Bringing a medical device to market is a daunting prospect for even the largest manufacturers. There’s nurturing a concept from prototype to finished product; determining how and where to manufacture it; conducting trials for safety and efficacy; and getting FDA approval.
And while the U.S. is home to some of the world’s largest medical device manufacturers, including Johnson & Johnson, Medtronic, Becton-Dickinson and Boston Scientific, more than 80 percent of U.S. medical device companies actually have fewer than 50 employees. Many are start-ups with little or no sales revenue. These companies excel at innovation and product development, but simply lack the manpower to master manufacturing or regulatory issues. A little help can mean the difference between sustained success and going belly up.
Author: John Sprovieri for assembly magazine