Medicom Acquisition Amplifies Phillips-Medisize’s Connected Health Capabilities

Even casual observers of the medtech industry know that connected health, Internet of Things, and electronics are expected to play a major part in the field's future. It's a shift that is happening quickly. There were fewer than 1 million annual units of drug delivery devices with integrated electronics available in 2014, according to data from IMS Health, but that is forecasted to grow to approximately 70 million units in 2018.

Given the rapid transition toward the brave new world of connected health devices, it's not surprising that OEMs would want to work with a contract manufacturing organization (CMO). Phillips-Medisize Corporation, a major provider of outsourced design and manufacturing services for the medical device and pharmaceutical industry, has recognized this opportunity.

Speaking at the MD&M East Conference in New York City Tuesday, Matt Jennings, chairman, CEO, and president of Phillips-Medisize, noted that OEMs are looking for partners who have experience in developing FDA-regulated connected health devices and bringing these products to market. He cited a number of OEM customers, including one who said, "Connected health systems are increasingly important for us, and a CMO who has proven delivery expertise will be valuable."

With that in mind, on June 1 Phillips-Medisize acquired Medicom Innovation Partner, a development and production provider focused on connected health and drug delivery devices. Medicom, a firm of 88 specialists and engineers, was a technology venture for well-known audio and video manufacturer Bang & Olufsen.

Medicom brings strengths in injection and inhalation devices, as well as connectivity capabilities. The advantage lies in the interfaces between the mechanics, chip, app, software, and other components that are required in "mechatronic" devices. Jennings pointed out that Medicom and Phillips-Medisize have the IP around integrating and combining those interfaces. "We can plug and play all those technology accelerators and customize them based on the device and drug combination that the customer is looking for."

The purchase adds to Phillips-Medisize's design and development facilities with locations in Struer and Copenhagen, Denmark, and Cambridge, United Kingdom. The company now has six design development centers and 15 manufacturing operations locations around the world, which Jennings pointed covers most of the innovation centers around the world, with the exception of New England. "That'll be our next challenge," he said, "to figure out how we fill that gap in New England." Any strategic partners would need to have the right culture to make it a smart fit, he said.

Having expertise and experience in connected health is important in appealing to OEM customers, Jennings said. "[Customers] want to make sure they're going into it with someone who has been there before." With any medical device, the design process needs to account for the product's functional requirements, safety and effectiveness, and patient requirements, with each step vetted, documented, and verified, before development and industrialization. Taking the right approach and meeting every requirement at each stage is a must. "At the end of the day, when all of that comes together, the documentation has to tell a story that it's safe and effective to FDA," Jennings said.

Connected health devices bring a new level of complexity, Jennings pointed out. "When you're going into connected health, there's a whole other dimension beyond just the device in terms of the communication, electronics, the apps, and how that's all going to go, that needs to be though through."

What's more, regulatory policy is still being shaped in the connected health arena. Bill Welch, Phillips-Medisize chief technology officer, explained, "Validation tends to be in the eyes of the agency that you're dealing with and the policy is still being shaped. I think what we have seen so far on the devices that we've been bringing through development, we expect that to evolve over the next several years."

For OEMs that are planning to offer connected health devices, having an experienced partner to take them through design, development, validation, and beyond may be worthwhile. As Jennings noted, "Very few have successfully brought to market something that's FDA or equivalent agency approved for use."

[Image courtesy of STOCK IMAGES/FREEDIGITALPHOTOS.NET]