Global CRO Icon has packaged a combination of its services to create a medical device and diagnostics research group designed to provide global clinical trials, health economics and pricing and market access tools.
The Medical Device & Diagnostic Research Group incorporates Aptiv Solutions, a CRO specializing in medical device and adaptive trials, which Dublin-based Icon acquired last May.
“When we talk to large medical device companies, they really want to work with a large CRO that has a device service line and staff who understand how the FDA deals with device evaluations and approvals,” said Vicki Anastasi, Icon’s vice president of medical technology, who will lead the new group.
Within weeks after closing the Aptiv acquisition, Icon executives saw how different the device and diagnostic markets were from the traditional pharmaceutical and biotech models, Anastasi explained. That distinction, she said, was the genesis for forming a separate organization tailored to devices and diagnostics.
The goal of the new group is to create end-to-end service for medical device manufacturers, from early-stage development to post-approval market access, said Elizabeth Thiele, president of Icon Commercialization and Outcomes. It will operate under specific medical device standard operating procedures (SOPs) and International Organization for Standardization (ISO) certification, she said, with the expertise and flexibility to help manufacturers cut time and cost from their development programs and maximize the value of their products.
Anastasi said Icon’s device focus will be in the cardiovascular, orthopedic and spine and diagnostics areas, adding the group also expects to work with companies developing wound care and diabetes products.
“In the cardiovascular area, we are seeing combination products that contain a device with a pharmaceutical drug, or a biologic and a device, as better ways to treat the disease,” she added. “We also see tremendous increase in wearables and new communicating devices emerging to become a standard of care along with software.”
Anastasi said Quintiles, the world’s largest CRO, has a significant medical device business but does not separate it out from pharmaceuticals, as Icon has done. Quintiles strengthened its medical device capabilities 18 months ago with the acquisition of Novella Clinical, which provides CRO services to emerging oncology and medical device companies. Icon also will see competition from specialist medical device CROs, which are smaller, niche providers that have strengths in certain therapeutic areas or geographies.
Just as pharmaceutical outsourcing came in a wave nearly 20 years ago, the trend now is catching on among medical device firms, according to Neal McCarthy, managing director of investment banking firm Fairmount Partners.
“The medical device world is 10 years behind in developing a thorough outsourcing program,” said McCarthy. “Icon wants to be the recipient of that outside wave, recognizing that device needs are very different from pharmaceutical industry needs—as different as playing baseball and cricket equally well. If you are good at one, you are not likely to do as well in the other.”
He said over the last five years, some medical device companies have shifted their initial clinical trials to Europe due, in part, to easier access to CROs with device expertise and faster approval times, before seeking FDA approval.
Now, device companies are seeking the expertise of large CROs on both sides of the Atlantic to address their unique needs.
“A pharmaceutical cardiology study can choose from over 1,000 worldwide sites, but in the device world an interventional cardiology study, in which you are implanting a new defibrillator or heart valve, few sites have the expertise to put that device in the human body and make sure it works,” said McCarthy. “That’s why some CROs may separate out their pharmaceutical and medical device specialties.”
Anastasi said Icon’s strength in Europe, combined with its extensive U.S. CRO operations, enables medical device companies to build a global strategy. Icon has 10,300 employees operating from 76 locations in 37 countries.
“The medical device industry is maturing and will be looking for CRO partners to help them deal with regulators, payers and clients,” she said. “We want to become their partner as easily and quickly as possible.”
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