Celebrating Rubber Band Day
Every year on March 17th, we commemorate the invention of the rubber band, patented by Stephen Perry in 1845. This innovation followed Charles Goodyear’s groundbreaking discovery in 1838 that adding sulfur to polyisoprene creates crosslinks, significantly enhancing its elastic properties. This breakthrough led to the development of rubber tires. Composition of Rubber Bands Rubber bands […]
FDA Layoffs: Impact on Medical Device Review and Patient Safety
Over the February 15-16, 2025 weekend, the new U.S. administration laid off a substantial number of FDA reviewers from the Center for Device and Radiological Health (CDRH), the branch that reviews the safety and efficacy of new medical devices, including hip and knee implants, cardiovascular and respiratory devices, ophthalmological treatments, wound care, and thousands of […]
Quantifying Rapid Rheological Changes
Blood vessel with hemostatic agent In the world of material science and product design, understanding and measuring rapid rheological transitions is crucial. These transitions, which can be triggered by various stimuli such as UV light, electrical fields, or chemical interactions, play a significant role in applications ranging from hemostatic agents to 3D printing materials. While […]
FDA’s Regulatory Freeze: Implications for Medical Device Standards and Patient Safety
Medical device development relies heavily on standards to ensure patient safety, efficacy, and regulatory compliance. Organizations such as ASTM, AAMI/ISO, and USP establish critical test methods to ensure adequate cleaning and sterility, mechanical performance, biocompatibility, and material integrity. These standards streamline innovation while safeguarding patients, reducing redundant testing, and maintaining U.S. competitiveness in global markets. […]
NAMSA Acquisition of U.S. Medical Device Testing Operations of WuXi AppTec
NAMSA, a medical device contract research organization, announced last week the acquisition of the US medical device testing operations of WuXi AppTec, a biopharmaceutical and medical device testing laboratory headquartered in China. This acquisition is part of a recent trend of acquisitions of medical device testing laboratories by larger multinational testing conglomerates over the past […]
INEOS ABS Closure: Impact on Medical Device Manufacturers
The recent announcement of INEOS’s decision to permanently close its ABS (acrylonitrile butadiene styrene) production facility in Addyston, Ohio, has sent ripples through the medical device manufacturing industry. This closure, set to begin in the second quarter of 2025, will significantly impact manufacturers who rely on ABS plastics for various medical applications. The situation calls […]
Have an ABS-olutely Fab Holiday
Holiday Hours Please note that our lab will be closed on the following dates to allow our team to enjoy the holidays: December 24 – 25 (Christmas Eve & Day) December 31 – January 1 (New Year’s Eve & Day) We will resume normal business hours on January 2nd, ready to tackle your new materials challenges in […]
New Release of ASTM F2459: Expanding Standards for Medical Device Cleanliness
ASTM recently published a new version of F2459 “Standard Test Method for Extracting Residue from Medical Components and Quantifying via Gravimetric Analysis.” This updated standard expands its scope beyond metallic implants to include ceramic and polymeric medical devices. Key Updates and Applications Expanded Scope: The standard now covers residue assessment for metallic, ceramic, and polymeric […]
Polymer Deformulation by Multi-Step Pyrolysis GC-MS
Polymer deformulation typically involves multiple tests to identify the type of polymer, assess the presence of potential blended polymers, and evaluate the incorporation of additives such as colorants, stabilizers, and processing aids. An elegant and more rapid alternative involves a form of pyrolysis gas chromatography mass spectrometry. During pyrolysis, polymeric materials are rapidly heated to […]
FDA Workshop Explores Potential Expansion of ASCA Program to Include Chemical Characterization
On November 6, 2024, the FDA held a workshop to discuss the potential expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical characterization per ISO 10993-18. This expansion would build upon the current ASCA program, which primarily covers select biological endpoint tests according to ISO 10993. Because the FDA has already […]