From a U.S. regulatory standpoint, it doesn’t much matter much where in the world medical devices are manufactured. Whether the path to market is the 510(k) or the PMA pathway, FDA doesn’t care if you make your products in Southern China, India...

Make no mistake about it: healthcare reform is coming. And that’s the case whether Obama or Romney is elected this November, regardless of which party controls Congress, or whether there is a split Congress.

Companies often struggle with the outsourcing process. “They need to come to terms with outsourcing,” John Carey, vice president, new business development for Foliage, said in a June 14 webcast. His presentation focused on the best steps to take...

 Clinical trials are arguably the most stressful point the development process for medical devices. Companies without proper expertise risk shooting themselves in the foot by improperly conducting trials, which can set them back months or even...

Lack of standardization in change control agreements and notably lack of clarity on machine equivalency are causing significant and unnecessary inefficiencies in the supply chain. Highly varied standards across medical device companies, and even...

Some of the traits that make a contract manufacturer attractive to corporate and private equity group buyers also make it a good outsource partner for OEMs.

The increasing shift to outsourced production and assets in the medical device industry is following paths of other industries such as automotive, consumer electronics, pharmaceuticals and personal computers, to name a few. In many ways, the road...