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Portfolio – ICON Plc

ICON Plc provides medical and health industry outsourcing services around the world.  I work with ICON Plc to provide its blog with posts on topics related to medical devices, commercialization and outcomes, smart early development, and innovative trial execution (including adaptive clinical trials), with a particular focus on important developments from an industry and regulatory perspective.  I also record podcasts and monthly news round-ups for ICON Plc.

Prior to this, I performed nearly identical services for Aptiv Solutions, which was acquired by ICON Plc in 2014.  Before that, I wrote blog posts for MDCI, which was itself acquired by Aptiv Solutions.

Below you will find links to some of my most recent posts published by the ICON Plc and Aptiv Solutions blogs.

Networked Medical Device Technologies Improving Emergency Outcomes

Video Podcast: Risk-based Monitoring for Late Phase Research – A podcast I recorded and hosted with ICON’s Vice President and Global Head of Research and Alliance Services, Peri-Approval and Observational Research, Hady Khoury.

Video Podcast: Postmarket Surveillance For CE Marked Devices – A podcast I recorded and hosted with ICON’s Bernard Sweeney, Senior Vice President, Medical Devices, and Vytis Jusevicius, Project Director, Project Management.

Health Canada Revises Medical Device Safety Regulations

Customized Medical Devices: The Next Wave of 3D Printing Revolution

CDRH Issues Final Plan of Action in Response to Booz Allen Hamilton Evaluation

Mexico Deregulates Over 500 Medical Device Types

FDA Warning Letter Data Shows Improvement in 2013

Adaptive Trials Offer Potent Weapon Against Phase 3 Failures

FDA Guidance Discusses UDI Labeling Requirements For Small Medical Device Manufacturers

Video Podcast: Innovation in Clinical Trial Execution for Adaptive Trials – A podcast that I recorded and hosted with Corey Dunham, Senior Vice President for Biometrics at Aptiv Solutions, and Michael Remavich, Senior Director of Clinical Data Management at Aptiv Solutions.

Video Podcast: Streamlining Endpoint Adjudication – A podcast that I recorded and hosted with Gene Resnick, MD, Chief Medical Officer at Aptiv Solutions, and Angela Silverman, MSN, CANP, Manager of Clinical Operations, Endpoint Coordinating Center also at Aptiv Solutions.

New FDA Draft Guidance Explains 510(k) Clearance Transfers

FDA Warning Letter Data Shows Improvement in 2013

Japan Changes PAL and PMDA To Enhance Medical Device Innovation

Blood Lancet Devices Facing Reclassfication

Pulse of the Industry Report Offers Insight For Medical Device Manufacturers – An analysis of the Ernst & Young “Pulse of the Industry: Medical Technology Report 2011.”

FDA Makes Changes To Informed Consent Requirements for Medical Device Trials – A post that examines alterations made to FDA informed consent requirements.

Smaller Medical Device Companies Facing Extended 510(k) Review Periods – A blog post that investigates the disparaity in review periods between small and large medical device companies.

New ISO 14155 Standard Focuses on Medical Device Safety – A closer look at ISO 14155 for medical devices.

AdvaMed Releases Competitiveness Agenda to Preserve Medical Device Innovation – A blog post that discusses the details of the AdvaMed Competitiveness Agenda.

FDA Proposes Draft Guidance for Regulating Mobile Medical Device Apps – This post examines potential FDA regulation of mobile device apps.

IOM Report Recommends Scrapping 510(k) Medical Device Approval Process – A blog post that takes a look at the controversial IOM report on the 510(k) process.

Medical Device Excise Tax to Cost Industry $20 Billion – A discussion of the potential impact of a proposed excise tax on medical devices.

FDA Releases Draft Guidance for Artificial Pancreas Medical Device Development – A blog post that details FDA draft guide concerning the artificial pancreas.

FDA Loosens Premarket Notification Requirements for 30 Medical Device Types – A report on relaxed FDA premarket notification standards for specific devices.

Report Reveals Wirelessly-Accessible Medical Devices Vulnerable to Hackers – A closer look at the potential for medical device hacking.

CDRH’s Shuren Warns Medical Device Manufacturers About Rough Road Ahead – A report on CDRH future projections of the medical device regulatory environment.

Health Canada Draws Criticism for Handling of Medical Device Applications and Safety – This blog post looks at Health Canada and recent medical device application developments.

Getting To Yes From A Reimbursement Perspective – A post I wrote that looks at how medical device companies can best work to gather the data necessary to convince practitioners and insurance companies to include their products in their respective reimbursement schedules.

Making A Dent In The Established Insurer – Practitioner Order – A post that discusses effective strategies for device companies looking to establish a foothold in the complex world of established medical practitioner habits.