The U.S. Food and Drug Administration (FDA) qualified MSK’s WOUND-Q™ questionnaire as a Medical Device Development Tool (MDDT) in November 2024. WOUND-Q is the latest of only 18 MDDTs that have earned the qualification since the MDDT program began in 2017.
WOUND-Q contains patient-reported outcome measures (PROMs) in four domains important to patients living with chronic wounds: wound characteristics, health-related quality of life, care experience, and treatment.
WOUND-Q is the most recent addition to the Q-Portfolio, a collection of PROMs rigorously developed and clinically validated by global investigators. Q-Portfolio tools are available for non-exclusive licensing by commercial entities for use in product development or clinical trials, investigator-initiated trials funded by for-profit entities, and providers of electronic platforms for administering PROMs.
“MSK is proud to be a part of the team bringing the Q-Portfolio to clinical research and practice. With this new addition, the Q-Portfolio now includes FDA-qualified scales from three PROMs: WOUND-Q, FACE-Q® (Aesthetics Module), and BREAST-Q® (Reconstruction Module),” said Imke Ehlers-Surer, PhD, Director, Technology Development & Licensing, in MSK’s Office of Technology Development.
“The FDA’s MDDT program qualifies select tools for use in medical device development and evaluation. With fewer than twenty PROMs having achieved this rigorous qualification, we are pleased to achieve the qualification of WOUND-Q—a milestone that will advance innovation and improve patient outcomes,” said Andrea Pusic, MD, MHS, FACS, FRCSC, Chief of Plastic & Reconstructive Surgery at Brigham and Women’s Hospital and Joseph E. Murray Professor of Surgery at Harvard Medical School. Dr. Pusic previously served as a plastic and reconstructive surgeon at MSK, where she established the electronic platform for collecting and using BREAST-Q data in clinical care.
MSK’s OTD licenses a number of Q-Portfolio PROMs including the Breast-Q®, Face-Q®, and Body-Q®. Learn more.