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Cutting Through the Red Tape of Combination Product Approvals

October 11, 2006 8:47 am | Product Releases | Comments

As the development and use of combination products increases, the FDA realizes it needs to establish specific guidelines to oversee this technology. This article explores some of the pivotal issues pertaining to how a combination drug-device, drug-biologic, or device-biologic is regulated.

LISTED UNDER: Regulatory Affairs

Innovation Plus Collaboration Equals a Successful Combination

October 11, 2006 7:37 am | Product Releases | Comments

Companies need to move rapidly to take advantage of developing trends in healthcare treatment modalities. This article examines many of the factors combination product manufacturers need to consider to accelerate their product’s time to market.

LISTED UNDER: Product Design | Microbiology/Chemical Testing | Wire and Cable

Helping Hand From Computer Giant Enhances Drug Delivery

October 11, 2006 7:37 am | Product Releases | Comments

This article describes how a design-centered company leveraged its innovative consumer design expertise from the audio-visual world and transferred this knowledge to its drug delivery device affiliate, while receiving the collaborative assistance from a computer technology leader.

LISTED UNDER: Design Services
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Films That Dissolve Diagnostics Manufacturers' Needs

October 10, 2006 6:15 am | Product Releases | Comments

Dissolvable films are currently used in a variety of applications such as consumer breath freshener products and as vehicles for over-the-counter drug delivery. Manufacturers are also exploring the technology’s unique characteristics for use with in vitro diagnostic devices.

LISTED UNDER: Films | Product Design

Fabricating Components . . . Rapidly

October 10, 2006 6:15 am | Product Releases | Comments

Medical device manufacturers require device components to be produced quickly to ensure their products are available to the marketplace as soon as possible. However, quality cannot be sacrificed in this effort. Rapid prototype tooling is a unique option that satisfies both of these two criteria.

LISTED UNDER: Rapid Prototyping | Prototyping | Rapid Prototyping

Assembling the Perfect Design Team

October 10, 2006 6:15 am | Product Releases | Comments

Since most manufacturers do not staff experts in every area of technology they may need to create a finished medical device, collaborating with professionals who are can be the ideal formula for success.

LISTED UNDER: Design Services | Product Design

Measuring Up Lean: The Journey Towards Operational Excellence

October 10, 2006 6:06 am | Product Releases | Comments

Lean manufacturing is commonly associated with automotive manufacturers but medical device makers are rapidly discovering the advantages of using it in their marketplace.

LISTED UNDER: Full Service Contract Manufacturing | Control | Flow

Manufacturing Capabilities Brochure

September 7, 2006 5:12 am | Product Releases | Comments

Gauthier Biomedical, a leading provider of orthopedic and spinal instrumentation, has introduced a new brochure featuring the company’s capabilities, manufacturing and prototyping services, and ISO certification.

LISTED UNDER: Prototyping
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The Art and Science of Rapid Prototyping

September 5, 2006 7:16 am | Product Releases | Comments

Speed is the name of the game in getting a product to market before the competition. One technique medical device manufacturers are employing to help achieve faster design cycles for their products is rapid prototyping.

LISTED UNDER: Rapid Prototyping | Prototyping | Rapid Prototyping

Critical Questions of Outsourcing

September 1, 2006 4:56 am | Product Releases | Comments

Medical device manufacturers’ interest in outsourcing is growing and with it come many misconceptions and questions.

LISTED UNDER: Full Service Contract Manufacturing | Prototyping | Rapid Prototyping

19 W External Power Family

August 8, 2006 12:51 pm | Product Releases | Comments

A 19-watt family of external switch-mode power supplies are the first in a family of power devices that meets with the requirements of the EPA’s Energy Star program. The PW148 series is available in desktop or wall plug-in styles with a single output of 15 to 19.

LISTED UNDER: Power Supplies | Product Design

3D Laminate

August 8, 2006 12:51 pm | Product Releases | Comments

A high-durability grade of three-dimensional laminate called Kydex HD surpasses high-pressure laminates, melamines, and rigid thermofoils in resistance to surface and edge impact.

LISTED UNDER: Surface Modification

Vinyl Coating

August 8, 2006 12:51 pm | Caplugs | Product Releases | Comments

The ability to vinyl coat wheelchair handles, handlebar grips, and anything else that needs to have a soft, ergonomic finish molded to is available.

LISTED UNDER: Device Coating

Workbench

August 8, 2006 12:50 pm | Lista International Corporation | Product Releases | Comments

Ergonomically designed, the Arlink 7000 versatile workbench system significantly improves productivity and maximizes the use of floor space. It has received Class 10,000 cleanroom compliant certification.

LISTED UNDER: Carts and Workstations | Cleanroom Assembly

Miniature Medical Connectors (3233)

August 8, 2006 12:50 pm | Omnetics Connector Corp. | Product Releases | Comments

Medical connectors need to be small, lightweight, and comfortable in use, but built for rugged handling and extended performance and reliability. These miniature medical interconnects suit those needs. Standard and custom designs and shapes have been applied to catheters, probes, and instruments.

LISTED UNDER: Connectors | Prototyping

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