Stacie Depner
Director of R&D, Hydrafacial

Stacie Depner is known for her high impact approach to achieving breakthrough business results. After earning a BS in Mechanical Engineering, she began her career as a medical device engineer and quickly transitioned into management. She has more than 20 years of experience in cross-functional team leadership, Lean/Six Sigma in manufacturing, and product development.

Her work has created innovative solutions and turnaround of several companies. Her result-driven approach with executive teams to set their strategy, align their organization to the strategy, and coach cross-functional teams to identify dramatic changes in most vital areas of business has given her insight on best practices within medical industry management.

In her previous role as engineering program director at Symbient Product Development, Stacie led multi-disciplinary design and engineering teams, holding them to high standards of excellent user experience, integrated design and engineering, and focused design for manufacturing. Across the business, she was responsible for delighting clients, motivating employees, and assuring profitable business success. Depner joined Hydrafacial, an FDA registered manufacturer of advanced aesthetic technologies and products, as director of engineering in 2020.

Depner is into traditional hot rods and customs. As a matter of fact, she built a ’30 Model A Roadster from the ground up and has a ’60 Buick Invicta as well. In her spare time, she likes to take on custom paint and pinstriping projects.

Jennifer Joe, MD
Principal, Vanguard.Health

Jennifer Joe, MD, is a Harvard-affiliated Massachusetts General Hospital and Brigham and Women’s Hospital nephrology graduate turned physician entrepreneur CEO and Co-Founder of Medstro & MedTech Boston. Under her leadership, Medstro, which was founded in 2013, was cash-flow positive in only 14 months, profitable in only the second year of operations, and had revenue grow at a CAGR of 267% since 2014. Medstro & MedTech Boston were acquired in 2018, at which time it had seven full-time and five part-time employees and had large contracts with companies like the New England Journal of Medicine, American Medical Association, Boston Scientific, and Google.

Joe has been a leader in catalyzing the Boston and nationwide healthcare innovation ecosystem. She has led over 50 healthcare open innovation events with both the public and the private sector, including Google, Boston Scientific, Philips, the Brigham and Women’s Innovation Hub, the Massachusetts accelerator PULSE@MassChallenge, Healthbox, and Harvard Medical School’s Spaulding Rehabilitation Hospital, just to name a few.

Joe has been invited to speak, mentor, or judge at hundreds of local, national, and international events, including South by Southwest, Google, HIMSS, Partners HealthCare Innovation, the Massachusetts Medical Society, IN3 Medical Device 360, the International Society of Wearable Technology in Healthcare, MassTLC, the Office of the National Coordinator for Health Information Technology (ONC) Market R&D Challenge, the Federation of State Medical Boards, Partners World Medical Innovation Forum, MATTER Chicago, and Health 2.0.

Joe currently teaches two regular Harvard Medical School classes, one on social media and on women in leadership, and is a practicing emergency room, urgent care, and hospitalist physician at three Boston hospitals, where she also oversees students, residents, and fellows training.

Valmeek Kudesia, MD
Owner/Consultant, Kindura

Valmeek “Vick” Kudesia is a Forbes-published physician-leader, engineer, informatician, and systems consultant with extensive experience across research, provider, payer, and care management settings. He comfortably leads interdisciplinary teams of engineers and clinicians to integrate and make the best use of data across multiple domains e.g. EHR, provider, member, claims, payor, genomic (germline and somatic). This combination equips healthcare organizations with informatics and advanced analytics platforms for patient and organization success in cutting-edge biomedical/life sciences research and high-complexity value-based care settings. 

Kudesia has implemented, with noted distinction, an advanced data platform, interdisciplinary team, and major clinical system to bring the benefits of advanced analytics, dataOps/MLOps, and a data-informed culture to the care of high-risk, high complexity individuals. He has also designed and led a national-scale cancer genomic research, the Precision Oncology Program (POP), in the Veterans Affairs (VA) Healthcare System that combined national-scale clinical data, cancer genome data, and linkage to bucket/basket clinical trials in partnership with major research centers. The POP required extensive partnership across governmental agencies (e.g., VA, DOD, and NIH), academic communities (e.g. ASCO, SWOG), and pharma R&D; this work is the basis of the VA interagency response to the White House cancer moonshot program. 

Kudesia is a servant-leader who transforms healthcare organizations into learning organizations via the use of “data products” and “data as a therapeutic tool.” He describes himself: “I’m a doctor who talks tech, does data, and does systems. I take care of people and build things that take care of people.”

Nadia Routhier
Human Factors Engineer, Product Development, StarFish Medical

Nadia Routhier is a human factors engineer working for StarFish Medical in Victoria, BC.She is originally from Montreal, QC, where she completed an undergrad in industrial design and a master’s in ergonomics. She began her career in the aerospace industry working on the design of cockpits and flight simulators.

Since joining the product development team at StarFish Medical, Routhier has contributed to the design of a wide range of products, including diagnostic tools, monitoring devices, and neurosurgical instruments. 

Her hands-on approach to product design focuses on rapid and frequent prototype evaluations together with user-centered activities. As a human factors engineer, her role also requires developing test plans and protocols throughout the product development lifecycle for uncovering usability issues and ensuring new medical products support user needs for efficiency and efficacy without introducing risks of harm.

