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4th Human Factors Engineering & Usability Studies Summit -

4th Human Factors Engineering & Usability Studies Summit
February 4–5, 2019
San Francisco, CA

Designing Medical Devices, Combination Products, and IFUs that Satisfy Regulators, Eliminate Errors, and Improve the User Experience

Faculty – 4th Human Factors Engineering & Usability Studies Summit

Didier Clerc

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Creative software engineer with a passion for usability who like building things.

I started my career in electronics, designing hardware prototypes and moved to software development. Very quickly, my artistic skills allowed me to focus mainly on UI and UX development, involving programming, graphics design as well as motion design. My goal is to put the user in the center of the experience and build products around the users. I have a passion for mobile application and I believe that success comes from a good user experience.

I am actually working as a Product Manager at Leman Micro Devices, a Switzerland based startup that creates a sensor for measuring the 5 vital signs, embedded in a smartphone.

Serge Dubeau
Vice President, Design and Human Factors, WORRELL

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In his nearly 20 years of experience, Serge has led design and engineering teams in a variety of projects for both Fortune 100 and start-up companies, resulting in various design awards and more than a dozen patents. He currently leads the design and human factors engineering teams at Worrell, focusing on user and patient safety. He holds a degree in Industrial Design from the University of Montreal, and is multi-lingual, having lived and worked in Spain, Canada, and the United States.

Sami Durrani
Senior Manager, Human Factors, FRESENIUS MEDICAL CARE

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Sami Durrani, Senior Manager – Human Factors Engineering at Fresenius Medical Care, leads a team of human factors engineers dedicated to the improving the use-safety and user experience of home-use kidney care systems. Sami received his Ph.D. in Human Factors from the University of Central Florida in 2009. He also holds an M.S. in Industrial Engineering with a focus on systems engineering and a B.S. in Mechanical Engineering. Sami has conducted human factors research in the medical, emergency responder, transportation, and simulation training domains. He has extensive experience conducting user research, usability testing, and ergonomic analysis. Sami is also an active member of the human factors research community and has authored over a dozen publications. Additionally, Sami currently serves as the Chair of the Human Factors and Ergonomics Society’s Product Development Technical Group and teaches graduate and undergraduate classes at Tufts University.

Sathya Elumalai

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Sathya Elumalai is a medical device executive with over 15 years of experience working with the payers, providers, pharmaceuticals, and patients. At Multisensor Diagnostics (MDx), Mr. Elumalai has developed a revolutionary tricorder-style rapid medical assessment device and AI-enabled triaging system for efficient management of chronic disease patients at home. In addition to his efforts at MDx, Mr. Elumalai also serves as an Advisory Board Member at Rutgers University, and an Ambassador & Merit Reviewer at Patient Centered Outcome Research Institute.

Mr. Elumalai holds a dual master’s degree, Masters in Public Health and MBA in Healthcare Management, from the prestigious Johns Hopkins University. He is also a certified professional in healthcare quality and safety with over 10 years of diverse leadership experience at the Johns Hopkins Medical Institute.

Mr. Elumalai is a proven leader recognized for building scalable processes, integrating analytics into decision making, improving customer satisfaction, and driving large-scale digital transformations in healthcare.

Sean Hägen
Principal, Director of Research and Synthesis, BLACKHÄGEN DESIGN

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Sean earned a Bachelor of Science in Product Design from The Ohio State University’s Industrial Design program, minoring in human factors. Sean has over 30 years of R&D experience in a variety of industries ranging from luxury yachts to mission-critical ruggedized electronics and medical devices.

Since founding BlackHägen Design in 1995, Sean has been the principal investigator for design research and usability design, within both institutional and home environments, across eighteen countries. Sean’s current focus is on the design research and insight translation phases of product development. That focus includes usability testing, user-centric innovation and establishing user requirements as they apply to product definition. Sean has published numerous articles on usability research and design as well as contributing to domestic and international standards for usability development processes as a member of the AAMI HE committee. As an AMI HE committee member, Sean was a contributing author for AAMI TIR 50 and 59 as well as ANSI/AAMI HE75. He was the IDSA Medical Section Chair from 2010 to 2017 and sits on the Board of Directors. He implemented, as chair, the first IDSA Medical Design conference (2014).

Ed Israelski
Technical Advisor, Human Factors, ABBVIE

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Ed Israelski, Ph.D., has been Director of Human Factors at AbbVie since 2001. He leads a cross-division team and manages an R&D group to imbed best practice human factors engineering HFE design methods into all of AbbVie’s products to ensure safety and usability. He is responsible for corporate HFE policies and guidances and internal HF education. He is past co-chair of the Human Factors Committee for the AAMI Standards organization and convener of the medical device Usability Engineering groups for the international standards organizations ISO and IEC. He is a board Certified Human Factors Professional and a Fellow of the Human Factors and Ergonomics Society.

James Kleiss
Sensory Quality and Emotional Design Specialist, GE HEALTHCARE

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Dr. Kleiss received his M.A. and Ph.D. degrees in Cognitive Psychology from Rice University. He has held positions researching product usability and product sensory quality in a variety of industries including military aviation, automotive, telecommunications, software/websites and healthcare. Dr. Kleiss is currently employed in the Global Design organization at GE Healthcare where he helps product teams meet regulatory requirements for safe and effective use and explores design issues intended to improve both user and patient experience in clinical settings.

