04.28.22 -- The Importance Of Risk Documentation In Medical Device Design

Selective laser sintering (SLS) systems use a high-powered laser to selectively melt and fuse powder particles of a bioresorbable polymer in a layer-by-layer 3D printing process to manufacture a final implantable medical device part. Depending on the part geometry, these systems can typically print geometries as small as 0.4 mm with a tolerance of +/- 0.25 mm.

Application-specific design in actuators ensures unparalleled motion control, reliability, and longevity in both the component and the device it serves.

There is a need for environmentally sustainable materials in the medical device industry, and Celanese’s Hostaform MT POM ECO-B fills the gap. From feasibility to development to commercialization, Celanese’s scientists and engineers are there to provide development services, GMP material supply, and regulatory support.

To ensure patient safety, a medical device needs to be kept as clean and free of contaminants as possible. As part of the solution, silicone molders will need to wash the component before packaging and shipping through the use of a cleanroom. 

Next-generation bioprinters will need fast, precise performance coupled with versatility to create tissue spheroids and extracellular matrix hydrogels. The Lee Company's VHS Series valves have printed a variety of cell cultures with impressive viability and accuracy and are currently in service with numerous commercial customers and research institutions.

Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.

A technology company using modeling tools to help their customers improve the design, safety, and efficacy of medical devices tailored to individual patients uses simulation solutions to help clinicians and medical device manufacturers customize patient treatment.