Mary Kay Smith
Director, Michigan State University Learning and Assessment Center

Mary Kay Smith serves as the director of the Michigan State University Learning and Assessment Center, where she is also an assistant professor. She holds a doctorate in higher, adult and lifelong education administration. Smith is the current chair of accreditation for the International Society for Simulation in Healthcare (ISSH), and accreditation reviewer, team leader, and member of the SSH Directors’ Committee and IPE Committee. She is also the quality assurance chair for the American Heart Association Great Lakes Emergency Cardiovascular Care Committee and member of the Association for Standardized Patient Educators, SimGhost, and Sigma Theta Tau International.  

Smith has been a leader with regard to simulation, medical device, and packaging interface, presenting internationally and multiple collaborative research initiatives. Her clinical expertise as a nurse includes 19 years in emergency department and three years in ICU/CCU and clinical education.

Kelly Umstead
Assistant Professor of Industrial Design and Director of Graduate Programs in Industrial Design, NC State University

Kelly Umstead is an assistant professor of industrial design and the director of graduate programs in industrial design at NC State University. She has product development and management experience in the medical device industry. With graduate degrees in biomedical engineering and industrial design, Umstead’s design process is human-centric, from the identification of user needs to the translation of those needs into viable products. In academia, her research focuses on design in healthcare, human-centered design, and research methodologies. 

Mark Wehde
Chair, Mayo Clinic
Division of Engineering

Mark Wehde is chair of the Mayo Clinic Division of Engineering, assistant professor of Biomedical Engineering in the Mayo Clinic College of Medicine and Science, fellow in the Mayo Clinic Academy of Educational Excellence, and associate lecturer for the University of Wisconsin MBA Consortium program. 

He is on the board of governors for the IEEE Technology and Engineering Management Society and the IEEE Systems Council. He is a technical committee member for the IEEE International Symposium on Medical Measurements and Applications and an affiliate for the University of Minnesota Medical Industry Leadership Institute. 

Wehde has been a past juror for the Medical Design Excellence Awards, the R&D 100 Awards, and the Edison Awards. He is also a member of the South Dakota State University Electrical Engineering Industry Advisory Board. He is also a member of the FDA Center for Devices and Radiological Health Network of Digital Health Experts.

Wehde received a MS in Biomedical Engineering from Iowa State University, a BS degree in Electrical Engineering from South Dakota State University, and a MBA through the University of Wisconsin.  

Stephanie Whalen
Product Design Manager

Stephanie Whalen is an accomplished mechanical engineer with extensive product development experience in medical device and consumer electronics. She has guided companies, from startups to multinational corporations, in every stage of the product development and production cycle. Specializing in R&D, Whalen has developed home health systems, wearable patient and practitioner measurement devices, therapeutic (ablation) and diagnostic electrophysiology catheters for AF and VT, inpatient and outpatient surgical aids for many types of treatment, and surgical trainers. She holds a Bachelor of Science in Mechanical Engineering from the Massachusetts Institute of Technology, as well as a Master of Business Administration certification.

Michael E. Wiklund
General Manager of Human Factors Engineering, UL

Michael Wiklund serves as General Manager of the human factors engineering (HFE) practice at UL (Underwriters Laboratories). Previously, he founded Wiklund Research & Design, a human factors consulting firm that UL acquired in 2012. 

Wiklund has more than 30 years of experience in human factors engineering, much of which has focused on medical technology development—optimizing hardware and software user interfaces as well as user documentation. He is a Certified Human Factors Specialist and Licensed Professional Engineer. He is author, co-author, or editor of several books on human factors, including Writing Human Factors Test Plans and Reports for Medical Technology Development, Usability Testing of Medical Devices, Handbook of Human Factors in Medical Device Design, and Medical Device Use Error – Root Cause Analysis. He is one of the primary authors of today's most pertinent standards and guidelines on human factors engineering of medical devices: AAMI HE75, IEC 62366-1, and IEC 62366-2. 

In addition to leading UL's human factors engineering practice that now includes over 60 human factors engineering and user interface design specialists, Wiklund is a professor of the practice at Tufts University, where he teaches graduate courses on human factors engineering, including applying human factors engineering in medical technology development.

Stephen Wilcox, PhD, FIDSA
Chairman of the Board and Founder, Design Science

Stephen Wilcox, PhD, FIDSA, is the Chairman of the Board and the founder of Design Science (Philadelphia), a 40-person consultancy that specializes in optimizing the usability and safety of healthcare-related products for clients that include many of the largest manufacturers worldwide (e.g., J&J, Baxter, Medtronic, Fresenius, AstraZeneca, Sanofi, BD, Otsuka, Merck, and Novartis). 

Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He served for several years as chair of the IDSA Human Factors Professional Interest Section. Wilcox has served on the advisory boards of the Industrial Design Department of Philadelphia University and the School of Design of Carnegie Mellon University, the Human Factors Engineering and Home Use Environment committees of AAMI, on the ISO/IEC committee (“Working Group 4”) that wrote the medical device human factors standard IEC/ISO 62366, and on the editorial board of Medical Device and Diagnostic Industry. 

He holds a BS in psychology and anthropology from Tulane University, a PhD in experimental psychology from Penn State, and a Certificate in Business Administration from the Wharton School of the University of Pennsylvania. He has won a number of design awards, has guest-edited the journal, Innovation, several times, has served as a judge for a number of product design award competitions, and has chaired the national IDSA Design Conference and the London-based Include Conference on inclusive design. 

Wilcox has given hundreds of invited addresses to various organizations, has published more than 70 articles in professional journals, was a recent Editor-in-Chief of the Human Factors and Ergonomics Society journal, Ergonomics in Design. He is currently teaching Human Factors in the Integrated Product Development Program at the University of Pennsylvania. His book, Designing Usability into Medical Products, co-authored with Michael Wiklund, was published in 2005.