DAY 1 - NAVIGATE2020 Speakers 

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David Cronin, Founder and CRO, Cognition Corporation
David Cronin is Founder and CRO, Cognition Corporation. He assists life science companies in creating early reimbursement strategies and successfully completing both PMA and 510(k) submissions. David serves as the Chairman of the Board for two companies: Cognition Corporation in the United States and Cognition Europe in the Netherlands.

Before joining Cognition Corporation, David worked in the fields of biotechnology, medical imaging systems, lasers, and medical devices. In the summer, he enjoys saltwater fly fishing on Cape Cod.

David has undergone formal training in corporate board governance, systems engineering, new product development, Design for Six Sigma, and FDA regulatory compliance. He is a member of Vistage International, the CEO organization. He has a bachelor of science in electrical engineering and a High-Tech MBA, both from Northeastern University in Boston, MA.

Sandy Weininger, Senior Electrical/Biomedical Engineer, US FDA
Sandy is a Senior Electrical/Biomedical Engineer at US FDA. He operates at the intersection of electronic system design, systems engineering, and physiologic signal properties to achieve patient safety and promote innovation.

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Anita Finnegan, CEO, Nova Leah
Dr Anita Finnegan is the CEO of Nova Leah, the first provider of intelligent software solutions for addressing cybersecurity risk management compliance requirements for connected medical devices. She is an internationally recognized expert in the field of medical device cybersecurity risk management and is an active member of a number of International Standards Communities. Her PhD research focused medical device cybersecurity through the use of security assurance cases. In additional to many peered reviewed journals and a number of book chapters, Anita authored and was the international project leader for two technical reports (IEC/TR 80001-2-8 and IEC/TR 80001-2-9). She represents NSAI as Ireland’s medical device security expert at International Standards meetings and is a member of the following working groups: MITA's MDS2 Canvass Group, NTIA Software Transparency Group, UL 2900 Steering Group and a Project Lead for the development of a new cybersecurity assurance standard for ISO/IEC 81001.

Ben Higgitt, Regulatory Engineering Specialist, Cognition Corporation
Ben studied Physics at the University of Birmingham, UK and graduated with a Master of Science (MSci) in 2005. Immediately after graduating, Ben was employed by a large British engineering firm (IMI Plc.) before becoming a founder member of a new medical device start-up in 2008 where Ben worked as an engineer on device design and is a named inventor on a number of patents. Ben joined Cognition in 2013 as an Application Engineer and is now the Engineering Technical Lead involved with the development strategy and design of Cockpit and future medical focused products.

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Ryan Ward, Director of Engineering, Zimmer Biomet
Ryan Ward is a Senior Director of Engineering Services at Zimmer Biomet, with a focus on new product development processes.  He has extensive experience in the design of new hip replacement products, especially those designed for revision surgery.  Prior to Zimmer Biomet, Ryan designed inkjet printers, traveling extensively in Asia for their development.  Ryan is married with four kids, and when he’s not hanging out with family or serving at church, he can be found rooting for Chicago Bears football or playing Ultimate Frisbee.

Nancy Singer, President, Compliance-Alliance
My career began as an attorney with the United States Department of Justice where, during a three year period, I successfully prosecuted seven firms for violations of various criminal statutes. Subsequently I was a partner at the law firm of Kleinfeld Kaplan and Becker.

I received my B.S. from Cornell University, and J.D. and LL.M. degrees from New York University Law School. During my career I was an instructor at Catholic University Law School, George Washington University Law School, University of Southern California, and at compliance symposia at Harvard University.

I created Compliance-Alliance LLC to specialize in professional development for those employed in drug, device and other manufacturing industries. In addition to other successful courses, I developed the course, “Dangerous Documents” when I was employed as General Counsel for a drug and device firm and have been presenting it to both individuals and groups with resounding success for more than eight years.

I received Vice President Gore’s Reinventing Government Hammer Award, the FDA Commissioner’s Special Citation, and the Food and Drug Law Institute’ s Distinguished Service and Leadership Award. In 2009 I was selected as one of the 100 Most Notable People in the Medical Device Industry. I am a retired Commander in the United States Naval Reserve.

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Edwin Schumacher, Managing Partner, Synergio
Edwin is a managing partner at Synergio with almost 33 years of experience in product development, both hard- en software. As a management consultant he is an expert on Lean-Agile transformations of product development organizations and improving innovation. A Lean-Agile transformation is not only a change in processes and organization, it is a mindset shift from top to bottom throughout the organization. You can read some of his article about Lean-Agile here.

