With a global footprint in more than 44 countries, Lee Spurgin Jr, SVP and general manager of medical device and diagnostic development, told Outsourcing-pharma.com Theorem is one of the only CROs to offer services for device and diagnostic developers looking to comply with regulators’ requests for long-term data.
Spurgin said Theorem wants to capture a share of the “huge uptick" in demand for trials of implantable devices coming from drug companies looking to diversify into the space through partnerships and alliances, adding that “this is our niche.”
Earlier this week Theorem announced a strategic alliance with the Emergo Group, one of the medical device industry’s top regulatory consulting firms, which Spurgin said has a similar global footprint and understanding of the industry.
The alliance is “not a plan for an overall integration,” he said, noting that the company’s philosophy behind partnerships is to “do what you do and do it well.”
He added that the alliance further cements the relationship between the two companies as leaders in their industry. Emergo provides global regulatory consulting services, including reimbursement consultation and in-country regulatory representation services, to the medical device and in vitro diagnostic industry.
“[Emergo] recognizes they’re a leader in the space, and that complements our larger clients going forward,” Spurgin said.
He noted that a number of larger drug companies are looking to acquire smaller device companies. Johnson & Johnson “is the perfect example” of a large pharma company purchasing smaller device companies and expanding them.
Companies are beginning to recognize the value of devices that can complement the drug arena, and that “most patients will have to use some type of device” in their lives, he said.
Theorem is also pursuing partnerships with RadMD, a consulting company for radiology and medical imaging in trials, the consulting company Ximedica, as well as Cardiocore and CardioNet – as 35% of device trials are in the cardiovascular field, he said.