The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic recommendations will be presented on how to implement these requirements into the medical device design, development and approval processes. Finally, Human Factors methods and best practices will be covered that the FDA is requiring.
Learning Objectives:
- Are you familiar with the role of Human Factors with respect to combination products and the FDA requirements?
- Are you current on the FDA's current perspectives on Human Factors?
Human Factors has become increasingly important to the FDAs approval of medical devices. It is a part of the design and development of the device and the collateral information, e.g., labeling, IFUs, and training. Incorporating Human Factors into the device development process can get a product to market faster and cost less. Hence, this seminar will cover all of the current and future Human Factors FDA requirements and show how to not increase costs or time.
Areas Covered:
- Overview of Human Factors and the FDA perspective
- Human Factors Methods and Device Product Life Cycle
- Human Factors and Risk Analysis & Management
- Human Factors: What Devices Require Human Factors Evaluation and Validation?
- Human Factors and Combination Products
- Human Factors and Combination Products Submitted in an ANDA
Who will Benefit:
- Quality Assurance
- Regulatory Affairs
- Device Engineers
- Device Manufacturers
- Pharma / Medical Device
- Registration Process - (8:30 am till 8:45 am)
- Lecture 1: Overview of Human Factors and the FDA perspective
- Lecture 2: Human Factors Methods and Device Product Life Cycle
- Lecture 3: Human Factors and Risk Analysis & Management
- Lecture 4: Human Factors: What Devices Require Human Factors Evaluation and Validation?
- Lecture 1: Human Factors and Combination Products (Part 1)
- Lecture 2: Human Factors and Combination Products (Part 2)
- Lecture 3: Human Factors and Combination Products Submitted in an ANDA (Part 1)
- Lecture 4: Human Factors and Combination Products Submitted in an ANDA (Part 2)
Virginia A. Lang
Principal and Founder HirLan, Inc. and HirLan International SA
Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.
In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California and a Consortium arrangement in London, UK. In February 2013, Virginia founded HirLan International SA, a Geneva, Switzerland based company. Both HirLan and HirLan International have been supporting Top Ten pharma/medical device companies, as well as, start-ups with consulting and testing services. These services are in conjunction with their clients FDA 510(k) and CE mark applications.
Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.
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