When not doing the above, Dr. Kleiss enjoys creating optic flow patterns riding his bicycle or driving his car around rural Wisconsin and listening to a recent song by Sam Baker.

John Kruse
Senior Human Factors Specialist, 3M

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I apply a variety of approaches to do user research, prototyping, and usability testing. My role is to apply principles of perceptual and cognitive psychology to assure good usability and an enjoyable user experience for 3M products. I also do research into new technology opportunities.

Products I’ve worked on include welding helmets and other personal protective equipment, patient warming and other medical products, the Post-It Plus smartphone app, fingerprinting devices, passport scanning devices, etc. In the past I’ve worked on RFID technology for library systems and asset management, web-based product selection products, and visual perception and conspicuity for safety applications. I have over 20 patents.

I recently attended firefighter training to gain insights for 3M safety products for the fire service.

I presented “Tactics for efficient and effective formative usability testing – lessons learned” at the 4th Annual Human Factors Excellence for Medical Device Design conference in Minneapolis in 2018.

I’ve taught a course on design and usability about 15 times over the last 20 years for the Master’s of Science in Software Engineering (MSSE) program at the University of Minnesota.

Janet Lowe
Senior Manager, Device Development, Medical Affairs, ICU MEDICAL

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I have over thirty years of experience as a Registered Nurse in healthcare and the life sciences industry. The first ten years of my nursing career were spent working in various Intensive Care units. Upon leaving bedside nursing, I moved into the medical device and pharmaceutical industry where I’ve held permanent positions in global corporations that include Abbott Laboratories, Hospira Inc., Pfizer and currently ICU Medical. My competencies include human factors usability, risk management, quality assurance and compliance, training, and supporting medical device development at all points along the product lifecycle (concept, development, launch, on market). I’ve been responsible for the usability requirements essential for filing and registering products both US and internationally and have lead teams of Device Development Specialists responsible for patient safety and risk associated with medical software, infusion pumps, and consumable infusion products.

Susan McDonald
Senior Human Factors Engineer, XIMEDICA

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As a Sr. Human Factors Engineer at Ximedica, Susan strives to improve the usability of products. She does this by applying knowledge of the capabilities and limitations of the intended users and context of use to inform design and by testing products with users throughout design development.

Susan is skilled in early user research as well as validation studies and in the formative studies in between.

She structures HF efforts to ensure compliance with regulations including FDA Guidance and the International Standard, IEC 62366.

She has contributed to the development of:

  • a surgical assistive robot
  • a diverse range of drug delivery systems including infusion pumps, transdermal patches, and inhalation devices

Susan holds a B.S in Human Factors Engineering from Tufts University and a M.S. in Engineering Management from Northeastern University. She is a member of HFES and of the AAMI Human Factors committee.

She lives in Massachusetts with her family.

Darin Oppenheimer
Executive Director, Head, Drug-Device Center of Excellence, MERCK

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Dr. Darin S. Oppenheimer is an Executive Director of the Drug Device Center of Excellence focusing on Medical Devices and Combination products at Merck based in Upper Gwynedd, PA.

Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due dili­gence, and active participation on industry trade organizations and standards committees. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery.

Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a Graduate Certificate in Biotechnology Enterprise. Recently Darin has completed his Doctorate degree in Regu­latory Science from the University of Southern California.

Suraj Ramachandran
Director, Regulatory Affairs, Drug Device Center of Excellence, MERCK

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Suraj Ramachandran, MS, RAC, is a Director, Regulatory Affairs in the Drug Device Center of Excellence at Merck based in Rahway, NJ. Suraj is currently responsible for supporting various medical devices and combination products, such as auto injectors, prefilled syringes, inhalers and contraceptives. In addition, he is heavily involved in providing guidance for digital solutions and has led many development efforts regarding medical device software, intended for both domestic and international markets. In previous roles within industry, he was responsible for an infusion pump platform as well as supporting all new product development and lifecycle maintenance activities including regulatory submissions, design control, audits, and CAPAs. Suraj holds both a Bachelors and Master’s Degree in Biomedical Engineering from the University of Michigan. In addition, he has earned the RAPS RAC certification.

Tina Rees
Associate Director, Human Factors, FERRING PHARMACEUTICALS

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Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.

Marc Stern
Director, Product Management, CERUS CORPORATION

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Marc Stern has spent the last 20+ years driving growth at med-tech companies in a range of marketing and project management roles. He is currently Product Management Director at Cerus Corporation, which is focused on blood transfusion safety. Prior to Cerus, Mr. Stern worked at Thoratec, Carl Zeiss and Johnson & Johnson and as a management consultant focused on the new product development process.

Wenjing Wang
Regulatory Affairs Manager, DENTSPLY SIRONA

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Wenjing Wang has a master’s degree in both Biochemistry and Regulatory Affairs and a Bachelor’s degree in Biotechnology. With over eight years’ of Biomedical research experience and several years working experience in Regulatory Affairs/Quality Assurance, she has gotten a good understanding of international regulations expanding from FDA and Health Canada to EMA, JMHW, CFDA, and other foreign agencies for Medical Devices, In vitro Diagnostic Devices and Drugs.

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