Panel Session: Patient perspectives across the medical device product lifecycle
The FDA’s Center for Devices and Radiological Health (CDRH) launched a Patient Preference Initiative in September 2013 to examine ways in which it could broaden patient input in medical device regulation. This initiative stemmed from recognition in a landmark 2012 guidance issued by CDRH that patients’ perspectives on benefit-risk tradeoffs will vary according to individual expectations and tolerance and should be considered by regulators for both PMA applications and de novo petitions. Last year the FDA’s draft guidance document took the next step and provides guidance on patient preference information that may be used by FDA staff in decision-making relating to PMAs, Humanitarian Device Exemption (HDE) applications, and de novo requests.
In 2015, the Medical Device Innovation Consortium (MDIC) published a first-of-its-kind framework and catalog of patient preference assessment methods to create a vision for how the patient perspective can be effectively integrated into the benefit-risk assessment of innovative medical technology and across the product lifecycle. Both MDIC and CDRH recognized that patient preference assessment should not be limited to just the regulatory benefit-risk analysis; improving the science of patient engagement has application across the medical device product development lifecycle. This panel will feature perspectives from CDRH, MDIC, and patient advocates about the integration of patient engagement across the product lifecycle: from design to clinical trials to regulatory review.
Introduction from MDIC
o Stephanie Christopher
Introduction – Patient panelists
o Kelly Close
o Michelle Colder
o Suzanne Schrandt
Introduction – Physician perspective
o Vani Sabesan
Introduction – Science of patient engagement
o John Bridges
FDA CDRH’s commitment to patients as partners
o Annie Saha
Stephanie Christopher, Program Manager, CTIR & PCBR
Stephanie Christopher, MA, has a background in health communication, public health project management and communication education and training. Stephanie worked for seven years with an academic public health team working on interventions to improve the quality of communication between physicians and parents of newborns with abnormal newborn screening results. In 2012-13, Stephanie went on leave from her academic position to do a special assignment for the Food and Drug Administration Center for Devices and Radiological Health (CDRH), updating and training staff on a new risk communication process. Stephanie also teaches introductory communication courses in the College of Professional Studies at Marquette University.
Stephanie earned her Bachelor of Arts in Communication-Print Journalism from Pacific Lutheran University in Tacoma, Wash. and Master of Arts in Science, Health, and Environmental Communication from Marquette University in Milwaukee, Wis. Stephanie is also a Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals.
Kelly Close founded Close Concerns in 2002, a healthcare information company focused exclusively on diabetes and obesity. At Close Concerns, Kelly and her team write approximately five million words each year on diabetes, obesity, and digital health. Kelly’s passion for the field comes from her extensive professional work as well as from her personal experience, having had diabetes for nearly 30 years. Kelly is the author of over 20 peer-reviewed manuscripts as well as “Targeting A Cure for Type 1 Diabetes: How Long Do We Have to Wait?” a widely-praised book published by the ADA in 2013. Kelly is on the editorial board of Clinical Diabetes, a journal focused on diabetes for primary care physicians published quarterly by the ADA. Close Concerns won the ADA’s “Excellence in Health Communications” Award in 2012 and Kelly and her team write a quarterly column in Journal of Diabetes, a peer-reviewed journal based in Shanghai.
Kelly is founder and Editor-in-Chief of diaTribe, founded in 2006 as an educational resource for people with diabetes. She also chairs The diaTribe Foundation, a nonprofit established in 2012 to improve the lives of people with diabetes and pre-diabetes and to advocate for action. Before starting Close Concerns and the diaTribe Foundation, Kelly’s work focused on life sciences more broadly. Over nearly a dozen years, she worked on Wall Street (investment banking at Goldman Sachs, medical technology equity research at Merrill Lynch and Piper Jaffray) and at McKinsey & Company, where her work centered on pharmaceutical, managed care, and nonprofit organizations.
Kelly has a BA in Economics and English from Amherst College and an MBA from Harvard Business School. She was a founding board member of the Institute for Responsible Nutrition, led by Dr. Robert Lustig, and a previous executive board member of the Diabetes Hands Foundation and the Behavioral Diabetes Institute. She and husband John are co-hosts of the popular discussion series CPS Lectures. They live in San Francisco with their three children.
Michelle Colder Carras, PhD
Michelle Colder Carras is a postdoctoral fellow in the Psychiatric Epidemiology Training Program of the Department of Mental Health at the Johns Hopkins Bloomberg School of Public Health. Her thesis work used latent class modeling to detect heterogeneity in populations of heavy video game users based on their concurrent online social interactions, providing support for a distinction between “addictive” and highly-engaged but normative video game play. Her current research interests include exploring the phenomenology of Internet Gaming Disorder through crowdsourcing methods and investigating the benefits and harms associated with commercial video game use in U.S. military veterans. In addition to her Ph.D. in public health, she also has a certificate in public health informatics. She is an active patient advocate with the lived experience of bipolar disorder, a trained public speaker and peer mentor, and has participated in two neurological devices panels for the FDA as well as numerous other workshops and conferences. She is currently on the public policy committee of Mental Health America.
Suzanne Schrandt, JD, Deputy Director for Patient Engagement, Patient-Centered Outcomes Research Institute (PCORI)
Suzanne Schrandt, JD, is the Deputy Director of Patient Engagement at the Patient-Centered Outcomes Research Institute (PCORI). In this role, she supports the Director of Patient Engagement and engages patients to provide broad-based input on the development and execution of PCORI’s research. Schrandt has been involved in health policy and patient advocacy since being diagnosed with a form of rheumatoid arthritis at a young age.
Engaged in numerous patient and clinician education initiatives since the mid 1990’s, the focus of Schrandt’s advocacy work is increasing early diagnosis and appropriate, patient-centered management of chronic disease. Before coming to PCORI, Schrandt led the Health Reform Team for the Kansas Health Institute, where she educated the state’s policymakers, clinicians, and consumers on the implications of the Affordable Care Act and other federal and state law. Schrandt has held previous posts as the Coordinator of Public Health and Public Policy for the Arthritis Foundation in Kansas City, as a Research Associate at the Beach Center on Disabilities where she served on a Human Genome Research Institute ELSI project, and as a Medical Analyst for Shook, Hardy, & Bacon, LLP.
In addition to her role at PCORI, Schrandt currently serves on the Curriculum Development Committee and is a Patient Faculty Presenter for the Rheumatoid Arthritis Primary Care Initiative for Improved Diagnoses and Outcomes (RAPID) CME program. She is a Patient Partner Instructor with the University of Kansas Medical School Patient Partners Program and serves on the Arthritis Foundation Scientific Discoveries Advisory Committee.
She is a graduate of the University of Kansas School of Law, and a member of the Kansas Bar Association, the American Health Lawyers Association, and Public Responsibility in Medicine & Research.