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Biomedical Engineering Technology Medical Expert Witness


Expert Witness No. 2265

California


Summary

Expert 2265 has over 20 years of experience in designing and developing medical device to clinical problems. He has extensive experience as a surgeon having performed procedures/surgeries such as laryngectomies, tracheostomies, bronchoscopies, laryngoscopies, head & neck surgeries and many other types of general surgeries. While practicing surgery he got inspired with technological solutions to clinical problems and completed his Master’s & Ph.D. in Biomedical Engineering at the IIT.  His post-doctoral research at the University of Michigan, Ann Arbor was in Nephrology, Artificial Organs and Blood when he developed, evaluated and tested a stem cell-based Artificial Kidney Device and worked on a de-heparinization and blood device that can be used in Cardiac surgeries.

Expert 2265 teaches courses titled Medical Device Design & Development, Human Physiology in Health & Disease, Overview of the Medical Device Industry and Medical Devices- the Basics & the Business, Cardio-Pulmonary Pathophysiology and Devices for University of California extensions at Berkeley, Santa Cruz & Irvine. He is also a medical device adviser and consultant.

Expertise

Biomechanics & Implants           
Biomedical Engineering
Blood devices and Cardiac devices
Cardiac Devices & Artificial Organs
Disease & Device Interventions
ENT devices – ex: CPAP devices
Medical Device Design
Medical Membrane Technology
Medical Software & Informatics                             
Nephrology & Renal Devices
Patent Analysis                                                          
Stem Cell Technology
Surgery – ENT, Obstetrics, Plastic                           
Wireless Medical Devices


Education

1998
University of Michigan, Ann Arbor, MI         
Post-Doctoral Research in Biomedical Engineering

1995
Indian Institute of Technology, Mumbai        
M. Tech & Ph.D. Doctorate in Biomed Engineering

1986
Karnatak University, Dharwad            
MB BS, DLO - in Ear, Nose & Throat Surgery

2006
University of California, Santa Cruz, CA       
Certificate in Clinical Trials Design and Management


Professional Experience

2011–2012
PRIVATE CORPORATION, SANTA CLARA, CA 
VICE PRESIDENT | HEAD - MEDICAL DEVICE VERTICAL

   
Created “proof of concept” medical device solutions to Medical Device clients.
Obtained the ISO number Certification for the company. 
Involved in projects involving: Sleep Apnea devices, Pulmonary devices, Cardiac monitoring devices, Mobile health monitoring devices.


2009–2011
PRIVATE CORPORATION – MILPITAS, CA 
ASSOCIATE VICE PRESIDENT - MEDICAL DEVICES AND HEALTHCARE VERTICAL

  
Worked on design and development projects relating to the following devices: 

  • Biochemistry Analyzers and Bioanalytical Instruments
  • Cardiology  Devices - ICDs, Pacemakers
  • Cardiac  & Diagnostic Imaging
  • EMR-device interface & Hospital Information Systems
  • Hemapheresis & Therapeutic  Apheresis
  • Laparoscopic surgery  Instrumentation
  • Neuromodulation & Hearing Devices
  • Patient Monitoring & Hospital Info Systems.
  • Radiation Therapy Devices
  • Surgical Planning Software
  • Therapeutic Devices


2008–2009
PRIVATE TECHNOLOGY COMPANY – MOUNTAIN VIEW, CA 
MEDICAL DIRECTOR - PRODUCT STRATEGY AND ARCHITECTURE
   
Worked on market research and market strategies, medical device solutions, and medical device consulting.  Solutions worked on were around Telepathology and Cardiology.


