Frontiers of Engineering Reports on Leading-Edge Engineering from the 2014 Symposium (2015) / Chapter Skim
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Regulatory Perspectives on Technologies for the Heart--Tina M. Morrison
Regulatory Perspectives on Technologies for the Heart--Tina M. Morrison
Pages 79-86
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From page 79... ...
In addition, with the increasing cost of health care alongside the aging baby boomer population, there is a need to improve quality of life, decrease the number of doctor visits and length of hospital stays, and provide more efficient treatment options that reduce costs for people living with heart disease, as highlighted in Box 1. The objectives of this paper are to highlight the regulatory process for medical devices from an engineering perspective, to discuss how manufacturers of medical devices can leverage different tools and techniques to get their devices to the Note: The symposium presentation on regulatory perspectives was given by Sonna Patel-Raman of Halloran Consulting Group, Inc.
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From page 80... ...
Class III implantable devices include pacemakers, defibrillators, heart valves, coronary stents, ventricular assist devices, and artificial hearts. Manufacturers that wish to market Class III devices in the United States need to demonstrate that there is a reasonable assurance of both safety (i.e., the probable benefits to health outweigh 2 Information about the Center for Devices and Radiological Health is available at www.fda.gov/ AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm300639.htm.
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From page 81... ...
For many implantable devices to treat heart disease, a premarket approval (PMA) application is the appropriate pathway; PMA is "the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices."3 3 Information about the PMA is available at www.fda.gov/Medicaldevices/Deviceregulationand guidance/Howtomarketyourdevice/Premarketsubmissions/Premarketapprovalpma/Default.Htm.
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From page 82... ...
that will be used to demonstrate that the function of the device will be attained and/or that the failure mode will not likely occur. In vivo animal studies provide anatomic and clinical pathologic information of the local and systemic responses to device use.
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From page 83... ...
For example, the long-term durability of permanent metallic implants (e.g., stents and heart valve frames) can be evaluated using accelerated durability bench testing and computational modeling, and the resulting data complement the outcomes from the clinical study regarding mechanical performance.
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From page 84... ...
Summary Firms must provide valid scientific evidence from animal, bench, computational, and human models to support their marketing applications, and the amount of data collected from each model depends on the disease to be treated, the affected patient population, the location of the implanted device, the expected duration of the implant, and the surgical procedure. The data portfolio may change even more as companies expand their use of high-performance scientific computing to reduce time and cost in their efforts to bring safe and effective devices to patients in the United States.
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From page 85... ...
With access to "digital patients," device designers can download anatomic and physiologic computer models of patients with a given disease.6 They can then take their new device concepts and "deploy" them in the digital patients to simulate device performance, leading to more effective bench testing, in vivo animal studies, and (actual) clinical trials.
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From page 86... ...
2011. Forecasting the future of cardiovascular disease in the United States: A policy statement from the American Heart Association.
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