Seminars in Pediatric Surgery 24 (2015) 101

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As a resident in general surgery, when considering a subspecialty two came to my mind, pediatrics and cardiovascular. Both of these represented significant challenges to the trainee. Pediatrics had two challenges: first was the inability to communicate with the patient and the second was and still remains a lack of technology. Available instruments were primarily adult instruments often used by surgeons not trained in pediatric procedures. It was soon recognized the needs of the newborn infants and preteens were not being met. These needs gave birth to the subspecialty of pediatric surgery. The specialty has rapidly changed the scenery, improving and creating the diagnostics and therapeutic instruments that are now available. Challenges remain. The first is the funding of these needs of our younger population. The new technologies in the field of medicine almost always are generated by the startup companies funded by individuals, special interest groups, venture capitalists, and an occasional larger company. The very few venture capitalists that would invest in early stage companies no longer will. Why not? In the current climate, the cost to innovate in the United States has become unaffordable. The cause of this increase in cost is multifactorial. One of the main reasons is related to the inappropriate and 1055-8586/& 2015 Elsevier Inc. All rights reserved.

excessive clinical trials that are required in the United States. Delays occur because of misunderstandings between the companies seeking approvals and the FDA’s perspective on what constitutes safety and efficacy. It is our responsibility to collaborate and cooperate with our regulatory and reimbursement bodies for the benefit of young patients. The specialty of pediatric surgery is well equipped to do this and this should be one of their primary objectives. The Fogarty Institute for Innovation is trying to address this issue by focusing on a lack of technology in the mother and infant space. This is an underserved need that can be addressed by providing better procedures, instruments, and services. Conventional funding in this space is extremely difficult. Large companies consider the market too small to invest in. They say this without appreciating the size of the market and the potential benefit in terms of our ability to provide better care at reduced cost. A coordinated effort by all interested parties will be needed to address this issue.

Thomas J. Fogarty, MD Guest Editor

Pediatric surgical innovation. Preface.

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