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
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.
Extensive experience with cardiology, radiology and vascular surgery disciplines in cath labs throughout North America, Europe, Japan and India.
Exceptional capabilities in building sophisticated analytical models of complex engineering, mechanical and financial systems.
Finite Element Analysis
Accomplished analyst with two decades of practical experience planning, managing, and performing cardiovascular implant simulation 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, R Studio, Python, Jupiter, ImageJ, Weka Segmentation, JMP Statistics, OsiriX, Mathcad, Autocad, OpenSCAD, Noesis Optimus, Hypermesh. Expertise in Python and C programming, GitHub, LaTeX, Eclipse IDE, Atlassian JIRA, Atlassian Confluence, Apache, WordPress, Bootstrap, Discourse, Eclipse Business Intelligence Reporting (BIRT), Pentaho Data Integration, SQL, Workfront (AtTask) Enterprise Work Management, Amazon Web Services, Digital Ocean and Linda VPS, Objective-C and Swift for iOS development, Amazon Alexa development, KiCAD, Arduino IDE, Atmel Studio, Keil uVision, Datafari/Manifold/Solr enterprise search. Systems administration for Google Apps, and native and virtualized Windows, Mac OS and Linux environments.
- 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.
- 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.
- Printed circuit board (PCB) design and development, including schematic capture, board layout, and rapid prototyping, and assembly.
Outstanding written, visual and oral presentation capabilities and experience. Frequently invited speaker at customer functions across the industry and throughout the world.
FIRST ARTICLE SERVICES, Phoenix, AZ. April 2022-present. Principal. Design, prototyping, and strategy for durable medical implants.
CONFLUENT MEDICAL TECHNOLOGIES, Fremont, CA. August 2016-2022. VP Applied Technology.
NITINOL DEVICES & COMPONENTS, Fremont, CA. June 2008-August 2016. VP Technical Services. 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 a rebranding initiative and the Nitinol.com website, 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 from concept to commercialization
- Testified in legal proceedings regarding competitive devices
- Managed fatigue testing hardware
- Operated 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
- 2002 Philip Hoffman Award for Excellence in Research and Development, Johnson & Johnson
- 2007 Standards of Leadership Award, Johnson & Johnson
- 2013 Maker Faire Blue Ribbon for Open Clock Project, invited participant at the Hardware Innovation Workshop and featured in Makezine.com and Tested.com
- 2019 Editor’s Choice Award, Shape Memory and Superelasticity Editor’s Choice Award for The Role of Parent Phase Compliance on the Fatigue Lifetime of Ni–Ti.
PUBLICATIONS and PATENTS
- Structure and mechanical properties of a multilayer biomedical shaft tubing: effect of layer composition. https://doi.org/10.1515/polyeng-2021-0266
- A probabilistic approach with built-in uncertainty quantification for the calibration of a superelastic constitutive model from full-field strain data. https://doi.org/10.1016/j.commatsci.2021.110357
- Venous Biomechanics of Angioplasty and Stent Placement: Implications of the Poisson Effect. https://doi.org/10.1016/j.jvir.2020.02.033
- The Role of Parent Phase Compliance on the Fatigue Lifetime of Ni-Ti. https://doi.org/10.1007/s40830-019-00253-2
- Effect of Prestrain on the Fatigue Life of Superelastic Nitinol. https://doi.org/10.1007/s11665-019-04334-2
- Chapter 14 – Device Design and Computational Simulation. Handbook of Vascular Motion. https://doi.org/10.1016/B978-0-12-815713-8.00014-0
- Innovating across borders: Advice on partnering in the medical device ecosystem. Oxford Medical Device Innovation seminar. April 2018. Slides: https://doi.org/10.6084/m9.figshare.6169271
- Nitinol Design Concepts. 2017. doi.org/10.5281/zenodo.583328 References: github.io
- Volume Weighted Probabilistic Methods for Nitinol Lifetime Prediction. Shape Memory and Superelastic Technologies (SMST) Symposium and Exposition. May 18, 2017. References: ASM, youtube.
