You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

The FDA’s Sentinel Initiative, mandated by Congress two years ago to include and cover medical devices, aims to electronically track the safety of investigational products after they have reached post-market. Recently, however, John Rising of The Pew Charitable Trusts informed a congressional subcommittee that lack of unique device identifiers on insurance claims forms poses a major road block to ensuring the effectiveness of this initiative.

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

For a patient receiving a medical device or for the doctor who is administering the device, more often than naught, the primary concerns of either party include: “Is this device going to be effective?” and “Is this device safe?” However, what individuals may not consider when asking these types of questions is the extent to which the device designer has already taken into account such concerns. For every medical device that has its own clinical trial or has made it to post-market, there is a team of engineers and designers who make it their job to consider the structural components and environmental factors that will allow the device to remain safe, yet effective. Often times the environment that these medical devices call home is the hospital where the patient was admitted. But as home health care becomes more predominant in today’s society, designers now have a new set of challenges to consider when constructing medical device prototypes.

If you’re at all familiar with the scientific community then you’ll probably recognize the National Institutes of Health, also known as the NIH, as scientific research’s biggest advocate. Part of the U.S. Department of Health and Human Services (HHS), the NIH serves as our nation’s premiere medical research agency, granting greater than 80% of its budget to research and academic institutions through the distribution of almost 50,000 competitive grants. With such a generous hand for developing research, there is no question as to why so many academic and medical professionals both welcome the support and praise the involvement of the NIH in their research ventures.

String the letters F-D-A together and almost instantly you’ll picture the well-recognized scientific safe-haven of the United States. Formed in 1906, the Food and Drug Administration was created to ensure the responsibility and protection of US citizens’ interaction with the market of commercial science. From cosmetics to veterinary medicine, the FDA regulates and supervises the advances that intend to make life more manageable. However, in Colorado terminally ill patients are advocating for a little liberation from this tight hold the FDA so often advocates when regarding human subjects.  As of May 17, 2014 Colorado is officially the first state to grant patients access to experimental pharmaceuticals still resting in the developmental pipeline - ones either awaiting or working towards federal approval for lawful commercialization.