Innovation in Anesthesiology

Technology, Development, and Commercialization Handbook

1st Edition - April 29, 2024
Editors: Adam E.M. Eltorai, Ashley Szabo Eltorai, Nancy Patterson, Piyush Mathur
Language: English
Paperback ISBN:
9 7 8 - 0 - 1 2 - 8 1 8 3 8 1 - 6
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 1 5 4 3 4 - 2

Innovation in Anesthesiology: Technology, Development, and Commercialization Handbook reflects recent trends of industry globalization and value-conscious healthcare. Writte… Read more

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Innovation in Anesthesiology: Technology, Development, and Commercialization Handbook reflects recent trends of industry globalization and value-conscious healthcare. Written by a team of leading anesthesiologists, engineering development professionals, business analysts, commercialization experts, regulatory and reimbursement specialists, and legal authorities, this volume in the Clinical and Medical Innovation series provides a clear process for the identifi cation, invention, and implementation of new solutions in anesthesiology. This is the ideal resource for anesthesiology innovators who desire to deliver patient solutions and applications to their inventions. Featured case studies on innovative products highlighting the stages required are included for reference.

The book will lead researchers, clinicians, entrepreneurs, and investors through a clear process for the identification, invention, and implementation of new clinical technology solutions. Expert medical device inventor/entrepreneurs provide case studies on globally innovative products including successes, failures and practical advice. The book will be a key reference for entrepreneurs developing emerging technology in anesthesia, investors funding innovation in anesthesia, life science business leaders seeking to understand market trends in technology development, tech transfer offices determining prioritization of patenting dollars, distributors seeking to understand trends in anesthesia technology, as well as researchers and engineers seeking to understand market development needs and trends.

