Medical Electronics Symposium Conference Proceedings


Authors: Anthony Primavera, Ph.D. and Jamie Hoffpauir
Company: Guidant Corporation
Date Published: 4/25/2005   Conference: Medical Electronics Symposium

Abstract: While military, aerospace and automotive electronics must endure extreme end use conditions, few applications require a more robust overall product reliability than life sustaining medical products. Life sustaining medical / implantable devices have extremely high demands placed on them for very obvious reasons; they sustain a person's life. Therefore, the products must work consistently for long periods of time (in many cases > 10 years) without the benefit of downtime, battery recharging, or repair.

In addition, the products should not cause patients adverse effects under any circumstances. While the implantable electronics device enjoys one of the most benign end use environments (37C +/- 2 degrees), the overall reliability concerns are extremely high. Patients expect and deserve to lead a healthy and active life after receiving an implanted device. To further complicate matters, each patient provides a unique set of needs and requirements. Examples of unique needs include product therapy, patient age, weight, activity level, living environment, and regional / country regulatory requirements.

In an attempt to ensure a robust product, extreme reliability and process testing is required to prove long-term reliability. This paper discusses reliability requirements and approaches to assess long-term robustness of implantable medical devices.

Key words: Medical, Implantable, Reliability.

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