There is no greater satisfaction than seeing a patient being helped by a technology that you've had a hand in creating. And thanks to continuing advances in science and technology, healthcare is more open for innovation than at any time in history.
Despite this promise, however, medical technology innovators face significant hurdles – especially in the new era of cost containment. If not managed skillfully, patents, regulatory approval, reimbursement, market dynamics, business models, competition, financing, clinical trials, technical feasibility, and team dynamics (just to name a few of many potential challenges) can all prevent even the best idea from reaching patient care.
So, where should you begin as an innovator? What process can you use to improve your chances of success? What lessons can you learn from the inventors, engineers, physicians, and entrepreneurs who have succeeded and failed in this endeavor before? This book delivers practical answers to these important questions.
Who should read it and why?
Biodesign: The Process of Innovating Medical Technologies provides a comprehensive roadmap for identifying, inventing, and implementing new medical devices, diagnostics, and other technologies intended to create value for healthcare stakeholders. It has been written to be approachable for engineering, medical, and business students at both the undergraduate and graduate level, yet comprehensive and sophisticated enough to satisfy the needs of experienced entrepreneurs and medtech executives. For instructors, it provides a proven approach for teaching medical technology innovation that begins pre-idea and extends through preparing for commercialization. It is ideally suited to support team-oriented, project-based learning experiences in academic and industry settings.
The text describes the biodesign innovation process, which we initially developed to support the biodesign innovation and fellowship programs at Stanford University. Over 13+ years, the process has been built and refined based on:• Presentations and mentoring by more than 200 industry leaders who have participated in our training programs• Our experience advising more than 150 project teams that have applied the process to their work• Feedback from those who have learned the process through our executive education courses, as well as input and suggestions from students, fellows, instructors at other universities, and industry representatives using the first edition of the book• Extensive field-based research
Our confidence that the process is effective is based on the results of the students and fellows trained at Stanford and through our university-based partnerships in India and Singapore.