Medical Device News and Insights

Getting To Yes From A Reimbursement Perspective

Monday, May 10th, 2010 | FDA Medical Device Regulations, Medical Device Clinical Trials, Medical Device Market

Imagine putting together an extensive - and costly - clinical trial focused on gathering the data that you need to convince the FDA that your medical device is safe and effective at treating the specific condition for which you plan on marketing it.  You plan for months, iron out every detail, and hire the staff that you feel will be able to see your trial through from beginning to end and provide you with the type of data that will allow the FDA to come to the same conclusions that you already have regarding your device.

Judgment day arrives and you are overjoyed to hear that the FDA has granted you the approval you were seeking.  Now the challenge is to convince healthcare providers, hospitals, and insurers to add your treatment to their schedules.  While these stakeholders may show real interest in how your device improves patient outcomes, they also have questions.

Most of these questions don’t have as much to do with the actual benefits of the device itself as they do with the economic argument surrounding its use.  Boiling it all down, the message from the financial gatekeepers who will ultimately determine whether your device fits into their future treatment plans is “why should we reimburse for this particular treatment strategy?”  Looking down at your reams of efficacy and safety data, you suddenly realize that while it your trial may have been well-run and provided you with a goldmine of regulatory-required information, it was lacking the numbers that medical payers look for when examining the case for reimbursement.

At MDCI, this is a situation that is encountered on a regular basis.  Overcoming regulatory hurdles is only half the battle when it comes to successfully marketing a medical device.  It is equally important to be able to offer those gatekeepers, who will ultimately invest in your device in the form of sales, with the specific data they are looking for and prove a positive cost-benefit ratio in comparison to established treatments.

It is often prohibitively expensive for a small medical device company to return to square one and run a second trial that focuses on the economics of their treatment in addition to its outcomes benefit.  This is why at MDCI we always stress the importance of combining both economic and clinical endpoints when putting together the initial trial.  This type of two-pronged study consolidates costs to the degree where the required reimbursement and regulatory data can both be gathered in a much more affordable manner.

Naturally, putting together this type of trial is more complicated than a standard clinical study, which is why many medical device companies turn to us in order to leverage our expertise in providing custom-tailored solutions for trial designs that take into account every aspect of what must be accomplished in order to successfully bring a device to market.  Early involvement is key to achieving the required data points in the most cost-effective manner possible.

Tags: FDA, FDA device approval, insurance companies, medical device clinical trial design, medical device development

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