LEADER 00865nam0-22003251i-450- 001 990008488690403321 005 20070629105732.0 020 $aIT$b7710413 035 $a000848869 035 $aFED01000848869 035 $a(Aleph)000848869FED01 035 $a000848869 100 $a20070321d1977----km-y0itay50------ba 101 0 $aita 102 $aIT 105 $ay-------001yy 200 1 $aMedioevo ereticale$fa cura di Ovidio Capitani 210 $aBologna$cIl mulino$dc1977 215 $a323 p.$cill.$d22 cm 225 1 $aProblemi e prospettive$iSerie di storia 676 $a273$v18$zita 676 $a273.6$v19$zita 702 1$aCapitani,$bOvidio 801 0$aIT$bUNINA$gRICA$2UNIMARC 901 $aBK 912 $a990008488690403321 952 $aSDI-KD 367$b1151$fSDI 959 $aSDI 996 $aMedioevo ereticale$9224539 997 $aUNINA LEADER 05109nam 22006015 450 001 9911057021603321 005 20260114120408.0 010 $a3-032-12649-5 024 7 $a10.1007/978-3-032-12649-8 035 $a(CKB)44969359800041 035 $a(MiAaPQ)EBC32491489 035 $a(Au-PeEL)EBL32491489 035 $a(DE-He213)978-3-032-12649-8 035 $a(OCoLC)1574121032 035 $a(EXLCZ)9944969359800041 100 $a20260114d2026 u| 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aFDA and Intellectual Property Strategies for Medical Device Technologies $eIncluding Artificial Intelligence, Software and Applications /$fby Gerald B. Halt, Jr., John C. Donch, Jr., Amber R. Stiles, Brandon R. Theiss, Michelle Byrne, William F. Hodnick, Joshua Eldridge, Randy Goodman, Lisa Jenkins VanLuvanee, Dana L. Blue 205 $a2nd ed. 2026. 210 1$aCham :$cSpringer Nature Switzerland :$cImprint: Springer,$d2026. 215 $a1 online resource (472 pages) 225 1 $aEngineering Series 311 08$a3-032-12648-7 327 $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. 330 $aThis book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States Food and Drug Administration (US FDA) regulatory review and approval/grant/clearance 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 and approval/grant/clearance process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA, 510(k), and De Novo application processes. The complexities of medical device commercialization in the US market are also discussed. Additionally, this book explores how Artificial Intelligence (AI) and new software innovations are impacting the medical regulatory space. 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 US FDA medical device approval/grant/clearance process and commercialization of these products in the US market; Addresses some of the major FDA hurdles that medical device innovators often face while seeking approval/grant/clearance; Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy. 410 0$aEngineering Series 606 $aBiomedical engineering 606 $aElectronics 606 $aMicrotechnology 606 $aMicroelectromechanical systems 606 $aBiomedical Engineering and Bioengineering 606 $aElectronics and Microelectronics, Instrumentation 606 $aMicrosystems and MEMS 615 0$aBiomedical engineering. 615 0$aElectronics. 615 0$aMicrotechnology. 615 0$aMicroelectromechanical systems. 615 14$aBiomedical Engineering and Bioengineering. 615 24$aElectronics and Microelectronics, Instrumentation. 615 24$aMicrosystems and MEMS. 676 $a610.28 700 $aHalt$b Jr., Gerald B$0929460 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9911057021603321 996 $aFDA and Intellectual Property Strategies for Medical Device Technologies$94531691 997 $aUNINA