Human Factors and Design Controls for Medical Devices and Combination Products

• 8:30 – 9:00 AM: Registration
• 9:00 AM: Session Start Time

• Combination Product Regulatory
• Product profile, data, and performance
• Metrics: mean approval times by product types or regulatory pathway
• Recent and upcoming guidance documents
• Are companies going to OCP for help with designations?
• Making best use of OCP during the combination product life cycle
• Jurisdiction of kits and other ambiguous products
• Office of Planning report on FDA handling of combination products
• The Combination Product Development Process
• Evaluation of process improvement
• IT assessment
• Evaluation of industry performance
• Key issues and deficiency
• Quality by Design vs. Design Control
• Compare and contrast the objectives and approaches
• What is part of design validation?
• Will CDRH and CDER accept the other’s approach?
• Aligning the processes
• Pharmaceutical CGMP and the Medical Device QSR
• The GMP guidance document
• Pharmaceutical CGMP
• Purchasing controls in drugs vs. devices
• The problem of retains and lot sizes
• Panel discussion – How did you modify your quality system to accommodate combination products?
• Pharmaceutical companies
• Medical device companies
• Managing internal documentation at each facility
• Case studies

• Developing Clinical Evidence
• Different drug and device clinical evidence requirements
• Differing knowledge of mechanisms of action
• Challenges of conducting device clinical studies
• When is clinical evidence necessary, and what information should be collected (e.g. in bridging studies)
• How do cGMPs / QSR apply during clinical studies?
• Factors best addressed in simulated real use environment vs. controlled environment
• Good Clinical Practices
• Human Factors and Combination Products
• FDA human factors guidance – status or report
• Cultural differences – medication errors vs. engineering approaches
• Case study – FDA review approach: roles and responsibilities of CDER vs. CDRH reviewers
• Should non-significant risk human factor studies be submitted in the IND?
• Value of or need for non-observational (real world use) usability testing
• Risk Management and Combination Products
• Reconciling drug and device approaches
• The risk of the whole vs. the risk of the parts
• Companion Diagnostics Regulations and Process
• What is a companion diagnostic?
• What are the challenges with companion diagnostics?
• How do the proposed changes to FDA’s stance on LDT regulation affect companion diagnostics?
• The Global Landscape of Combination Products
• Definitions and Regulatory Pathways
• Challenges

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.