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Medical Device Expert in Product Development, R&D, and Regulatory Support (FDA, ISO, CE)

Technical Consultant #2032


  • Medical device product development, market positioning, strategic planning, and branding strategy.
  • Regulatory affairs and compliance, (FDA, ISO and CE approval processes).
  • Technology leader providing equivalent support for the health care, security, intellectual property, and space industries while successfully developing new businesses in the U.S. and abroad.
  • Budget and resource management, contract management and negotiation, change management and restructuring, profit and loss accountability, forecasting and trend analysis, mergers and acquisitions and joint ventures.


Undisclosed Company, President, 2013 - Present

  • Consultancy for early stage medical companies.
  • Raising capital, global market position and distribution network, regulatory approvals and audits, reimbursement strategy, research and development, intellectual property, project and program management.

Biolase, Inc., Irvine, CA , General Manager, 2012 - 2013

  • Biolase develops state of the art medical lasers and imaging solutions for surgical, dental, ophthalmic, pain, dermatology and other clinical markets.
  • Acting as Vice President handling Development, Engineering and Regulatory clients.
  • Analyzed business processes across all divisions including management, organization/personnel, sales and marketing, regulatory, quality, product development, clinical research, production, supply, service and product management.
  • Implemented strategic initiatives targeting key business goals including customer satisfaction and improved efficiency.
  • Developed and drove new product, regulatory and clinical research roadmaps.
  • Revamped product development process and implemented across all divisions.
  • Vigorous business development including dynamic merger and deals.
  • Facilitated expansion into medical imaging.

Gamma Medica, Northridge, CA, General Manager, 2005 - 2012

  • Gamma Medica develops cutting-edge, fully digital pre-clinical (translational medicine, pharmaceutical), clinical, space, and security imaging systems.
  • Built company's clinical imaging, (Molecular Breast Imaging) operation's from scratch, which involved establishing division's sales, marketing, production, supply chain, engineering, operations, distribution, service, and applications.
  • Recruited VP of Marketing, Sales Directors, Engineering Director, Applications Director, and service and production staff.
  • Accountable for budget management, sales, forecasting, marketing, production, research and development, service, strategic planning, and collaborations with prominent hospitals.
  • Division operated as a separate company with its own profit and loss.
  • Grew division's annual revenue from zero to multiple millions within 2 years.
  • Developed business, technology, and product roadmaps with forecasts and budgets.
  • Established a vibrant domestic and international distribution network.
  • Built reimbursement system for Molecular Breast Imaging and obtained FDA, CE and other regulatory approvals.
  • Responsible for ISO 9001 and 13485 compliance and audits.
  • Forged relationships with high-profile organizations such as Mayo Clinic, Cedars Sinai, UCLA, and University of Pittsburgh Medical Center.
  • Awarded and managed multimillion-dollar research, development, and multi-center clinical trial grant project from the National Institutes of Health and National Cancer Institute.
  • Created strong industry presence for division through exhibitions, presentations at conferences, marketing campaigns, and use of online media.

Chief Operating Officer

  • Directed all operations of company, including production, supply, research and development, sales, service, marketing, business development, merger and, strategic planning, forecasting, and board and investor relations.
  • Led 3 divisions: Clinical, Pre-Clinical, and Industrial. Managed sales to hospitals, universities, research labs, government labs, physic labs, and space agencies in both domestic and global markets.
  • Oversaw 100 personnel across 4 sites located in Los Angeles, London, Ontario, Sherbrooke, Quebec, and Oslo, Norway. Managed collaborations with the world's top universities.
  • Acquired competitive pre-clinical division of GE Healthcare in London, Ontario and orchestrated commercial deal. (GE marketed, sold, and serviced company's products and Gamma Medica manufactures, conducted research and development).
  • Integrated all operations within Gamma Medica and managed the sales and marketing relationship with GE.
  • Created necessary business operations that increased annual sales over 400% to nearly $30 million.
  • Assimilated newly acquired Advanced Molecular Imaging operations into Gamma Medica Canada.
  • Responsible for ISO 9001 and 13485 compliance and audits.
  • Integrated GE Healthcare quality system.
  • Integrated digital PET technology from Advanced Molecular Imaging into company's product portfolio.
  • Raised $16 million in private sector capital and managed millions of dollars in grants.
  • Secured contract manufacturing agreement with Sieko Instruments Nanotechnology (SIINT) U.S. and negotiated and managed the distribution of pre-clinical systems in Japan through SIINT Japan.
  • Served as Board Chairman for Gamma Medica-Canada and Board Chairman for Gamma Medica-Norway.

Honors & Publications


  • Hindi

Academic and Professional Affiliations

  • Project Management Institute
  • Institution of Electrical Engineers
  • World Molecular Imaging Congress
  • Society of Photo-Optical Instrumentation Engineers
  • Society of Nuclear Medicine
  • European Nuclear Medicine Congress
  • Biomedical Engineering Society
  • Device Alliance (Orange County, CA)-Program Committee: Big Data in Medicine, International Markets
  • Ability to understand and work within Government Contracts.

Publications and Patents

Author and Co-Author

  • 28 publications in peer reviewed journals
  • 52 Nation and International Presentations.
  • Accomplished Inventor with 8 patents that have been introduced worldwide.


  • Ph.D. Biomedical Engineering, University of Akron, Akron, OH
  • M.S. Biomedical Engineering, University of Akron, Akron, OH
  • B.S. Electrical Engineering, University of Michigan, Ann Arbor, MI
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