The Advisors
CAROLINE RHIM, PHD
Caroline is regulatory consultant who has been enamored with medical devices since her first internship in college. With over 20 years of experience leading global consulting teams, she helps innovators turn red tape into usable roadmaps. At FDA, Caroline served as a lead scientific reviewer in the orthopedic and cardiovascular groups and as the Branch Chief for the orthopedic spine team. Caroline spends her time now engaging with companies of all sizes to navigate the regulatory landscape, where she loves to blend science, technology, and strategy to make regulatory feel a little less overwhelming.
VANESSA OTERO, JD
Vanessa is the Founder and CEO of Ad Fontes Media, a company that rates the news for reliability and political bias and produces a well-known infographic called the Media Bias Chart. The company provides data to individuals educational institutions, and companies who interact with the news, and as a result, Vanessa regularly speaks at schools, for civic organizations, and at conferences in various industries. Prior to starting the company, she practiced as a patent attorney.
LANCE BLACK, MD, MBID
Lance is currently Senior Associate Dean of Innovation & Strategic Projects at Texas A&M’s School of Engineering Medicine (EnMed) in Houston, TX. A physician and biological engineer by training, he has spent more than a decade guiding medical device and digital health startups from concept to commercialization. Prior to his academic role, he served as a family practice physician and flight surgeon in the U.S. Air Force and later as a leader in the health innovation ecosystem. His work bridges medicine, engineering, and entrepreneurship, with a focus on translating ideas into impactful healthcare solutions.
TRACY SCHAAF
Tracy is a passionate champion of patient-centered innovation, with over 20 years in the medical device industry. She specializes in content strategy and production, marketing communications, and market insight focused on innovative, life-changing medical technologies – with a keen understanding of, and appreciation for, their rigorous journey onto the market and impact across the continuum of patient care. Through her recent consulting work with leading organizations like LSI, Outset Medical, Stanford Mussallem Center for Biodesign, and top medtech PR firms, she collaborates with visionary teams to bring life-changing technologies to patients and consumers so that they can live their very best lives.
SAMIR SHREIM, PHD
Samir is a MedTech innovator and service provider. At Aly Development, he is focused on accelerating innovative technologies by directly solving the toughest technical challenges from R&D to manufacturing and clinical validation. Samir advises multiple startups, and is supporting the next generation of innovators as a mentor and sometimes panelist / guest lecturer at UC Irvine (UCI). He previously instructed undergraduate courses in Biomedical Engineering at UCI and supports the National Science Foundation (NSF) as a scientific reviewer.
NATASHA BOND, CEng, MEng, PMP
Tasha brings 30 years’ experience in the engineering, management, manufacture, compliance and regulatory approval of novel medical devices. She holds multiple degrees, is a Chartered Engineer of the UK’s Royal Institute of Mechanical Engineers, and a Certified Project Management Professional (PMP). She is a fellow, mentor and advisor in multiple industry and academic groups for services to medical innovation (e.g., Medtech Innovator, Texas Heart Institute, Texas Medical Center and Cleveland Clinic Innovations). She has worked as an adjunct professor of innovation at Rice Biodesign and Stanford Biodesign programs and for the Colorado Bioscience Institute. Tasha is a serving board member and advisor for several start-up medical device companies, has seen multiple successful exits to Abbott, Johnson & Johnson and Phillips Healthcare and holds patents for heart valve technologies and novel quality management systems.
JESSICA RICHTER
Jessica started Richter Advisory Collective to help innovators bring solutions to patients faster. With 20+ years in medical devices, diagnostics, and digital health (including leadership roles at Covidien, Medtronic, BD, and a 450+ person CRO team at Veranex), she has learned that success comes from having the right people and strategy at the right time. Whether as a consultant, board member, or fractional executive, Jessica helps to guide and integrate regulatory, quality, clinical, commercial, and strategic partnership programs for clients. She is also passionate about giving back through speaking engagements, board service, accelerators, and mentoring the next generation of MedTech leaders.
MARK DOMYAHN, MBA
Mark provides expertise to clients in medical technology, provider reimbursement, and health economics. Prior to joining JD Lymon, Mark founded Pursuance Consulting, a reimbursement consulting practice developing successful reimbursement strategies and tactical execution for medical device companies ranging from start-ups to Fortune 500 companies. He has also service in market access leadership positions at Medtronic, Restore Medical, Zimmer and St. Jude Medical. Throughout his career, Mark has successfully established incremental and permanent increase in Medicare payment for multiple technologies across a wide variety of therapeutic areas.
CATHERINE KANG, PHD
Catherine is a regulatory and quality consultant that enjoys working with complex medical devices and combination products (devices + drug/biologics/cells/tissues). She helps guide product development, authors documentation for global product registrations, and develops effective processes to keep safe and effective products on the market for the patients who need them. Her unique blend of technical, regulatory, and leadership experience defines her as an exceptional regulatory and quality consultant.
ISABELLA SCHMITT, MBA, RAC
Isabella has a well-rounded background across regulatory affairs, clinical trial design and management, product management, quality assurance, marketing, and business development. She has guided strategies for more than 100 successful regulatory filings and FDA interactions, and loves to share her expertise through ISO working groups, articles, podcasts, and speaking engagements. One of her favorite things is to turn complex and sometimes stuffy subject matter into something at least somewhat accessible and fun. She holds a RAC certification, an MBA, and a BS in Chemistry, and has been recognized with honors such as the Stevie Business Award, Houston Business Journal’s Women to Watch, and Cardiovascular Business’s 40 Under 40.
NADA HANAFI, MSc, MPH
Nada is the co-founder of MedTech Strategy Advisors, LLC —where life science companies go when they need someone who speaks fluent FDA. After 12 years inside the beast (aka FDA's CDRH), where she co-founded game-changing programs like Health of Women and made "patient preference" a thing people actually care about, Nada broke free to help MedTech innovators navigate the regulatory wilderness. Nada doesn't just decode regulations—she hunts for the human stories behind the science. Whether she's moderating a fireside chat or connecting the dots on a panel, she has this uncanny ability to find the thread that ties everything together. She is a co-founder of MedTech Color and co-chairs committees for the Gates Foundation and Milken Institute.
ETIENNE NICHOLS, PMP
Etienne Nichols is a recovering mechanical engineer who helps medical device companies bring safer products to market faster. As a LinkedIn educator and influencer, he loves connecting people across medtech and sparking the conversations that shape the industry’s future. With a background in engineering and deep experience in quality, product development, and regulatory strategy, he makes complex topics simple, actionable, and engaging.
SUSAN FRANCIA, MBA, OLY
Susan Francia is the CEO and co-founder of Repeat Therapeutics, a biotechnology company pioneering first-in-class therapies for ALS and other repeat expansion disorders. She combines the rare grit of an Olympic champion with more than a decade of biotech leadership to advance transformative, patient-centered treatments. An MBA graduate of UCLA and the daughter of Nobel laureate Dr. Katalin Karikó, Susan pairs lifelong proximity to science with a resolute vision: leading Repeat Therapeutics in developing novel therapies that bring hope to patients and families impacted by ALS.