What you will learn with this Book
This book is a unique compilation of all that is needed for a clinical research professional in Medical Devices. The drug and device differ in clinical science from various aspects, which are not only operations but also are pragmatic. Missing regulatory harmonization and wide-spread diversity of the devices is among the additional factors that add to the complexity of the still-developing device clinical requirements. Amid existence of this gross dependency on drug methodology for device clinical studies, there were continuing discussions in the industry about a need for describing a differentiated and distinguished process. Hence, over years, requirements for drugs have evolved as significantly larger and better detailed than for medical devices, while medical device clinical studies continued to depend upon conventional retrofitting from drugs-oriented systems and methods.
While there have been a few efforts from some authors, a few regulatory bodies, and some universal standards forums like CDISC and ISO, an end-to-end compilation of all that is needed in medical device clinical research was grossly missing before this book. In this book, the overall clinical research requirements for medical devices are compiled from end-to-end. It has three main aspects, distributed over four parts. The first part is the basic concepts of medical devices and a small part on what are convergences and diversities between clinical research of drugs and devices. This part provides a high-level background of the regulatory process of market approval for medical devices, so that the research professional understands the purpose of the clinical research that they need to conduct. The second and third parts include scientific aspects of clinical research including medical writing, data management, safety, medical coding, biostatistics and clinical operations. The fourth and the last part includes some extended applications in the rapidly changing medical device technology such as software as medical device, software in medical device, diagnostic devices etc.
Medical Device Marketing Authorization
Overview of process of marketing authorization for over 100 countries in the world, and a high-level list of requirements. Comparison of medical device classification rules for medical devices. Risk management and quality management requirements...
Clinical Evidence requirements for medical devices
what are various clinical evidence requirements for Medical Devices? Are the requirements same for all device classes? Is there a requirement to conduct Phase I to IV studies for all devices? What is the most appropriate method for writing clinical evaluation reports? ...
Differences Between Drug and Medical Device Clinical Research
What are the differences between drugs and medical devices? How do these differences affect the clinical evidence of drugs and medical devices? Do medical device clinical research studies follow the same principles? What are differences between drug studies and device studies? ...
Standards for Medical Device Clinical Research
ISO 13485, ISO 14155, Various IMDRF and other regulatory standards, SDTM-MD, ADaM-MD, various USFDA guidance, Australia guidance, Japan Guidance, MedDEV and MDCG guidelines etc. Additional guidance documents TransCelarate, ICH etc. applied to the medical device requirements....
Comprehensive Treatise On Clinical Research
Not only for medical devices, but this book is also a comprehensive guide for the Medical Writers, Data managers, Medical Coders, Medical monitors, Clinical Research Associates, biostatisticians and other clinical and medical device professionals to understand the process of clinical research in details ....
Effect of Diversity on Medical Device clinical Research
· Human factor Diversity in operators / users · Device Diversity of design, size, shape etc. · Patient Diversity by demographics and treatment responses · Geo-regulatory diversity due to availability of various parallel and concomitant therapy requirements
Views of Industry Leaders
Introduction
This book is a unique compilation of all that is needed for a clinical research professional in Medical Devices. The drug and device differ in clinical science from various aspects, which are not only operations but also are pragmatic. Missing regulatory harmonization and wide-spread diversity of the devices is among the additional factors that add to the complexity of the still-developing device clinical requirements. Amid existence of this gross dependency on drug methodology for device clinical studies, there were continuing discussions in the industry about a need for describing a differentiated and distinguished process. Hence, over years, requirements for drugs have evolved as significantly larger and better detailed than for medical devices, while medical device clinical studies continued to depend upon conventional retrofitting from drugs-oriented systems and methods.
