Medical Device Link.

Originally Published MX September/October 2005

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Five strategies can help medtech firms discern among the hundreds of CROs out in the marketplace.

Jon LeSage

In the process of developing innovative medical products and preparing them for market launch, clinical research organizations (CROs) play an integral role. While some device manufacturers can afford the luxury of a fully staffed clinical research function, most medtech companies rely on the services of CROs to perform the myriad duties related to the clinical testing of their products. Such extramural organizations assist in clinical trial design, selection of investigators, patient recruitment, study monitoring, data analysis, and a variety of other tasks that may ultimately determine whether a medtech company's product is safe, efficacious, and ready for the marketplace.

For medtech company leaders, choosing the right CRO to field a particular study can be difficult. The most obvious issue is that there are hundreds of CROs serving the North American market. Many claim to serve medical device and diagnostics manufacturers, but verifying their appropriateness for a particular clinical trial quickly becomes a gray area.

MX talked with experts in the field to develop the following strategies for conducting due diligence on potential CRO partners.

Deep Medtech Experience

RCRI's top executive leadership team (from left): Steve Norsted, Terry Norsted, and Jennifer Marrone. (click to enlarge)

When searching for CROs in directories of medical product development experts—or on the Internet—one will find literally hundreds of such organizations serving North American companies, from small consulting firms to large companies with offices around the world. The challenge for medtech clinical affairs directors is to identify CROs that have demonstrated experience in the field. Most CROs are focused on pharmaceutical research, and many also specialize in biotechnologies. Very few have in-depth medical device experience.

Does this matter? Aren't clinical trials conducted according to uniform scientific principles transferable from one sector of the healthcare market to another? Well, according to the experts, it does make a difference. One basic distinction is that administering oral pharmaceuticals to test subjects is much simpler than installing and testing implantable medical devices.

Experienced executives and researchers make a big difference, says Juli Stabile, director of business development for Regulatory and Clinical Research Institute Inc. (RCRI; Minneapolis). Her firm maintains a staff of professionals with backgrounds in industry, academia, and government and an extensive track record of transitioning concepts and prototypes into commercially released products. "RCRI's top executive leadership team has an average of 26 years of medical device and diagnostic field experience per person, and each has worked for at least one Fortune 500 medical device company in the past."

Get Right Sized

Nancy Stark

"You should find a CRO that is compatible with your size and style," says Nancy Stark, president of Clinical Device Group Inc. (Chicago). "If you are a small start-up, look for a boutique CRO that will work closely with you. If you are a Fortune 1000 company, look for a large CRO that will run with your project."

Stark explains that having each partner of a similar size is important because a small device company is more likely to be overwhelmed by the bureaucracy of a major CRO. Moreover, she says, a large CRO might easily overlook or neglect the unique needs of a much smaller medtech company.

CROs run the gamut in terms of number of employees and scope of services. Most will use subcontractors. It's a good idea to inquire about the numbers of employees and subcontractors used by a CRO, and to be certain who will be performing each function contracted to the CRO.

Most CROs subcontract functions out to various technical experts, such as statisticians, monitors, toxicologists, database managers, and regulatory affairs specialists. This is a perfectly acceptable and effective structure. However, company executives would be wise to seek a deeper understanding of the relationship between a CRO's staff and its subcontractors, and to have a clear knowledge of the professional credentials of its outsource specialists.

It's All About Timing

Clinical trials need to be conducted in a timely and efficient manner. This phase of research can't be unduly rushed, but medtech product developers can't afford to waste precious time either.

Experts advise that company leaders should find out about the CRO's typical project turnaround time. For example, what would be the average turnaround time from a monitor's visit to a field site until a report is delivered to the client manufacturing firm?

