Here’s a staggering statistic for you- inefficient clinical trials are costing some companies between $4 and $6 billion each year in unnecessary expenses. This is according to study data published by the Tufts Center for the Study of Drug Development (CSDD).

We continue to reach out to our colleagues, customers, and friends in the most convenient places- from Facebook to Linked-In  to Twitter, and even in your very own inbox! Today we distributed the 21st issue of the IMARC e-Newsletter.

The wind, rain, and power outages of Hurricane Sandy did not stop the 2012 Medical Innovation Summit that welcomes approximately 1,000 leaders in new medical technology to convene at The Clinical Clinic. The Summit, held over 3 days in North East Ohio, is attended by investors, regulatory, clinical, medical affair and business development executives in the healthcare industry, buy and sell-side researchers and other healthcare service providers.

There has been a downward trend in certain knee procedures for osteoarthritis. According to a recent study published , researchers from Emory University examined the trend in hopes of showing the effectiveness of study evidence and the positive impact it can have on study dollars. This is because the New England Journal of Medicine published many reports between 2002 and 2008 associated with changes in clinical practice patterns.

Recently an article was published in PLOS titled “Strengthening Medical Product Regulation in Low- and Middle-Income Countries” which strongly suggests developing countries must become a global health priority. In fact, The Word Health Organization (WHO) recognizes regulatory system functions as one of the six core building blocks of health systems.

Affordable Care Act: Impacting America’s Leadership? At the Medical Device Conference 2012(MedCon), held at Xavier University, in Cincinnati, Ohio, Kem Hawkins, President and CEO of Cook Incorporated and Cook Medical, delivered a powerful keynote address. In his speech, Hawkins proposed that FDA has not demonstrated the leadership necessary for the United States to maintain its position as global forerunner in the healthcare arena. Hawkins also touched on his opposition to the medical device tax included in the Patient Protection and Affordable Care Act (ACA).

In a recent speech in Minneapolis, Steve Silverman Director of the FDA’s Center for Devices and Radiological Health’s Office of Compliance, urged the industry to expand their focus beyond compliance and build high-quality medical devices.  The speech in was based on the agency’s focus on building a quality framework.  Silverman explained that while the FDA will continue to enforce regulation, its success won’t be judged by that enforcement work alone.

In an effort to promote innovation while protecting the population at large, FDA has been on a path to revise the existing regulatory pathway surrounding the 510(k) process for medical devices for several years. This continues to be an area of many questions and considerations. In fact, we’ve devoted a whitepaper to these issues to help researchers understand the 510(k). Recently FDA released a Draft Guidance on the eCopy Program for Medical Device Submissions. While this system is currently voluntary, the draft guidance gives industry an idea of what might be in store for device submissions.

It hit the headlines in a dizzy twist on words. The CEO of St. Jude put the cart before the horse in warning investors that he was expecting a warning letter from FDA before one was actually even issued! According to a report on MedCity News, this type of announcement apparently has no precedent. Have you ever heard of a company proactively telling Wall Street they’re going to receive the dreaded warning letter before receiving it- or even a FDA form 483? This was something that was on the mind of analyst Bob Hopkins of Bank of America.

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.