Citeline Podcasts

Alderley 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.

On 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 Proposals From US Trade Commission To Be Scrutinized This Week http://bit.ly/2oXuIx2

Brain Trust Advises US FDA On Aneurysm Device Trials http://bit.ly/2oJZl9d

Neuro Panel Takeaways: Detailed Responses On Aneurysm Devices From US FDA Advisors http://bit.ly/2DfNJ21

A Post-IPR World Would Hold Patent Risks And Benefits For Medtech Companies http://bit.ly/2FAGGGD

FDA Commissioner Scott Gottlieb has been most effective, room for improvement, and what would make for a second successful year.

Medtronic'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.

In 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: Abbott, Boston Scientific Head List Of Early 2018 Trial Announcements

Following 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.

This 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-market considerations, as well as common pitfalls to avoid.

In 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: Positive Data Intensifies Spinal-Cord Stim's Big-Four Rivalry

https://medtech.pharmaintelligence.informa.com/articles/2018/02/05/nans-2018-positive-data-intensifies-spinalcord-stims-bigfour-rivalry

VC Deals Analysis: 2018 Off To A Flying Start

https://medtech.pharmaintelligence.informa.com/articles/2018/02/09/vc-deals-analysis-2018-off-to-a-flying-start

This 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 design, and how combo product manufacturers differ from the typical medical device or drug firm.

On 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 Future: http://bit.ly/2Et48F0

• DC Reflections: Mark Leahey On MDMA's 2018 Priorities And The Medtech Landscape: http://bit.ly/2EbSLls