Director, External Expertise and Partnerships CDRH/Office of Center Director
B.S., Bioengineering, University of Pittsburgh, 2005
Patient preferences, stated-preference research, patient-reported outcomes, patient engagement, regulatory science, public-private partnerships
Proposed Research Project for FDA Commissioner's Fellow:
The FDA values the experience and perspectives of patients, and understands that patients and care-partners who live with a disease or condition on a daily basis may have developed their own insights into and perspectives on the benefits and risks of medical devices reviewed by the FDA. Recent FDA guidance (https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446680.pdf) encourages submission of patient preference information to aid in regulatory decision-making. FDA is conducting patient preference and patient-reported outcome studies to support FDA decision making and patient-centric benefit-risk assessments. The fellow will aid the development, conduct, and dissemination of patient preference or patient-reported outcome studies and conduct regulatory reviews to support medical device benefit-risk assessment.
• Experience in one or more of the following areas:
o Patient preferences
o Patient-reported outcome measures
o Biostatistics, epidemiology
o Health economics, behavioral economics
o Qualitative research
o Patient interaction, patient engagement, or patient input
o Clinical trial design
• Graduate degree in related field
• Excellent written and oral communication
Selected Recent Publications:
1. R. Malinauskas, A. Saha, and M. Sheldon. Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation. Artificial Organs, 39(4), pp. 293-299, 2015.
2. M. Eydelman, A. Saha, and M. Tarver. Tapping Into Valuable Expertise From Private Practitioners and Academicians: Casting a Wider Net. JAMA Opththalmol, 2015. 133 (8), pp. 865-866.
3. R. Jaffe, K. O’Callaghan, A. Saha, S. Christopher, and W. Murray. Advancing Regulatory Science: Research Success in a Public-Private Partnership. RAPS Regulatory Focus, 2015.
4. H. Benz, J Yao, L Rose, O Olgac, K. Kruetz, A Saha, and E. Civillico. Upper extremity prosthesis user perspectives on unmet needs and innovative technology. EMBC.
5. M. Ho, A. Saha, K. McCleary, B. Levitan, S. Christopher, K. Zandlo, R. Braithwaite, and A. Hauber. A Framework of Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies. Value in Health. 19 (6), pp. 746-750.