Medical Technologies

Determining Device Reliability

Using a tightly integrated approach to testing and data analysis, SES can quantitatively predict the reliability of your product.
MEDICAL DEVICES PRESENT UNIQUE CHALLENGES

It is common to have only weeks to determine how a product that is supposed to last for many years will perform in service. Reliability issues are further complicated by the effects of sterilization and sustained pre-load, both of which impact shelf life and long-term storage. ......................................................................
Reliability of a product is governed by both design and materials. Our unique understanding of materials and their relationship to design is what allows us to develop protocols to accurately predict reliability. Using extensive in-house laboratory facilities we can conduct accelerated tests and interpret the results to generate reasonable life predictions.

The Process is Key

Determining device reliability early requires testing, analysis, life calculations and understanding tolerances. Establishing long-term device reliability is a way of looking into the future.

It is not an art, but it is indeed a physics-based science. Using techniques like Fault Tree Analysis, Reliability Block Diagrams and accelerated life testing, it is possible to predict how reliable a product will be in the hands of end users. The data generated can also be used to predict product performance, and durability. SES can make these reliability assessments at different points in your development process, including the pilot phase and prior to the start of full production.

D medical.stress.com

Fault Tree Analysis

Fault Tree Analysis is one method used to build mathematical models for calculating reliability. The FTA allows you to focus on key top-level failure modes, which are defined by how the device fails to meet requirements. Developing the FTA ensures that the most critical failures are identified. In contrast, a Failure Modes & Effects Analysis (FMEA) focuses on individual component failures at the risk of missing an overall system failure.

controlled experiments to determine appropriate accelerating factors such as temperature, humidity, chemical environments, stress and UV. The results of the testing are brought together using statistical analysis methods to calculate product reliability and life.

Accelerated Life Testing

One common objective of verification and validation is to determine how long a product will last. Accelerated life testing is a reliable, fast and cost effective method for determining long-term product reliability using short term tests. SES runs

To Predict Medical Device Reliability

Call SES Today at 513-336-6701
ON THE WEB AT MEDICAL.STRESS.COM
CINCINNATI HOUSTON NEW ORLEANS BATON ROUGE CALGARY

2012 Stress Engineering Services, Inc.

424