Safe Medical Devices for Children (2006) / Chapter Skim
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Appendix C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context
Appendix C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context
Pages 302-326
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C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context Annetine C Gelijns, Ph.D., Brigid Killelea, M.D., Michael Vitale, M.D., Vipul Mankad, Alan Moskowitz, M.D.*
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The incremental nature of the device innovation process and the inherent limitations of premarket studies argue for ongoing monitoring and evaluation of the outcomes in widespread clinical use. Ongoing evaluation is costly, however, and of particular concern in the realm of pediatric medical devices, where the markets are small and the economic incentives to innovate weak.
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of medical devices, developed by approximately 10,000 to 11,000 device firms, either domestic or foreign, operating in the United States (FDA, 1992)
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The global medical devices market has more than doubled since 1991, when the worldwide market was about $70 billion (The Lewin Group) , to $169 billion in 2000 (AdvaMed, 2004)
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play a particularly important role in the development of medical devices. Around the country, academic medical centers may have a slightly different organizational structure, but they are generally comprised of a medical school, its teaching hospital, a potential network of affiliated hospitals, and a nursing school.
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Such evaluative studies may yield clinical data that may provide support for FDA approval, coverage by payers, and postmarket surveillance of pediatric devices. There are around 250 children's hospitals in the United States, which account for a substantial percentage of all National Institutes of Health (NIH)
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It also pays for clinical interventions through Medicare, Medicaid, and numerous other benefit programs. Federal Support for Research and Development Federal support for R&D in medical devices flows through multiple institutional and disciplinary channels.
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, DNA probes, or laser angioplasty devices. Any device introduced since 1976 is automatically placed in Class III unless the sponsor successfully petitions the FDA to reclassify it as "substantially equivalent" to a device that was on the market before the amendments took effect.
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The changes incorporated in the Safe Medical Devices Act should encourage higher quality device evaluations and provide more useful information about safety and efficacy. At the same time, some of these changes also have important consequences for the timely introduction of new medical devices to market, and for the degree of financial risk and costs associated with the innovation process.5 For some Class III devices, especially those targeted to a narrow market such as is often the case in pediatrics, gathering sufficient evidence for premarket approval may be a lengthy and/or risky process because of the small number of affected patients.
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APPENDIX C 311 only recover the costs of production. Currently, there are six active HDEs for pediatrics, including the LVAD, a heart valve, bladder stimulator, and fetal bladder stent, gastric stimulator, and cultured skin.
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312 SAFE MEDICAL DEVICES FOR CHILDREN Reimbursement Decisions about medical coverage and reimbursement for use of pediatric devices are made primarily by individual state Medicaid programs and by commercial health insurance companies. These decisions influence not only the quality of health care for children, but also the innovation process, marketing, and availability of devices for children.
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Generally, the development of a new device prototype is driven by the conjoining of new technological capabilities with the perception of unmet clinical needs. Because the markets for medical devices are often fragmented and relatively small, the medical device industry has historically not invested heavily in basic research.
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The reliability of the pediatric LVAD, for example, is generally tested in mock loop systems, and pre-clinical testing of the device, depending on the age of the recipient, can be done in dwarf pigs or calves. Premarket Clinical Evaluation Following bench and animal testing, some Class II and all Class III devices enter the stage of human evaluation.
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CRO usage among the medical device industry is not common; only 13 percent of medical device firms employ CROs (whereas 90 percent of drug firms use CROs) , and few CROs have extensive experience conducting implantable device trials (Centerwatch, 2005)
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These modifications are not only in the device itself, but also in the clinical management of a patient with a device. A case in point is the REMATCH trial, which evaluated the efficacy and safety of a left ventricular assist device for long-term therapy of end-stage heart failure patients.
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APPENDIX C 317 Once the optimal time to begin a pivotal clinical trial is established, decisions concerning which venue and which clinicians to engage in testing a particular device can have a major effect on how the results of the trial will be interpreted and whether the device achieves broader usage. In contrast to pharmaceuticals, the efficacy of a surgically implanted device can be linked to the skill of the implanting surgeon.
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The small patient populations that frequently result in singlearm studies or registries hamper not only the identification of treatment effects, but also leave the assessment of cost-effectiveness without a comparator. The short-term nature of many randomized trials makes it difficult to accurately assess the long-term economic impact of treating a particular patient population for the individual payer.
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Currently, the database contains over 1,000 citations of full economic evaluations from January 1980 to the end of December 2003. However, searching the database for device-related economic evaluations, we found only 30 citations analyzing 11 different device categories (e.g., cochlear implants, amplatzer catherization techniques for occlusion of atrial septal defects, and laparoscopic spelenectomy)
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Most medical devices achieve new indications by transfer from one organ system to another, although these transfers often require design modifications. The first endoscopes, for example, were used for cystoscopy early in this century.
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Mandatory and voluntary reporting of device-related deaths and serious adverse events to the FDA by manufacturers and clinicians has been plagued by underreporting. As part of the voluntary reporting system, the FDA has been implementing the MedSun system since 2002, an Internet-based pilot reporting system, comprised of over 180 hospitals and nursing homes.
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Moreover, this uncertainty is exacerbated by the fact that devices keep evolving long after they have moved out of the clinical development phase into widespread clinical practice itself. Observations by users about the limitations of devices are fed back into the R&D process and may lead to subsequent modifications.
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APPENDIX C 323 cal and economic impact of devices, and, hence, our understanding about best practices in caring for patients. Yet, there is a tension between stimulating innovation and increasing the requirements for collecting more data on the clinical and economic impact of device therapies, which is exacerbated by the small size of many of the markets and affected patient populations.
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. Letter to Food and Drug Administra tion re: Response to FDA's Request for Comments on the Availability of Appropriately Designed and Adequately Studied Medical Devices.
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2004b. Report to Congress: Barriers to the Availability of Medical Devices Intended for the Treatment or Diagnosis of Diseases and Conditions That Affect Children.
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Medical Device Industry. The Health Industry Manufacturers Association, Wash ington, DC.
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