
Compliance In Focus
Posted by John Lehmann on Tue, Aug 13, 2013

Obstacles for Bionic Medical Devices

Bionic medical devicesChances are you may have seen an amputee or person with a disability with a sophisticated and complex medical device before.  What you probably didn’t stop to consider is where they got it and who created it?   Bionic medical devices are devices that have an electrical component which allows them to sense muscle contractions in the human body, then send electrical signals to nerves allowing a response.  Since bionic medical devices are devices by definition, they must also seek a pathway to FDA approval before they can be marketed in the U.S.  Given the small population of individuals, relatively speaking, who need these devices the most common pathway to approval is through a Humanitarian Device Exemption (HDE).  Like any pathway to marketing approval (510(k), Investigational Device Exemption, Investigational New Drug) there is a consider amount of research and development, and capital needed to achieve it.  Jamie Hartford, the managing editor of Medical Device and Diagnostic Industry (MD+DI) News Products and Suppliers recently published an online article outlining some of the common obstacles faced when working to achieve approval for these bionic medical devices.

The number one reason cited in the article that makers of these devices fail to reach marketing approval is a lack of venture capital.  The research, development, and time it takes to get these devices to market are extensive.  According to the article, people do not want to invest due to these factors, which are estimated at 10 years and $125 million dollars.  Because of this, they estimate that 1 out of every 10 actually make it, as most can’t endure the time and cost associated.

The article continues to explain that even if one of these bionic medical devices makes it to market, the next obstacle faced is one of insurance coverage.  Obtaining a reimbursement code is an additional step that they estimate can take 2 to 5 years to achieve.  The go on to say that even when a reimbursement code is obtained, it may not be for the amount requested or even enough to cover the cost making the device.  Let’s not forget, these are complicated devices that are traditionally more expensive to manufacture than non-bionic devices.  As such, bionic medical device makers need to be creative in ways to overcome these obstacles. 

Does it seem fair to potentially delay access to these innovative bionic devices?  Can you think of any other creative ways makers of these products can streamline their path to market?  We would love to hear your ideas and overall thoughts about the article.

Photo Credit: Ekso Bionics

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Topics: MD+DI, Humanitarian Device Exemption, Bionic Medical Devices


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