Comprehensive Textbook on Medical Device Clinical Research Released
Medical devices differ fundamentally from drugs in design pathways, regulatory expectations, and evidence generation requirements. Yet, device studies have historically been forced into drug-centric clinical frameworks due to lack of regulatory harmonization and the vast diversity of device categories. Dr. Indani’s work addresses this gap by compiling device-specific clinical research requirements from start to finish, creating a unified framework for professionals working across the device lifecycle.
The book is structured across four major parts, beginning with foundational concepts such as device classifications, global regulatory pathways, and the scientific differences between drug and device research. It then covers core scientific disciplines that drive device clinical evidence—medical writing, safety, data management, medical coding, biostatistics, and clinical operations—offering a complete understanding of how device studies are designed, conducted, and interpreted.
The final section explores advanced topics shaping modern device development, including Software as a Medical Device (SaMD), data science applications, software quality management systems, software development life cycles, and ISO frameworks for diagnostic and digital devices. It also covers several additional critical areas such as insurance for clinical research, publications, diagnostic devices, and software.
Positioned as the first detailed publication to provide end-to-end device research coverage, the book emphasizes global compliance expectations, quality standards, and practical strategies for conducting device trials aligned with FDA, EMA, and international regulatory frameworks. Through structured explanations and real-world case studies, it equips professionals with tools to navigate complexities in evidence generation, post-market surveillance, and safety reporting across diverse global markets.
The book is intended for clinical research professionals, regulatory affairs specialists, biomedical engineers, device developers, researchers, and students in healthcare and biomedical sciences. Its step-wise approach makes it accessible to beginners, while offering depth and practical insights valuable for experienced professionals.
Speaking about the journey behind the book, Dr. Indani told Medical Dialogues, “When I started my career in the medical device clinical research space, like many others, I carried with me the clinical research principles designed for pharmaceuticals. As I progressed, I began to understand that device clinical science is entirely different from drug research, and apart from ethical principles, very little is the same. Yet there was no single, compiled source of knowledge. What began as a small manual—a simple concept—slowly grew. I sought help from fellow professionals, but everyone had commitments that limited their ability to contribute. So, I decided to follow the principle of ‘ekala cholo re.’ These 12 years have been a roller-coaster journey; every time I completed substantial material and was close to printing, regulatory changes forced us to halt and redo the work. Editors, publishers, and I had to revise everything repeatedly. I am grateful to my colleagues, friends, and especially my family for supporting me throughout this long journey.”