Before Synergio Edwin was a Product Management Director for almost 10 years, leading a global product management team for 2 product lines.

Synergio (www.synergio.eu) improves product development processes in IT, Civil Engineering, Manufacturing and Life Sciences, using Lean-Agile software and systems engineering methods and practices. Synergio provides training, coaching & consultancy and software tools.

Arno van Herk, Managing Partner, Synergio
Arno is a managing partner at Synergio with almost 39 years of product development experience, specializing in supporting and implementing productivity tools for product development teams. As a management consultant applies his expertise on Lean-Agile transformations of product development organizations and improving innovation. As such he is a certified SAFe 5 Program Consultant and a Rapid Learning Cycles (RLC) Certified Advisor.

Before Synergio, Arno was an independent consultant focusing on software process improvement and Director Delivery Methods & Practices for a large US based software vendor, leading a 60-member team focusing on developing and sharing best practices related to product development.

Synergio (www.synergio.eu) improves product development processes in IT, Civil Engineering, Manufacturing and Life Sciences, using Lean-Agile software and systems engineering methods and practices. Synergio provides training, coaching & consultancy and software tools.

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David Taylor, Chief Technology Officer, Cognition Corporation
David Taylor is Chief Technology Officer at Cognition Corporation. David drives the Agile software development process to stimulate and push innovation across all Cognition product lines. He is also the product owner for the Cognition Cockpit compliance system where he ensures Cockpit keeps up with the rapidly changing regulatory environment. Outside of Cognition he studies Uechi Ryu karate.

Prior to joining Cognition, David served as a Mechanical Servo Engineer at Iomega Corporation and as a Mechanical Engineer at IBM Semiconductor and Bell Communications Research.

David holds certifications in Design For Six Sigma (DFSS), Geometric Dimensioning and Tolerancing, Agile Software Development, Test Driven Development, Regulatory Compliance, and Systems Engineering. David has a BS in Mechanical Engineering and an MS in Math from RPI. He also holds an MS in Engineering from Princeton University.

Dale Gallaher, President, Cognition Corporation
Dale Gallaher is President of Cognition Corporation. Cognition Corporation has been offering solutions for product and process development for more than twenty years. During his time at Cognition, Dale has consulted with many product development companies to provide assistance in implementing specific parts of the product development process.  Dale has also been the technical lead in the design and development for several of Cognition’s software tools.

Prior to Cognition, Dale was product development engineer at General Electric. He has over 25 years of product development experience, most of which was focused on implementing leading edge product development tools. Dale holds a B.S.M.E from Bucknell University and M.S.M.E from MIT.
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DAY 2 - SYSTEMS ENGINEERING IN HEALTHCARE SPEAKERS

Tracy Rausch, CCE, Founder and Chief Innovation Officer, DocBox
Tracy Rausch, CCE is the founder and Chief Innovation Officer of DocBox. Tracy has a 20-year career of the research, design, and integration of technologies into healthcare systems from the manufacturer, delivery and research roles in both the private and public sector. DocBox, a medical device company developing and open platform which enables the ability for health care providers to deploy innovative technology in order to improve efficiency, reduce cost and improve patient safety. She is a technical advisor to the Medical Device Plug and Play program at Massachusetts General Hospital. She serves on and is an active member of various standards related to the integrated clinical environment, and medical device communications. For the past decade she has been the PI in excess of $14M dollars in federal funded Research, Development, Test and Evaluation Funding from the USARDC (formerly USAMRMC), NIST, and NIH related to medical device interoperability, safety critical medical systems platform design, regulatory science of medical devices systems of systems, and autonomous medical systems.

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Kelly Weyrauch, Principal Consultant, Agile Quality Systems
Kelly Weyrauch is the owner of Agile Quality Systems LLC, a consultancy working with software and systems creators to apply Agile Product Development concepts and Quality Management System principles to the unique context of their development environment. He has more than 30 years of software and systems development experience. As a leader of the Agile movement at Medtronic and now as a consultant working with many organizations, he has worked with project teams to evolve Agile Principles and Practices in the context of a robust Quality System. As one of the principal authors of AAMI TIR45 “Guidance on the use of AGILE practices in the development of medical device software”, Kelly has worked with the FDA and industry leaders on the application of Agile practices to the medical device world. Kelly has a BS degree in Mechanical Engineering from the University of Minnesota, and a MS degree in Software Design and Development from the University of St. Thomas (Minnesota).