Helen Colquhoun

"We always strive to be efficient," says Helen Colquhoun, president and CEO of Pleiad Inc. (Cambridge, MA). "Normally we can set up a study in eight weeks if a final protocol is available. We issue reports within 10 days of each monitoring visit. We are typically able to close out sites within four weeks of the final patient visit. For planning purposes, our clients generally use a three-month setup time and a three-month closeout time from last patient visit to draft study report."

Demonstrated Expertise

Every CRO says that it has expertise in medical device testing. However, it's important to validate such claims by asking for evidence of this experience and expertise. Good indicators of a CRO's expertise in the field include the curriculum vitae of each principal, presentations at pertinent conferences, articles published in academic or scientific journals, medtech client references, and other supporting information.

David West

Former staff of FDA's Center for Devices and Radiological Health (CDRH) frequently find second careers working for CROs. "Our staff includes a former deputy director of the CDRH Office of Device Evaluation (ODE), former branch directors and reviewers from ODE, former FDA bioresearch investigators, the former director of the CDRH Office of Compliance, a former FDA regional director, a former district director, and a variety of industry experts," says David West, vice president for medical device development at Quintiles Consulting (Durham, NC).

A number of Quintiles staff members are former FDA employees who developed many of the agency's current guidance documents and operating policies, says West. "Our staff is in high demand and regularly presents at various conferences and workshops sponsored by the Regulatory Affairs Professionals Society (RAPS), the Food and Drug Law Institute (FDLI), and AdvaMed, among other organizations. Members of our staff have also written articles for trade and professional publications such as Regulatory Affairs Focus and IVD Technology, and have written chapters for books edited by RAPS and FDLI, among others."

Current Events

As a medtech company's executive team becomes more experienced and adept at speaking the language of CROs and evaluating their appropriateness to meet their company's needs, it wouldn't hurt to discuss developments and trends in the field. Successful medtech manufacturers want to work with a CRO that's staying abreast of important developments in regulatory, technology, and research methodology issues.

Linda Alexander

"A mistake many device companies make is to treat clinical and regulatory matters as necessary evils," says Linda Alexander, president of Alquest (Minneapolis). "In fact, they are the drivers of faster approvals, faster market acceptance, and faster and more-substantial reimbursement. I'm concerned that FDA-mandated postmarketing studies may become the device industry's Achilles' heel. If companies don't start taking their postmarket obligations seriously, there likely will be an industrywide crackdown. Now is the time to seek assistance—not after warnings are issued."

There are certainly other questions that medtech companies should consider when looking at potential CRO partners. Some areas that should be reviewed include the following.

Geography. In which geographic regions will the clinical trials be conducted? Does the CRO work in North America, Europe, Asia, or whatever regions need to be covered?

Pricing. What type of pricing structure does the CRO use? Will the medtech clinical affairs director receive a fixed bid, unit-priced bid, or fee for service? Most CROs will state that it depends on the project, but this part of the contractual relationship should be analyzed carefully.

Role Definition. Will the CRO act as a surrogate research consultant, or will its staff only carry out the technical aspects of a medtech company's trials? A device manufacturer may have enough research scientists and product developers on staff so that it requires only a highly competent field research organization. On the other hand, the device manufacturer may require more extensive hand-holding, and will need to find out about the CRO's capabilities.

Conclusion

In the past, clinical trials for medical devices have tended to be short studies involving relatively few patients. But FDA is increasingly insisting that manufacturers conduct long-term ‘condition of approval' studies as a requirement of their product's clearance for marketing. Such requirements will almost certainly mean that device companies will be conducting more clinical research than ever before.

A similar need for cost-effectiveness data is impelling many medtech companies to undertake significantly more outcomes research than in the past. Such studies help to develop the data foundation required to obtain reimbursement coverage from the Centers for Medicare and Medicaid Services and other third-party payers.

Whichever way you look at it, CROs will continue to play an important role in the development of innovative medical devices. The strategies outlined here should help medtech manufacturers develop a short list of qualified CRO prospects.

Jon LeSage is a freelance writer based in Southern California.

Copyright ©2005 MX