Failure analysis of polymer-based medical devices is critical to guarantee that process or material improvements can be made to prevent repeated failures.
Should a product fail or not perform as expected, investigation of the root causes is needed to develop a corrective action plan and solve the problem. Failure investigations are critical in determining whether the failure is related to:
- Material deficiencies
- Poor product design
- Process related issues
- Improper use of the product
With decades of experience in polymer chemistry, plastics processing and evaluation of polymeric products, Element’s polymer chemists and engineers work closely with your team to develop a failure investigation program that is designed to fit your timeline and budget. We carry out the analysis and provide updates, as well as recommend changes to the program scope if necessary as the data becomes available.
Failure analysis at Element involves the following steps:
- Collection of background data
- Inspection of samples
- Complete analysis of the failed material
- A thorough examination of the failed part
- Tests to simulate environmental and physical stresses that may have played a role in the failure
- Selection and testing of alternative products or procedures that will significantly improve performance. Full product re-engineering services if requested
- On-site evaluation and consulting service
We have well-equipped analytical, mechanical and physical testing facilities to conduct accurate failure analysis investigations. Our experience covers all types of polymeric products and industry sectors.
Our failure analysis capabilities include metallurgical, chemical, composite and polymer analysis. Our team of expert metallurgists, chemists, and material scientists are internationally recognized as some of the most experienced in their field. Failure analysis not only helps us learn from the past, but it also helps prevent future failures. As your chosen asset life partner, Element can contribute to improving your company’s products, protect your valuable reputation and build a safer future together.
For more information about our polymeric failure analysis for medical devices, contact us today.
Medical Product Testing
With a clear understanding of your markets, regulations, and challenges, we provide our expertise and experience with cGMP, GLP, ISO/IEC 17025 testing to help your product reach the market sooner and with safety and quality built in.
Medical Grade Polymer Testing
Polymers are some of the most commonly used materials in medical device manufacturing. Characterization of the relevant properties is key to ensure their quality and performance standards.
Pharmaceutical Raw Material and Finished Product Testing
Our raw material and finished product testing bring peace of mind to manufacturers of drug products ensuring the safety, purity, and quality of both starting materials and manufactured products.
Test Protocol for Medical Devices
A protocol and plan will mitigate your risk, prevent confusion, set clear expectations, and preserve the necessary information for future reference and use.