Acting FDA Commissioner Andrew von Eschenbach said the agency needs to go beyond the "incremental" improvements it has made in speeding up the review of device premarket applications under the Medical Device User Fee & Modernization Act (MDUFMA).
Medical device companies today struggle with the continual need for design innovation and faster time-to-market, while under pressure to comply with strict FDA regulations.
To help design engineers determine the proper installation torque for the fasteners in their product designs, Archetype Joint LCC is offering a free Torque & Tool Reference Card. This handy 4 3/4 x 3 1/2 in. reference card provides reference on installation torque values for fasteners 1/4 to 5/8 in.
Danaher Motion has introduced a new guide to Portescap Miniature Specialty Motors. The guide highlights the Portescap family of brushless DC motors, brushed DC coreless motors, and stepper motors, as well as its digital linear actuators, gearheads, and encoders.
The Open Prosthetics Project has adopted the Alibre Design 3D parametric modeler as the CAD standard for industry-wide collaboration. On the project’s website, medical product designers can post new ideas for prosthetic devices as CAD files, which are then available to the public free of charge.
Bimba Manufacturing offers a powerful, web-based Sizing and Selection module for designing-in Bimba products. The user-friendly software allows engineers to find the right part for the job, test it to different application variables, and easily generate a model number for ordering.
Beswick Engineering designs and manufactures high-performance miniature fluid power devices and its web site now offers 3D models for download. Many customers have transitioned from 2D drawings to 3D models to shorten their design cycle.
IDES Inc. has launched their vertical search engine for the plastics industry. In one simple search, IDES gives users free access to articles, technical documents, and websites.
Gems Sensors & Controls has opened a web site dedicated to addressing the fluid sensing and control needs of medical equipment design engineers.
Minco, a designer and manufacturer of critical components for critical applications, offers the “Sensor Configurator”a configuration tool that allows customers to specify, price, and order Minco sensors, instruments, and assemblies online in one easy process.
The PoleVault is an innovative hypotube for catheter manufacturers seeking to improve outcomes for patients undergoing angioplasty. The hypotube is a long metal tube with micro-engineered features along its length.
3M and Forward Technology have cooperated to optimize a cleaning process that employs Novec 7200 engineered fluid and methyl soyate. Both are clean air solvent certified by the South Coast Air Quality Management District of California.
The Smooth-flo fluid delivery system is a fully programmable dispensing system which is controlled by precision stepper motors. The phase-canceling technology uses three separate valveless pump heads, uniquely timed, to eliminate pulsation.
The Flexi 6864 is a polyester/foil/heat-seal coated polyethylene for physically demanding applications such as orthopedic parts, cardio kits, diagnostics, and other heavier medical device/sterile medical disposable items.