Curriculum Vitae

CRAIG L. BONSIGNORE

An accomplished medical device designer, project manager and MBA, applying unexpected approaches to design and development.  Recognized in the medical device field for a balanced ability to see market opportunities, clinical needs, technological capabilities and intellectual property considerations in early-stage implantable device design.

TECHNOLOGIES & CLINICAL EXPERTISE

Pre-clinical Experience

More than a decade of hands-on experience employing intravascular techniques to deliver, deploy, test and analyze prototype devices using in-vivo and cadaver models.

Clinical Experience

Extensive experience with cardiology, radiology and vascular surgery disciplines in cath labs throughout North America, Europe, Japan and India.

Analytical Modeling

Exceptional capabilities in building sophisticated analytical models of complex engineering, mechanical and financial systems.

Finite Element Analysis

Accomplished analyst with more than a decade of practical experience modeling cardiovascular implants using ABAQUS nonlinear FEA, and design optimization and robustness simulation.

Software and Systems

Extensive experience with a wide variety of engineering and technical applications, including Abaqus, SolidWorks, Noesis Optimus, Mathcad, Autocad, Hypermesh.  Expertise in Pyhton and C programming, and systems administration in Windows, Mac OS and Linux environments.

MATERIALS

  • Extensive design experience with 316L stainless steel and Nickel Titanium alloys including superelastic and shape memory Nitinol.
  • Hands-on design and processing experience with bioabsorbable polymers including polyglycolic acid (PGA), polydioxanone (PDO) and blends such as PGLA.

PROCESSES

  • Experience with stent fabrication and analysis processes including Nd: YAG laser micromachining, thermal shape setting, transition temperature tuning, electropolishing, corrosion testing and fatigue testing.
  • Familiarity with thin film deposition technology, particularly relating to design considerations for thin film derived structures.
  • Electrostatic spinning of submicron scale polymer fibers, including process and equipment design, as well as hands-on experience creating nonwoven nanofiber polymer mesh.

COMMUNICATION

Outstanding written, visual and oral presentation capabilities and experience.  Frequently invited speaker at customer functions across the company and throughout the world.

PROFESSIONAL HISTORY

NITINOL DEVICES & COMPONENTS, Fremont, CA. June 2008-present. General Manager, NDC Medical Development (NDC.md). Responsible for building a design and analysis services business as part of divested and relaunched NDC. Managing a staff of engineers and technicians, and responsible for technical and business aspects of client relationships. Actively involved in developing and applying advanced design exploration, optimization, and virtual experiment techniques in conjunction with nonlinear finite element analysis to accelerate insightful product design and development for medical device clients. Also responsible for ongoing rebranding initiative, the Nitinol.com website, and NitinolUniversity.com, as NDC relaunched its identity as an independent firm.

PROXIMAL DESIGN, LLC, Pleasanton, CA. September 2007 – June 2008. Principal. Provided design, simulation, and analysis services to a variety of cardiovascular and orthopedic medical device firms.

JOHNSON & JOHNSON / CORDIS, Fremont, CA. May 1999 – September 2007. Held various positions of increasing responsibility with J&J’s design and innovation center for Nitinol implant technology.

2003–2007  Principal Engineer / Program Manager, Cardiovascular Device Design

  • CVD: founded and led group in its mission to design novel cardiovascular implants, applying NDC technologies to unmet clinical needs
  • ‘BLX’: inventor and program manager; developed design and process for a novel hybrid vascular implant; managed team, business plan, intellectual property development, licensing, key vendors and pre-clinical activities
  • COBRA: initiated European clinical study to investigate dynamic biomechanics of the superficial femoral artery in pre- and post-stent implantation
  • ‘ZPL’: concept design and prototyping of an ultra high-pressure noncompliant balloon using a novel metal/polymer composite material
  • Darwin: creator and evangelist for a wiki-based knowledge management system to enable early-stage collaborative design across a multi-site global enterprise

2000–2003  Staff Engineer, Endovascular New Product Development

  • Responsible for design of Sirolimus-eluting Nitinol stent for peripheral vascular indications.  Addressed fatigue durability and dynamic fracture resistance
  • Developed rigorous fatigue and endurance testing methodologies for abdominal aortic aneurysm (AAA) components
  • Responsible for due diligence during acquisition of Teramed, Inc.

