JUN 2013

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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LEgAL, CLINICAL & REgULAToRy Navigating the Clinical Research Paradigm for Cost Savings and Efciencies Companies may encounter many issues and barriers in the course of developing a new device or biologic product for market entry. It is only by working effectively through the timelines and deliverables from reimbursement, the FDA regulatory pathway, data requirements and clearance that companies can take advantage of the opportunities that exist to bring their product to market on schedule, on budget and in regulatory compliance. But many companies lack the staff or resources required to successfully negotiate the regulatory pathway and bring their product to market within company timelines. A clinical research organization (CRO) can provide the assistance to ensure that requirements of both the company and regulatory agency are fulflled. This article provides an overview of the marketplace for new spinal and orthopaedic technology, and provides basic guidance for successfully navigating the commercialization process with the help of a CRO partner. Today, companies interested in bringing a product to market must have two or three contingency plans in order to achieve a modicum of success. Current Marketplace The stock market crash of 2008 contributed to suppressed innovation in spine research due to fnancial constraints related to funding new trials. Moreover, the FDA process has become so arduous that often the smaller companies simply don't have the resources to survive the research and commercialization process in the U.S. In 2011, The New York Times published an interesting article discussing the costs and regulatory challenges faced by companies pursuing FDA clearance for new devices or biomaterial technologies. ("Medical Treatment, Out of Reach," February 2011) This theme has since echoed in other articles and explains why, due to the FDA process, the U.S. has developed a reputation as a very diffcult place to commercialize new products. The article notes a number of device manufacturers moving 52 BONEZONEā€¢June2013 Marcy T. Rogers, M.Ed. SpineMark Corporation sales operations to regions like China, India, Brazil, the European Union and emerging markets. The primary reasons? Cost and time to market. Another stumbling block is heightened scrutiny from FDA of purported conficts of interest raised by special interest groups relative to principal investigator (PI)/physician relationships and their consulting agreements with those bringing new products to market. These and other factors have led companies to change to-market strategies. A U.S. spinal device company with both cervical and lumbar artifcial discs found itself having to forego an initial strategy of commercializing frst in the U.S. due to an inability to overcome FDA objections on their device and regulatory plan. The company ultimately decided to sell the discs abroad. This decision revitalized sales and the company itself. A revised strategy was devised to reconsider another presentation to FDA for approval of their products. Numerous companies have found similar success abroad, partially due to the advent of medical tourism and patient consumer education, which sees many patients willing to travel to receive the latest technology. Another reason they fnd success is simply by avoiding the resources that are exhausted trying to work through FDA's tortuous regulatory pathway. Today, companies interested in bringing a product to market must have two or three contingency plans in order to achieve a modicum of success. Timeline for Device Trials and Market Approval The typical timeline for approval of a new orthopaedic or spinal medical device via clinical trial and premarket approval application (PMA) might be between three to six years, depending upon the regulatory pathway, predicates in the marketplace and outcome data requirements to support effcacy and superiority against the "gold standard of care." Site and PI selection must undergo sponsor-initiated due diligence to objectively quantify the patient recruitment potential for either an IDE pivotal trial or an outcome study for a 510(k) application. Enrollment typically lasts 24 months, but might greatly increase due to nuances in control device selection, randomization, etc. In some cases, no matter how many biomechanical tests a sponsor might perform, these might not satisfy FDA's requirements. In addition to issues of clinical trial setup and management, the timeline to marketing approval by FDA must be considered. With the average PMA review time of one year,

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