February 2013

For Medical Device Companies

Featured Articles

Brett Castano

Introduction to High Risk Software Automated Testing

by Brett Castano
Clinical Operations Manager, RealityCorp

In today's world, high risk software applications are managing a majority of clinical trial data collected in the field. In the early 2000s, the clinical trial industry saw a switch from managing the data collection process through manual means to doctors utilizing secure software applications that allow the doctor to enter the data electronically through the use of a computer or mobile device. MasterControl itself is an example of a high risk software system that is utilized within the clinical trial industry, as it is focused on creating and regulating the process by which clinical trial documentation is managed. In this article, applications created by vendors (such as MasterControl) that will be utilized by doctors or other managers in the field to aide and assist in the management of clinical trials will be referred to as eClinical software, while the collective group of software providers comprise the eClinical industry (http://en.wikipedia.org/wiki/EClinical_trial_technology/).

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Cindy Fazzi

Finding Ways to Cope with New Medical Device Tax

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Medical device companies started paying a 2.3 percent excise tax this past January as part of the Affordable Care Act, also known as "Obamacare." The industry has opposed the tax, which is being assessed on total revenues, not profits. The Obama administration has said the excise tax will be offset by an increased number of insured people receiving treatments; it's something that remains to be seen.

Some companies have addressed their new financial burden by announcing layoffs and reducing their R&D investment. Now more than ever, medical device companies must do more with less. Let's explore a few ways of doing that, but first, consider the following facts about the industry.

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