1999–2001  Senior Engineer, Cardiology New Product Development

  • Viper: designed and developed NDC’s first coronary Nitinol stent; achieved first-in-human clinical trial, working with a three-site cross-functional team
  • StentBuilder: developed a suite of analytical and computational methods for predicting Nitinol stent performance and exploring design input/output relations

1994–1999 JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS / CORDIS, Warren, NJ. Advanced from entry to senior level at this fast growing division of J&J during the era that included the 1997 merger of JJIS and Cordis.


1997-1999. Senior Engineer, Research & Development

  • MiniCrown: designed and developed the Palmaz-Schatz MiniCrown stent; took concept to commercialization
  • Testified in legal proceedings regarding competitive devices
  • Managed fatigue testing hardware
  • Ran CNC laser micromachining center

1994–1997. Engineer I, Engineer II, Research & Development

  • Identified and implemented J&J’s first finite element analysis (FEA) system, now fundamental to all stent design efforts
  • Tested, evaluated and reported on competitive devices in support of Engineering, Marketing and Legal interests
  • Part of team that developed and launched the Palmaz-Schatz Intracoronary Stent

AWARDS

  • 2002 Philip Hoffman Award for Excellence in Research and Development, Johnson & Johnson
  • 2007 Standards of Leadership Award, Johnson & Johnson

PUBLICATIONS

  • Heating of Cardiovascular Stents in Intense Radiofrequency Magnetic Fields. Biomagnetics 20:112-116 (1999). PubMed Link. PMID:10029137
  • A Survey of Stent Designs. Minimally Invasive and Allied Technologies. 2002:11(4) 137-147. PMID:16754063
  • A Decade of Evolution in Stent Design. Proceedings of the 2003 International Conference on Shape Memory and Superelastic Technologies (SMST).
  • US7,797,071 Expandable Slide and Lock Stent
  • US7,780,714 Implant Delivery Apparatus
  • US7,637,933 Method for Preparing and Employing an Implant Delivery Apparatus
  • US7,264,633 Anvil Bridge Stent Design
  • US7,214,240 Split Bridge Stent Design
  • US7,175,654 Stent Design Having Stent Segments Which Uncouple Upon Deployment
  • US2005/0080482 Graft Coupling Apparatus and Method of Using Same
  • US2005/0085897 Stent Design Having Independent Stent Segments Which Uncouple Upon Deployment
  • US2005/0182479 Connector Members for Stents
  • US2006/0122685 Prosthesis Comprising Dual Tapered Stent
  • US2007/0073373 Intraluminal Medical Device with Nested Interlocking Segments
  • US2007/0100431 Intraluminal Medical Device with Strain Concentrating Bridge
  • US2008/0300668 Stent/Fiber Structural Combinations
  • US2009/0112158 Medical Device / Thin Metallic Film / Polymeric Component / Methods
  • US2009/0112306 Stent Segments Axially Connected by Thin Film
  • US2009/0149835 Medical Device / Metallic Substrate / Polymeric Component / Methods
  • US2009/0228088 Apparatus Having Variable Strut Length and Method of Use
  • US2010/0043199 Stent Segments Axially Connected by Thin Film
  • US2010/0131048 Expandable Slide and Lock Stent
  • US2011/0009940 Vascular and Bolidy Duct Treatment Devices and Methods
  • US2011/0009941 Vascular and Bolidy Duct Treatment Devices and Methods
  • US2011/0009950 Vascular and Bolidy Duct Treatment Devices and Methods
  • US2011/0106237 Alternating Circumferential Bridge Stent Design and Methods for Use Thereof
  • US2011/0230957 Alternating Circumferential Bridge Stent Design and Methods for USe Thereof

EDUCATION

UNIVERSITY OF CALIFORNIA AT BERKELEY, HAAS SCHOOL OF BUSINESS, Berkeley, California
MBA, May 2007

BUCKNELL UNIVERSITY, Lewisburg, Pennsylvania
BS in Mechanical Engineering, May 1995

TRAINING & CONFERENCES

TRANSCATHETER CARDIOVASCULAR THERAPEUTICS (TCT)
2010, 2009, 2008, 2006, 2005, 2004, 2002, 1998

SHAPE MEMORY AND SUPERELASTIC TECHNOLOGIES (SMST)
2010, 2006, 2003, 2000 —invited speaker, 2003

CLEVELAND CLINIC STENT SUMMIT
Invited speaker in 2004, 2008

FDA Workshop on Computer Methods for Medical Device Design
2008, 2009, 2010, 2011

INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS, ISES Visiting Industry Partners Program. Instructed and certified by Dr. Frank Criado, 2000

BUCKNELL UNIVERSITY, Lewisburg, Pennsylvania
Institute for Leadership in Technology & Management, Inaugural Class, 1994–1995