Synopsis
Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful.
The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book.
About the Authors
Prakash Srinivasan Timiri Shanmugam, PhD, is currently a Senior Toxicologist at Avanos Medical, Inc. in Alpharetta, Georgia. He was previously contracted as an SME–Biocompatibility at Baxter International, Inc. in Round Lake, IL, United States, and at Johnson & Johnson Medical Device Sector. He has an MSc and a PhD in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras, Tamil Nadu, and completed his postdoctoral research at Tulane University and LSUHSC-Shreveport, Louisiana. He has authored 5 books, contributed several book chapters, and published research articles in various peer-reviewed international journals and conference proceedings/abstracts.
Logesh Chokkalingam completed his Bachelors Degree in Mechanical Engineering from Vellore Institute of Technology. Also he has completed his Diploma in Tool and Die Making from NTTF, Specialized course in Design and Manufacturing of Press Tools, Injection Moulds and Jigs & Fixtures. Mechanical Engineer with specialized knowledge on design & development, Program management in various Medical devices regulations, supply chain integration, portfolio optimization, asset transfer, Verification testing and Validation, and Value Engineering. Innovative, detailed – oriented problem solver with strong program management skills. Experience working in a collaborative environment. Implement and suggest new process to improve existing manufacturing process. Flexible to work in domestic and international settings. Responsible for Global partnering of MDR Programs, Spine account management globally, developing CoE for Biocompatibility and Product Stewardship
Pramila is a Doctorate in Toxicology and has around 14 years of experience in regulatory toxicology as Scientist and Quality Assurance. She was instrumental in establishing a preclinical testing facility at Sri Ramachandra University and acquiring GLP certification for the same. She has 17 publications both National and International Journals in various disciplines such as Environmental Toxicology, Toxicology and Pharmacology. She is a recipient of Fellow of Academy of Sciences (Animal Welfare). She is also a member of Society of Research Quality Assurance. She has worked with Pharmaceuticals, Cosmetics, Medical Devices, Agrochemicals, Industrial chemicals and Veterinary drugs.
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