Will FDA accept reprocessing instructions from a predicate device? What do proposed guidelines say about the requirement of multiple markers to properly demonstrate cleaning efficacy? This week’s Ask the Engineer covers some frequently asked questions on this topic.
Several questions are asked about light curing adhesives and are answered by Irene Boutin, Application Engineering Manager, Dymax Corporation
Compliant, noncompliant and semi-compliant balloons—which one is right for you? Read to know how to choose the right manufacturing process for your silicone medical balloon.
Software verification and validation is a process that produces objective evidence that the software in a medical device has been thoroughly designed, tested, and meets user requirements. The level of depth of testing and documentation is based on overall risk. This installment of ‘ Ask the Engineer ’ addresses the question of when and where to start the software verification and validation process.
Hose barbs are a common feature on fittings and connectors. However, several key factors need to be considered when designing these. This column discusses how all barbs are not created equal.
Liquid Silicone Rubber or LSR is a thermoset elastomer based on silicone dioxide (sand). And in recent years, use of LSR is growing in usage and popularity. This installment of Ask the Engineer addresses some questions on uses of LSR in medical devices, how it can be injection molded, and 2K molding (multi-component LSR molding).
New and Revived: Your questions on adhesives usage answered by Christine Salerni Marotta at Henkel-Loctite.
Pose your product development questions to Jeff Wickham , Principal, LifeHope Medical Inc.
Q: What are the best materials for electromagnetic applications? A: This depends on the application, and on factors such as the performance, cost and specific geometry. Electromagnetic materials are commonly compared using B-H curves (B stands for induction and H for magnetizing force), which are basically a plot of how much magnetic flux a material will carry versus the intensity of the magnetic field. This can be experimentally seen by using an electromagnet and observing how strong…
Q: I designed a cantilevered snap fit that extended as a continuation of a wall, but some of the prototypes cracked at the snap finger barb. Usually, the highest stresses are at the base of the cantilever. So why did the snap finger crack where it did? A: The snap finger would likely have cracked at its base if it were extending from a flat surface rather than as a continuation of a wall. In this case, because it was extending from a wall there was no stress concentration at the base,…