2004–2008
PRIVATE COMPANY – SANTA CLARA, CA
FOUNDER AND MEDICAL DIRECTOR   
Rendered effectual support to start-up companies in developing technology plans, establishing positioning in the medical devices market, and devising clinical and regulatory strategies. 
Specialized in Biomedical, Clinical, consulting. Consulting services includes Medical Education, Key Opinion/Thought Leader Advocacy, Medical Affairs, Clinical Consulting, and Medical Information & Medical Content Management.  Convey/acquire safety information on bioproducts.  Teach workshops on Good Clinical Practices (GCPs), Cardiac Pathophysiology: Drugs/ Devices


2005–PRESENT
UNIVERSITY
INSTRUCTOR IN MEDICAL DEVICES & HUMAN PHYSIOLOGY   

Summary:   As an industry expert in Medical Devices, teach courses in Medical Devices and Human Physiology at several extension campuses. 

Courses taught were: 

Medical Device Design and Development 


This course provides insight into the entrepreneurial nature of the medical device industry, as well as a detailed look at the design and development process for new medical devices. Beginning with an overview of device terminology, applied patho-physiological concepts, and biocompatibility, the instructor and guest speakers move on to explore how technologies are translated into medical devices. Using case studies on numerous families of devices, they address hardware and software design, biomaterials, as well as the process of securing IP protection for the innovation by the Patent application process.  Brief coverage is also given to device manufacturing and testing, marketing pathways and strategies to navigate the regulatory bodies.  This course benefits professionals from all backgrounds who are working in or interested in exploring opportunities within the medical device arena.


Human Physiology in Health and Disease

This course introduces the fundamental principles of human physiology in health and disease, and provides insights into the cutting-edge and established therapies being developed and used to treat a range of disease processes. Designed for individuals who lack formal medical training, the course begins with an overview of the hierarchical organization of the body, from cells to coordinated organ systems, and continues with a discussion of the key integrative/homeostatic control mechanisms. With these topics as a foundation, the instructor progresses through the functions of major systems, including renal, cardiovascular, respiratory, neuromuscular, digestive, endocrine and reproductive. This course benefits clinical research, biopharmaceutical, and engineering professionals who need a basic understanding of the physiological processes and therapeutic approaches that underlie the biomedical projects or clinical trials on which they work.

Cardiovascular-Pulmonary Physiology & Engineering: Drugs and Devices

Gain an in-depth understanding of the structure and function of the cardiovascular and pulmonary systems. Expand your knowledge of the biomedical engineering principles involved in the design and development of cardiovascular and pulmonary devices, drugs, and diagnostics. In addition, participants are introduced to patho-physiology, diagnostic techniques, and therapeutic interventions for cardiovascular and pulmonary systems.  Topics to be covered include:
  • Cardiovascular rheology and hemodynamics, and pulmonary biomechanics
  • Thrombosis, hypertension, ischemic heart disease, chronic Obstructive Pulmonary Disease (COPD), and lung pathologies
  • Pulmonary devices, Sleep Apnoea devices, Spirometry, PFTs
  • Therapeutic interventions in the form of drugs, cardiac pacemakers, defibrillators and ventricular assists.


SCIENCE & TECHNOLOGY OF MEDICAL DEVICES FOR QUALITY PROFESSIONALS

The Biomedical industry is one of the fastest growing sectors in North America which hosts a large concentration of this industry. The explosion of scientific advances in biomedicine and the demographics of an aging population have fuelled the growth of this industry.  Biomedical engineers play a pivotal role in the concept, design, development, manufacture and support of biomedical devices and diagnostics. 


Engineers who are considering this industry require breadth of knowledge in the underlying medical/ clinical science and familiarity with the highly regulated environment.  Because of its comprehensive nature, this course will be most valuable to Quality professionals, Engineers, Technologists, managers whose current domain is not biomedical but are very much interested in this sector. Topics included are: 

  • Medical Devices - Types and Classification 
  • Cardiovascular Devices & Stents 
  • Biomedical Sensors, BioPhotonics & BioChips 
  • Medical Imaging Techniques 
  • Stem Cells, Human Genomics & Gene Therapy 