Cover image
Title page
Table of Contents
Copyright
List of contributors
About the editors
About the series editors
About the authors
1. Introduction—overview and innovation process flow diagram
Abstract
Chapter outline
Key points
Why it matters
Get started
Potential pitfalls
Resources
References
2. Technology in anesthesia and perioperative medicine: exploring opportunities and challenges
Abstract
Chapter outline
Introduction
Ergonomic design issues
Robotically assisted anesthesia
Artificial intelligence in anesthesia and perioperative medicine
Anesthesiology, artificial intelligence, and the technological singularity
Regulatory hurdles
Remaining challenges
Conclusions
Acknowledgments
Declarations
References
3. Specific opportunities for innovation in anesthesia
Abstract
Chapter outline
Trends in anesthesia care
Issues and unmet needs in anesthesia care
Summary
Appendix A
References
4. Validate, refine, and define the problem to be solved
Abstract
Chapter outline
Idea validation
Value
Data and design
Assumptions
Trial and test
Explore and enhance
References
5. Market analysis—the anesthesia market landscape
Abstract
Chapter outline
Key takeaway points
Key term definitions
Market analysis in anesthesia
Determining procedure-driven market size
Changes in the anesthesiology care team
Considering the cardiac anesthesia market
References
6. Competitive analysis
Abstract
Chapter outline
Abbreviations
Introduction
The competitive arena—industry analysis through Porter’s Five Forces
Bargaining power of suppliers
Bargaining power of buyers
Threat of new entrants
Threat of substitute products or services
Rivalry among existing firms
Identifying your competitors
Conclusion
References
7. Product requirements for emerging anesthesia technologies
Abstract
Chapter outline
Key points
Glossary terms and definitions
Introduction
Discovering requirements
Analyzing requirements
Examples of product development in anesthesiology
Conclusion
8. Partner with a successful expert
Abstract
Chapter outline
Key points
Glossary terms and definitions
The partnership
Selecting a partner
Potential pitfalls to a successful partnership
Strategies for a successful partnership
Examples of partnership in anesthesiology
9. Conceptualizing idea to solution
Abstract
Chapter outline
Idea, concept, invention, and innovation
Ideas are everywhere
Generating new ideas
Getting it on paper
Concepting idea
References
10. Prior art searching
Abstract
Chapter outline
Introduction
What is prior art?
Priority date
Types of prior art searches
Your patents and publications can be used against you as prior art
Patents do not infringe patents
Who conducts the prior art search?
Cost/timing of searching
Define the scope of the search—casting a wide net versus too narrow
Duty of disclosure
Prior art search and IP due diligence during fundraising or exit strategies
Examples of vendors and databases
Conclusion
11. Patent strategy—patent types and timing
Abstract
Chapter outline
Glossary terms and definitions
Chapter outline
Key points
Introduction
The patent strategy
Strategies for commercializing novel ideas without a patent
Patenting pitfalls to avoid
Examples of patents in anesthesiology
Further reading
12. Concept testing and selection—where and why will it fail
Abstract
Chapter outline
Glossary terms and definitions (a list of 5–10 terms with their definitions—this list may be identical to your keywords but needs to include the definitions)
Chapter outline
Key points
[Potential Pitfalls]
References
13. What to prototype?
Abstract
Chapter outline
Key points
Glossary
Introduction/why it matters
Processes before prototyping
Prototyping
Examples
Get started
Potential pitfalls
Reference
14. Medical device development
Abstract
Chapter outline
Glossary terms and definitions
Chapter outline
References
15. Pilot study
Abstract
Chapter outline
What is a pilot study?
Why pilot studies are performed? Considerations and advantages
How to conduct a pilot study?
Practical considerations
Examples of pilot studies
Summary
References
16. Clinical research
Abstract
Chapter outline
What is clinical research?
Purpose of conducting clinical research
Clinical study design
Ethics in clinical research
Conclusion
References
17. Licensing–how to, terms, expectations, examples for university technology transfer
Abstract
Chapter outline
How to maximize the value of licensing technologies
Value of technology commercialization to key stakeholders
Examples of best practices in innovation marketing
To option or to license?
Key terms in a license
18. Funding approaches—why, from where, how much, terms
Abstract
Chapter outline
Key points
Introduction/why it matters?
Why do you need funding?
“From where?” Sources of funding
“How much?” Stages of funding rounds
Pitching your business idea
“Terms?” The term sheet
References
19. Personnel—teams needed, roles
Abstract
Chapter outline
Key points
Introduction/why it matters?
Stay a solopreneur or look for a co-founder?
Essential roles in a founding team
Essential startup company personnel
Success factors of a startup team
Get started
Glossary
References
20. Physician entrepreneurship—three steps to success
Abstract
Chapter outline
Key points
Glossary terms and definitions
Step 1—Make a plan
Potential pitfalls
Real word examples
Step 2—Identify potential partners
Potential pitfalls
Real world examples
Step 3—Research an exit strategy
Potential pitfalls
Real world examples
References
21. Choosing an entity structure for your business
Abstract
Chapter outline
Abbreviations
Choosing an entity structure for your business
Sole proprietorships
Partnerships
Corporations
S-corporation and C-corporation
Limited liability companies
Changing the structure of a business
Key considerations for business founders
Summary
References
22. FDA regulation of anesthesia and critical care medical devices
Abstract
Chapter outline
Introduction
Medical devices and combination products
Regulation of software and medical devices with digital health technology
The 21st century cures act
Software in and as a medical device
Clinical decision support software
Automation in anesthesia
FDA regulation of AI/ML technology
References
23. Step-by-step guide for Food and Drug Administration listing, 510(k), premarket approval
Abstract
Chapter outline
Key points
Glossary
Introduction/why it matters?
Get started
References
24. Anesthesia reimbursement
Abstract
Chapter outline
Introduction: why does billing matter?
Getting started: maximum allowable fee
Completing the puzzle: provider coding
Special situations
Special events during medical direction
References
25. Business models
Abstract
Chapter outline
Types of anesthesia groups
Types of business entities
Types of contracts
Business models
Competitive strategy
Further reading
26. Marketing, sales, and distribution
Abstract
Chapter outline
Key points
“Why it matters?”
Abbott Laboratories versus Edwards Lifesciences: transcatheter mitral valve devices
Baxter spectrum IQ infusion pumps
Nevro HF10 spinal cord stimulators
References
Further reading
27. Business strategy—valuing emerging technology companies
Abstract
Chapter outline
Introduction
Revenue forecasting and the anatomy of the profit and loss statement
Pricing
Expenses
Operating expenses
Valuation
Conclusion
28. Business operations
Abstract
Chapter outline
Key points
Introduction
Operating plan
Staffing requirements
Sales projections
Budget requirements
P&L statement
Cash flow statement
Exit scenarios
Think like an investor
Case example
References
29. Post launch physician relationships
Abstract
Chapter outline
Introduction
Elements of marketing to healthcare
Market environment: a few basics about US healthcare
Regulatory approval: medical device approval in the United States and Europe
Successful strategies for post launch physician relationships
Understanding customers: physicians, hospitals, and hospital systems
References
30. Innovation in anesthesiology: technology development and commercialization handbook
Abstract
Chapter outline
Key points
Glossary
Why it matters
Background
Journal of Parenteral and Enteral Nutrition/Vol. 35, No. 1, January 2011
Getting started with practical advice
Getting started summary
Patent history from USPTO.gov:
References
31. From idea to commercialization: development of a breathing-controlled gaming device for pediatric anesthesia induction
Abstract
Chapter outline
Problem/opportunity
Concept
Product development
Commercialization pathway
Funding
Regulatory
Challenges, solutions
Advice
References
32. Case study: improve the safety and compliance of drug preparation and administration with barcode technology
Abstract
Chapter outline
Company introduction
Company background
Product definition
Continued development
Strategic insights
Financial and risk
References
33. Revolutionizing blood transfusion: HemaLogiX-optimizing clinical appropriateness and resource utilization
Abstract
Chapter outline
Key points
Problem/opportunity
Concept
Pathway
Building a company
References
34. FirstLook LTA from Guidance Airway Solutions
Abstract
Chapter outline
Concept
Pathway
Index

