Current Status of Development and Regulatory Approval of Cardiac Devices
Medical devices are rapidly advancing and changing the medical field. Progress has been demonstrated in many fields such as minimally invasive surgical techniques for valve replacement and 3D cardiac mapping of arrhythmias. These medical device advances a
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Stephen A. Howard, Michael G. Bateman, Timothy G. Laske, and Paul A. Iaizzo
Abstract
Medical devices are rapidly advancing and changing the medical field. Progress has been demonstrated in many fields such as minimally invasive surgical techniques for valve replacement and 3D cardiac mapping of arrhythmias. These medical device advances allow physicians to help more patients quicker and more efficiently. The field of cardiac device development can be considered as relatively new, beginning in the early 1950s, and today new technologies in this field are presented at ever increasing rates. Many times, these advances come from an unmet clinical need. In some ways, physicians are unable to treat (or are at best ineffectively treating) certain types of patients in this aging society. Motivated by these needs, medical device designers—scientists, physicians, patients, or simply individuals with good ideas—choose to undergo the rigorous, yet rewarding, path of medical device development. The development path follows a certain route from device conception, intellectual property generation, and testing to regulatory approval. Since cardiac medical devices are created to help patients, they must also undergo stringent testing for durability, biocompatibility, and manufacturability. To complete these assessments, both animal and clinical testing can be utilized, especially with regard to valve replacement devices. Once an adequate amount of data pertaining to the safety and efficacy of the device has been collected, it will then be sent to a regulatory body to gain approval to market the device. Keywords
Cardiac device design • Cardiac device development • Device ideation • Risk mitigation • Intellectual property • Device testing • Regulatory approval
Abbreviations DFM FDA FMEA HDE
Design for manufacturability Food and Drug Administration Failure mode and effect analysis Humanitarian device exemption
S.A. Howard, PhD (*) • M.G. Bateman, PhD • T.G. Laske, PhD Medtronic, Inc., Mounds View, MN 55112, USA e-mail: [email protected] P.A. Iaizzo, PhD Department of Surgery, University of Minnesota, Minneapolis, MN, USA
IDE IFU IP USPTO VOC
42.1
Investigational device exemption Instructions for use Intellectual property United States Patent and Trademark Office Voice of customer
Introduction
All it takes is a napkin drawing or a rough shape crafted with clay. Such humble beginnings can spark an idea or revolution for the way that cardiac care is administered. Ideas can blossom into intricate high-tech medical devices that push
© Springer International Publishing Switzerland 2015 P.A. Iaizzo (ed.), Handbook of Cardiac Anatomy, Physiology, and Devices, DOI 10.1007/978-3-319-19464-6_42
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the envelope of design and advance the field of medicine. These are exciting opportunities, yet the journey of creating a medical device can be daunting. However, for those who are successful in developing such devices, there can be great rewards. This is the reason for so many entrepreneurs enter
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