Essential Reading 1

Two books that will give you a solid foundation of knowledge and provide a springboard for further learning are reviewed here by Dr Stuart Grant.

Want to get a deeper understanding of the MedTech product lifecycle but don’t have the time to plough through reams of reading materials?

 

When I’m asked for my recommendations, I suggest just you read just two books - Biodesign by Yock, Zenios, Makower, Brinton, Kumar, Watkins, Denend, Krummel, and Kurihara and Medical Device Design: Innovation From Concept To Market, by Ogrodnik.

Why?

While both are quite lengthy at over 500 pages, when read in tandem they offer a comprehensive understanding of the medical technology product innovation process across the entire product life cycle.

 

And, since both are textbooks, they are fully referenced, which gives you the option of delving deeper into the subject matter.

Biodesign: The Process of Innovating Medical Technologies (Yock et al)

This is a valuable resource for anyone interested in the convergence of medicine, technology, and entrepreneurship. Yock, a renowned cardiologist and innovator, brings a wealth of experience, insight and a well-rounded perspective on the complexities and challenges of medical device innovation.

 

The book takes the reader through the entire innovation process, with detailed methodologies for each phase of the innovation process, supported by real-world examples and case studies. This hands-on approach makes the book not just theoretical but a practical guide.

 

Beginning by examining the process of identifying clinical needs, stressing the significance of comprehending the healthcare environment and patient requirements, it then explores the process of innovation, with a focus on brainstorming and conceptualising solutions. The development phase includes prototyping, testing, and refining ideas, while the final sections address regulatory approval, business planning, and commercialisation strategies.

 

Biodesign also addresses the often overlooked aspects of innovation, such as teamwork, communication, and navigating the regulatory landscape - highlighting the holistic nature of medical technology innovation, where technical skills are balanced with business acumen and interpersonal abilities.

 

Its blend of theory and practical advice makes it an invaluable resource, fostering a deeper understanding of the innovation process.

Medical Device Design: Innovation From Concept To Market (Ogrodnik)

With his extensive experience as a biomedical engineer, Ogrodnik crafts a detailed guide that walks the reader through the entire lifecycle of medical device innovation, from initial concept to market entry.

 

The book is structured to provide a clear understanding of each phase of the medical device design process. Ogrodnik begins with an insightful overview of the medical device industry, highlighting the unique challenges and regulatory requirements that innovators must navigate. This sets the stage for a comprehensive exploration of the design and development process. Three standout features of the book:

• A practical approach - Ogrodnik does not merely present theoretical concepts; he integrates real-world examples, case studies, and practical exercises, ensuring readers can apply the concepts to their projects, making the book a valuable tool for both students and professionals.
• Demystifying the complex regulatory landscape - Ogrodnik provides clear guidance on compliance with standards such as ISO 13485 and FDA regulations. His step-by-step approach to design verification and validation provides an especially useful compliance roadmap.
• Focus on user-centred design – Ogrodnik underscores the importance of understanding the end-users’ needs and incorporating their feedback throughout the design process. This user-focused approach not only enhances the usability and effectiveness of medical devices but also aligns with current industry best practices.

 

Ogrodnik’s expert insights and practical guidance provide a comprehensive framework for navigating the complex journey from concept to market, making this book a cornerstone in the field of biomedical engineering and an essential read for anyone involved in medical device innovation.