Introducing Roadmap to Innovation:
A Comprehensive Guide for Medical Device Developers
NASS is excited to announce the launch of Roadmap to Innovation, a groundbreaking new book by Eric J. Muehlbauer, the CEO and Executive Director of NASS. This comprehensive guide is poised to become a critical resource for anyone involved in medical device innovation. The primary audience for the book is those individuals who are at the beginning of their medical device development journey. It is an introduction to the steps you might take to move forward. The entire development process is quite tricky and there is a lot of depth in many areas. This book gives the framework for organizing your thoughts and efforts. The title is available to NASS members for $50, while nonmembers can purchase the book for $150.
In Roadmap to Innovation, Muehlbauer offers a detailed look into the complexities and challenges of medical device innovation, guiding readers through the entire process from ideation to commercialization. “There are guides on bio-design and other processes, but I have not seen a summary that includes a comprehensive roadmap on this subject.” Muehlbauer remarked, reflecting on his inspiration for writing the book. This unique resource fills a crucial gap in the medical device industry, where entrepreneurs often struggle to navigate the intricate regulatory, financial, and operational landscapes.
"Years ago, when I was president I had to give a talk on developing new products, the RUC process, and getting those new products to market. I remember calling Eric Muehlbauer, and he laid it out so casually while I was writing down every word. I thought at that time, no one knows this better. This guy needs to write a book."
Jeffrey Wang, MD, 2018-2019 NASS President
A Unique Perspective on Medical Device Innovation
Muehlbauer’s extensive experience in the medical field, particularly his NASS tenure, has greatly influenced the content of the book. “I’ve seen what works for companies and what doesn’t seem to work,” he explains. His insights into key areas, including the importance of coding and navigating regulatory challenges, stem directly from his interactions with industry leaders over the years.
The book also addresses how the medical device sector has evolved in recent years. Muehlbauer notes that while the spine market was once considered "hot," the landscape has cooled, with venture capital investors becoming more cautious due to the unpredictability of the approval process. “Venture capital has pulled back over time,” he explains, highlighting the broader shifts in investment trends.
Challenges and Opportunities in the Current Market
Within the book, Muehlbauer doesn’t shy away from discussing the obstacles faced by innovators. One of the major challenges, he notes, is the lack of predictability in the US regulatory environment, particularly with the FDA and Medicare, which can stifle innovation. “The regulatory environment can be more of a hindrance than supportive of device innovation,” he observes. Despite these hurdles, Muehlbauer remains optimistic about the future, emphasizing that advancements in materials and iterative improvements will continue to drive innovation.
For those just starting in the industry, Muehlbauer offers a candid warning: “Be careful what you wish for. Be sure you understand how complex the system really is and be ready to persevere through numerous obstacles.” This pragmatic advice is echoed throughout the book, making it a valuable tool not only for medical professionals but for anyone considering entrepreneurship in the medical device field.
The Future of Medical Device Innovation
Looking ahead, Muehlbauer believes that artificial intelligence and machine learning will play an increasingly significant role in the medical device sector. He sees these technologies as areas with great potential, although he acknowledges that the industry is still figuring out how to harness their full capabilities. These emerging trends, combined with ongoing improvements in materials and iterative advancements, will likely shape the future of medical devices over the next decade.
Pricing:
NASS Members: $50
Nonmembers: $150
For more information or to purchase Roadmap to Innovation, visit the NASS store.
Roadmap to Innovation offers a comprehensive guide for navigating the multifaceted world of medical device innovation. Whether you're a startup founder, an industry veteran with an idea, or a physician considering a move into the entrepreneurial space, Muehlbauer's book provides actionable insights and strategies to help you succeed in this competitive field. The book is now available to NASS members and nonmembers alike, offering a valuable resource for anyone looking to bring groundbreaking medical devices to market.