The images below show a continuous glucose monitor, a device with an implanted sensor for diabetics; pace maker, an implanted electrical device that helps control abnormal heart rhythms; and a cochlear implant, a device implanted into the cochlear to restore hearing in people born without hair cells in the ear.
Medical devices like these, which are meant to be inserted into or on the human body (either temporarily or permanently) are known as implants and are regulated in the United States by the Food and Drug Administration (FDA), which separates the devices into three classes depending on risk:
- Class I – pose the least risk and require least amount of control
- Class II- need more regulation and are required to undergo specific requirements before approval
- Class III – support or sustains human life and require the most regulatory controls before approval
Exponent’s multidisciplinary expertise provides technical and scientific support to assist our clients in addressing complex issues related to cardiovascular, neurovascular, and peripheral endovascular implantable medical device technology. Our professionals have experience working with a variety of bioelectronics implants of all Classes, including:
- Implantable cardioverter defibrillators (ICD)
- Insulin pumps and glucose monitors
- Pressure sensors in vascular systems
These biomedical implants encompass many technologies for imaging, control, and diagnostic means that Exponent scientists and engineers have knowledge, experience, and understand of. Some of those technologies include batteries (for long-term implants like pacemakers), biocompatibility packaging (to minimize infection and rejection of implants), embedded systems (for control and monitoring), sensors and sensor systems (for devices like glucose monitors) and wireless transmission (for transmitting sensor data to a handheld unit).