Millstone Medical Outsourcing. LLC has announced that the company will offer customers an expanded medical device distribution service, which includes the ability to distribute directly to patients and to provide wholesale distribution to distributors, hospitals, and sales representatives. Millstone Medical has been securing medical device distribution licensing in all states that require the licensing. In addition, Millstone Medical has instituted a robust program for the continuous monitoring of requirements for the two types of licenses, direct to patient and wholesale distribution, in 50 states.
The impetus for development of the service was 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 (VAWD) accreditation. In addition, the processes and timeframes for renewal are state dependent and the regulations governing medical device distribution are regularly reviewed and updated.
Millstone is aiming to help manufacturers deal with things such as licensing fees and redirection of key personnel. This new 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. The licensing process, though, can be onerous for device manufacturers, ” said Chris Ramsden, chief executive officer of Millstone Medical Outsourcing, in the April 23, 2013 news release. “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.”
Asked about those obstacles, Ramsden told OTW, “Two obstacles Millstone Medical clears for customers with the expanded distribution service are: first, approval from the Federal Drug Administration to store and distribute bone and tissue product, and, second, the licensing required to ship bone and tissue product and medical devices to every state in the country.”
