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November 2009
Exclusive Online Articles

President to Industry: Get Involved in Healthcare Reform

Former president Bill Clinton addressed AdvaMed at its conference in Washington, DC, October 14. Following his remarks, he sat with Michael Musallem, chairman of AdvaMed, and answered some pointed questions about the effects of healthcare reform on the medical technology industry.

Outstanding OEM: Small Beginnings Inc: Born in the NICU

Surrounded by new life, Mary Sharon Rogone conceived the idea for her first device.

Outstanding OEM: US Endoscopy: Keeping It Local and Focused

As companies send manufacturing offshore in large numbers, US Endoscopy is committed to making product innovations in its home state.

Outstanding OEM: Zoll Medical: Breathing New Life into Resuscitation

Zoll Medical has thrived thanks to innovative devices in the resuscitation area.

Outstanding OEM: Luminex: Multiple Strengths on a Single Platform

Luminex looks to the future with one advanced technology.

Expanded Online Articles

Inventory Collaboration: An Untapped Opportunity

Automated, Web-based inventory collaboration lets manufacturers strike a balance between having sufficient products available and minimizing inventory carrying costs.

Enhancing Business through Technology Assessment

A proper assessment can help manufacturers understand the competitive landscape and make better use of their intellectual property.

October 2009
Exclusive Online Articles

The Development Edge: Software Design-For-Test

The push for cost-effective medical device development may get some assistance from adopting rigorous software simulation practices.

Expanded Online Articles

Analysis of Risk: Are Current Methods Theoretically Sound?

Applying risk assessment may not give manufacturers the answers they think they are getting.

September 2009
Exclusive Online Articles

Five Ways to Ensure a Successful Tubing Project

Increasing competition and market changes mean companies and their tubing vendors must develop even stronger relationships.

Flexible Assembly in a Lean World

The flexibility of an assembly operation can make the difference in profits for medical manufacturing.

Professional and Consumer Healthcare Technologies Converge

It is important to know how to design for and market products that move from the doctor’s office into the consumer realm.

August 2009
Exclusive Online Articles

Trends in Laparoscopy: Sealing Technology

Advances in seal designs can lead to better trocar use and manipulation for surgeons.

CRO Partnerships: Strategies for Successful Postapproval Studies

Successful postmarket surveillance starts with a healthy partnership. Specific strategies can help make that happen.

June 2009
MD&DI's 30th Anniversary Timeline

This interactive timeline features photos, videos, and maps for significant events from the last 30 years. Culling the rich history of medical devices, the timeline exhibits developments that have transformed the industry.

May 2009
Exclusive Online Article

Quality System Compliance
Using Documentation Provides Advantages beyond Compliance

Good documentation helps meet requirements and also increases the efficiency, productivity, and consistency of processes and employees.

Expanded Online Articles

Software
Diagnosing Medical Device Software Defects Using Static Analysis

Automated static analysis can improve reliability of medical device software. Here are the key criteria that need to be considered when selecting a static analysis tool.

Cleanroom Technology
Assessing Cleanroom Compatibility of Injection Molders

One study explores whether electric machines are more suitable than hydraulic machines for medical cleanroom applications.



April 2009
Expanded Online Article

Regulatory Outlook: Converting CAPA to an Advantage

CAPA violations still generate a substantial number of warning letters. These tips can help make CAPA systems a benefit instead of a liability.


March 2009
Product Development Insight

Doctors aren't the only ones with purchasing power in hospitals. Medical device companies must improve the appeal of devices to meet nonclinical buyers' needs. Use an online calculator to get your hospital integration needs score.

Podcast

For the March issue, newest EAB member Andrew Dallas spoke with MD&DI about trends in the industry and his unique background. Click here to listen to snippets from the interview.

Expanded Online Article

Unraveling Misconnections in Medical Tubing

Video

See videos of the microgripper described in this month's R&D Digest section in action.


February 2009
Downloads
AdvaMed Code Comparison Chart

Web Site Directory
Need a quick reference point for your favorite manufacturers' Web sites? Look no further.

30 Years, 30 Devices

In celebration of MD&DI's 30th anniversary, we're looking for the 30 most influential medical devices. This is a chance for readers to vote for the finished medical device products that have changed the industry. From those nominations, the editors will choose devices that they feel best represent the industry's growth over the past 30 years. The results will be published in the June 2009 issue. Respondents can make multiple entries. Submissions are closed. Look for our 30 Years, 30 Devices feature in the upcoming June 2009 issue.

Expanded Online Article

Developing Diagnostic Products: Polymer Laminate Technology

Building Quality into Medical Device Software

Business Briefings: Bucking the Trend in the Recession


January 2009

Podcast

Download an audio presentation of Advances in Cardio Technology, MD&DI's Panel Discussion at the MD&M Minneapolis 2008 Conference.

Video

View videos that demonstrate the CAD initialization and the functionality of a vacuum cast prototype.

