Compliance In Focus

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.

On August 5th we introduced the notion that there is an overwhelming abundance of information available at the fingertips of the consumer.  In Part One we took a closer look at the role of the FDA in Personalized Genomics and direct-to-consumer genetic tests. Now in Part Two we will take a closer look at the role of the FDA in regulating mobile medical applications.