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Commercialization of Contact-Free Blood Pressure Monitoring Technology Commercialization of contact-free blood pressure monitoring technology By SMITHA RADHAKRISHNA Submitted in partial fulfillment of the requirements for the degree of Master of Science Department of Biology CASE WESTERN RESERVE UNIVERSITY May, 2010 CASE WESTERN RESERVE UNIVERSITY SCHOOL OF GRADUATE STUDIES We hereby approve the thesis/dissertation of Smitha Radhakrishna candidate for the Master of Science degree *. (signed) Christopher Cullis PhD (chair of the committee) James. E. Zull PhD Steven Girouard PhD Roy Ritzmann PhD ________________________________________________ (date) March 18th 2010 *We also certify that written approval has been obtained for any proprietary material contained therein. Dedicated to my Parents for their love and encouragement! TABLE OF CONTENTS LIST OF FIGURES ........................................................................................................... vi Abstract ............................................................................................................................. vii 1. Introduction ................................................................................................................. 1 1.1. Internship at BioEnterprise ............................................................................. 1 1.2. EarlySense overview ....................................................................................... 1 1.3. Scope of thesis ................................................................................................ 2 2. Technology description ............................................................................................... 2 2.1. Scientific background ..................................................................................... 2 2.1.1. Overview of the circulatory system .............................................................. 2 2.1.2. Structure and physiology of the heart ........................................................... 4 2.1.3. Heart valves .................................................................................................. 5 2.1.4. Pumping action of the heart .......................................................................... 7 2.1.5. Pressures in the circulatory system ............................................................. 13 2.1.6. Arterial pressure pulsations ......................................................................... 16 2.2. Technology platform ..................................................................................... 21 2.2.1. Theory of pulse transit time ........................................................................ 21 2.2.2. Pathological conditions that affect blood pressure ..................................... 24 2.3. Product description ....................................................................................... 31 3. Description of the commercialization plan ............................................................... 38 3.1. Need for smart patient supervision systems.................................................. 38 3.1.1 Need for blood pressure monitoring ............................................................ 39 iv 3.2. Value proposition .......................................................................................... 39 3.3. Patient monitoring market............................................................................. 41 3.3.1. Overview ..................................................................................................... 41 3.3.2. Revenue forecasts for patient monitoring industry ..................................... 42 3.3.3. Favorable trends .......................................................................................... 44 3.3.4. Market restraints ......................................................................................... 46 3.4. Competition analysis ..................................................................................... 48 3.5. Business model ............................................................................................. 51 3.5.1. Target market .............................................................................................. 51 3.5.2. Customers ................................................................................................... 52 3.5.3. Intellectual property .................................................................................... 52 3.5.4. Regulatory status ......................................................................................... 53 3.5.6. Reimbursement ........................................................................................... 56 3.5.7. Implementation of business model ............................................................. 57 3.5.8. Market strategy ........................................................................................... 59 3.5.9. Timeline ...................................................................................................... 60 4. Business analysis ...................................................................................................... 61 4.1. EverOn Value................................................................................................ 61 4.2. Key issues and risks ...................................................................................... 64 4.3. Summary ....................................................................................................... 65 References ......................................................................................................................... 67 v LIST OF FIGURES Figure 1: Structure of the heart ........................................................................................... 4 Figure 2: Events of the cardiac cycle .................................................................................. 8 Figure 3: Normal blood pressure in different portions of the circulatory system ............ 13 Figure 4: Pressure pulse contour recorded at the root of the aorta .................................. 16 Figure 5: Abnormal aortic pressure pulse contours I ........................................................ 18 Figure 6: Abnormal aortic pressure pulse contours II ...................................................... 18 Figure 7: Diagram showing the measurement of PTT using the R wave of the ECG ...... 21 Figure 8: EverOnTM........................................................................................................... 31 Figure 9: Parameters detected by EverOn ........................................................................ 32 Figure 10: EverOn in use .................................................................................................. 33 Figure 11: Components of the control unit ....................................................................... 34 Figure 12: Measurement of PTT using motion sensors .................................................... 36 Figure 13: Analysis of signals using PTT ......................................................................... 37 Figure 14: Segment analysis of the patient monitoring industry ...................................... 41 Figure 15: Revenue projections for the North American patient monitoring equipment market ............................................................................................................................... 42 Figure 16: Unit and demand analysis of the patient monitoring equipment market ......... 43 Figure 17: Supply and demand of nurses .......................................................................... 44 Figure 18: Case study of a patient showing abnormal changes in heart rate .................... 55 vi Commercialization of contact-free blood pressure monitoring technology Abstract by SMITHA RADHAKRISHNA This thesis will provide a commercialization strategy for a contact-free blood pressure monitoring application with an overview of the circulatory system, blood pressure, pathological conditions affecting blood pressure and the technology platform of the application. The EarlySense patient supervision system, EverOn™, comprises a contact- free sensor and a bedside unit that currently displays the patient’s heart rate, respiratory rate and body motion. The company intends to incorporate the additional functionality of contact-free blood pressure monitoring. Upon detection of a fluctuation in blood pressure, EverOn will alert care providers by activating an alarm. The additional functionality will allow the company to expand into new markets and to effectively predict patient deterioration. The EverOn device has received FDA 510(k) clearance, is CE approved and has demonstrated successful clinical trials. EverOn’s initial target market comprises general medical wards in hospitals. Future markets include home care and long term care markets. vii 1. Introduction 1.1. Internship at BioEnterprise I joined BioEnterprise in January 2009 as a Business Analyst and have been involved in conducting market research, preparing initial reviews and due diligence summaries for early stage medical device and therapeutics companies. I have also been very active in the area of grant writing and have played significant roles in a National Science Foundation (NSF) grant and a commercialization grant for the Global Cardiovascular Innovation Center (GCIC). The GCIC grant was written on behalf of EarlySense to secure funding for the introduction of the blood pressure monitoring application into their
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