress In 2018: What's Ahead - https://medtech.pharmaintelligence.informa.com/MT121983/Medtechs-Unfinished-Business-For-Congress-In-2018-Whats-Ahead
Device WDevice Week, Jan. 4, 2018 – Making no bones about EU ortho surgical growtheek January 04
January 04, 2018 10:33 - 17.4 MBIn this edition of Device Week, Medtech Insight’s Tina Tan chats to Marion Webb about key trends in orthopedic and spine procedures in the EU’s five key markets: Germany, France, UK, Spain and Italy. These include which procedures are expected to grow the fastest and why. 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: EU Ortho Close-Up: Rising, But Varying Orthopedic/S...
Device Week, Dec. 20, 2017 – Medtech Regulatory Landscape In 2018
December 20, 2017 11:14 - 19.6 MBOn this week's podcast, David Filmore discusses with Shawn M. Schmitt some of important dynamics that will impact medtech regulations globally in 2018, with a focus on the US, Europe and Asia. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight content addressed in this episode: Interactive Timeline: Global Regulatory Deadlines: http://bit.ly/2An8xn8 5 Ongoing US FDA Device Center Pilot Programs: A Listing: http://bit.ly/2kmlx71 ...
Device Week, Dec. 14, 2017 - MTI 100
December 14, 2017 19:17 - 12.3 MBOn this week's podcast, we discuss our latest MTI 100 rankings, providing a view on top revenue-getters in the medtech space and what issues are driving up and down movements on the list. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.
CARE Awards 2018: How to win an Award
December 11, 2017 10:00 - 14.5 MBThe deadline for entries to the CARE Awards is fast approaching! In this podcast, Doro Shin, Head of Pharma Intelligence Thought Leadership, speaks to Citeline’s Executive Director, Karen Currie, chair of the CARE Awards judging panel about how enter and how best to enhance one’s chances to win one of the CARE Awards categories.
Device Week, Dec. 6, 2017 – How Investigator Familiarity Breeds Recalls, Poor Quality
December 06, 2017 20:09 - 15.7 MBOn this week’s podcast, we highlight an eye-opening study that shows that the chummier a device-maker is with US FDA investigators, the more likely it is that those firms will experience quality system troubles and face costly product recalls.
Device Week, Nov. 30, 2017 – Eyes on fast-growing micro-invasive glaucoma surgery market
November 30, 2017 12:38 - 17.2 MBIn this edition of Device Week, Medtech Insight’s Tina Tan chats to Marion Webb about the ophthalmic surgical devices market, specifically the smallest but fastest-growing segment of micro-invasive glaucoma surgery (MIGS) devices. Marion gives an insight into some of the emerging players in this space and the feedback from clinicians who have used MIGS devices in their practice. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR Medtech Ins...
Device Week, Nov. 23, 2017 – Implementing The EU Regs
November 21, 2017 22:15 - 37.5 MBIn this week's podcast, Amanda Maxwell talks about where things stand and the big challenges ahead for implementation of the EU Medical Device and IVD Regulations. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles addressed in this episode: New 'Transitional Measures' Taskforce To Answer EU's Most Critical Questions EU Roadmap: Catalyst For More Work, And A Long Way To Go EU Commission May Be Swamped As Notified Bodies R...
AdvaMed CEO Talks Azar, Device Tax, Legislative Strategy
November 17, 2017 20:56 - 29.4 MBIn a Medtech Insight exclusive, AdvaMed CEO Scott Whitaker talked about advising Trump HHS nominee Alex Azar on his confirmation process, frustration with permanently repealing the medical device tax, potential for another temporary tax moratorium and lobbying priorities for 2018.
An Inside look at Intuitive Surgical
November 09, 2017 18:24 - 39.7 MBRobotics surgery is one of the hottest and fastest-growing markets that has long been dominated by one player, Sunnyvale, California-based Intuitive Surgical. Medtech Insight sat down with Catherine Mohr, Intuitive’s VP of Strategy, to talk about the new da Vinci Sp, expected to be released in 2018, the competitive landscape and where the innovator foresees new opportunities and technologies ahead.
