Insights Into the Aptiv-MDCI Merger

Executives at Aptiv Solutions and Medical Device Consultants Inc. had a code name for the negotiations that occurred before the two entities merged late last month: marathon.

“Took a long time so it became a marathon,” joked Aptiv Solutions Chairman and CEO Patrick Donnelly during a press briefing during the second day of AdvaMed 2011 – The MedTech Conference in Washington, D.C. “But it really became an opportunity to learn the culture of each organization and also learn how to put the two organizations together.”

The two organizations announced their merger in late August. For Aptiv, the move broadens its reach in medical device regulation and strategy, while MDCI stands to benefit from Reston, Va.-based Aptiv’s global platform. North Attleboro, Mass.-based regulatory consulting and clinical research organization MDCI has been around since 1980, offering regulatory and clinical services to the med-tech sector. The company addresses regulatory and clinical trial requirements for emerging growth firms and well-established medical device and diagnostic innovators.

MDCI has developed, prepared and submitted more than 600 successful 510(k)s, participated in the development of more than 20 successful Pre-Market Approval (PMA) applications, and managed hundreds of clinical trials to support medical device approvals and clearance worldwide. The acquisition brings a strong team of dedicated professionals adding depth and breadth to the Aptiv Solutions medical device consulting and clinical trial services business, according to Donnelly. Aptiv Solutions has offered clinical trial management services to the medical device industry since 1983, helping clients earn 32 PMA and Humanitarian Device Exemption approvals through innovative designs accompanied by full-service clinical trial support and site management.

“MDCI brings a lot to the regulatory side; when we went out looking, that was first and foremost in our desires,” Donnelly noted. “MDCI hit on all cylinders on that side of the house. We don’t see any redundancies, there may be a handful of backshop folks. But as we went through putting a perspective customer list together, there was very little overlap.”

The benefits, however, are not exclusive to Aptiv. MDCI President and Founder Bill Horton said the merger will enable his company to enter the pharmaceutical and combination products sectors. “For years, MDCI was focused exclusively on medical devices,” he explained. “We had very little experience with pharmaceuticals and combination products, so joining with Aptiv Solutions makes for a strong organization in looking at combination products and pharmaceuticals.”

The merger is expected to be finalized by the end of 2011.