I had a university professor—a scruffy, industry-hardened curmudgeon of a man—who used to tell his journalism students, “You don’t trip over a job well done.” And while many students floated through school—and then probably through life—doing enough just to get by, some of us understood his message clearly (and endeavored to heed it): Quality is no accident.

 

In the medical device industry, those words aren’t just a rallying cry to rouse the complacent; they’re words to live by. The quality issue pervades the process from clinical trials through FDA review, to product launch and mass production. This month’s issue of Medical Product Outsourcing examines the medical device industry’s attention to detail in its many different forms. 

 

For our annual full-service outsourcing cover story, “Taking the Pulse of Full-Service Outsourcing,” MPO polled industry insiders to find out how and why the finished-goods sector is giving component manufacturers a run for their money. Device manufacturers traditionally have been conservative about letting go of control of device development and production. Judging by the rate at which the outsourcing market for devices has expanded (and is expected to continue growing), hesitation has given way to cooperation. But no matter how strong this new spirit of cooperation may be or how attractive the cost savings or supply chain benefits are, no OEM would have a contract manufacturer supply the smallest of components—let alone the most complex device—unless the supplier had the mettle to the pass the stringent quality expectations of its clients and government regulators.

To help suppliers meet those expectations, this month’s issue also features “The Century of Quality,” a look at the trends and tasks that are keeping quality control officers—and industry consultants—working overtime. Some insiders predict a tougher road ahead.

“The FDA feels that the industry has been getting away with too much. More warning letters are ahead—and more legal actions. The FDA will make the most of its staff and power in order to hang a few companies out to dry,” Alan Schwartz, executive vice president of MDI Consultants in Great Neck, NY, told Editor Jennifer Whitney. That kind of warning is enough to make even the most compliant of manufacturers sit up and take notice.

On a lighter but still quality-focused note, MPO is pleased to announce additions we expect will continue to improve our service to readers. R. Scott Etlinger, senior vice president of global operations for Minnetonka, MN-based American Medical Systems, and Kevin Quinley, senior vice president of Medmarc Insurance Group in Chantilly, VA, are the newest members of our Editorial Advisory Board. In addition, we also have added to our editorial staff. Christina Zarrello joins the team as associate editor.

Some of the faces may be new, but, as always, the goal remains the same: to provide useful insight and information to help our readers do business better.

And that’s no accident.