Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices Review

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(More customer reviews)I am using this text in a commercializing biomaterials course and highly recommend it to graduate students and post-docs who want to enter the world of start-up biotechnology. I think it would also be very helpful to junior faculty who are thinking about commercializing their research. It is brilliantly constructed to walk you through the basics of taking your research from the bench to bedside and the challenges you are going to face along the way. I also found the author's use of vignettes and specific examples very helpful to illustrate complex points. This book won't write your business plan for you but should help you do your market analysis and give you the questions to ask when you initiate disclosures to your university's Technology Transfer office. Highly recommended.

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Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This 2008 book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.

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Design, Execution, and Management of Medical Device Clinical Trials Review

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(More customer reviews)In Latinamerica it is important increasing our knowlege in Medical Devices. This book is an excelent oportunity to improve the methodology of clinical trials with this kind of products.

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The Architecture of Medical Imaging: Designing Healthcare Facilities for Advanced Radiological Diagnostic and Therapeutic Techniques Review

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(More customer reviews)A comprehensive guide to the planning and design of all types of imaging facilities for health care: radiology, MRI, CT scan, PET scan, etc. Clearly written, abundantly illustrated, this book belongs on the reference shelf of any architect working on health care facilities.

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The cornerstone guide for designing tomorrow's medical imaging facilitiesThe Architecture of Medical Imaging is the foremost guide to the design of state-of-the-art medical imaging facilities for radiography, MRI, and CT and PET scans. Written by an industry expert, this useful resource discusses complex issues in a user-friendly language that is fully understandable to healthcare planners, department heads, and executives. No other reference makes it easier to understand the technical requirements of radiological equipment and procedures.The Architecture of Medical Imaging is divided into six convenient parts:* Part 1 explains the importance of quality design and how it relates to changes in the healthcare and medical imaging industries* Part 2 describes how to organize and manage an architectural project from the owner's perspective* Part 3 presents the vast range of today's imaging techniques, as well as those still in research and development* Part 4 addresses important planning and design concepts for medical imaging facilities* Part 5 discusses medical imaging trends and their impact on facility design* Part 6 provides useful appendices that examine specific imaging facility projects

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Talking with Patients and Families about Medical Error: A Guide for Education and Practice Review

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(More customer reviews)Talking with Patients and Families About Medical Error: A Guide for Education and Practice is based on guidelines from the Institute for Professional and Ethical Practice and the author's own experiences, and tells how to initiate a discussion and handle patient reactions to medical error. From documenting medical records and explaining them to handling questions about financial compensation, this aims to promote resolution and healing and stresses clear, empathic communication for any involved in medical practice. Professional health collections will consider this essential.


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More than a million patient safety incidents occur every year, and medical error is the third leading cause of death in the United States. Illuminating the experiences of those affected by medical error-patients, their loved ones, and physicians and other medical professionals- Talking with Patients and Families about Medical Error delves deeply into the challenges of communicating honestly and openly about mistakes in medical practice.Based on guidelines from the Institute for Professional and Ethical Practice and the authors' own experiences, the practice-based approaches outlined here offer concrete guidance on• initiating discussions • dealing professionally and compassionately with patients' reactions • who should be included in the conversation• what information should be documented in the medical record• how to respond to questions about financial compensationAimed at promoting resolution and healing, this book stresses the importance of clear, empathetic communication that will improve clinical and organizational responses to medical missteps and mismanagement. It emphasizes five features of the physician-patient relationship deserving of special attention: transparency, respect, accountability, continuity, and kindness (TRACK). Narrative examples of common situations demonstrate how conversations about medical error can lead to healing. (2011)

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Biodesign: The Process of Innovating Medical Technologies Review

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(More customer reviews)I am a recent graduate of the Stanford Graduate Student of Business and have worked in the life sciences industry for many years. While at the GSB, I took the 2-quarter BioDesign class which used a beta version of this book as its text. The course - and text - has a rather ambitious aim, namely to explore the medtech entrepreneurial and innovation process and to do so in a cross-functional, comprehensive, and hands-on fashion. As one of the more popular courses at Stanford and one that has resulted in numerous new VC-funded start-ups, I think they have succeeded in this goal.
More so than entrepreneurialism in other industries, starting a new business in medical devices requires bringing together many disciplines and functions, including engineering, medicine, and business. This book takes this comprehensive view of the process. You'll learn about:
* Medical - learn about the clinical trials process for medical devices (e.g. 510k / PMA) ... learn how to put together a clinical development plan & clinical trials plan
* Engineering - learn about prototyping, produce concept definitions, R&D strategy
* Business - learn about doing a market assessment ... how to put together a reimbursement strategy ... how to do a marketing & business plan ... how build your financial models
But more than just looking at the individual disciplines, this text looks at the innovation *process*. That is, it walks through idea/concept creation and screening, researching new clinical need areas, and important early due diligence (i.e. IP searches, researching unmet medical needs, doing a stakeholder analysis). Then, once you have your concept it takes you through developing your early prototype and putting together a development and business plan. Next, it discusses how you will want to go about pitching this to VCs and obtaining funding to implement your product. And finally, it touches on operation issues and exits once your product is launched.
The book is highly readable and is accessible to a wide range of backgrounds and knowledge levels. This is because it was designed to be a text for a course that was taken by b-school students, engineering graduate students, and med school students. Additionally it is very hands-on, and discusses the tangible *things* that need to be done as you go through the start-up innovation process, and includes numerous case studies. Some chapters are rather dense but these can be skimmed until you actual need to reference the material.
On caveat is that, while I think this text can be relevant for people that are interested in innovation and start-ups in biotech or other areas of life sciences, it is clearly targeted to medical devices & medtech.
Being a successful entrepreneur in medical devices requires a thorough understanding of each of these steps in the innovation process and all of the cross-functional disciplines that are involved in bringing a new innovation to market and to patients. This textbook understands this and tackles this topic with that principle in mind.

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Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. A three-step, proven approach to the biodesign innovation process - identify, invent, implement - provides a practical formula for innovation. The experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, offer a realistic, action-orientated roadmap for successful biodesign innovation. Real-world examples, end-of-chapter projects, and Getting Started sections guide the reader through each of the key stages of the process and provide a template to create their own new medical devices. Addressing common medical, engineering, and business challenges to develop well-rounded expertise, this book is the complete package for any biodesign entrepreneur. The text is supported by valuable resources, including up-to-date industry changes: found at ebiodesign.org.

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