Friends, not foes

Former rivals MDCI and CDSS join forces to streamline regulatory approvals in U.S. and Europe

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NORTH ATTLEBORO, Mass.—U.S.-based Medical Device Consultants (MDCI), which provides contract research and regulatory consulting services to the medical device industry, has formed a strategic partnership with a former competitor, U.K.-based contract research organization (CRO) Clinical Development & Support Services (CDSS).

The dovetailing of the two companies in this partnership will allow both firms to support medical device clinical trials in the United States and Europe and help their clients meet both U.S. Food and Drug Administration (FDA) and European Union (EU) regulatory requirements.

MDCI is led by President William Morton and CDSS is helmed by Managing Director John Illingsworth.

According to sources on both sides of the arrangement, MDCI and CDSS identified the opportunity to join forces over the last year, having known of each other in the marketplace for many years. The companies formalized the partnership in August of 2010.

The companies say that each is unique in that they are both "niche" CROs, which offer focused in-depth expertise in specific areas.  

For example, each medical device is different, particularly the novel, highly innovative products currently under development. It stands to reason that every medical device trial will be different as well, the companies say.

Illingsworth and Morton assert that many large, global CROs advertise that they conduct medical device trials, but device companies often learn that a big CRO is managing their study like a drug trial, with all the associated complexity and costs not typically demanded by a device trial.

The two leaders also add that large CROs are inherently less efficient than smaller, leaner companies because of layers of bureaucracy and redundancy at larger organizations.

"These are obstacles to quick action and effective communication—both of which are characteristics of smaller, agile, niche CRO teams," Illingsworth adds.

The marketplace is no stranger to these types of partnerships.

According to John Lewis, vice president of public affairs for the Association of Clinical Research Organizations, this is not at all an anomalous occurrence. Lewis, who is not familiar with either CRO in this deal, says that, "In general, smaller CROs often partner up, usually to have expanded geographic capabilities."

Morton and Illingsworth agree with this assessment.

"Our primary goal was the ability to offer more global services for our clients," Morton says. "We believe that our partnership will allow us to provide high-quality and responsive global clinical expertise to clients conducting European-based clinical trials in an efficient and cost-effective way."

"The partnership provides our clients access to a network of skilled clinical research associates across Europe," Illingsworth adds. "This eliminates any language or cultural issues, and our partner can facilitate the local competent authority applications and ethics committee submissions where required."

To this assessment, Illingsworth adds, "CDSS also provides highly-trained contract research nursing staff which may be positioned at clinical sites to facilitate the conduct of the trial."

MDCI is a full-service consulting firm and CRO that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics and combination products," says Morton. "Our clients trust us to deliver customized strategic guidance and creative 'hands-on' solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the product lifecycle."
CDSS has a similar background, although both for devices and pharmaceutical products, adds Illingsworth.

"We now have a far better geographic reach using our own European expertise in addition to MDCI's expertise with the FDA, which goes well beyond what is to be found in the various CFR documents," he says.

CDSS and MDCI have helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally, say Morton and Illingsworth.

"By leveraging our comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity and stay competitive in an increasingly complex global marketplace," Morton says. "It is a plus to have a partner with both the diversity of therapeutic experience and local regulatory knowledge that CDSS brings to the relationship. European medical device regulations are being upgraded but many regulations still differ from country to country. By working with CDSS, overcoming these local hurdles is simplified."

The partners expect that the new working arrangement will allow both companies to benefit from sharing of referrals and sales and marketing practices that are more in synch.

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