Expanded Online Article

A Look Into the Future of the U.S. Medical Device Market


December 2008

2008 Salary Survey

Use MD&DI 's Salary Approximation Worksheet to calculate your cross-tabulated salary based on this year's survey results. Then take a poll to let us know how close the model is to your actual salary.

Podcast

Download an audio presentation of Combination Products: A Convergence of Technologies and Market Opportunities, MD&DI's Panel Discussion at the MD&M Minneapolis 2008 Conference.

Special Report

News from the Cleveland Clinic Innovations Summit

Expanded Online Articles

M&A Analysis: M&As Key to Device Growth Strategies

M&A activity continued to be strong in 2008, providing a lucrative option for companies seeking to grow. More of the same is expected in the coming year.

Web Exclusives: MedTech Snapshot


November 2008

Outstanding OEMs: Web Exclusive Features

Volcano Corp.: Growing Against the Odds

Once only a software company, Volcano Corp. turned a 'four-letter word' into its own stronghold in the medical device marketplace.

Abbott Laboratories: Restoring Faith

The success of Abbott Laboratories' new product has injected optimism into a plagued stent market.

Also: Watch a video demonstration of Abbott Laboratories' new Xience stent.

Expanded Online Articles

Regulatory Outlook: Gleaning Good Practices from Warning Letters

Warning letter data provide an informative look at patterns in the device industry.

Getting a Grip on Electronic MDRs

Technologies available today are enabling medtech engineers to plan for the electronic regulatory reporting future.


October 2008

Downloads

Download a sample of the 2008 International Compliance Code Compendium

Expanded Online Articles

Developing an In-House Reimbursement Paradigm

Effective reimbursement strategies start with open communication channels in-house.

Q&A: Preaching the Value of Human Factors

For more than 30 years, Peter Carstensen was CDRH's chief authority on human factors engineering. He's now bringing his expertise to the private sector.

Regulatory Outlook: Identifying the Right Notified Body for Entering the European Market (includes expanded table)

Device manufacturers need to consider many factors when choosing a notified body. Finding the right one can increase chances for successful market entry.

Video

See a Video Demonstration of Vibration Testing

(Read the NewsTrends Article: Proper Product Testing Avoids Bad Vibrations)


August 2008

Q&A

The Case for Evidence-Based Compliance

Erik Swain

The government now expects companies to show that the policies to stop inappropriate payments and perks to physicians are working. Michael Bell is helping enable firms to do that.

Guide to Outsourcing

Five Considerations for Opening an Offshore Facility

Roger Brink

Lessons learned during the hunt for the perfect manufacturing location.

Video

Sample Instructional Animation Videos

Animated Demonstrations of Magnetic Field Technique

Expanded Online Articles

UV Micromachining: Shorter Pulses or Shorter Wavelength?

For many medical devices, cost-effective state-of-the-art micromachining can be obtained by using a laser with short output pulses and high beam quality.

Animated Videos Guide User Interactions with Complex Medical Devices

For many medical devices, cost-effective state-of-the-art micromachining can be obtained by using a laser with short output pulses and high beam quality.

The Greening of Medical Product Design

How to make medical device products more sustainable.

12 Key Questions for Selecting a Supplier

Answering these questions will help a company zero in on the right supplier.

Automated Testing for Real-Time Embedded Medical Systems

Medical device companies, especially those with real-time embedded-system products, are often burdened with lengthy verification cycles.


July 2008

Cardio Technology Trends Video

Diagnosing Heart Disease Through PET·CT Scans

Revolutionizing Heart Care

Expanded Online Article

Microwire Use in Catheter-Based Medical Device Applications, Part 2

Incorporating microwires into catheter design offers new opportunities for sensor applications.


May 2008

Testing

Segmental Compression Benchtop Testing Video

See bonus footage of a segmental compression system measuring and recording the radial stiffness and strength of a self-expanding stent.


April 2008

MDEA 2008

Medical Design Excellence Award Winner Videos

For the first time ever, MD&DI has posted videos of Medical Design Excellence Award winners. These are the same videos entrants supply to MDEA jurors.


March 2008

Guide to Outsourcing

What Your Mother Never Told You About Outsourcing to China

Rick Rogers and Gray McCord

Thinking about moving your manufacturing to China? It's not an easy process, so be sure it's the right decision.


February 2008

Web Site Directory

Need a quick reference point for your favorite manufacturers' Web sites? Look no further.

Regulatory Outlook Expanded Version

Revised EU Directives: Many Changes in Store

Roger Gray

A directive revising European medical device regulations is scheduled to take effect in March 2010.


January 2008

A Comprehensive Guide to the Quality System Regulation Preamble

Kristin Miller and William A. Hyman

Q&A Expanded Version

Global Harmonization Is Here to Stay

Erik Swain

Larry Kessler, chair of the Global Harmonization Task Force, has seen his organization make great strides, but some obstacles remain.