When an Opportunity Knocked, the Wound Care Community Responded

The US Food and Drug Administration (FDA) recognized the value of bringing together private- and public-sector members, in a continuing forum, to collaborate on medical device/drug challenges to achieve key patient-centered objectives and outcomes. The FDA encouraged and helped establish several Collaborative Community platforms to address these issues for various medical sectors, including wound care. Participation in Collaborative Communities was one of the FDA Center for Devices and Radiological Health’s (CDRH) strategic priorities for 2018–2020. The FDA participates as a member of 10 established communities managed and controlled by external stakeholders.

After collaborating with the FDA on new wound care endpoints through the Wound Care Experts/FDA-Clinical Endpoints Project (WEF-CEP), the FDA recommended that the leadership consider becoming a Collaborative Community to continue pivotal work in the wound care sector. In response, Vickie R. Driver, DPM, MS, FACFAS; Peggy Dotson, RN, BS; and Lisa Gould, MD, PhD developed the required charter document to establish a Wound Care Collaborative Community (WCCC) and applied to the FDA in fall 2020. Approval was granted in early 2021. As part of this approval, the FDA appointed federal liaisons and an executive sponsor to the WCCC to help advance the Agency’s mission to protect and promote public health.

The WCCC is a volunteer, diverse member group representing the broad wound care community, including opinion leaders, experts, providers, associations, societies, payors, manufacturers/industry, researchers, and patients. Along with the FDA, participants address the public health issues of patients with complex and chronic wounds.

To support the efforts of the WCCC, a non-profit 501(c)3 was established, an administrative management company engaged, a website launched, and fundraising/grant application efforts initiated. WCCC meetings started in March 2021 to engage with members, finalize major goals, and develop Work Groups to address priority issues. The WCCC is actively seeking members to join work groups focused on Gaps, Tools, and Real-World Data.

The WCCC officers have recruited over 40 members who have signed agreements to participant in the Community and established a 15-member Steering Committee. The Steering Committee experts represent the broad aspects of wound care and will guide the execution of the major WCCC objectives.

The overarching goal of the WCCC is to help assure that health care professionals and patients with complex and nonhealing wounds have access to the best standards of care and innovative, timely, and efficient treatment options that will support a reduction in comorbidities, which are too often sequelae for many patients. To guide these objectives, the WCCC has developed short- and long-term goals (1–5 years) with a timeline, action items, and associated work streams.

The WCCC will work to identify methods, tools, and appropriate clinical evidence that will enhance understanding and improve evaluation of product safety, quality, and effectiveness. Initiatives aim to accelerate access to cutting-edge medical technology while reducing cost and time to market with goals to: 1) Identify the clinical validated methods and tools with sufficient evidence to measure wound care clinical and patient-centered endpoints, especially those demonstrated as priorities for patients and providers through the WEF-CEP research. 2) Discuss the growing access to diverse “real-world” data sources and its role in enabling new approaches to close persistent evidence gaps. 3) Create a collaborative document that articulates general acceptance of key standards that constitute good clinical and scientific evidence to be used in clinical trials and top-level publications. 4) Accelerate the development of science-based solutions to policy challenges, assuring patients receive access to innovative treatment options that are paid for when being prescribed. 5) Develop standards for good clinical and scientific evidence in the wound healing community. 6) Develop an understanding and discuss regulations that would embody sufficient flexibility to accommodate the emerging tools and methods in the wound care field. 7) Engage with government payers to define and standardize acceptable evidence for coverage decisions and identify improved processes to provide patients more rapid access to new devices and drugs for wound care.

The following is a growing list of key associations, societies, and government and industry representatives active in the WCCC: 3M; Association for the Advancement of Wound Care; American Diabetes Association Interest Group–Foot Care; Alliance of Wound Care Stakeholders; American Geriatric Society, Special Interest Group in Wound Care; Angiogenesis Foundation; American Podiatric Medical Association; American Professional Wound Care Association; Becton, Dickinson and Company; Critical Limb Ischemia Global; the FDA (CDRH, CBER, and CDER); Humana; Integra LifeSciences; Kent Imaging; LifeNet Health; Medical Device Manufacturers Association; Mölnlycke Health Care; Serena Group, Inc.; TissueTech, Inc. & Subsidiaries; Urgo Medical North America; and the Wound Healing Society.

Please contact us at info@woundcarecc.org or 312-201-6771 if you would like to be a member of the WCCC. Additional details are also available at www.woundcarecc.org