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Medical Device Innovation: Blurring the Lines Between Medical Necessity and Personal Accessory



Medical Device

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September 9, 2015 | by Sarah Massey

The medical device industry is currently experiencing a period of rapid growth, which can be attributed to recent advancements in wearable medical technology. In 2012, the wearable tech industry was worth $2 billion; this number increased by 26 percent as of 2014, when the industry was worth an estimated $2.7 billion.

As sales of wearable medical monitors rise, and healthy, average consumers increasingly look for high-tech gadgets to monitor their health, device manufacturers are developing technology which can be marketed to both healthy individuals as well as those with specific medical conditions. Following recent changes in FDA regulations for medical devices, there’s never been a better time for device innovation in the industry.

The current generation of smart medical technology boasts features that benefit the health-conscious consumer, just as well as they benefit the patient with a manageable illness. As medical device technology gets more sophisticated however, there is a need for the development of advanced security features, to keep the wearer safe.

FDA Regulations for Medical Device Manufacturers

The Food and Drug Administration (FDA) in the US, has established guidelines for medical device manufacture, which must be followed by device developers in order to receive agency approval. The administration classifies medical devices into three distinct categories, depending on the level of sophistication and potential risks involved with use.

  • Class I General Controls: These devices are simplistic in nature and carry no risk associated with use. These devices include tongue depressors and elastic bandages, and the only regulations they must follow are those associated with proper labelling and manufacturing processes.
  • Class II General Controls and Special Controls: These devices are more complex than Class I devices, but they still carry very little risk involved with use. Examples of devices in this class include electric wheelchairs and surgical needles.
  • Class III General Controls and Premarket Approval: These devices are the most sophisticated in terms of design, and as such, they present the most risk. These devices may be used to sustain life, and are often implants such as a pacemaker. As these devices are considered to be the most risky, their approval requires extensive testing to determine product safety and risk/benefit potential.

The FDA recently announced that in the past five years they have made a significant improvement in the time it takes to approve a medical device. The agency noted that the approval time for device submissions has been reduced for 510(k)s, Premarket Approvals (PMAs), Investigational Device Exemptions (IDEs), and de novo requests. The total times to a decision on each device have been improved from 2010 to 2014 as follows:

  • 510(k)s: From 132 days to 115 days
  • PMAs: From 352 days to 242 days
  • IDEs: From 442 days to 30 days
  • De novo requests: From 992 days to 300 days

The FDA also reported that the overall percentage of approved devices has risen, compared to the percentage in 2010. In 2010, the percentage of approved 510(k)s was at 73 percent, which increased to 84 percent in 2014. The percentage of approved PMAs rose from 59 percent in 2010, to 86 percent in 2014.

In light of the changes made by the FDA, new medical devices are being approved and hitting the market, in record time.

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Keywords: Medical Device, FDA, Health



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