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140746925
Hardware Bible: Build a Medical Device from Scratch: The Book I Wish I Had Before My First Device
Item #:
140746925
€ 35
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This is the unvarnished truth about bringing medical devices to market, written by someone who's been doing this for over a decade.
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What Stands Out
Comprehensive Guidance
This book offers step-by-step instructions on medical device development, ensuring readers navigate the complexities with confidence and avoid common pitfalls.
Real-World Insights
Authored by an expert, it shares practical experiences and lessons learned, providing invaluable knowledge for aspiring medical device innovators.
Targeted Audience
Designed for engineers and entrepreneurs in the medical field, this book addresses specific challenges they face, making it an essential resource for successful device creation.
Product Details
| Publisher | Independently published |
| Publication date | May 26, 2025 |
| Language | English |
| Print length | 207 pages |
| ISBN-13 | 979-8285270478 |
| Item Weight | 13.3 ounces (377.06 grams) |
| Dimensions | 6.24 x 0.71 x 9.24 inches (15.8 x 1.8 x 23.5 cm) |
Who Should Buy?
-
Aspiring Inventors
Ideal for individuals looking to design and prototype their first medical device with comprehensive guidance.
-
Students in Engineering
Beneficial for engineering students seeking practical insights and foundational knowledge in medical device development.
-
Entrepreneurs
Great resource for entrepreneurs aiming to commercialize medical innovations and understand product development fundamentals.
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Seasoned Professionals
Experienced developers may not find new insights or challenge their existing knowledge in building medical devices.
Product Description
Hardware Bible: Build a Medical Device from Scratch: The Book I Wish I Had Before My First Device
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Biomedical Engineering Editorial Review
Hardware Bible: Build a Medical Device from Scratch: The Book I Wish I Had Before My First Device provides a clear and practical guide for anyone in medical device development. The author offers invaluable insights, especially regarding the FDA regulations, presenting complex topics in an understandable manner. With a focus on real-world applications, it helps readers identify potential pitfalls and avoid costly mistakes. The risk management chapter is noted as particularly exceptional. While some readers seek deeper discussions on clinical trials, the overall feedback highlights the book’s usability and efficiency in navigating medical device regulation, making it a must-read for medtech entrepreneurs.
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Pros
- Clear explanations of FDA regulations
- Practical insights on device development
- Exceptional risk management chapter
- Great for both beginners and experienced
- Helpful real-world examples
Cons
- Some chapters could provide more in-depth analysis
Product Price History
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€ 35
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Features & Benefits
- Learn why 80% of medical device startups fail and how to avoid those pitfalls.
- Gain insights into the real regulatory challenges of obtaining FDA clearance.
- Discover how to identify valuable clinical needs worth solving.
- Explore design principles that ensure safety for life-critical devices.
- Understand manufacturing realities that can derail promising prototypes.
- Find effective go-to-market strategies tailored for healthcare.
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