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Medical Products & Technology Expert Witness

Provides Opinion & Testimony In:

Medical Products, Devices, Safety, Efficacy, Intellectual Property Analysis, Patent Infringement, Clinical Studies, Least Invasive, Surgical Therapies, Product, Process Development, Surgically Implanted Mesh

Expert No. 3008

Summary of Experience

Mar 2011 to Jun 2012: Contract CEO, Private Company

Feb 2009 to Present: Private Company, other start-ups and Investment Institutions: Business Development, Financing, Product Development and Intellectual Property Planning; work with CEO’s and BOD’s to address pivotal strategies; collaborate with investment principals to assess start-up dynamics
                         
June 2007 to Feb 2009: Vice President, R&D, Volcano Corporation
Manage all Product Development, New Technology, and Intell Prop’y for this public Company with revenues exceeding $ 200 MM in Interventional Cardiology

Sept 2004 to Present: Consultant, Board Member, Consulting Expert:
Round Table Group Scholar program; Consulting Expert Witness; Medical Specialty Consultant
Advise legal counsel, representing BSC, on multiple technical and practical aspects
leading to jury trial; provide intellectual property and associated data testimony

The Battelle Institute
Advise on key organization changes and recommended practices to realize business opportunities with medical devices and associated technologies

IVIT, Inc.
Acting CEO for a Vascular Access company developing technology for chronic hemodialysis patients, emphasizing least invasive vascular procedures

CryoCath, Inc.
Mentor VP R&D and staff for an electrophysiology / cardiology company seeking fast time-to-market for least invasive treatment of cardiac arrhythmias, with emphasis on atrial fibrillation (subsequently acquired by Medtronic)

Biovention, Inc.
Direct, via Board position, strategy and development path for this novel, heparin-additive, drug-eluting coronary stent company, targeted at prevention of sub-acute and late stent thrombosis; currently operating in mainland China

Multiple Companies and Investors
Analyze and advise, in consulting capacity, on multiple product development programs, including obesity therapies, wireless cardiovascular implants, in vitro diagnostics, aorta implants for aneurysm treatment, non-vascular applications of intravascular imaging, and gastroenterological least invasive therapies; enable specialized contract developers / manufacturers to drive selected aspects of product development for expediency.

Sept 2003 to April 2005: President & CEO, LumeRx, Inc.: managed all aspects of this development stage company focused on light-based therapy in Gastroenterology; raised $7 MM private equity financing; recruited and managed key technical staff , consultants and contract organizations for Clinical/Regulatory/Quality and Marketing, organized and managed SAB with opinion-leading Gastroenterologists, orchestrated photo-optic consultants with internal engineering staff, led key clinical, regulatory and re-imbursement strategies and plans, and established detailed financial accounting and reporting system, directed new patent application filings.

August 2003 to December 2006: Consultant CTO, TherOx, Inc.: consulting continuity with emphasis on business development and new financing support for this multiple opportunity company; continued Board of Directors activities; manage focused programs for cancer therapy, wound and skin care, and GI therapies.

May 2001 to August 2003: Chief Technical Officer, TherOx, Inc.: identified and managed multiple cardiovascular business opportunities with key technical support, emphasizing CV Surgery and intra-PTCA alternatives for hyperbaric Oxygenation solution technology, specialty wound care therapy, and selected oncology therapies using vascular administration; managed all aspects of Intellectual Property, including 20 plus patent Portfolio.

June 1994 to May 2001: President and Co-founder, TherOx, Inc.: managed all operating aspects of this start-up, integrating a hardware/software bedside system with disposable catheters, focusing on 1)Acute MI, 2) skin & wound care, 3) cancer therapy; raised more than $ 52 MM in private capital with KPCB as lead investor; recruited initial 45 employees in all operating functions, achieved multiple FDA and CE Mark approvals, established clean room manufacturing of disposables and electromechanical control + delivery systems, directed extensive, multi-phase clinical studies in US and Europe, established and maintained opinion-leading SAB, and recruited key international technology consultants for breakthrough developments; directed development and management of all intellectual property (primarily patents).

May 1991 to June 1994: VP R&D, Baxter Bentley: managed all product development, advanced manufacturing, clinical, and related technical support aspects for this cardiopulmonary bypass company with $ 150 MM annual revenue; served as group R&D and strategic planning representative for all Cardiovascular Group divisions with $ 900 MM annual revenue base to enable key growth and diversification strategies; coordinated use of selected Baxter corporate capabilities to achieve operating efficiencies

May 1986 to March 1990: President & Co-founder, InterTherapy, Inc.: managed all aspects of this start-up focused on intracoronary ultrasound for interventional cardiology; raised more than $ 11 MM venture capital; organized SAB and Clinical Investigator array with opinion-leading Interventional Cardiologists in the US and Europe; accomplished rapid FDA approval for marketing, ISO certification, and aggressive early marketing with pilot in-house manufacturing capability; managed Intellectual Property development.
(was merged with CVIS, then acquired by BSC).

Previous experience included Executive R&D management positions with Johnson & Johnson, Edwards Labs, and Meadox Medicals, and a Special Expert position for the National Institutes of Health. Additionally, served 3 years of active duty as a Captain in the USAF, performing cardiopulmonary research with human subjects for development of life support systems for high performance aircraft.


Education

PhD,  Univ. of Michigan, Biomedical Engineering  – NIH pre-doctoral fellow
M.S.,  Univ. of Michigan, Aerospace Engineering - NSF fellow
B.S.,  Univ. of Notre Dame, Aerospace Engineering - USAF Scholarship

Publications and Patents

Available Upon Request


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