Medical Device CRO Blog

At the recent OMTEC 2012 Conference in Chicago, there was a panel discussion on the current status and future challenges facing the orthapaedic industry.  Interestingly enough, it seems similar adversities stretch across most of the clinical research industry touching various segments.

The panel discussion focused on the current status of the industry and how the orthopaedic market is primed for growth. However, an increase in financial and regulatory burdens has created a perfect storm that has the potential to threaten innovation at a time when it is most needed.

So why is this important?

On the other side of every device or investigational product is a patient, and despite the fact that patients are (and should be) the driving force in this business, we still fall flat as an industry in meeting the regulatory requirements that have been put in place to protect patients.

This prompted the authoring of an article for ORTHOWORD entitled “Building a Basic Good Clinical Practice to Weather the Storm.”

As discussed in the article, there are two key areas to prepare for in this perfect storm:

1. The additional clinical data requirements being placed on device manufacturers
2. Increased scrutiny of how clinical trials are being conducted

My recommendation is that you start with knowledge.  Knowledge is key and it will help you run a well-controlled, compliant, clinical trial.

Take time to read and digest the article.  We would welcome your thoughts and feedback, so feel free to post your comments below our blog post.

Photo Credit:  ttstam