Device Week, November 9, 2017 - US Supreme Court Preview
November 09, 2017 18:21 - 12.3 MBOn this week's podcast, we discuss some cases that might come up in the current session of the US Supreme Court and have an important impact on the device industry – in the realm of patent reviews and consumer and state lawsuits. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles addressed in this episode: US Supreme Court Preview: Cases To Watch For Medtech http://bit.ly/2yN9ZTx To Change How Courts View 510(k) Cleara...
Rose Report - October 2017
November 08, 2017 23:22 - 15.7 MBRose Sheet’s editorial team counts down top news items in the cosmetics and dietary supplement sectors over the past month. On the cosmetics side, we discuss the newly proposed FDA Cosmetic Safety and Modernization Act, J&J talc litigation, emerging class action threats, ISO 16128 natural/organic guidelines and EU REACH compliance costs; for dietary supplements, Hi-Tech Pharmaceuticals’ legal woes, Amarin’s failed omega-3 fair-trade complaint, pre-DSHEA ingredients and more.
Device Week, Nov. 2, 2017 – More M&A, Merck and Med In Ireland
November 02, 2017 13:09 - 18.1 MBIn this edition of Device Week, Medtech Insight’s Tina Tan chats to Catherine Longworth about the recent surge in M&A deal-making and wonder if this would impact 2017’s overall outlook. They also chat about Merck’s ambitions to be an all-round leader in fertility treatment, for both drugs and devices and what makes Ireland continue to be an attractive medtech hub for generating innovation. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR M...
Compliance 360° Part 11: Turn Your CMO Nightmare Into A Dream Come True (2 of 2)
October 30, 2017 16:07 - 16.3 MBThis is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 11th installment – the second of two parts – former FDA investigations branch director Ricki Chase discusses some of the more complex problems that may arise in the relationship between the owners of regulated products and contract manufacturing organizations (CMOs), and how to solve them.
Device Week, Oct. 27, 2017 – The Power Of Artificial Intelligence
October 27, 2017 22:32 - 13.3 MBOn this week’s podcast, we talk about how artificial intelligence is being used in the quality and regulatory arenas to review, sort and process big data to find quality systems or product problems.
A Conversation About Cybersecurity With Medtech Industry Advocates
October 26, 2017 20:35 - 47.1 MBIn a broad chat with top officials at AdvaMed, and the Health Care and Public Health Safety Sector Council, Medtech Insight dives into what the groups have been up to to encourage better cybersecurity on medical devices and how they see the world evolving.
Compliance 360° Part 10: Turn Your CMO Nightmare Into A Dream Come True (1 of 2)
October 23, 2017 14:34 - 19.5 MBThis is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 10th installment – the first of two parts – former FDA investigations branch director Ricki Chase explains how owners of regulated products can learn "tricks" to managing their relationships with contract manufacturing organizations (CMOs) to avoid being "treated" to an FDA-483 inspection observation form.
Device Week, October 19, 2017 – IVD Updates, And Watchman Scrutiny
October 19, 2017 19:55 - 17.8 MBOn this week's podcast, we highlight progress by several startups in the molecular diagnostics space, and discuss growing scrutiny in the cardiology community of Boston Scientific's Watchman stroke device. For more information on Medtech Insight and to start a free trial, click here: bit.ly/2w7LnlR Medtech Insight articles addressed in this episode: • genedrive Signs Sysmex To Distribute Decentralized-Setting HCV Test: http://bit.ly/2zmkpW3 • MDxHealth Gears Up For Major EU Growth: http://b...
Partnering In The Pharma World Podcast
October 17, 2017 16:23 - 23.7 MBPartnering In The Pharma World Podcast • life science partnering conference • Bio Europe 2017 • 23RD Annual International Partnering Conference • Partnering in the Pharma World
Device Week, Oct. 12, 2017 – Tomorrow’s Technologies At The Medtech Conference; M&A Keeps A-Pace
October 12, 2017 06:53 - 18.3 MBIn this edition of Device Week, Medtech Insight’s Tina Tan chats to Marion Webb about AdvaMed’s annual Medtech Conference held at the end of September and which were the most interesting startups showcased at the meeting. She also speaks to Reed Miller to discuss the more notable M&A deals that have happened in this recent surge of acquisition activity. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR Medtech Insight articles addressing t...
