Combination Products 2.0: Applying the New FDA Regulations
June 29, 2011 10:11 am | by Steven G Richter, Ph.D, RAC, SM(NRM) | Articles | CommentsCombination products, those that contain medical devices embedded with pharmaceutical or biologic components, have become a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new product submissions to the FDA. This article reviews testing and FDA compliance concerns with them.
LISTED UNDER: Control | Full Service Contract Manufacturing | Medical Device Testing
Molding Services for Medical Device Components
June 15, 2011 7:07 am | B. Braun Oem Division | Product Releases | CommentsThe B. Braun OEM Division of B. Braun Medical Inc. offers injection molding, insert molding and over molding for the production and customization of medical device components.
LISTED UNDER: Molding | Molding Equipment | Molding Systems
Contract Manufacturing, Production, Assembly of Class I & II Devices
May 31, 2011 7:02 am | Sanbor Medical | Product Releases | CommentsSanbor Medical is a 21 year old full service U.S. Contract Manufacturer/Assembler with a high quality / cost effective FDA Registered production facility in Xiamen China, providing off shore pricing with on shore reliability.
LISTED UNDER: Full Service Contract Manufacturing | Full Service Contract Manufacturing
4G Outsourcing Partnerships
March 10, 2011 11:26 am | by Rich Nazarian | Minnetronix, Inc. | Articles | CommentsOutsourcing is a thriving aspect of the medical device manufacturing landscape. However, these partnerships have developed from different “generations.” This article highlights the three generations of current outsourcing partnerships and gives insight into what the fourth generation will likely bring for both OEMs and their partners.
LISTED UNDER: Full Service Contract Manufacturing | Electronic Components
Perspectives on Time to Market—Part 1
December 16, 2010 10:33 am | Cirtec Medical Systems | Articles | CommentsFor your area of the industry, what is your best recommendation for getting a medical device to market faster? Heather Dunn, Director of Engineering, CIRTEC Medical Systems: CIRTEC Medical Systems is commonly requested to perform accelerated product developments for our clients. The CIRTEC approach in those situations involves a few key tactics.
LISTED UNDER: Full Service Contract Manufacturing | Power Supplies | Medical Device Testing
Medical Balloons Produced in 300 mm Lengths
October 19, 2010 6:59 am | Interface Catheter Solutions | Product Releases | CommentsInterface Catheter Solutions has extensive experience in producing medical balloons to client specifications for a variety of clinical applications, either on a prototype or contract manufacturing basis.
LISTED UNDER: Full Service Contract Manufacturing
Microprecision Contract Manufacturing of Medical Devices and Implants
September 24, 2010 10:02 am | Norman Noble, Inc. | Product Releases | CommentsNorman Noble, Inc. is a single source for microprecision contract manufacturing of medical devices and implants. Its experienced engineers and technicians develop manufacturing processes for the most challenging of projects.
LISTED UNDER: Full Service Contract Manufacturing | Micro-machining | Laser MachiningDesign for Use: An Integrated Approach to Product Development
August 25, 2010 5:06 am | by Chris Evans | Articles | CommentsIn 2009, after more than five years in development, the members of an integrated drug delivery device team from West, The Tech Group and Insight Product Development gathered in Raleigh, NC for a final round of usability testing. This stage included mock self injection by perspective in-home users of a proprietary device with the potential to challenge the auto-injection market with a new, easy-to-use design featuring visual, audible and tactile features to help end users comply with drug delivery instructions.
LISTED UNDER: Full Service Contract Manufacturing | Medical Device TestingProtecting Product Quality in an Outsourced Manufacturing Model
April 30, 2010 6:18 am | by Chris Rehl | Articles | CommentsToday’s chilling economic climate is accelerating the adoption of cost-cutting initiatives. Outsourcing component and sub-assembly manufacturing, as well as application development, has long been standard practice for high-tech and consumer manufacturing, and medical electronics manufacturers are now increasingly following suit.
LISTED UNDER: Full Service Contract Manufacturing | Electronic Components | Medical Device TestingMillipore's Biomanufacturing Courses Receive IACET Certification
April 6, 2010 5:07 am | Product Releases | CommentsMillipore Corp. announced that its Access Knowledge Institute Courses for Biomanufacturing have been certified by the International Association for Continuing Education and Training (IACET), and authorized to grant continuing education credits. The certification is valid for five years.
LISTED UNDER: Full Service Contract Manufacturing
The Ultimate Design Guide 50 Showcases Nordex Components
April 6, 2010 5:07 am | Product Releases | CommentsNordex Inc. has announced its Ultimate Design Guide 50. This latest 850-page edition is available both in print and online, and offers hundreds of new and expanded lines of inch and metric components, further enhancing the company's capability for high mix/short run contract manufacturing.
LISTED UNDER: Full Service Contract Manufacturing | Full Service Contract Manufacturing
FlexLink's Website Offers Comprehensive Technical Information
April 6, 2010 5:07 am | Product Releases | CommentsFlexLink has launched a new web site that features easy navigation, presenting products, solutions, and corresponding customer value. The entirely new website will help users find the right solution through a comprehensive offer description where all related information is one click away.
LISTED UNDER: Full Service Contract Manufacturing
Perspectives on Lean Manufacturing, Part II
January 22, 2010 10:59 am | Articles | CommentsLean manufacturing can help companies eliminate waste, reduce costs, and improve timeliness.
LISTED UNDER: Micro Molding | Full Service Contract Manufacturing | Medical Device TestingFive Developments in Laser Cutting Technology
December 2, 2009 4:28 am | by Paul Dirienzo | Articles | CommentsLaser die cutting advancements have been made rapidly over the last several years. Design engineers who are not maintaining close watch of this industry may not be aware of some of the more recent benefits that are being realized.
LISTED UNDER: Precision Cutting Tools | Prototyping | Rapid PrototypingReducing Cost in Medical Disposable Manufacturing
December 2, 2009 4:25 am | by Tom Ferris and Pawel Wasniowski | Articles | CommentsThe Project: Reduce costs in the production process of medical disposables without requiring a redesign of the device. The Solution: Move the product to a lower cost labor market and upgrade the production line while implementing principles of Lean and Six Sigma.
LISTED UNDER: Full Service Contract Manufacturing | Medical Device Testing
