Web Code: ComboP5-11
Member/Nonmember Price: $75
Human Factors studies are an integral component of product development for most combination products today. This seminar will discuss the special considerations for designing formative and summative human factors studies for combination products, including unique user group requirements and how they are defined (elderly, visually impaired, pediatrics), sample size, and environmental use conditions. Industry experience as well FDA’s perspective will provide insight into common issues and challenges and how to address them, and how to best present human factors information and study results in a regulatory submission to facilitate a timely FDA review.
Department Operations | Regulatory Affairs | Clinical Affairs | Manufacturing | Quality| Product and Process Development Engineering | Project Management
Individuals, at all levels, working in strategic roles in quality, regulatory, clinical and manufacturing departments in drug, biologic or medical device companies engaged in the development and manufacture of combination products
Michael Wiklund, Founder, Wiklund Research and Design, Inc.
Michael Wiklund is president of Wiklund Research & Design (Concord, MA), a human factors consulting firm that specializes in making medical devices safe, effective, usable, and appealing. He received his M.S. Degree in Engineering Design (Human Factors) from Tufts University, where he annually teaches a graduate course on applied user interface design. In 2003, he was named a “100 Notable Person” in the medical industry by MD&DI magazine. His books include Usability Testing of Medical Devices, Handbook on Human Factors in Medical Devices, Usability in Practice, and Designing Usability into Medical Products. Additionally, he has written over 50 technical articles for MD+DI magazine and serves on its editorial advisory board.
Michael is a voting member of the AAMI and IEC Human Factors Committees. Funded by FDA, he developed the original text for AAMI HE74:2001, Human Factors Process for Medical Device Design. He was also a lead author of several sections of AAMI HE75:2009, Human Factors Engineering – Design of Medical Devices.
A board-certified human factors professional, Michael has developed high-quality user interfaces for ventilators, dialysis machines, infusion pumps, glucose meters, insulin pumps, defibrillators, hospital beds, and many more products used by clinicians and laypersons. He holds several user interface design patents.
Steven T. Johnson, Principal Consultant, Global Regulatory Affairs, CMC, Eli Lilly & Company
Steve Johnson is a Principal Consultant in Global Regulatory Affairs (CMC) at Eli Lilly and Company. He joined Lilly in 1988. He has held a variety of positions in API manufacturing operations, process engineering, construction design and management, environmental quality, quality assurance, global auditing, and regulatory management at Lilly.
In his current position in regulatory affairs, he supports worldwide registration of drug/device and biologic/device combination products as well as medical devices. Steve is active in industry groups including PDA’s Combination Products Task force and Regulations Subcommittee. Steve received a Bachelor of Science degree in mechanical engineering from the University of Illinois Urbana-Champaign. He completed a Masters of Business Administration at Indiana State University.
Kimberly Trautman, Medical Device GMP/Quality Systems Expert, CDRH, FDA
Kimberly A. Trautman is FDA’s Expert on Medical Device GMPs and Quality Systems. She was responsible for writing the final Quality System regulation and preamble published in 1996. Ms. Trautman was also responsible for the development and implementation of the extensive Quality System regulation Roll-Out and training programs. She reviews inspection reports of foreign and domestic medical device manufacturers to identify violations of the Good Manufacturing Practice (GMP) requirements, and provides GMP guidance to FDA field investigators and the medical device industry. Ms. Trautman provides GMP expertise to CDRH for various legal actions and regulatory reviews.
Ms. Trautman has given lectures at medical device training courses for FDA field investigators, DSMICA GMP workshops, AdvaMed conferences, RAPS conferences, FDLI workshops, ASQ/FDA Biomedical Industry Update Seminars, and many others.Ms. Trautman received her Bachelor of Science degree in Molecular and Cell Biology from The Pennsylvania State University, University Park, Pennsylvania, and a Masters of Science degree in Biomedical Engineering from The University of Virginia, Charlottesville, Virginia.
Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093