Originally Published MDDI December 2005
FROM THE EDITORS
The New Industry Yearbook
The New Industry Yearbook
Welcome to MD&DI's Industry Yearbook. In some ways, it may look very familiar. That's good because we've included many of the useful resources—like the salary survey—that you've come to count on each December. As in years past, the MedTech Snapshot presents facts and figures for the year in review, from corporate finance to FDA.
Packed with information, this yearbook will be a useful resource all year long. In addition to old favorites, you will also see a host of new features, including a directory of contract manufacturers of finished devices. More than 80 contract manufacturers are listed in this comprehensive directory. Details for many companies include years in business, registrations, manufacturing locations, primary devices manufactured, and key personnel. It is the only directory of its kind.
Also new this year is an in-depth analysis of the mergers and acquisitions activity of the past year. On page 40, Clyde Burkhardt and Stephen Tardio look at the year's M&As in the device industry. But, they give you more than just a list of who bought whom. They provide perspective for how your company fits in that picture moving forward. According to Burkhardt and Tardio, “The next few years could be the perfect time for the owner of a medical device OEM company, a component manufacturer, or outsourcing provider to explore the sale of the company.”
In place of his usual column, James G. Dickinson examines the year in review. He takes a detailed look at FDA enforcement in 2005 and its effect on the industry's relationship with the agency. In particular, he notes FDA's October seizure of Baxter Healthcare infusion pumps, and, of course, FDA's long battle with Utah Medical. And, he reveals that despite FDA's three-year effort to gain industry participation in its third-party inspection program, no firm has yet volunteered. Read his column on page 22 for more details.
If you are considering becoming a volunteer for the program, be sure to see the new feature, “Quality Systems Inspections: Registrars and FDA Accredited Persons,” on page 106. This first half of the list provides a sampling of registrars accredited to assess a company's quality management system and to issue a certificate confirming that the organization's quality management system meets the requirements of ISO 13485. The second half lists third parties that FDA has accredited to perform inspections of eligible manufacturers of Class II or Class III devices.
And don't forget about getting your product to market. Regulatory intelligence is key to speeding your product submission through FDA. On page 104, Wallis Weiler Cady has compiled a list of Web resources that can be used to get the information you need to devise a regulatory strategy.
These are just a few of the new and updated features included in this special Yearbook issue. We hope that you find it to be a valuable resource from year to year.
Sherrie Conroy for The Editors
Copyright ©2005 Medical Device & Diagnostic Industry