TJ Green Associates, LLC


Expert Witness

Throughout his 30-year career Thomas J Green has gained considerable expertise with the materials and processes used in microelectronic packaging for high reliability military and medical device applications. Specifically, in the area of hermetic package sealing and hermeticity testing of hybrids and other types of hermetically sealed implanted Class III medical devices. Having spent time in industry, government research labs, and academia, Tom has developed a unique and balanced perspective on the many possible causes of device failures.

 

Tom has proven to be a reliable expert witness and recently participated in the full trial cycle of a case involving a cochlear implant failure.

 

Class III implants may fail in the body due to loss of hermeticity. A hermetic seal is effectively an airtight seal that prevents moisture from penetrating the device cavity and interfering with the sensitive microelectronics contained inside. If moisture builds up inside a device implanted in the human body it may fail prematurely and have to be surgically removed. 

 

There have been and continues to be problems with hermeticity and high moisture inside implanted Class III medical products:

  • In the past implanted pacemakers failed in patients, as reported in a Medical Device Alert (#MDA/2005/047) … "Hermeticity failure may lead to ingress of body fluids, which may adversely affect the operation of electronic circuits and device performance."
  • Cochlear implants have also failed after surgical implant and according to the  FDA (news release P04-92) …”some of the devices may malfunction due to moisture.”

References available upon request.

 

Expert witness fees as arranged. Monthly retainer fee schedule available.

 

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