Medical Device Replacement Support

Goals

To evaluate the potenial market for a market potential to provide support to patients with aged-out or recalled implantable medical devices (like breast augmentation, knee replacement, pacemakers, and/or) stents.
  • Ideally, three use cases will be identified that could have high potential for patient support and advocacy.

Early Findings

DATA AVAILABILITY

Data specific to the support and advocacy for patients facing a medical device removal seems to be extremely limited within the public domain.

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  • The 11 most commonly implanted medical devices are:
    • Artificial Eye Lenses
    • Ear Tubes
    • Coronary Stents
    • Artificial Knees
    • Metal Screws, Pins, Plates, and Rods (Traumatic Fracture Repair)
    • Intra-Uterine Devices (IUDs)
    • Spine Screws, Rods, and Artificial Discs
    • Breast Implants
    • Heart Pacemakers
    • Artificial Hips
    • Implantable Cardioverter Defibrillators (ICDs)
  • Data from the FDA indicates that metal hip replacements, insulin pumps, and spinal stimulators are the three most common medical devices which lead to patient injury reports.
    • Approximately 50,000 - 60,000 spinal stimulators are implanted each year. These devices are designed last between 2-10 years depending upon the battery. No data was located within the scope of the early findings which indicate how many of these procedures are due to age or recalled equipment.
    • Data from the American Academy of Orthopaedic Surgeons indicates there are approximately 450,000 total hip replacements performed in the United States each year. They also predict that by 2030, 72,000 hip revision surgeries will be performed each year. No data was located within the time frame of these early findings which clearly correlates the need for revision as to being the result of outdated or recalled medical devices.
    • "Collectively, insulin pumps and their components are responsible for the highest overall number of malfunction, injury and death reports in the U.S. Food and Drug Administration’s medical device database, according to an Associated Press analysis of reports since 2008."
  • The Breast Implant Safety Alliance is a non-profit organization with the mission to "raise awareness, optimize outcomes and ensure informed consent for patients considering breast implant surgery." The group works with support groups across the country, and it can be logically assumed that some of these support groups work to assist patients with aging or recalled implants.
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SUMMARY

Unfortunately, very little data specific to support systems for patients with aging or recalled medial devices was found. As a result, the development of three use-case examples is highly unlikely within the pubic domain. Alternatively, in order to begin to obtain data which could help to quantify the market potential for this type of service, the top devices implanted each year were identified as well as the top three which account for the most patient injury reports. It is suggested that in order to identify potential market opportunities, continued research seek to 1) identify how many surgeries for each of the top 11 device implants are completed each year, 2) how many of these are revision or replacement surgeries, 3) an overview of any recall data for each device, and 4) if any support groups exist for each of the devices. Please note that if support groups for each device are located, there may be no way to delineate if this is general support or support for replacement.

Research proposal:

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