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Navigating the Clinical Research Paradigm for Cost Savings and Efficiencies

Data is critical to the research process, particularly detailed, sound data that supports medical efficacy, comparative effectiveness research and evidence-based care pathways. It will only become more imperative as we move toward the full implementation of healthcare reform. Many insurance carriers are denying coverage and thereby inhibiting the process for innovative treatments to get through to the consumer. This is due to a lack of what the carriers have determined is proper utilization and support in terms of patient outcomes, publications and efficacy in the spine community.

Achieving Accelerated Enrollment
The sponsor is always in search of ways to accelerate enrollment and obtain faster market approval without increasing costs. Companies are starting to utilize the combination of U.S. site and international site data. Utilizing this route, one must carefully determine how you will use the data obtained from international sites and receive FDA permission to use that data.

It’s important to note that each country has its own registration requirements for not only getting the product into the country but also for commercializing the product under its system. Monitoring and audits differ from place to place, and you have to follow each country’s specific guidelines. This is where an experienced CRO with a strong regulatory component can be of tremendous benefit.

Paying for clinical services varies from country to country, and is often very different from the U.S. For example, in the U.K., global packages for clinical services are now fully adopted into their research units, a model that originated in the U.S. Prior to this paradigm shift, it was almost impossible to use a global package payment strategy in the U.K.; everything had to go through the national health system, a process that significantly slowed enrollment. These are just some of the issues the sponsor needs to consider in terms of accelerated enrollment and lower study costs.

Another factor to consider is the tremendous opportunity for commercializing outside the U.S. by receiving a CE Mark. It requires a much smaller number of cases than FDA approval, and getting to market and generating revenue is often easier.

Pre-enrollment and Enrollment Strategies
As mentioned earlier, strategic site selection is critical to a successful trial. There must be a process to pre-qualify the site’s participation and quantify what is reasonable and realistic in terms of enrollment. That comes from its infrastructure, data mining, looking at prior clinical trial history and researching any historical experience the site has with FDA. All of these components are vital.

Marketing strategies for patient recruitment must be multi-focused. Education is a huge driver, as is data mining and community outreach. Print and online advertising are effective tools, with sponsors often helping maximize the trial’s exposure for attracting patients. Social media has become a large force in recruiting patients for clinical trials, and there are even groups that can identify databases of patients you can opt-in to meet your needs.

It is important to note that the recently-passed Sunshine Act makes full disclosure of all compensation agreements for physician consulting as well as clinical and administrative services for clinical trials. Full transparency is now required or organizations may face legal ramifications, not to mention postponement or cancellation of the study.

Post-market Strategies
You have significant work to do once you get through the FDA process, because you must train your sales force and develop tools for distributing the technology to facilities and physicians. Many companies will implement hotline support for questions about sales and pre-op qualifications.

A credentialing program is a requirement for many of these new devices or technologies. This program will be presented to payors and used to sustain a long utilization pattern in the industry.

If you’re proactively working in your markets and looking at opportunities for utilization, you should develop regional programs around your key sites and constantly educate the physicians, hospitals and payors in those communities. Reimbursement and coverage decisions are regional, not national, so it’s very important you develop relationships with the payors around your service sites.

Never stop collecting data. FDA-required post-market surveillance and studies as a condition of approval are becoming the norm. Data collection is not a single event; it’s a process.


Marcy T. Rogers, M.Ed., is President and Chief Executive Officer of SpineMark Corporation, the premier global spine service company for the development of Spine Centers of Excellence and Spine Research Organizations in partnership with medical professionals, hospitals and industry medical manufacturers. She can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

SpineMark Corporation


Continue to learn from Ms. Rogers: Attend her educational session at OMTEC 2013 in Chicago.

How to Design and Execute a Clinical Trial
Wednesday, June 12, 11:10 a.m.-12:10 p.m. Badges copy

Just one in every five medical device clinical trials actually finishes on time. Delays lead to lost revenue, rise in expenses and the missed opportunity to be first to market with improved products, instruments and standards of care. Statistics also show that nearly 80% of medical device companies that commit significant time, talent and money to acquiring promising technologies, engineering them into products and conducting exhaustive pre-clinical studies eventually fall short of executing a successful clinical trial.

The presentation will address these specific points:

  • Investigative site selection and initiation
  • Patient recruitment and retention
  • Investigative site management
  • Pre- and post-study reimbursement strategies and payer mandates for coverage
  • Surgeon training and certification


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