000			05225nam a22005655i 4500
001			978-3-030-04462-6
003			DE-He213
005			20220801213810.0
007			cr nn 008mamaa
008			190124s2019 sz | s |||| 0|eng d
020			_a9783030044626 _9978-3-030-04462-6
024	7		_a10.1007/978-3-030-04462-6 _2doi
050		4	_aR856-857
072		7	_aMQW _2bicssc
072		7	_aTEC059000 _2bisacsh
072		7	_aMQW _2thema
082	0	4	_a610.28 _223
100	1		_aHalt, Gerald B. _eauthor. _4aut _4http://id.loc.gov/vocabulary/relators/aut _934421
245	1	0	_aFDA and Intellectual Property Strategies for Medical Device Technologies _h[electronic resource] / _cby Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue.
250			_a1st ed. 2019.
264		1	_aCham : _bSpringer International Publishing : _bImprint: Springer, _c2019.
300			_aXXIV, 333 p. 35 illus., 5 illus. in color. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
505	0		_aIntroduction -- Development of A New Medical Device -- Determining If A Medical Device Technology Is FDA Regulated -- Basic FDA Regulatory Requirements For Medical Devices -- Other Regulatory Consideration For Medical Devices -- Benefits of Having FDA Approval -- Patents -- Trademarks and Trade Dress -- Trade Secrets -- Copyrights In Medical Device Technology -- Design Protection For Medical Devices -- Intellectual Property Issues in Medical Device Labeling and Marketing -- Enforcement, Infringement and Monetization of Intellectual Property Rights -- Successful Implementation of a Medical Device Company’s IP Strategy -- Tips for Avoiding and Preventing Intellectual Property Problems -- Successful Implementation of a Medical Device Company’s Regulatory Strategy -- Tips for Avoiding and Preventing Regulatory Problems -- Potential Combined IP and Regulatory Pitfalls.
520			_aThis book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators. Investigates the FDA approval process as it pertains to medical device technology Address some of the major FDA hurdles that medical device innovators often face while seeking approval Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy Explores the benefits of protecting, managing and enforcing intellectual property obtained for medical device technology so that innovators can obtain the best possible commercial results from their IP ownership Uses real case studies to illustrate concepts covered.
650		0	_aBiomedical engineering. _93292
650		0	_aElectronics. _93425
650		0	_aIndustrial Management. _95847
650	1	4	_aBiomedical Engineering and Bioengineering. _931842
650	2	4	_aElectronics and Microelectronics, Instrumentation. _932249
650	2	4	_aIndustrial Management. _95847
700	1		_aDonch, John C. _eauthor. _4aut _4http://id.loc.gov/vocabulary/relators/aut _934422
700	1		_aStiles, Amber R. _eauthor. _4aut _4http://id.loc.gov/vocabulary/relators/aut _934423
700	1		_aVanLuvanee, Lisa Jenkins. _eauthor. _4aut _4http://id.loc.gov/vocabulary/relators/aut _934424
700	1		_aTheiss, Brandon R. _eauthor. _4aut _4http://id.loc.gov/vocabulary/relators/aut _934425
700	1		_aBlue, Dana L. _eauthor. _4aut _4http://id.loc.gov/vocabulary/relators/aut _934426
710	2		_aSpringerLink (Online service) _934427
773	0		_tSpringer Nature eBook
776	0	8	_iPrinted edition: _z9783030044619
776	0	8	_iPrinted edition: _z9783030044633
856	4	0	_uhttps://doi.org/10.1007/978-3-030-04462-6
912			_aZDB-2-ENG
912			_aZDB-2-SXE
942			_cEBK
999			_c75608 _d75608