Navigating the Perilous Road: A Special Panel On Regulatory and Reimbursement Issues

The US market represents huge profit potential for an innovative company, but not if unexpected FDA issues impede the launch, or reimbursement issues and adverse patent actions interfere with the success of the product.

Recent studies have indicated that the time to gain approval is dramatically different between a CE Mark in Europe and a 510K in the United States. The time it takes to get a product to market takes on average, 6 months in Europe, compared to 2 years in the US, but, there is no evidence that suggests products in Europe are not safe. Increasingly, companies are launching in Europe while waiting for approval in the United States. A special morning panel at OneMedForum NY 2011 will explore the merits of this strategy in terms of creating capital efficiency. It will consider other strategic planning considerations in the process of getting approval and reimbursement.

The morning session will explore the implications of this for emerging companies and investors and will focus on a case study of how to get approval,  considering both Europe  and the United States.

Panelists include: Rod Barnes, former VP Reimbursement at Alcon Lab;  Rosina Robinson, RN, MEd, RAC, MDCI; Richard Naples, Sr. Vice President, Regulatory Affairs, Becton Dickinson; and Corinne Lebourgeois, Med C Partners .

Corinne Lebourgeois notes that reimbursement in Europe is very fragmented with healthcare and funding varying from country to country. She aims to dissect this issue and bring knowledge of navigating the  reimbursement process to the forefront.  While Europe is and will remain for the coming decade at least, the second-largest market for medical devices worldwide, with approximately 33 percent of global sales taking place there, it’s complexity is high. Although the European Union tries to harmonize its different regulatory systems, in practice many differences still exist in the application of reimbursement systems. These include a number of institutions involved in the whole process in a given country, the application time, and the number of product classes defined.

In today’s environment, payers are increasingly sophisticated and rely more and more upon specific clinical evidence and health economic data to drive the reimbursement process. This makes it necessary for regulatory professionals to involve reimbursement professionals early in the product planning process and adjust clinical and regulatory strategies— not only to meet FDA’s needs, but to also ensure that the product will be reimbursed adequately, achieving marketplace success.

Rosina  Robinson of MDCI is expected to comment on how regulatory strategies have changed over the last 5 years. In Europe, a 2007 Medical Device Directive reinforces the need of clinical data, yet even with that amendment that took effect last year, it has been a less difficult route to approval and reimbursement compared the  510 k process in the United States.

Rod Barnes has been performing global studies involving pharmaceuticals and medical devices for the last 13 years and will discuss his experience with devices getting reimbursement in the US faster than in Europe, a rarity.

The panel will meet Thursday June 23rd at the historical Roosevelt Hotel. For more information, click here.

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