Table of Contents

1 Introduction—overview and innovation process flow diagram
2 Technology in anesthesia and perioperative medicine: exploring opportunities and challenges
3 Specific opportunities for innovation in anesthesia
4 Validate, refine, and define the problem to be solved
5 Market analysis—the anesthesia market landsc
6 Competitive analysis
7 Product requirements for emerging anesthesia technologies
8 Partner with a successful expert
9 Conceptualizing idea to solution
10 Prior art searching
11 Patent strategy—patent types and timing
12 Concept testing and selection—where and why will it fail
13 What to prototype?
14 Medical device development
15 Pilot study
16 Clinical research
17 Licensinghow to, terms, expectations, examples for university technology transfer
18 Funding approaches—why, from where, how much, terms
19 Personnel—teams needed, roles
20 Physician entrepreneurship—three steps to success
21 Choosing an entity structure for your business
22 FDA regulation of anesthesia and critical care medical devices
23 Step-by-step guide for Food and Drug Administration listing, 510(k), premarket approval
24 Anesthesia reimbursement
25 Business models
26 Marketing, sales, and distribution
27 Business strategy—valuing emerging technology companies
28 Business operations
29 Post launch physician relationships
30 Innovation in anesthesiology: technology development and commercialization handbook
31 From idea to commercialization: development of a breathing-controlled gaming device for pediatric anesthesia induction
32 Case study: improve the safety and compliance of drug preparation and administration with barcode technology
33 Revolutionizing blood transfusion: HemaLogiX-optimizing clinical appropriateness and resource utilization
34 FirstLook LTA from Guidance Airway Solut

About the Author

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.

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.

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. 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.