Rose Report - September 2017
October 06, 2017 16:14 - 16.4 MBRose Sheet’s editorial team counts down top news items in the cosmetics and dietary supplement sectors over the past month, including possible cosmetics regulatory convergence under a renegotiated NAFTA, the FTC’s first enforcement action against social media influencers, FDA movement to develop a list of “old dietary ingredients” pre-dating DSHEA, and more.
Device Week, October 5, 2017 – Big Moves At FDA
October 05, 2017 21:46 - 16.4 MBOn this week’s podcast, we discuss big announcements from FDA at AdvaMed’s recent MedTech Conference on digital health policy and an upcoming device-center reorganization, as well as the recent resignation of Tom Price as US HHS secretary. 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: 'Excellence' In Health-Software Design: US FDA Taps Nine Firms To Figure Out What Th...
Shuren Discusses New ‘Super Office’
September 29, 2017 19:12 - 26 MBCDRH Director Jeff Shuren talked to Medtech Insight at this year’s Medtech Conference about the planned “super office” at the agency that would take over the roles of a number of critical offices and upend the center’s bureaucratic structure.
Device Week, Sept. 28, 2017 – Social Media And Health; New Heart Player On Horizon
September 28, 2017 11:29 - 15.9 MBIn this edition of Device Week, Medtech Insight’s Tina Tan and Catherine Longworth discuss the increasing body of research into social media’s role in health care, including the use of platforms like Instagram to monitor patients’ behavior and potentially screen for mental health issues. They also take a look more closely at acute heart failure therapy specialist Magenta Medical, whose $15m series B round was among September’s batch of venture financing deals, and see what makes this start...
Bakul Patel Discusses PreCert Pilot Winners
September 26, 2017 17:00 - 14.6 MBFDA Commissioner Scott Gottlieb announced the agency had selected Apple, Verily, Samsung and Fitbit among the nine companies that will participate in its Pre-Certification Program at this years The MedTech Conference. The top FDA official leading the effort Bakul Patel spoke to Medtech Insight about their selection process and what’s next.
AdvaMed Wants Device Tax Full Repeal, Could Consider Temporary Moratorium
September 25, 2017 22:33 - 9.86 MBSpeaking to reporters at AdvaMed's annual 2017 Medtech Conference in San Jose, Scott Whitaker and Nadim Yared, president and chairman of the medical device lobby group, talked about their ongoing medical device repeal efforts and possible acceptance of a temporary moratorium instead of a full repeal.
Top FDAer Chats About Recent 3D Printing Workshop
September 25, 2017 13:33 - 17 MBFDA recently had a chance to talk face-to-face with additive manufacturing stakeholders at its Maryland headquarters. James Coburn, a senior engineer at FDA's device center, chatted to Medtech Insight after the meeting to talk about what he learned and what he thinks will be the next step with this rapidly evolving technology.
Device Week, September 22, 2017 – How FDARA Will Change US FDA Inspections
September 22, 2017 15:47 - 16.4 MBDiscover upcoming tweaks to the agency’s facility inspection approach on this week's Medtech Insight podcast. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR Medtech Insight article addressing topics discussed in this episode: US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say : http://bit.ly/2xnAXgy
Device Week, September 14, 2017 – Product Approvals Spotlight
September 14, 2017 20:14 - 12.3 MBOn this week's podcast, we discuss Medtech Insight's August analysis of global device approval trends. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
FDA Commish Wants More 'Systematic' Review Of Regulations
September 12, 2017 13:43 - 6.04 MBFDA’s Scott Gottlieb says the agency has gone through periodic reviews of regulations on a random basis and would like to see a "systematic process" to continuously evaluate whether regulations need to be updated or withdrawn.
