Maureen Shaffer
New York City, New York
Overview
As a retained commercialization strategy partner, I consult with early-stage startup and growth-stage global medical device companies—particularly those anticipating US market entry for the first time—to build a focused market adoption strategy aligned with US healthcare reality. Want to avoid cash-burning, investor-frustrating, time-delaying obstacles? Let’s talk in advance because: ✗ Approval is not adoption. ✗ Content creation is not adoption. ✗ Post-clearance promotion is not adoption. ✓ Driving market adoption starts alongside product development, flows through clinical trial endpoint
About
As a retained commercialization strategy partner, I consult with early-stage startup and growth-stage global medical device companies—particularly those anticipating US market entry for the first time—to build a focused market adoption strategy aligned with US healthcare reality. Want to avoid cash-burning, investor-frustrating, time-delaying obstacles? Let’s talk in advance because: ✗ Approval is not adoption. ✗ Content creation is not adoption. ✗ Post-clearance promotion is not adoption. ✓ Driving market adoption starts alongside product development, flows through clinical trial endpoints and embeds in submitted regulatory claims–before US regulatory clearance or approval. → I built Mingletoe and proprietary frameworks to bridge this common gap. Every engagement begins with a proprietary diagnostic–ADOPT·Dx surfaces the unknowns to identify gaps and opportunities, across the competitive and partner ecosystem, customer constellation of patients, healthcare providers, and places of service in 5 hours of team meeting over five weeks. From there, engagements scale from prescribed strategy (ADOPT·Rx) to embedded commercial leadership (ADOPT·Tx) based on what the initial diagnostic discovers and we mutually decide. I have 20 years of corporate medical device commercialization experience, including three Vice President of Marketing roles. At AtriCure, I led marketing, reimbursement, and clinical education through a growth arc from approximately $10 million to nearly $50 million in revenue—through an IPO—while maintaining the number one market share position against Medtronic, Edwards and St. Jude Medical (now Abbott). That work required navigating off-label use by cardiac surgeons and working with unlisted CPT codes while supporting creation of new codes, coverage and reimbursement. As CEO of Mingletoe, I now engage with medical device clients as an advisor or as a fractional Chief Marketing Officer (fCMO), including: ✓ Cardiovascular ✓ Gastroenterology ✓ Imaging and Radiology ✓ Oncology ✓ Neurology and Neurosurgery ✓ Pediatrics, adults and seniors ✓ Physician and patient-facing data, digital health and software I hold a BSE in Biomedical Engineering (BME) from Duke University with completion of a multitude of post-graduate courses. I volunteer as a: • Board Member — Duke FIRST Advisory Board and Executive Committee • Mentor and Speaker — DxD Healthtech Program (supported by Fogarty Institute + Stanford Mussallem Biodesign) • Program Reviewer — The MedTech Conference (AdvaMed) • Startup Judge — MedTech Innovator US and APAC