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

Expertise

• 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.

Experience

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

Languages

• 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.

Education

• 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