“We’re trying to stay ahead of the curve of the regulatory requirements,” Kelly Lucenti, president of Millstone Medical Outsourcing, says, adding, “We’re always trying to stay on the cutting edge of services that help our customers.”

Millstone offers inspection, cleaning, and sterile and non-sterile packaging. Their Fall River, MA headquarters offer many of these services, while the Olive Branch facility is more focused on the distribution aspect of medical devices.

The distribution directly to patients is a key strategy, as many companies are already looking to expand their devices in this area. However, there are special requirements for devices that are being shipped directly to the patient versus to a hospital, and can vary from state to state. These licenses help its customers with an increased speed to market, along with streamlined distribution and reduced cost.

In addition to its new distribution, the company also received FDA authorization for bone and tissue storage, which could be a boon for companies who have been looking to utilize those things into their medical devices.

“[Bone and tissue] has been an increased area of growth for all the medical devices that we have been working with,” Lucenti says. “We needed the capacity [to store bone and tissue] in order to make that [a priority] for the future.”

In order to register a facility with FDA for bone and tissue storage, an onsite audit has to be conducted. According to Lucenti, FDA can come out at any time for an inspection, making the pressure even stronger.

Since the move to Olive Branch, Millstone has partnered with Fedex to be able to take late orders, being able to turn around late night orders quickly from the distribution center. The move to the area has been a part of the success of the company’s expansion of services, as Millstone can provide a lot of backend services, including credit returns, relabeling, and marketing afterwork.

Millstone is looking to utilize everything their new facility in Olive Branch has to offer, including the ability to offer additional backend services, including credit returns, relabeling, and marketing afterwork. The growth doesn’t necessarily have to stop either, as according to Lucenti, there is plenty of room in the Memphis area.

Reina V. Slutske is the assistant editor for MD+DI.