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Demystifying Failure Mode and Effects Analyses (FMEAs) in Medical Device Manufacturing
Failure Mode and Effects Analysis (FMEA) is a design review tool used to identify and correct all possible failures in a product, service, design or manufacturing...
Breakdown of a Lateral Flow Test Strip
Lateral flow test strips are simple, easy-to-use devices that can detect the presence or absence of a target analyte (chemical or substance) in a specimen provided by a...
Lab-on-Chip: an Overview
Lab-on-chip (LOC) technology has the potential to provide a robust and portable point-of-care (POC) toolset at a fraction of the size and cost of conventional laboratory...
Biocompatibility Testing for Surface Medical Devices
All medical device companies must subject their products to a volley of FDA-approved tests to establish the safety of their devices. A particular series of these tests...
3D Bioprinting in Orthopedics
The use of flexible materials in the medical field has revolutionized the treatment of a variety of conditions. Orthopedics, in particular, has the potential to benefit...
Interview with Professor Charles Cooney on Bioprocessing
We had the opportunity to sit down with Charles L. Cooney (Robert T. Haslam Professor of Chemical Engineering, MIT) to discuss what he sees as being on the horizon for...
Challenges and Risks in Batch Bioprocessing
Batch bioprocessing is the industry standard in biopharmaceutical production. Although the advancements in biomedical technology that have allowed for batch...
Mutual Dependence: Continuous Bioprocessing and Single-Use Systems
The rise of continuous biomanufacturing (CBP) is tied to the ascendance of single-use systems (SUS). Single-use disposables enable CBP by providing a high degree of...
Innovations in Detectors and Sensors Enabling Continuous Bioprocessing
It has been known for some time that continuous bioprocessing would be a useful strategy in biopharmaceutical production, but it was not quite possible on an industrial...
What Does the Implementation of EU-MDR Mean?
The passing of the EU Medical Device Regulations (EU-MDR) is forcing medical device manufacturers to update their clinical testing practices and reporting mechanisms....