FDA Commish Wants More 'Systematic' Review Of Regulations
September 12, 2017 13:40FDA’s Scott Gottlieb says the agency has gone through periodic reviews of regulations on a random basis and would like to see a "systematic process" to continuously evaluate whether regulations need to be updated or withdrawn.
Device Week – The Impact Of 510(k) Exemptions, September 7, 2017
September 07, 2017 19:45 - 8.96 MBUS FDA recently exempted hundreds of device types from 510(k) submissions under a 21st Century Cures Act mandate. On this week's podcast, we discuss Medtech Insight's exclusive analysis of the impact of the exemptions on companies and FDA. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Device Week, Sept 1, 2017: POC Testing And Eye Drug Delivery Trends
August 31, 2017 15:06 - 23.2 MBDevice Week, Sept 1, 2017: POC Testing And Eye Drug Delivery Trends In this edition of Device Week, Medtech Insight’s Marion Webb and Tina Tan look more closely at the drivers that are accelerating the move away from centralized lab testing towards point-of-care settings like retail pharmacies, and highlight the challenges that still need to be addressed. They also delve into the ophthalmic space and look at what ocular drug delivery innovations are being developed to help fuel the fast grow...
Device Week - FDA Reauthorization Act Is Law
August 24, 2017 17:51 - 17.7 MBOn this week's podcast, Medtech Insight's David Filmore and Ferdous Al-Faruque discuss the recently enacted FDA Reauthorization Act. It comes with higher industry fees, but also a host of FDA commitments and reforms. The legislation was broadly supported by lawmakers and industry alike, but President Trump? Not so much. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Device Week – The Summer Of M&As, Aug. 21, 2017
August 18, 2017 19:24 - 11.4 MBIn this week's Device Week podcast, we look at recent mergers and acquisitions. While the year starter out slow, July was the busiest month for medtech M&A deals. A this rate the industry is set to break last year's deal count. We go in-depth into some of the major deals and more. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR
Device Week – Global Regulations Update, Aug. 9, 2017
August 09, 2017 20:17 - 31.8 MBWant to know more about medtech regulatory efforts in countries from Singapore to Myanmar to Russia, and more in between? In this week's podcast, Ashley Yeo provides an update from his reporting on what governments in the Asia and Eurasia regions are doing to focus on devices and diagnostics. Short answer: a lot. Medtech Insight articles addressing topics discussed in this episode: Medtech Associations Regulatory Networking, July 2017 – Singapore, the Philippines, Myanmar: http://bit.ly/2wuW...
Device Week – Earnings Takeaways
August 04, 2017 14:59 - 17.6 MBEarnings season is in full swing with most big medtech names having already reported their latest quarterly results. In our Aug. 4 podcast, Tina Tan and Reed Miller review the performance of companies across specific sectors, including orthopedics, and what’s driving or limiting sales growth, as well as how some of the industry bellwethers are faring. For more, check out Medtech Insight: Medtech.pharmamedtechbi.com. You can find our latest “Earnings Winners & Losers” articles here: Earnings...
Rose Report Podcast - July 2017
August 02, 2017 18:43 - 18.4 MBThe Rose Sheet’s editorial team counts off top news items in the cosmetics and dietary supplement sectors in July. In this installment we discuss developments under the EU’s cosmetics animal-testing ban, cosmetic preservatives positioned for elimination, and a bill advancing in California that would tighten requirements for continuity marketing; On the supplement side, warning letters are issuing regularly, but investments in the industry also are up, with innovations in the areas of medical ...
Improving R&D Productivity Through Better Trial Site Selection
July 31, 2017 12:41 - 13.2 MBMike Ward, head of global content for Informa Pharma Insights, discusses opportunities for greater drug development efficiency with Drug Dev's Elisa Cascade and Informa's Karen Currie and Loni Branon.
Device Week Podcast - Episode 104
July 28, 2017 21:04 - 16.5 MBDevice Week – US Policy Roundup, July 28, 2017 In this week's podcast, Medtech Insight journalists discuss what was a busy week in Washington, DC – the health-care fail on Capitol Hill, and what it means for medtech; FDA's new plan for digital health; and one case to watch during the US Supreme Court's next term. For more, check out Medtech Insight: https://Medtech.pharmamedtechbi.com. Medtech Insight articles addressing topics discussed in this episode: • Health-Care Bill Failure Trigger...