Adam E.M. Eltorai

Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.

Affiliations and expertise

Harvard Medical School, Boston, MA, USA

Ashley Szabo Eltorai

Dr. Ashley Szabo Eltorai is a staff physician in Anesthesiology and Critical Care at the YaleNew Haven Hospital. She is also an Assistant Professor in the School of Medicine at Yale University. Dr. Szabo Eltorai received her M.D. at the Case Western Reserve UniversitySchool of Medicine. She is a member of the American Society of Anesthesiologists and the Society of Critical Care Anesthesiology.

Affiliations and expertise

Staff Physician, Anesthesiology and Critical Care, Yale-New Haven Hospital; Assistant Professor, School of Medicine, Yale University, Connecticut, USA

Nancy Patterson

Nancy Patterson is a Venture Analyst and the President and CEO and Founder of Strategy Inc. (in 2000), a lifescience market analysis and valuation company for US and International clients. She has over 18 years’ experience in senior business development and marketing roles with emerging technology medical device companies. Patterson is an immunologist from University of Michigan and also has an MBA from University of Southern California.

Affiliations and expertise

President and CEO Strategy Inc., Texas, USA

Piyush Mathur

Dr. Piyush Mathur is a Staff Anesthesiologist and Intensivist at The Cleveland Clinic. Since 2015, he has been the Program director of the Anesthesia Critical Care Fellowship Program at The Cleveland Clinic. Dr. Mathur received his MBBS from the Armed Forced Medical College and completed subsequent fellowships at The Cleveland Clinic in Critical Care Medicine.

Affiliations and expertise

Program Director, Anesthesia Critical Care Fellowship Program, Anesthesia Institute, The Cleveland Clinic, Ohio, USA

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Innovation in Anesthesiology

Technology, Development, and Commercialization Handbook

Purchase options

Save 50% on book bundles

Institutional subscription on ScienceDirect

Adam E.M. Eltorai

Ashley Szabo Eltorai

Nancy Patterson

Piyush Mathur