 
MEDICAL & DEVICE TERMINOLOGY FOR QUALITY PROFESSIONALS

 
This workshop is perfect for Medical Device and Quality professionals who have no background in Biomedical sciences but who want to upgrade their skills and learn Medical terminology.  This course will provide you with a basic understanding of the human body, its functions and disease states.  Introduction to the basic word structure in medical terminology. Special focus on definition of medical terms by their roots, prefixes and suffixes. Emphasis on the roots, prefixes and suffixes to systems-based terminology.  Medical Device terminology with emphasis on Cardiovascular Devices, Neuro-devices, Nephro-devices, Imaging devices, Pulmonary & ENT devices and Patient Care devices will be discussed.  Also, Medical Device Regulatory terms such as 510K, PMA, IDE, Substantial Equivalence, Predicate Device, Adverse Events, Warning Letter and other related terminology will be discussed to give understanding of the terms used in the Medical Device Industry.     

2004–2009
PRIVATE TECHNOLOGY
EXECUTIVE-IN-RESIDENCE & ADVISER   
Summary:   As a pro bono Executive-in-Residence in the Girvan Institute of Technology, a Technology Incubator and as Adviser to The Enterprise Network (TEN) in the Silicon Valley, helped startup companies get off the ground.  Developed their technology plans, product positioning, clinical regulatory strategy.

2003–2004

PRIVATE COMPANY, SAN JOSE, CA
MEDICAL PROJECTS MANAGER   
Summary:   Quick technology assessment, presenting company capabilities to prospective clients, writing compelling proposals and closing project sales. 

2002–2003
PRIVATE CORPORATION – EAST BAY, CA
HEAD OF MEDICAL DIVISION   
Boosted revenue within 9 months; managed 15 direct reports; developed medical education programs; identified and recruited teaching faculty; as well as handled budgeting and P & L.

1998–2002

PRIVATE COMPANY, - SAN FRANCISCO,  CA   
MEDICAL EXPERT | CLINICAL ANALYST AND ENGINEER
HEDIS Reporting, which contained the computerized patient records of Oceania, a company that creates electronic medical records (EMRs), such as WAVE and OC Notes for HMOs and Kaiser.


EARLIER CAREER   

1996-1998
UNIVERSITY OF MICHIGAN, ANN ARBOR, MI, USA
POSTDOCTORAL RESEARCHER IN BIOMEDICAL ENGINEERING                                                                                                   

1983-1996

HOSPITALS IN KARNATAKA, MAHARASHTRA AND GUJARAT, INDIA
EAR, NOSE AND THROAT SURGEON | CLINICIAN- SURGEON

EAR, NOSE & THROAT SURGEON, B.J. WADIA HOSPITAL FOR CHILDREN, KARNATAK MEDICAL HOSPITAL besides others                                      

  • Years of general ENT experience, including the surgical and therapeutic management of: Head and Neck Cancers, Supraglottal Laryngeal malignancies, Nasal and sinus cancers, middle ear typmanoplasties.
  • Experience treating ENT and general surgery patients in ICU, NICU and ER.
  • While practicing surgery I got inspired with technological solutions to clinical problems, went back to school and got myself formally trained in engineering with a Ph.D. in Biomedical engineering at IIT, B.
  • Concurrently, worked in the IIT, Hospital as a consulting Ear, Nose & Throat Specialist/Surgeon


SELECT AFFILIATIONS
   

  •  Former Chairman of Life Science Committee, Silicon Valley Association of Startup Entrepreneurs (SVASE)
  •  Ex-Board of Directors at BioDevice Group, Silicon Valley, CA


AWARDS    

  • Selected for the inaugural class of Emerging Entrepreneurs in Biomedical Technology 2005 at Stanford University’s Bio Design Program
  • Received the National Research Service Award in Nephrology from the National Institutes of Health in 1997
  • Awarded with the International Travel Grants and Research Associateship by the CSIR in New Delhi in 1995

Selected Publications & Presentations

Available upon Request.

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