FDA’s Bakul Patel On Pre-Cert Pilot Program
July 27, 2017 18:54 - 20.3 MBFDA’s Bakul Patel discussed the agency’s pre-certification pilot program formerly known as the precheck program. If successful the program would allow medical device sponsors to get their digital health products to market potentially sooner and more streamlined based on trust they build with FDA. In some cases sponsors may not even need to file a premarket application. Tags: medical device, fda, pre-certification, precheck, bakul patel, digital health, digital health innovation action plan
Device Week Podcast - Episode 103
July 21, 2017 19:20 - 15.4 MBOn this week's Medtech Insight podcast: US Senate passes $2.8bn FDA spending bill; US approvals and clearances strong in first six months of 2017; the global heart-valve repair and replacement devices market is highlighted.
Device Week Podcast - Episode 102
July 14, 2017 17:06 - 19.4 MBOn this week's Medtech Insight podcast: FDARA user-fee bills progress in the US Congress; a deep-dive look into the US Open Payments database yields interesting news and trends; in an unusual step, US FDA publicly releases an inspection observation form after auditing Magellan Diagnostics; standards organization GS1 and the Healthcare Industry Distributors Association try to solve billing headaches; top management is shaken up at Zimmer Biomet.
Device Week Podcast - Episode 101
July 07, 2017 17:51 - 15.6 MBOn this week's Medtech Insight podcast: supply-chain oversight program MedAccred makes a splash in industry; first diagnostic to use flow cytometry to detect rare blood cancers wins US FDA clearance; Ethicon sues Intuitive over surgical tool patents; Konica Minolta snaps up Ambry Genetics for $1bn; “Petya” and “Wannacry” ransomware attacks concern industry; a Thermo Fisher leader talks with Medtech Insight about the regulatory experience surrounding its Oncomine Dx Target Test.
Podcast: Thermo Fisher On Challenges Getting Oncomine Dx Approval
July 05, 2017 20:11 - 42.1 MBUS FDA recently approved the first multi-drug next generation sequencing test made by Thermo Fisher Scientific called Oncomine Dx Target Test. The test is a companion diagnostic for lung cancer drugs made by Novartis, Pfizer and AstraZeneca, and the diagnostic company is looking to expand their partnership to other pharma companies. Medtech Insight chatted with Joydeep Goswami, president of Thermo Fisher’s Clinical Sequencing Division for this podcast.
Device Week Podcast - Episode 100
June 30, 2017 18:01 - 25.4 MBOn this week's 100th Medtech Insight podcast: a new value-based reimbursement scheme emerges between Medtronic and Aetna; a major escalation in cybersecurity threats to medical devices concerns industry; the US Senate plans to keep the device tax repeal in its reworked health-care bill; a look at US FDA funding; two innovative device companies are spotlighted; medtech legal advocates want to bring FDA’s 510(k) process before the Supreme Court; virtual reality therapy gains traction.
Real World Evidence with Office of Medical Policy Director Jacqueline Corrigan-Curay
June 23, 2017 21:36 - 20 MBWe talked to Center for Drug Evaluation & Research Office of Medical Policy Director Jacqueline Corrigan-Curay at BIO about FDA’s current work on real world evidence. Corrigan-Curay explained how FDA doesn’t see a contradiction between randomization and RWE and ways to gradually start incorporating real world data in the drug development.
Scaling Up Your Business
June 23, 2017 21:23 - 13.4 MBAll businesses that scale up have to tackle funding, location and people to speed the way to international markets. In this podcast, Informa’s Global Content Editor Mike Ward discusses growing a biotech business at this year’s BIO International Convention with Gil Van Bokkelen, chief executive of Athersys Inc; Chris Doherty, managing director of Alderley Park, the UK’s largest single site bio campus; and Steve Bates, chief executive of the UK’s BioIndustry Association. Link: https://mspl.co...