Outcomes research can be defined as “the study of the end results of health services that takes patients' experiences, preferences, and values into account—is intended to provide scientific evidence relating to decisions made by all who participate in health care.” Recently, the push has been for greater emphasis on outcomes and a new joint effort is a giant boost in this direction.

We ran across an article in the Wall Street Journal talking about how the medical device industry is being impacted by the continued venture capital drought.  A MedCity News article summarized the article this way:

I read an article in Businessweek that indicates the once U.S. centric medical device business is going global.  The article highlighted that a number of startups are forming overseas.  According to Jonathan Medved, founder and CEO of Jerusalem-based OurCrowd, “Traditionally, people have been very focused on the U.S. market, but now they are making sure a device is efficient enough to be sold in places like India and China.”  If you only focus your device for the U.S. market, you risk competitive pressures.

One of the results from the recent two-week government shutdown is a backlog of government submissions.  Although during the shutdown, the FDA continued to review device submissions that were submitted prior to October 1st, the agency was prevented from accepting any new fiscal year 2014 user-fee funded device submissions, including PMAs and 510(k)s.

As a follow-up to a recent blog about the European Union proposing tougher regulations that are similar to FDA’s pre-market approval program in the US, and the medical device industry’s concern over the legislation, it was reported that the EU parliament panel has recently approved the pre-market approval process.

A MassMEDIC commissioned survey, one-third of device firms queried expect the Affordable Care Act to increase their customer base.  In addition, one-third of the companies feel the new business will be enough to cover the medical device tax.

There are only four days left for the medical device industry to provide comment, as requested by the FDA, on the topic of extreme weather conditions and medical device safety and quality. Hurricanes, floods, earthquakes, and tornados can pose potential interference with the manufacturing, shipping, storage, or use of marketed devices which is a cause for concern for the safety and effectiveness of devices.

With market growth stalled in the U.S., European and Japanese markets, medical device companies are seeking entry into new markets.  According to an article in MD+DI, many companies are now looking to China as the next growth market.  On paper, this seems like a logical move.  China is a huge market that is growing with rising incomes and health care needs.

Thomson Reuters, the world’s leading source of intelligent information for businesses and professionals, released the 2012 State of Innovation Twelve Key Technology Areas and Their States of Innovation report which “showcases 12 leading sectors and analyzes their innovation levels based on patent activity”.  The medical device sector can proudly boast as the area that experienced the largest growth, 15.7% over the year, accounting for 8% of all patent activity in 2012. While “computers” hold the biggest area for patents in 2012, the medical device industry can boast largest growth rates.

We ran across this article in MD+DI asking what is the Office of Combination Products (OCP) doing?  For background, the OCP was set up at the urging of the medical device industry.  According to John Barlow Weiner, associate director, the mission of the agency is as follows: