Medical Device Design and Product Development Expert Specializing in Class III and Class IIb Devices

Technical Consultant #1841


Expertise

  • Medical device design, product development and commercialization experience of 21 years with a record of building and leading high performance product development teams, developing and commercializing new products, and driving increased revenues and profitability.
  • Successful track record in large (Medtronic, Baxter) and start-up (AVE, AngioScore, NanoVasc) corporations.
  • Research, product development and manufacturing experience with Class III and Class IIb devices (coronary and peripheral bare metal nitinol, SS, cobalt chromium and drug eluting stents and balloons, scoring balloon catheters, vascular grafts, hemodialyzers).
  • Program management: Endeavor Resolute DES system, Endeavor DES system, S7 Bare Metal Coronary Stent system; NanoVasc Vascular Graft.
  • Business Development and Upstream marketing.
  • Intellectual property management.
  • Knowledge and experience with clinical studies and regulatory filings (PMA, 510k, CE, Shonin).
  • FDA, MDD and PMDA regulations, ISO 13485 and cGMP standards.
  • Strategic and critical thinker with exceptional technical, analytical and problem solving skills.
  • Hiring, retaining (zero attrition rate for the past 14 years) and developing teams.

Experience

Medical Device Experience

Undisclosed Company, Senior VP of Research and Development - Operations, 2010 - Present

  • Early stage medical device start-up developing a disruptive technology for renal and vascular diseases.
  • Responsible for building and managing research and development and manufacturing operations (production, supply chain, engineering, facilities) as well as intellectual property.
  • Participated in all Board of Director's meetings.
  • Created and presented the new product development strategy and commercialization plans for Series B VC financing ($14 million) and NIH SBIR Continuation Grant ($3 million) proposal.
  • Executed business development strategies, generating key corporate interest.
  • Successfully completed GLP design verification and validation testing, GLP animal studies, and First-In-Human (FIH) clinical study with 6-month follow-up in Germany and Paraguay for vascular arterio-venous dialysis access graft.
  • Prepared pre-IDE submission package and attended pre-IDE meetings with FDA; received verbal approval for the US IDE study protocol.

Angioscore, Inc. Fremont, CA, 2006 -2010

  • Filling the positions: Senior Vice President of Research and Development and Manufacturing, Chief Scientific Officer for a $40 million private medical device company.
  • Developing in globally markets scoring balloon angioplasty catheters for use in the treatment of coronary and peripheral arterial diseases.

Vice President (Research and Development) and Chief Scientific Officer, 2006 - 2009

  • Built a world class, high-performance research and development organization (12 FTE's) and a state-of-the-art research and development lab.
  • Built and sponsored a high performance cross-functional new product development team.
  • Accountable for the budget and execution of all new product development projects.
  • Developed the overall product development strategy and brought to market 7 new coronary and peripheral products in 3 years, all of which were introduced ahead of schedule and under budget and have become multi-million dollar annual revenue contributors (annual revenues increased from $300 thousand in 2006 to $30 million.
  • Instrumental in raising two rounds of funding ($60 million), meetings with "strategics" for potential merger and acquisition deals, joint ventures for co-marketing of products or developing novel synergistic products.
  • Developed and demonstrated proof-of concept of a drug coated scoring balloon and an aortic valvuloplasty scoring balloon for TAVI procedure.
  • Managed and strengthened AngioScore IP by receiving global (US, Japan, Europe) approvals for all major patent applications as well as filing new applications.
  • Promoted to Senior Vice President of Research and Development and Manufacturing Operations and CSO, quickly turned around a challenging manufacturing organization including global supply chain management, production, manufacturing engineering, and facilities (55 FTE's).
  • Established strong relationships and collaborated with KOLs in Interventional Cardiology and Vascular Surgery worldwide.

Medtronic Cardiovascular, Santa Rosa, CA, 1998 - 2006

  • Global leader in medical technology and the largest medical device manufacturer in the world.