ESSENTIALS OF MEDICAL DEVICE CLINICAL RESEARCH (VOLUME I)
CONTENT
1) History of Medical Devices
2) Structure and Function of the International Medical Devices Regulators Forum (IMDRF)
3) Medical Devices Definition and Classification
4) Lifecycle of a Medical Device: From Concept to Proof of Concept and Further
5) Fundamental Differences between Drug and Medical Devices
6) Marketing Authorization Requirements for a Medical Device in the World
7) Basics of ISO 13485
8) Basics of ISO 14155
9) Addressing the diversity of Medical Device Types, its uses and Human Factors in Clinical Research
10) Preclinical Studies for Medical Devices
11) Medical Device Risk management and Risk Benefit Analysis
12) Materiovigilance Concepts and Process
ESSENTIALS OF MEDICAL DEVICE CLINICAL RESEARCH (VOLUME II)
CONTENT
13) Clinical Evidence, Substantial Equivalence or Design and Process Equivalence
14) Clinical Evidence by Clinical Experience for Medical Devices
15) Translational Research: Deriving Clinical Real-World Safety, Performance and Efficacy of Medical Devices Data from their Preclinical Studies and Unorganized Clinical use Data Like Complaints
16) Clinical Evaluation and Clinical Evaluation Report
17) The Process of Literature Search and Appraisal
18) The Clinical Investigation Basic Concept and Its Comparison with Drug Clinical Trials
19) Designing a Clinical Study for Medical Devices
20) The Clinical Investigation Plan
21) Patient Safety and Consent Document
22) Medical Coding for Medical Devices
Upcoming
Part II volume 3 Expected by January 2023,
Part II Volume IV Expected by April 2023
23. Clinical Data Management for a Medical Device Clinical Investigation (62)
24. Statistical Considerations for a medical device clinical investigation
25. Clinical study Report
26. Clinical Operations: Principles of Monitoring for a medical device clinical study
27. Clinical Operations: Site identification, feasibility, selection, Budget Management
28. Clinical Operations: Trial Master File, Site Documentation, ethical and regulatory approval process
29. Clinical Operations, Project Management, Steering committee meetings and the study progress analysis for medical device study
30. Budget and costs of a medical device clinical investigation
31. Independent clinical assessment of clinical materials and outcomes - clinical events committee
32. Clinical trial agreement for a medical device study (With Sites, CROs, KPOs and other functions) Essential components of a clinical study Agreement
33. Various Insurance policies for a medical device - important points to remember
34. Effective medico-marketing for medical devices
35. Field Safety Corrective Actions: Field Assurance Reports, Field Safety Notice, Medical devices discontinuation, withdrawal and recall
36. Publications for medical devices and good publication practice guidelines
37. Software as a Medical Devices
38. Embedded Software and user interphase devices
39. Diagnostic devices and ISO 20916
40. Medical Devices and Business 4.0
41. Robotics in Medical Devices
42. Devices with IoT functions and IoMT
43. Medical Devices without Medical Indication or Medical Intended use
Dr. Ashish Indani
Author/Writer
Dr. Ashish Indani, the Author of this book is a renowned Medical Device Professional, known in the Medical Device Community globally for his in-depth understanding of Various Medical Device Regulations and Clinical Research process. Through his career with AYUSH affiliated Medical Schools, and Medical Device companies for a large range of devices. He has worked closely with various regulations, for approval of his clinical studies in the global set up. He has continuously been vocal about not retrofitting pharma-oriented clinical research skills to Medical Device clinical research and not retrofitting engineering knowledge to drive clinical research.
During his tenure with Tata Consultancy Services has been an evangelist of applied information technology and data science advances for life sciences and has developed multiple applications in Artificial Intelligence and Machine Learning, Quantum computing, blockchain technology, internet of things, nano and microsensors, robotics, augmented reality, virtual reality and translational research.
Dr. Ashish Indani is a Medical Graduate and holds master’s degree in business administration. He has been awarded state award and President’s Scout award. He is an eminent Speaker on various national and international conferences. He holds many patents, publications, scientific papers and books.
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