BioSensing, Theranostics, and Medical Devices

This book provides up-to-date information on the prototypes used to develop medical devices and explains the principles of biosensing and theranostics. It also discusses the development of biosensor and application-orientated design of medical devices. In addition to summarizing the clinical validation of the developed techniques and devices and the regulatory steps involved in their commercialization, the book highlights the latest research and translational technologies toward the development of point-of-care devices in the health care. Lastly, it explores the current opportunities, challenges and provides troubleshooting on the use of biosensors in precision medicine. The book is helpful for researchers and medical professionals working in the field of clinical theranostics, and medical-device development wanting to gain a better understanding into the principles and processes involved in the development of biosensors.

Discusses the principles and explains the processes involved in the development of biosensor-based medical devices Reviews the clinical validation of medical biosensors Summarizes the regulatory steps involved in the commercialization of medical biosensors Highlights the current challenges for and future potential of biosensors in precision medicine

Autorentext

Vivek Borse is working as a DST INSPIRE Faculty at the Department of Medical Devices, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, Telangana, India. Earlier he was associated with the Centre for Nanotechnology, Indian Institute of Technology (IIT) Guwahati, Assam, India. He is a Graduate in Pharmacy with Gold Medal and University First Rank from North Maharashtra University, Jalgaon, Maharashtra. He has completed M. Tech. (Pharm.) from the National Institute of Pharmaceutical Education and Research (NIPER), Mohali. Further, he has completed PhD from the Department of Biosciences and Bioengineering, IIT Bombay, Mumbai. His thesis titled "Nanodiagnostics for Orthopedic Implant-associated Infection" was chosen for the "Award for Excellence in Thesis Work" for the year 2016-2018 for outstanding research contributions in PhD. The award was presented to Vivek Borse by the Hon. Prime Minister of India, Mr. Narendra Modi in the 56th Convocation of IIT Bombay.

Vivek Borse has published his research work in more than 20 international journals, 5 book chapters, and a book. He has expertise in the field of nanobiotechnology, nanodiagnostics, lateral flow immunoassay (LFIA), point-of-care devices, nanomaterials, polymers, biomaterials, novel drug delivery systems, and biomedical engineering. His research area includes an interdisciplinary field of nanotechnology, biotechnology, and pharmacy providing pertinent solutions to healthcare.

Prof. Pranjal Chandra is an Assistant Professor at the School of Biochemical Engineering, Indian Institute of Technology (BHU), Varanasi, India. He earned his Ph.D. from Pusan National University, South Korea and did post-doctoral training at Technion-Israel Institute of Technology, Israel. His research focus is highly interdisciplinary, spanning a wide range in biotechnology, nanobiosensors, material engineering, and nanomedicine. He has designed several commercially viable biosensing prototypes that can be operated for onsite analysis for biomedical diagnostics. He has published 10 books on various aspects of biosensors/medical diagnostics from IET London, Springer Nature, CRC press USA. He has also published more than original research articles in the journals of high repute. Dr. Chandra is the recipient of many prestigious awards, coveted honors, and fellowships such as; DST Ramanujan fellowship (Government of India) ; Early Carrier Research Award (ECRA) (DST, Government of India) ; BK -21 and NRF fellowship, South Korea ; Technion Post-Doctoral Fellowship, Israel ; Nano Molecular Society India Young Scientist Award ; Biotech Research Society India (BRSI) Young Scientist Award ; Young Engineers Award 2018 ; ACS / Elsevier Outstanding Reviewer Awards ; HIGHLY CITED Corresponding authors in The ROYAL SOCIETY OF CHEMISTRY (RSC), Cambridge, London ; Top 10% cited article in the General Chemistry Section RSC Jounal, Cambridge, London, Gandhian YoungTechnology Innovation Award (GYTI) 2020, Selected as Member of National Academy of Sciences (MNASc), India etc. Dr. Chandra also listed among the WORLD'S TOP 2% SCIENTIST in a report by Stanford University, USA.

Prof. Rohit Srivastava is working as a Himanshu Patel Chair Professor and Head, Department of Biosciences and Bioengineering at the Indian Institute of Technology, Bombay. Dr. Srivastava completed his Bachelor of Engineering in Electronics Engineering from VNIT Nagpur in 1999 and Master of Science and a Ph.D. in Biomedical Engineering from Louisiana Tech University, Ruston, LA, USA. His specialization lies in POC Diagnostic devices, Biomedical Microsystems devices (MEMS), nanoengineered biosensors, photothermal therapy in cancers and nanoengineered orthopedic applications. Dr. Srivastava's lab, in collaboration with Biosense Technologies Pvt. Ltd., has developed and commercialized "UChek" a portable urine analysis system based on the mobile platform and have also made a low-cost reader for quantitatively analyzing urine dipsticks for which he has received the DBT Biotech Process and Product Commercialization Award 2015 and the OPPI Young Investigator Award 2014. He has been awarded the prestigious Vasvik Award 2013 for Biological Sciences and Technology for Suchek, an indigenous, accurate, low-cost glucometer supported by the Indian Council of Medical Research. Dr. Srivastava is also the recipient of the prestigious Tata Innovation Fellowship Award from DBT for his translational work on diagnosing orthopedic implant-related infections. He has recently been awarded the prestigious DBT National Bioscience Award for translating technologies from the lab. He has recently been awarded the prestigious NASI Reliance Industries Platinum Jubilee Awards 2018 for Application Oriented Innovations in Physical Sciences. He has published more than 130 research articles in the journals of high repute and 100 international conference proceedings. He has been awarded INAE Abdul Kalam Technology Innovation Fellowship and elected as Fellow of National Academy of Science, India, Fellow of Royal Society of Chemistry (FRSC) and Fellow of Royal Society of Biology (FRSB), London.

Inhalt

Chapter 1_Biosensing: Material, methods and principle of detection.- Chapter 2_Biosensing applications in the development of medical devices.- Chapter 3_Theranostics: basic principles.- Chapter 4_Material and technique advancements in the development of theranostic products.- Chapter 5_Medical device development strategies.- Chapter 6_Research aspects for the development of medical devices.- Chapter 7_Biosensor-based commercialized point-of-care devices.- Chapter 8_Medical devices in clinical set up.- Chapter 9_Clinical validation of medical devices.- Chapter 10_Regulatory steps involved in the validation of medical devices.- Chapter 11_Protocol for registration process of point-of-care device at FDA or equivalent agencies.- Chapter 12_Opportunities and challenges in medical device development.- Chapter 13_Prospective journey of the research idea from laboratory to the user in the clinic.