Resources

“Land mine” is a term we use for something buried in your company that will blow up if it is uncovered. In court, even an innocuous phrase in a private email from one of your employees, such as, “This will negatively impact the bottom line,” could be a land mine. In a products liability action, […]

The medical device industry is rife with the exploration and development of new ideas and treatments for a startling array of health conditions. In some areas, however, medical device companies lag behind other sectors of the American economy, in particular, the number of companies that have adopted a social media strategy. The term “social media” […]

Just when you think that the FDA has to stick to the script by quoting chapter and verse of CGMPs, they get very progressive and offer straight talk about corporate commitment and leadership. We have reported before that the FDA expects corporate oversight of the Quality Management System. (The QA Pharm 4/17/11.) The Johnson & […]

The Internet offers a seemingly unlimited information resource for medical device developers, allowing them to tap into regulatory information and guidance, market reports and consumer opinion, as well as in-depth coverage of the state of the industry as a whole. Unfortunately, the broad reach of the online world also means that not all news sources […]

In March, MDCI touched on the sentiment of several medical device industry players and members of the federal government that the FDA is taking too long to approve new products. This feeling was drawn into focus in a blog post by Rep. Joe Pitts on The Hill’s Congress Blog that asked the Administration to improve […]

Once upon a time, I asked this question of a senior management group at an off-site “strategy” meeting. You know—one of those meetings where a working breakfast was followed by a day of golf, and I was the one doing the working. The question was particularly germane to the purpose of my invitation, because these […]

A new FDA final rule for Medical Device Data Systems (MDDS) went into effect this past month, with the intent of simplifying the regulations surrounding a significant portion of IT equipment and software used during the provision of health services. The key aspect of this new final rule is the reclassification of certain MDDS as […]

Imagine the stream of firms that venture in to their respective FDA District offices to give presentations on their Warning Letter response and to offer their assurance that they truly “get it”. You can be sure that theses firms had several “dress rehearsals” to hone their material before stepping into what they perceive to be […]

MDCI, a full-service CRO, has recently run across a number of cases where companies who have been importing medical devices into the U.S. for years suddenly encounter issues at U.S. Customs. In some cases, companies are not even aware that their products are regulated as medical devices by the FDA. In others, shipments of medical […]

I am convinced that there is an element in some pharmaceutical companies that enjoys the adrenaline rush of a crisis. These are the people who descend upon problems and save the day through sheer grit and determination. They work late to pull the proverbial baby out of the fire.  They are known as having a […]