Senior Director of Research and Development, Science and Technology, 2003 - 2006

  • Responsible for the business development and/or invention and proof-of-concept of new advanced products integrating biotechnology onto device platforms including drug-eluting metallic and biodegradable stents for coronary and peripheral (renal, SFA) applications.
  • Program Manager: Built and led the research and development cross-functional core team through the discovery and design development phases up to first-in-human of the 2nd generation coronary DES system, Endeavor Resolute. Accountable for $20 million annual budget.
  • Business development: Collaborated closely with corporate BD teams performing due diligence on several emerging technology companies. Joint research with PolyNovo, Australia developing a bioresorbable coronary stent. Joint research with Setagon (now subsidiary of Medtronic) developing a drug eluting porous metallic stent as a 3rd gen DES option.

Director of Research and Development, Endeavor Drug Eluting Stent, 2001 - 2003

  • Built and led the research and development pilot operations teams (35FTE's) that developed Endeavor drug eluting stent and processes. Served as research and development Core Team member.
  • Achieved safety and efficacy in GLP animal study and first in human clinical milestone (1/03) within seven (7) months after licensing the drug and polymer from Abbott.
  • Developed and optimized Medtronic's proprietary drug eluting stent technologies including coating, loading, sterilization, and packaging equipment and processes.

Director of Coronary Research and Development, Advanced Development Team, 2000 - 2001

  • Built and led the Advanced Development Team (38 FTE's) responsible for the development, design and process validation, pilot manufacturing and transfer to operations (U.S.A. and Ireland) of coronary stent systems (GFX2, GFS, S540, S660, S670, S7, Driver).
  • Program Manager: Led the cross-functional team that developed, validated, and launched the 7th generation S7 coronary stent and novel delivery system ahead of schedule and within budget in both OUS and U.S. markets.
  • Implemented several process improvements for balloon, catheter, and stent manufacturing through 30-day PMAS filings.

Director of Manufacturing Engineering, 1999 - 2000

  • Directed the U.S. ring, stent, catheter, and balloon manufacturing engineering departments (47 FTE's) responsible for process development/optimization and validation, operations ramp-up and maintaining product lines during commercialization.
  • Managed the process development, validation, ramp-up for launch and continuous improvement of GFX2, S540, S670, and S660 stent systems for both OUS and U.S. markets.

Engineering Manager, Arterial Vascular Engineering, Canada, 1998 - 1999

  • Managed research and development, manufacturing engineering, facilities, and document control groups (26 FTE's) and supported operations to manufacture GFX and GFX2 stent products.
  • Served as the principal contact with the headquarters in Santa Rosa.
  • Successfully transferred GFX2 catheter manufacturing technology to AVE, Ireland facility and started up for production.

Baxter Althin Medical, Inc., Miami, FL, 1993 - 1998

  • $150 million manufacturer of hollow fiber dialysis membranes and hemodialyzer.

Principal Project Engineer

  • Transferred 2 new hollow fiber membrane products from research and development to manufacturing including process development and validation, and scale-up for production.
  • Managed 3 capacity increase projects on time and within budget that increased membrane production by 33% and dialyzer production by 25%.

Honors & Publications

Languages

  • English, French, Spanish, Turkish

Academic and Professional Affiliations

  • Member of The Honor Society of Phi Kappa Phi
  • Member of Medical Device Manufacturers Association - MDMA
  • American Society of Mechanical Engineers - ASME
  • Society of Manufacturing Engineers - SME
  • New York Academy of Sciences
  • American Heart Association, ASME

Awards

  • Outstanding Achievement Award for New Product Development, AngioScore
  • Nominated as Technical Fellow for Medtronic's Bakken Honor Society
  • Star of Excellence Award for S7 stent with OD only weld development, Medtronic
  • Marketing Team Player Awards, Medtronic Vascular
  • Outstanding Achievement Awards, Baxter Althin Medical
  • Summa cum laude, Florida Atlantic University
  • Cum laude, Bogazici University, Istanbul, Turkey

Publications and Patents

  • Author and Co-Author of 11 publications and presentations for: The American Heart Association, Engineering Fracture Mechanics, Composites Science & Technology, and Composite Materials Journals.
  • 8 U.S. patents.

Education

  • Ph.D (Summa Cum Laude), Florida Atlantic University, Boca Raton, FL
  • M.S. Mechanical Engineering, Florida Atlantic University, Boca Raton, FL
  • B.S. Mechanical Engineering, (Cum Laude), Bogazici University, Istanbul, Turkey
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