MDCI provides clinical services for medical device companies, and is a full-service contract research organization.  I work with MDCI to provide their blog with posts on topics of concern to the medical device community, with a particular focus on important developments from an industry and regulatory perspective.

Below you will find links to some of my most recent posts published by the MDCI blog.

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FDA Proposes Draft Guidance for Regulating Mobile Medical Device Apps – This post examines potential FDA regulation of mobile device apps.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FDA Releases Draft Guidance for Artificial Pancreas Medical Device Development – A blog post that details FDA draft guide concerning the artificial pancreas.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.