Marcus Gitterle Consulting Group provides clinical, scientific, and strategic advisory services to medical device, biologics, pharmaceutical, and durable medical equipment companies operating in wound care and hyperbaric medicine.
Marcus L. Gitterle, M.D., is a practicing physician and recognized leader in wound healing and hyperbaric medicine. He serves as Chief Medical Officer of WoundCentrics, LLC, a multi-site wound care practice, and is a founding partner in True Woundcare, LLC, manufacturer of the innovative True3 Digital, Group 3 pressure-relieving mattress.
Dr. Gitterle is the developer of a topical antibiotic in pre-commercial development. He serves as Principal Investigator on approximately twenty randomized controlled trials in wound healing across advanced dressings, cellular and tissue-based products, topical therapeutics, and medical devices. He teaches accredited post-graduate courses in wound care and hyperbaric medicine, and lectures nationally on wound healing science, clinical evidence, and care delivery.
Consulting engagements are conducted through Marcus Gitterle Consulting Group, an independent advisory practice. All engagements are structured to preserve editorial and scientific independence, and relationships with industry are disclosed in accordance with applicable law, institutional policy, and the federal Physician Payments Sunshine Act.
Clinical strategy, evidence-generation plans, protocol design, endpoint selection, interpretation of published and internal data, and scientific review of Company positions and publications.
Study design input, investigator-meeting participation, site feasibility review, and, where appropriate, principal-investigator engagement at participating research sites.
Review of promotional concepts, product messaging, labeling-related materials, and medical-legal-regulatory submissions, consistent with FDA promotional rules and Company MLR process.
Invited lectures, webinars, preceptorships, advisory-board participation, and accredited or non-accredited continuing education in wound healing and hyperbaric medicine.
Advisory input on FDA submission strategy (510(k), De Novo, PMA), clinical evidence needed for coverage, and CMS/payer considerations for wound care products.
Where permitted and appropriate, introductions to clinicians, institutions, professional societies, and research sites relevant to the sponsor’s program.
Inquiries from medical device, pharmaceutical, biologics, and DME companies are welcome. Please include a brief description of the product or program, the nature of the engagement contemplated, and any timing considerations.