Millstone Medical Outsourcing Offers Device Distribution
Millstone Medical Outsourcing, a Fall River, Mass.-based orthopedic device contract manufacturing provider, has expanded its service offering to include medical device distribution. The company will distribute directly to patients and provide wholesale distribution to distributors, hospitals and sales representatives. Millstone Medical has been securing medical device distribution licensing in all states that require it. To support the new service, the company has instituted a program for the continuous monitoring of requirements for the two types of licenses, direct to patient and wholesale distribution, in 50 states.
Millstone made the decision to develop a distribution service because of the complexity of licensing requirements, which differ from state to state. Some states require a simple application, while others include finger printing of senior leaders and background checks, certification of designated representatives, surety bonds, and verified-accredited wholesale distribution accreditation. In addition, the processes and timeframes for renewal are state dependent and the regulations governing medical device distribution are regularly reviewed and updated.
The difficulty in gaining and maintaining the necessary licenses results in regulatory difficulties and high costs. From licensing fees to redirection of key personnel to manage the licensing process, cost becomes a major challenge that Millstone aims to help manufacturers overcome. Millstone’s offering is designed to deliver streamlined distribution, reduced costs, and increased speed to market.
“Distributing medical devices, even those used at home to improve circulation or enhance mobility after surgery, requires licensing in most states,” said Chris Ramsden, CEO of Millstone Medical Outsourcing. “The licensing process, though, can be onerous for device manufacturers. Our goal is to remove obstacles for our customers and to help them get their products to market faster. Our licensing, in conjunction with the federal and state requirements, allows our OEM partners to address regulatory hurdles and significant costs without cutting corners on quality.”
Millstone Medical Outsourcing offers inspection, sterile and non-sterile packaging, loaner kit processing, and distribution services to orthopedic device and product manufacturers.