Alex Baker, Senior Systems Engineer, Eli Lilly
Alex Baker is a Senior Systems Engineer at Eli Lilly and Company’s Delivery Device and Connected Solutions Innovation Center in Cambridge, MA. Since joining Lilly in 2014, Alex has held positions of increasing technical responsibility in the development of Class II and III medical devices as well as combination products. He is currently providing Systems Engineering support to the development of Lilly’s Automated Insulin Delivery (AID) System, part of the Connected Diabetes Ecosystem, which is being designed to make diabetes management easier by enabling people to use insulin more effectively. Alex has strong interests in user-centered design principles, human factors engineering, and agile development, particularly when applied to Lilly’s systems and solutions across multiple therapeutic areas. He earned his BS in Biomedical Engineering with a Minor in Mechanical Engineering from Purdue University.

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Rebecca Berg, Simulation Learning Consultant, Yale New Haven Health System
Rebecca Berg is a simulation learning consultant for Yale New Haven Health System. She holds a MS in Industrial Engineering with a focus in Human Factors and a BS in Biomedical Engineering from the University at Buffalo. Her background in human factors supports a range of projects including workflow analysis, facility design, work process development, as well as usability and device testing.

Matt Shedlov, CPPA, PMP®, Senior Manager (R&D) and Technologist - Boston Scientific
Matt is a Senior Manager (R&D) and technologist at Boston Scientific and is a certified PMP®. Matt heads up BSC’s Global Design Systems Council and is chartered with implementing the best enterprise-wide technical (engineering) tools and systems for product/systems development. He currently heads up BSC’s ERM (Electronic Requirements Management) platform, along with driving culture change in the area of Systems Engineering in Medical Device. Matt and his team at BSC also focus on creating high efficiency processes using software automation to accelerate BSC’s product development lifecycle.

Matt has six issued U.S. patents, is on Cognition Corporation’s Advisory Board and is a product development influencer at Dassault Systems SolidWorks via Enterprise Services. He is a judge for First Robotics competitions and enjoys time volunteering for STEM programs.

 

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David Nino, Ph.D., Senior Lecturer in the Bernard M. Gordon - MIT Engineering Leadership Program
David Niño, Ph.D., is a Senior Lecturer in the Bernard M. Gordon- MIT Engineering Leadership Program, where he heads leadership education for MIT’s graduate engineering students. A highly rated teacher, his work explores how leadership is developed and practiced in high technology organizations. David teaches graduate engineering classes at MIT that bridge the topics of leadership and creative teamwork, artificial intelligence, and negotiations. He also leads professional programs in engineering leadership and technical leadership for practitioner audiences at MIT and in Europe, China, the Middle East, and Latin America.

In 2018, David co-founded a digital learning program called the MIT Leadership Academy for Scientists, Engineers, and Researchers (see https://learn-xpro.mit.edu/leadership). The program launched with 1,100 professionals in 2019 and aims to become the largest leadership development initiative of its kind. He is currently the Program Chair of the Engineering Leadership Development Division of the American Society of Engineering Education. In this role, he oversees the organization and execution of the division’s annual conference, which includes over 1,200 members. He was also one of the founding officers of this division, which has emerged into the largest group of engineering leadership educators in the United States.

Prior to MIT, David was a faculty member in the schools of engineering and business at Rice University. He led Rice’s university-wide program in leadership development and later played a leading role in designing and establishing the university’s first four-year academic certificate in engineering leadership. He also organized a premier international conference on engineering leadership, which garnered participation from the President of the National Academy of Engineering, 28 universities, and leading companies such as Boeing, NASA, and Shell.

David has served as an advisor and board member to startups and has consulted with leading engineers and senior executives in organizations such as The Boeing Company, Lockheed Martin, Bechtel Corporation, and The Proctor and Gamble Company. He has published on the topics of organizational culture, courage, ethics, and the development of management and leadership skills. He holds a Ph.D. in Management from the University of Texas at Austin, where he also earned his B.A., B.B.A., and M.A. degrees. David lives in Weston, Massachusetts with this wife and three children.

