2011 was a busy year for the Aptiv Solutions medical device blog, with a record number of readers subscribing to our regular posts on the issues and news that affect the industry. We went back through our archives and singled out the top 10 most viewed posts from the past 12 months. These posts covered a diverse range of subjects, indicating just how many different areas of interest the professionals who read the Aptiv Solutions blog have.
Let’s take a look at a quick synopsis of the 10 most read posts from the Aptiv Solutions medical device blog for 2011.
10. CDRH Innovation Pathway Priority Review Program Open To Pioneering Medical Devices
An important issue within the medical device community has been the stifling of innovation due to regulations, slow approval times, and other bureaucratic issues. The proposal of a ‘priority review’ program for devices that significantly advance health care in the United States was an intriguing move by the CDRH, as well as an olive branch to medical device companies frustrated by current pre-market approval policies.
Close to 20 years of the GHTF came to an end in 2011 with the surprising announcement that the committee would disband and reform without the participation of medical device industry players. Jeff Roberts contributed to this post that reported on the disappointment from manufacturer groups regarding the decision to include only regulatory officials within the new organization’s membership.
8. Medical Device Labeling – A Major Issue for Pre-Market Approval
This explanation of FDA labeling requirements for medical devices provided manufacturers with an in-depth look at what issues typically crop up when submitting a product label for regulatory approval. Several suggestions as to how labels can be improved – and how to avoid the most common pitfalls – were offered as a general guideline for moving through this stage of the approval process with greater ease.
7. Safety Assurance Cases and Medical Device 510(k) Submissions
This post – put together with significant contributions from Aptiv’s own Mark Sheehan – explained how medical device companies can put together safety assurance cases that will satisfy FDA regulators while submitting a product for clearance.
6. New ISO 14155 Standard Focuses on Medical Device Safety
When ISO 14155 was released, revising the standard designed to ensure medical device safety and performance, Aptiv put out a blog post encapsulating what this meant for manufacturers. Specifically, the post touched on the changes associated with clinical trial obligations for investigators with respect to reporting, participant safety, and overall credibility.
5. What You Don’t Know About De Novo – A Primer For Medical Device Companies
The FDA’s De Novo process is a path towards medical device market approval that often has manufacturers scratching their heads due to its perceived complexity. Cindy Nolte and Helen Mayfield assembled this informative ‘primer’ to help medical device developers understand whether De Novo was appropriate for their particular products, and if so, how they could properly take advantage of this particular regulatory strategy.
4. Medical Device Companies Slow to Adopt Social Media Amid Lack of FDA Guidance
Social media has been a stumbling point for businesses in a number of different sectors of the economy, but the need to respect FDA regulations concerning advertising, off-label promotion, and responsibility for online content hosted outside of officially-sanctioned web servers has seen a sizable percentage of medical device companies paralyzed when it comes to developing a cohesive strategy. This post, written together with Aptiv’s Gia M. Griffith, took a closer look at how manufacturers can safely take their first steps into the social media world.
3. Government Shutdown and the FDA Impact for Medical Device Companies
In the spring of 2011, the possibility of a government shutdown due to a budgetary stalemate loomed as a very real possibility. Medical device companies braced themselves against the uncertainty surrounding how a cut in government services would affect the FDA, and consequently, trials and regulatory proceedings currently in progress. This Aptiv blog post took a look at past government shutdown scenarios and offered an analysis of what could happen should a similar situation once again come to pass.
2. What Is CLIA? A Primer For Medical Device Companies
Another in our popular series of posts designed to shed light on a subject that the staff at Aptiv are often asked about by both clients and prospective clients, this CLIA primer provides an overview of the most important points surrounding the laboratory testing standard. Thanks to the insight of Gail Radcliffe, the post also describes the different CLIA certifications, how they can impact product development, and how to bring LDT’s to market through the CLIA process.
1. Medical Device Excise Tax to Cost Industry $20 Billion
It’s no surprise that a blog post with such an attention-grabbing headline was the most popular piece of reporting on the Aptiv Solutions blog for 2011. The excise tax issue was a serious shot across the bow of industry players already struggling under the weight of increased regulatory scrutiny and a rough economy. This controversial tax is still a hotly contested topic amongst medical device companies and medical professionals working hard to make their voices heard at the federal level in order to scale back the potential impact of the measure.
Benjamin Hunting
Aptiv Blogging Team