- Present and Future Approaches to Lifetime Prediction of Superelastic Nitinol. Theoretical and Applied Fracture Mechanics. doi.org/10.1016/j.tafmec.2017.04.001 [pdf]
- Sensitivity of Nitinol Fatigue Strain to Material Inputs in Finite Element Analysis. Shape Memory and Superelastic Technologies (SMST) Symposium and Exposition. May 21, 2015. References: youtube, github.
- Finding Lorenzo. 2016. Amazon.
- Fatigue and in vivo validation of a peritoneum-lined self-expanding nitinol stent-graft. Journal of Endovascular Therapy. 2014;21:735–746. PMID: 25290804
- Strain Amplitude Volume Fraction Method for Evaluation of Nitinol Fatigue Durability. Shape Memory and Superelastic Technologies (SMST) Symposium and Exposition. May 15, 2014. References: ASM, github.
- Rotary-bending fatigue characteristics of medical-grade Nitinol wire. Journal of the Mechanical Behavior of Biomedical Materials 2013. PMID: 23838356
- Open Stent Design. Amazon.
- Histopathologic evaluation of nitinol self-expanding stents in an animal model of advanced atherosclerotic lesions. EuroIntervention. 2010:5(6) 737-744. PMID:20142227
- A “Point Cloud” Approach in Superelastic Stent Design. ASME International mechanical engineering congress and exposition; 2001 Advances in bioengineering.
- A Decade of Evolution in Stent Design. Proceedings of the 2003 International Conference on Shape Memory and Superelastic Technologies (SMST).
- 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
- US9,649,211 Alternating Circumferential bridge stent design and methods for use thereof
- US9,452,068 Expandable slide and lock stent
- US9,101,503 Apparatus having variable strut length and methods of use
- US9,066,827 Expandable slide and lock stent
- US8,906,085 Stent segments axially connected by thin film
- US8,795,345 Vascular and bodily duct treatment devices and methods
- US8,795,317 Embolic obstruction retrieval devices and methods
- US8,562,666 Intraluminal medical device with nested interlocking segments
- US8,545,547 Expandable slide and lock stent
- US8,523,936 Expandable slide and lock stent
- US8,439,967 Stent/fiber structural combinations
- US8,357,178 Vascular and bodily duct treatment devices and methods
- US8,262,720 Prosthesis comprising dual tapered stent
- US8,142,491 Stent Segments Axially Connected by Thin Film
- US8,142,490 Stent Segments Axially Connected by Thin Film
- US8,133,268 Stent/Fiber Structural Combinations
- 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 Bodily Duct Treatment Devices and Methods
- US2011/0009941 Vascular and Bodily Duct Treatment Devices and Methods
- US2011/0009950 Vascular and Bodily 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
- US2011/0245909 Expandable Slide and Lock Stent
- US2011/0251674 Expandable Slide and Lock Stent
- US2012/0179238 Stent Having Variable Stiffness
- US2012/0179240 Stent/Fiber Structural Combinations
- US2012/0179241 Stent Segments Axially Connected by Thin Film
- US2013/0211499 Intraluminal Medical Device with Strain Concentrating Bridge
- US2014/0067042 Expandable Slide and Lock Stent
- US2014/0094897 Expandable Slide and Lock Stent
- US2019/0276921 Materials having superelastic properties including related methods of fabrication and design for medical devices
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
Embedded Systems – Shape the World. UTAustinX – UT.6.02x. May 2015. edX certificate
VEITH Symposium 2016
EUROPEAN CONFERENCE ON FRACTURE (ECF) Invited speaker 2016
TRANSCATHETER CARDIOVASCULAR THERAPEUTICS (TCT) 2013, 2012, 2011, 2010, 2009, 2008, 2006, 2005, 2004, 2002, 1998
CHINA INTERVENTIONAL THERAPEUTICS (CIT) 2014
SHAPE MEMORY AND SUPERELASTIC TECHNOLOGIES (SMST) 2019, 2017, 2015, 2014, 2010, 2006, 2003, 2000
CLEVELAND CLINIC STENT SUMMIT Invited speaker in 2004, 2008
FDA Workshop on Computer Methods for Medical Device Design 2013, 2011, 2010, 2009, 2008
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