Resources
October 2010 Digital Edition
October 1, 2010 12:00 am Digital Editions CommentsInside: Read about enhancements in protection methods and power densities in “Charging Forward with Lithium-Ion Battery Technology,” from International Components Corp. Shared are professionals’ opinions on marketing, testing, and ER/surgical devices. Additionally, read about surgical device redesign, power, and five material considerations. Check out the selection of products, as well as the offerings for engineers in Design notes.
September 2010 Digital Edition
September 1, 2010 12:00 am Digital Editions CommentsInside: Read about low-volume layered manufacturing in “Parts Without Limits,” from Quickparts. Shared are professionals’ opinions on implantables and medical devices related to the military. Additionally, read about implantable cardiac devices, avoiding molding mishaps, disposables, and packaging and interconnects. Check out the selection of products, as well as the offerings for engineers in Design notes.
How to Respond to (and Avoid) FDA Form 483 Observations for Temperature, Humidity and Other Controlled Environments
August 26, 2010 7:57 am | by Ken Appel White PapersNo cGMP manufacturer wants to receive a Form 483 letter (“Notice of Inspectional Observations”). In such stringently controlled industries as pharmaceutical/biotechnical/medical device development, manufacturing and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality system.
Embedded Opportunity: Dynamics of Medical Device Evolution Driving Need for Static Analysis
August 26, 2010 7:46 am | by Klocwork White PapersEvolving end-user expectations for differentiated software functionality, sustained time-to-market, and cost pressures continue to fuel new software development within embedded devices. Time-to-market and cost considerations will continue to drive embedded systems manufacturers to utilize international engineering resources and legacy code assets whenever efficient and economical.
Patent Attorneys and Surface Texture
August 25, 2010 5:31 am | by Donald Cohen and Danny Padys White PapersOne of the most challenging assignments for a scientist or engineer in a cutting edge technical field is working effectively with a patent attorney. The world of the scientist or engineer is quantitative and precise.
Integrating Quality by Design (Qbd) in Medical Device Manufacturing - Concept, Benefits and Challenging
July 28, 2010 4:57 am | by Igor Veljanovski, Stevens Institute of Technology White PapersThe medical devices industry, as well as the pharmaceutical industry, is slowly butindisputably accepting the concept of Quality by Design into its design and developmentproduct phases, and is introducing the statistical tools and methods of the concept intoits process verification and validation phases as well. The Quality by Design concept orapproach has found its implementation in the medical devices life cycle management,under the guidance of risk regulations by the International Conference onHarmonization. Since the importance of successful implementation of this concept isever more evident in industry, this white paper will therefore discuss the concept and itspossible implementation in the medical devices industry, along with the benefits andconcerns expressed by the manufacturers.
Finding the Cure for Order Processing Pain in the Life Sciences Industry
July 13, 2010 5:35 am | by Esker White PapersIn the life sciences industry, Customer Service and Operations directors face the challenge of maintaining high margins to absorb soaring drug development costs while keeping customers happy and away from the competition.
July/August 2010 Digital Edition
July 1, 2010 12:00 am Digital Editions CommentsInside: Read about asking the right questions about high performance plastic from micromolding an MIS device in “The Critical Questions When Micromolding for an MIS Device,” from Mikrotech. Shared are professionals’ opinions on FDA review process and wireless medical technology. Additionally, read about lasers for orthopedics, 3D imaging, package testing, sensors, testing, and Petri dish diagnostics.
2010/2011 Buyers’ Guide
June 1, 2010 12:00 am Digital Editions CommentsInside MDT’s 2010/2011 Buyers’ Guide find a manufacturer and product directory, with a product index. Categories include: component fabrication; design/manufacturing services; electronic components; facility equipment/software; fluid/air transfer; hardware; materials; packaging/sterilization; and testing.
Enabling 21 CFR Part 11 Compliance
May 14, 2010 12:23 pm | by Epicor White PapersThis whitepaper describes the requirements for FDA 21 CFR Part 11 compliance at a high level and discusses how Epicor enables FDA regulated manufacturers to fulfill these demands.
Wireless Medical Devices - Endless Possibilities
May 7, 2010 12:51 pm | by Emblaze Consulting White PapersWireless technologies are bringing about dramatic improvements in the quality of healthcare by allowing patients unprecedented mobility while providing healthcare professionals with easy and real-time access to patient data. Awareness of telehealth and wireless medical applications is increasing with more high profile companies entering the space, along with prominent media coverage and a rise in the number of conferences highlighting the technology.
Timely Maintenance Key to Extending Life of Flexible Conveyor System
May 7, 2010 12:51 pm | by Bosch Rexroth Corporation White PapersTaking the time to perform several routine maintenance procedures on assembly conveyors significantly adds to the efficiency and longevity of the system.
The Future of Medical Imaging
May 7, 2010 12:51 pm | by Texas Instruments White PapersIn a technology enabled future, a bathroom mirror with a retinal scanner behind the glass collects vital signs and looks for clues to retinopathy, and a toilet with an embedded processor analyzes urine to identify kidney infections or the progression of chronic conditions such as diabetes.
The Effect of Gamma Sterilization on Select TPE Materials
May 7, 2010 12:51 pm | by RTP Company White PapersIt is well known and published that modern sterilization techniques can have a detrimental effect on polymers. In particular, gamma sterilization, which is the most common ionization method, can cause substantial changes in polymeric materials.
Technical Guide: How to Match Today’s Laser Cutting Technology to Application Requirements
May 7, 2010 12:51 pm | by Spartanics White PapersLaser cutting, a.k.a. digital die cutting, uses high-powered lasers to vaporize materials in the lasers’ beam path. The powering on and off of the laser beam and the way in which the beam path is directed towards the substrate effects the specific cuts that the artwork requires.