Chris Unger, Chief Systems Engineer, GE Healthcare
Chris Unger is Chief Systems Engineer for GE Healthcare, responsible for the definition and improvement of systems engineering process globally. He is the co-leader of the INCOSE Healthcare WG. Chris has worked as a systems engineer in the defense and medical fields for 30 years.  Chris is a certified Master Black Belt with fifteen issued patents and two patents applied for.  He is an INCOSE certified Experienced Systems Engineering Professional. He graduated with a B.S. in Mathematics and B.S. in Philosophy from M.I.T. and a Ph.D. in Physics from Boston University.

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Ed Medri, Senior Manager, Systems Engineering, Canon USA
Dr. Medri joined INCOSE in 2006 and was awarded the CSEP certification in 2013. Over the past 20 yrs, he has applied systems thinking principles to engineer patient monitors, glucose monitors, medical robots, non-invasive and in-vitro diagnostics equipment.

Dr. Medri is passionate about designing safe, reliable and effective medical systems by applying medical industry best practices, guided by a holistic, interdisciplinary view. He has held various product development positions with start-ups to billion dollar companies, that managed multi-million dollar annual budgets. Currently, he is the Senior Manager for Systems Engineering for Imaging and Robotic Systems at the Healthcare Optics Research Laboratory for Canon, USA, Inc. He received a B.S. in Biomedical Engineering from Boston University and a Master’s and Ph.D. in Biomedical Engineering from the University of Miami.

Randy Roberts, Senior Fellow, Otis Elevator Company
Randy Roberts, Sr. Fellow, Otis Elevator Company. Roberts began his UTC career at UTRC in 1984 working in the areas of jet engine and robotic controls with a focus on multi-variable and robust control design techniques. He later worked on active control projects for elevator systems and moved to Otis in 1996 where he formed and led the Modeling, Analysis, Simulation and Computing (MASC) group. He has contributed in applying computer models to optimize the design of the Coated Steel Belt (CSB)-equipped Gen2 line of elevators, developed and leads the certification process for MASC tools, developed and deployed robust design training and Discipline Health management processes, developed passive and active systems to minimize elevator sag and bounce issues, and is currently focused on applying Model-Based System Engineering methods in product development. Randy holds a doctorate and master degrees in mechanical engineering from Purdue University and a Bachelor of Science degree from The Ohio State University.

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Beth Wilson, Certified Architect and a Raytheon Certified Six Sigma Expert, Raytheon (Ret.)
Beth Wilson earned her PhD in Electrical Engineering from the University of Rhode Island. She is retired from Raytheon where she worked for 33 years as a design engineer, program manager, research scientist, functional manager, and test director on sonar, satellite, and radar programs. She was a Raytheon Certified Architect and a Raytheon Certified Six Sigma Expert.

Dr. Wilson is currently an Adjunct Professor at Worcester Polytechnic Institute in their Masters of Systems Engineering program. She is an INCOSE Expert Systems Engineering Professional (ESEP) and is a co-chair for the INCOSE Systems Security Engineering working group.

Dr. Clas Jacobson, Senior Fellow, Carrier Corporation
Dr. Jacobson is a Senior Fellow for the Carrier Corporation. In this role he works with the Carrier business units to ensure capability in systems engineering and controls is available for product development with specific attention to computational engineering capability and deployment in Model Based Development approaches to product development.

Prior to his role as Senior Fellow for Carrier he worked as the Chief Scientist, Controls for UTC and before that at the United Technologies Research Center (UTRC) in management and technical positions since 1995. He has held positions at UTRC as Director of the Carrier Program Office responsible for creating and managing projects in a stage gate project planning and execution process and also Director of the Systems Department at UTRC responsible for capability in the areas of systems engineering.

Dr. Jacobson received his Ph.D degree in electrical engineering in 1986 from Rensselaer Polytechnic Institute. He was an Associate Professor at Northeastern University in Boston from 1986-1995.

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Victor Rivas, Senior Project Manager, Jacobs
Victor is an experienced program manager and researcher with 18+ years researching transportation-related problems and implementing transportation solutions with emphasis on transportation systems operations and capital programming. His collaborative and multidisciplinary approach to problem solving has been applied to both the private and public sectors.

Prior to joining Jacobs Victor led the team in charge of planning, programming, implementing, and managing the capital investment program for the fifth largest transit agency in the U.S. He has a Master of Science in Urban Studies and Planning Massachusetts Institute of Technology, 2002, Concentration: Airline Industry | Infrastructure Finance, a M.U.P.P., Master in Urban Planning and Policy University of Illinois, 2000. Concentration: Urban Transportation | Spatial Planning, and a B.A., Art, Minor in Physics, Southern College, 1988