Compliance In Focus

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:

Many government agencies have been vocal regarding the recently passed Sequester that cuts 1.2 trillion dollars over the next 9 years. One agency has been rather quiet- FDA.

A headline recently caught our attention, “What Will the Device Industry Look Like in Two Years or Less?” The article was posted on MD+DI and sheds light on what the industry may look like in 2015 after taking into account historical patterns, analyst view points, and current trends across the device world.

As of this month, the US Medical Device Sales tax has become a reality. Many device companies have braced for the impacts of the tax, and we’ve covered the topic at length in anticipation for the changes ahead. An early observation that has been buzzing around the industry is that hospitals are bearing the brunt of the tax burden from the raising rates.

As a medical device CRO, we appreciate the medical device industry sector and look forward to its continued growth and expansion. So, a recent report that highlights the industry’s progression and outsourcing future caught our attention. While there looms uncertainty regarding the medical device tax and the effect on companies, one thing is certain - the medical device industry is experiencing tremendous growth.

As we embrace the coming year, many implore to make resolutions for the coming year in hopes to make 2013 an even more prosperous year then the previous. A recent article published in MedCity News points out the “Top 5 New Year’s Resolutions for the Medical Device Industry for 2013 and beyond.” With out doubt the industry has been through a rollercoaster of events in 2012, especially concerning the medical device tax; how can the industry set up for a thriving year?

Seeing those greatly effected by the recent storms is devastating. While in various places the assessment of damage is still being assessed, physically, FDA also is assessing the set-backs from the recent natural disaster. This was expressed in a recent FDA Voice Blog by Margaret Hamburg, M.D., FDA Commissioner.

A PricewaterhouseCoopers report titled “Operating performance in the med-tech industry: Trends and imperative” was recently published with highlights the operating performance trends for the medical device industry and its various segments. Being a medical device CRO, we read with interest the report, and an article in MassDevice which also covered the report.

Recently MD+DI published an article, “The U.S. Medical Device Industry in 2012: Challenges at Home and Abroad.” The article speaks to the Industry being a source of jobs, innovation and revenue for Americans. In addition, U.S. has been the longtime world leader for the medical device industry.

A recent Medcity News article caught my attention. The title reads, “What is the biggest challenge facing medical device manufacturers today?” The challenges seem endless! We recently wrote a blog dealing with money saving tactics for the device industry, since this is an ever present issue. However, the article in the online news site focuses on a different area of hardship.

MarketWatch recently had a news-release on “Markets and Outsourcing for Clinical Activities.” In the article, it’s noted that while in the US and Europe costs are continuing to rise for clinical activities, sales are not growing- or growing at an insignificant rate. This is in stark contrast to emerging markets, where the opposite seems to hold true. Not surprisingly,  this leads to  more medical device organizations evaluating an expansion of their clinical programs into emerging markets to cut costs and boost sales.