Medical Technologies

Design for Reliability

FMEA | FTA | Tolerance Analysis | Reliability Prediction | Materials Characterization & Testing | Accelerated Life Testing | Manufacturability
BUILT-IN RELIABILIT Y

Stress Engineering Services (SES) has the tools, expertise and reputation for innovation that incorporates all aspects of design, product performance, materials and manufacturing. The result: SES can help you design a more reliable product. This will reduce long term scrap rates, product inquiries, in-service product failures, and reduce the risk of product recalls. ......................................................................
SES is unique. Under one roof we have the ability to use all the critical tools and provide clients with key technical direction, along with essential regulatory documentation, early in the development process. In the business of developing and manufacturing medical products, knowledge obtained earlier is always better. Some of the tools SES uses are FMEA, FTA, accelerated life testing and tolerance analysis.

Failure Modes & Effects Analysis (FMEA)

FMEA identies aspects of the design which have the greatest effect on device reliability. SES routinely performs FMEAs at all levels, including design, process and application. Where clients are staffed and experienced to perform elements of this work in-house, SES can serve as a facilitator.

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Fault Tree Analysis (FTA)

FTA is a tool used to identify/quantify the critical failures that prevent a device from meeting target safety, functional and reliability requirements. It is done early in the design process, even before drawings or CAD models are available. This process helps answer some of the key questions, including Will this product be reliable and how long will it last? Both FTA and FMEA are experience driven. This means that it is essential to know specifically what questions need to be asked and answered.

analyses at the concept phase. It is possible to predict the reliability of a final product when the manufacturing process is known, even before the detailed part design is finalized. Not only can we predict assembly issues, we can also determine performance variations (torques, forces and mechanical advantages) before creating CAD models. These capabilities go a long way toward understandingand limitingrisk.

Materials Testing & Characterization

Selecting the correct material is one of the most important decisions in the product development process. SES can help ensure the selected material is appropriate through our testing and materials qualification program. SES has the experience and equipment to test your materials under representative environmental, fatigue and impact conditions. Our approach addresses long term storage, sterilization, material aging, stress cracking and other critical material behaviors. SES has the ability to evaluate material interactions such as friction and bond strength. We often deal with the behavior of elastomers, metals, foams, gels, plastics and over-molded products. The SES program provides confidence and supporting data that youve selected the correct material.

Accelerated Life Testing & Life Calculations

Predictive life assessment calculations are based on accelerated life testing of components and materials (delayed cracking, creep, chemical and biological exposure and sterilization effects). SES adds value to development projects through our ability to complete this testing in-house. We use the resulting data in engineering calculations and reliability determinations. Using short term testing techniques, we can predict with great accuracy how your device will perform years into the future.

Tolerance Analysis
Many quality problems are the result of inattention to manufacturing tolerances. SES recommends performing tolerance

To Improve Reliability & Reduce Risk

Call SES Today at 513-336-6701
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2012 Stress Engineering Services, Inc.

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