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Combination Products 2.0: Applying the New FDA Regulations

June 29, 2011 10:11 am | by Steven G Richter, Ph.D, RAC, SM(NRM) | Comments

Combination 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.

Pain Therapy Device Gains a Sure Grip

June 29, 2011 9:27 am | by Joe Kutka | Comments

The Project: A durable material was needed from which to fabricate protective bumpers for a portable pain management device. The Solution: A thermoplastic vulcanizate alloy was selected for its excellent surface quality, easy processability, high tear strength, and aesthetic benefits.

Next Generation Human Interface Adhesives Selection

June 29, 2011 6:59 am | by Peter C. Johnson, MD | Comments

Human interface adhesives address all areas of the body, but cannot serve those areas with equal efficacy due to a variety of differing factors. A new testing system addresses this by more accurately evaluating adhesives for the specific part of the body upon which they are to be used. This article provides the benefits of this system while also looking at applications where it can best be implemented.


Ultra Short Pulse Laser Processing

June 29, 2011 5:58 am | by Ronald D. Schaeffer, Ph.D | Comments

Laser processing and machining offer a variety of advantages to medical device manufacturers across a number of sectors in the industry. The next generation of laser systems is improving upon these technologies by providing enhanced results in a fraction of the time. This enables even greater precision with less impact on the material being used. 

Roundtable Q & A: Testing & FDA Compliance

June 27, 2011 12:58 pm | by Al Gale, John P. McCloy, Michael Anderson, Warren Ward-Stacey | Comments

Industry leaders Al Gale, Product and Material Engineer at DDL, John P. McCloy, PE, CWI President at Accutek Testing Laboratory, Michael Anderson, PhD Technical Manager at Empirical Testing Corp, Michael BoetzkesQuality Manager, Life Science Division at Vaisala Canada Inc., and Warren Ward-Stacey Sales Director—Life Sciences at PRISYM ID respond to questions regarding testing and FDA compliance.

Applying Tech: Telemonitoring

June 27, 2011 11:53 am | Comments

How are you influencing Telemonitoring devices?

Roundtable Q & A: Advanced Material

June 27, 2011 9:49 am | by Ken Breeding, Prakash Pawar | Comments

Industry leaders Ken Breeding, Platform Technology Manager, Medical Devices at Eastman Chemical Company and Prakash Pawar, Applications Development Engineer at Momentive Performance Materials, respond to questions regarding advanced materials for medical devices.

Applying Tech: Portable Medical—Part 3

June 27, 2011 8:34 am | Freescale Semiconductor, Inc. | Comments

How are you influencing Portable Medical Devices?


Applying Tech: Portable Medical—Part 2

June 27, 2011 7:09 am | Eldon James Corp. | Comments

How are you influencing Portable Medical Devices?

Applying Tech: Portable Medical—Part 1

June 27, 2011 6:12 am | Comments

How are you influencing Portable Medical Devices?

Getting a Reed on Miniaturizing Magnetic Switches

June 22, 2011 12:34 pm | by Paul Linsley | Comments

The reduction in size of medical electronics is a benefit of component suppliers across the board making their products smaller with lower power requirements. This article looks at the benefits achieved from the miniaturization of magnetic reed switches and the specific applications in which they are used. 


Seal of Approval

June 22, 2011 11:42 am | by Lynne H. Barton and Kent A. Hevenor | Comments

The market for sterile pouches is growing along with the demand for improved strength, puncture resistance, and barrier properties of new materials used to make the pouches. As medical device companies develop new products requiring different levels of protection, the selection of a medical pouch sealer becomes more critical.

Ceramic Replaces Titanium With Machining Assistance

June 22, 2011 9:55 am | by Klaus A. Burckhardt, PE | Comments

Coated titanium was to be replaced as the material for the stator housing in a right ventrical assist device. Zirconia ceramic was the material selected and expert machining met the needs for very tight tolerances to fabricate the component.


11 Critical Question Areas of Tubing

June 22, 2011 8:16 am | by Robert LaDuca | Comments

Tubing is available with a variety of options and in a range of styles. Selecting the right tubing for a specific application can be both challenging and daunting. This article attempts to clarify the process for device makers by highlighting some of the most commonly indicated choices.

Connecting Miniaturized Devices

June 22, 2011 6:50 am | by Bob Stanton | Omnetics Connector Corp. | Comments

Miniaturization is one of the biggest trends in medical device development today. Ensuring that these devices, as they get smaller, are still able to be connected reliably and securely is no simple task. This presentation discusses the miniaturization trend in the medical device manufacturing industry and briefly highlights the nano and micro connectors used in them.


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