When your product or process fails, you need more than just test results. You need to know the cause of your problem and how to implement a solution. Cambridge Polymer Group collects and analyzes data on your materials failure, to discover not only what went wrong, but also how to fix it.
Determining the root-cause of a manufacturing issue or device return can be complicated. Frequently, failure analysis relies more on experience than on easily recognized identifiers. The cause is often more complex than one simple failure mode and therefore understanding all of the phenomena involved is critical for determining how and why a process occurred. Factors originating in material selection, part or process design, polymer processing or part assembly, sterilization, and end-use service environment can all contribute to unanticipated failures.
CPG’s multi-disciplinary experts and their decades of experience in medical and consumer products provide a unique resource both for determining the failure of your material and for restarting your production process.
Cambridge Polymer Group laboratory scientists investigate your polymers, fibers, films, membranes, composites, rubbers, coatings or paints to characterize the mode of your material’s failure.
Common plastic and polymer failures include:
Depending on the nature of your problem, our laboratory investigation may include a number of analytical techniques, ranging from electron microscopy of fracture surfaces to manufacturing residue analysis to custom accelerated aging or reliability testing.
CPG can bring a wide array of non-destructive and destructive analytical methods to bear on your problem:
Whether you are submitting a new device for approval, making a material change in an existing device, or seeing an uptick in customer complaints, CPG can work with you to address both the cause of and solution to any failure-related issues you are experiencing.
CPG has extensive expertise related to devices used in applications such as:
Sulzer Orthopedics noticed that a group of metallic acetabular shells with porous backing for osseointegration were failing at high rates. Cambridge Polymer Group was hired, along with other consultants, to investigate the cause of the failure. Using statistical analysis and new testing protocols CPG scientists determined that the failure was not due to a manufacturing residue left on the compound, as was previously surmised, but rather was the result in the change of a nitric acid passivation process. Read more.
Another client presented catheter hubs that appeared to be cracking during their manufacturing process. The hubs were compound structures with polycarbonate embedding electronics and the catheter itself. A detailed understanding of the interaction between the materials and the processes in use was vital to allow determination of the cause of failure. Cambridge Polymer Group isolated the root-cause and proposed an alternative manufacturing strategy that the client adopted. Read more.
A client of Cambridge Polymer Group came to us with concerns over hazing that was occurring in a new formulation of intraocular lenses during manufacture. Through an extensive and complex testing procedure staining, drying, deformation and direct microstructure visualization using SEM, the cause of the cloudiness was traced to a poorly controlled reaction process resulting in microcavitation within the lens during the swelling process as the lens hydrated. Read more.