Clinical trials are arguably the most stressful point the development process for medical devices. Companies without proper expertise risk shooting themselves in the foot by improperly conducting trials, which can set them back months or even years. To ensure the process goes smoothly, more and more medical device companies are taking a cue from the pharmaceutical industry and outsourcing their clinical trials and research to contract research organizations (CROs).

CROs—also known as clinical research organizations—have been around for about 30 years. Their traditional domain has been clinical trials, but over the past 10 years they have broadened their service offerings and are catering more to medical device manufacturers.

The Association of Clinical Research Organizations (ACRO), a trade association representing a number of CROs that collectively operate in more than 155 countries, estimates that the medical device industry accounts for about about 5% of its members’ business, according to a recent survey. Biotech makes up nearly another third, while the pharmaceutical industry accounts for an estimated 60%.

John Lewis, vice president of public affairs for the ACRO, attributes the large disparity to the fact that drug development is a longer and costlier process than device development. “When you’re looking at the development of a new drug you’re looking at 10 years and maybe $1 billion in the research and development, and you’re looking at large scale trials with thousands of patients,” he says. “Device trails tend to be much smaller and new product development, to the extent you have the 510(k) process, is just not as involved of a development process.”

But medical device companies are increasingly turning to CROs. The medical device CRO market in the United States, valued at $1.6 billion in 2011, is expected to more than double over the next six years, according to a recent report by market research provider GlobalData. Worldwide the medical device CRO market is expected to reach $7.2 billion by 2018.

“We’re seeing medical device companies doing now what the pharmaceutical industry did about 10 years ago,” says Ryan Wilson, general manager of the medical device division of Medpace, a CRO serving the medical device industry. “[Medical device] companies are focusing more on R&D, distribution, sales, and patents and less on the execution of bringing something to market. Coming out of the last recession especially, we’re starting to see device companies focus more on outsourcing.”

And for good reason, he says. “[CROs] take a lot of the execution risk out of running a trial,” Wilson says. “We’ve seen a couple of notable cases where people have good products and then they’ve fallen down on the actual implementation of the trial and collection of data. We take a lot of that risk out.”

Today, CROs are also involved in areas of medical device development as diverse as animal research, regulatory affairs, approvals, reimbursement, and even marketing, Lewis says.

Medpace’s Wilson sees many advantages for medical device companies, big and small, in turning to CROs. “When you’re relying on individual employees you’re really hanging your hat on how good an employee that person is. That one person can set back your entire study quite significantly, whereas with a CRO it’s more about the expertise, the system, and the process of doing things where you can come in and test and qualify.”

CROs like Medpace now offer services in nearly every step of development. “Most [device] companies will do their first demand study on their own, and we’ll usually be brought in at a feasibility or CE Mark trail phase (in Europe), and then we’ll partner with them through the Investigational Device Exemption (IDE) in US.” Medpace can perform services including designing case report forms, getting local and country approvals, monitoring studies, claiming data, and preparing submission packages for regulatory approval.

As medical device companies seek to place their products in markets around the world, CROs are evolving to help them deal with regional regulatory requirements, clinical trial procedures, and standards. In the past, niche CROs catered to a specific region, so device companies often had to work with multiple CROs. Now, many CROs are one-stop shops. “Having options where that is all under one roof makes it easier and lowers the bar that much more for people being able to outsource,” Lewis says.

All of these things should be particularly attractive to medical device developers and OEMs given the FDA stance on CROs. “From an FDA perspective there’s fundamentally no difference if a sponsor is running a trial or if a CRO is,” Lewis says. The same regulatory structure, approval process, and data scrutiny apply to CROs as to any manufacturer who may be running clinical trials in-house. “The only tricky area is really in having defined roles and responsibilities within the role of the trail so it’s clear who’s responsible for what.”

Wilson says Medpace makes a point to outline and contract these things with clients. “The medical device industry has no transfer of obligations like pharmaceuticals, therefore FDA sees CROs as an extension of a manufacturer,” he says. “Any issues that come up will come up for the sponsor, not for us as the CRO. FDA holds the sponsor liable. However, our contracts will usually outline timelines, responsibilities, and penalties for the CRO.”

Though medical device CROs have a long way to go to match their pharmaceutical counterparts, Lewis says they are gaining momentum among medical device companies. “One thing [ACRO is] going to try to do next year is scope out the market in terms of size and research spending,” he says. “A lot of device trials are pretty small and pretty fast. There might be other reasons to outsource a device trial, other than speed…It’s a question of how much need and demand there is for CROs and how much focus they’re going to pay to the device sector.”

-Chris Wiltz is the Assistant Editor of MD+DI