Cardiovascular Medical Device Expert Witness

SENIOR EXECUTIVE / CTO

Senior medical device expert Senior medical device expert with broad expertise in cardiovascular and endovascular fields with a focus on percutaneous catheters, stents, grafts, heart assist devices, aneurysm treatment and vascular closure products. Former VP of Technology for a $400 MM medical device company. Inventor of some 40 US patents, including a principal concept for a new cardiology product, HeartMate PHP

Key qualifications include:

• Strong blend of business, technical, clinical and IP knowledge based on 29 years in medical device industry

• Successful in directing R&D and M&A activities and for a large publicly-traded medical device company
• Track record of driving projects forward within approved timelines and budgets
• Personal network of contacts with renowned US and EU cardiac surgeons and interventional cardiologists
• Inventor in 38 US and 70+ international patents
• Strong sense of new product marketability
• Management of intellectual property from a business perspective
• Competent hands-on leadership in developing major new products
• Coordinating internal and external R&D activities to reduce time to market

 

PROFESSIONAL EXPERIENCE

CORINNOVA INC. (since 2013) – Vice President, Product Development

Medical device start-up

• Leading a small engineering team and coordinating several external vendors in developing a novel external compression cardiac assist device
• PI on animal studies
• Coordinating patent strategy and filings in various countries

 

FRESH CONCEPT DESIGN CORP. (since 1992) – Principal

Consulting company providing patent services to individual inventors and small companies

 

DATASCOPE Corp., Montvale, NJ (1990 to 2009)

Diversified medical device company with $400 million total sales volume and major product lines in intra-aortic balloon pumping, patient monitoring, vascular sealing, and vascular grafts

Vice President, Technology (Aug 2005 to Feb 2009)

Responsible for directing R&D activities of all four divisions of the company with a total budget of $30+ million, regular market introductions of new products, identifying organic growth opportunities as well as technical and IP assessment for new business development and technology acquisitions

• Invented a key concept for a new revolutionary catheter-based heart assist device combining a low-profile insertion with full-flow assist capability – Percutaneous Heart Pump (PHP)
• Led internal and external technical teams with a combined yearly budget of $2 million in developing this concept through feasibility and achieving major performance goals
• Project acquired for $8.5 million by a major medical device company – Thoratec – now in clinical trials
• Acquired by Abbott for $450 million in 2016 after obtaining CE Mark
• Completed detailed technical and patent due diligence assessments on 100+ acquisition targets

Scientific Director (Oct 1998 to Aug 2005)

Responsible for advanced development of new generations of company products, primarily in the fields of counterpulsation, vascular closure and endovascular aneurysm treatment devices

• Invented a new intra-aortic balloon-based heart assist device
• Led in conception and early prototypes for an intra-aortic balloon with a fiber-optic pressure sensor and a novel minimally invasive abdominal aortic aneurysm treatment
• Completed proof-of-principle tests for several new vascular sealing devices
• Completed in-vitro and early animal studies for an endograft device for treating an aneurysm
• Established ties with clinical advisors for early clinical feedback to new product concepts
• Implemented several advanced feasibility projects, transitioned to product development teams

Early Positions: Engineer (1990 to 1994), Sr. Research Engineer (1994 to 1995), Principal Engineer and Sr. Principal Engineer (1995 to 1998)

• Implemented a tight membrane wrapping method to reduce IAB insertion profile
• Invented a combined blood pump and oxygenator system for use as emergency bypass
• Invented a single-roller blood pump with very low blood priming volume
• Completed early development for a bypass cannula with a side port for an intra-aortic balloon
• Implemented a new comprehensive in-house in-vitro hemolysis test system

 

SCIENTIFIC INSTITUTE FOR TRANSPLANTOLOGY AND ARTIFICIAL ORGANS, Moscow, Russia (1987 to 1990)

Lead Engineer – artificial heart laboratory (1988 to 1990)

• Controlled performance of the first Russian artificial heart in limited clinical use on 10 patients
• Implanted and evaluated outputs of several artificial heart prototypes in large animals
• Invented and patented 5 new concepts for centrifugal blood pumps

Engineer (1987 to 1988)

Recruited out of college to improve hydraulic performance for the Russian artificial heart program

 

EDUCATION

Masters in Mechanical Engineering – Moscow State Technical University, Russia, 1987

Advanced Ph.D. courses in biomedical sciences – Moscow, Russia, 1990

 

OTHER QUALIFICATIONS

Registered Patent Agent with US Patent and Trademark Office

• Experienced in preparing and filing of over 200 patent applications and all IP matters

Inventions

• Named inventor in 41 US and 70+ international patent filings
• Sole inventor or co-inventor in 40% of all patent filings by Datascope between 1990 and 2009
• 2009 “Inventor of the Year” nominee for lifetime of innovation achievements

Professional Societies Membership

• ASAIO – American Society for Artificial Internal Organs
• ESAO – European Society for Artificial Organs
• ISRBP – International Society for Rotary Blood Pumps
• AUTM – Association of University Technology Managers

Other

• Authored 4 peer-reviewed articles as well as 4 abstracts and oral presentations at scientific conferences
• Invited speaker at 2008 Medical Device and Manufacturing Conference
• Invited moderator for 2007 ASAIO conference
• Listed Reviewer for ASAIO Journal
• Adviser for a PhD thesis at PennState University

Senior medical device expert with broad expertise in cardiovascular and endovascular fields with a focus on percutaneous catheters, stents, grafts, heart assist devices, aneurysm treatment and vascular closure products. Former VP of Technology for a $400 MM medical device company. Inventor of some 40 US patents, including a principal concept for a new cardiology product, HeartMate PHP