The failure of a variety of medical devices has focused public attention on the approval process for medical products and the relationship between the medical device industry and those who prescribe these products. I am acutely aware of these issues and herein disclose my current relationship with two companies whose products I use and do endorse. I have a consulting relationship with Stryker Orthopedic Products division and with Salient Medical Technologies. Stryker is an industry leader in orthopedic product design and Salient the manufacturer of electrosurgical instruments used in orthopedic surgery and other surgical specialties to prevent blood loss. I feel these conflicts preclude me from involvement in any investigation or prosecution involving the above firms. I have no other conflicts of interest or exclusions in these maters.
Over the years I have had the opportunity to work on projects with other companies in similar arrangements. There are no ties, conflicts of interest or intellectual property rights in those relationships today. I am very aware of these issues and have always maintained transparency in these maters. I have filed public disclosures annually with the American Academy of Orthopedic Surgery. I am therefore, intimately familiar with orthopedic product design, approval process, and clinical applications of orthopedic devices. It is important to distinguish between a failure of design and faulty application of a product. I feel I am uniquely qualified in this area. I have had the opportunity to visit with the engineers, observe the manufacturing and design process, and participate at all levels in the area of these medical devices.
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