Last checked 30 September 2026. General information, not legal or regulatory advice. bioaccess® is not affiliated with Laura Minarsch, MMC Medical, or MMC Medical International Consulting Services. Their names are used here only to identify them. Statements about Laura Minarsch and MMC Medical are taken from the public case study and podcast listed below (sources) and are presented as the publisher's claims. Offers and facts change, so confirm current terms with each provider.
MMC Medical International Consulting Services is a credible, long-tenured rapid-execution specialist for first-in-human medical-device studies — reportedly founded in 1992 by Laura Minarsch, with 70+ device studies completed since 2019 per a published case study. bioaccess® is the alternative when the geography question is still open: a geography-neutral first-in-human CRO that tells you honestly whether your program belongs in a U.S. Early Feasibility Study or a Latin American first-in-human, anchors the program to FDA strategy from Miami, executes across 19 Latin American countries or at a Miami cardiovascular site where the device and study fit, and backs the timeline with a 12-month protocol-to-last-patient-last-visit written guarantee.
Honesty cuts both ways. MMC Medical is a credible choice when the geography question is settled and you want a long-tenured, rapid-execution first-in-human device specialist — decades of early-stage device work, a reported four to six weeks from protocol to first patient on a representative study, and strategic clinical affairs consulting for the medical device industry. If that is what your program needs, MMC Medical is a serious firm, and we say so plainly.
If the geography is still open — and you want someone who will tell you the truth about where your first-in-human belongs — that is where bioaccess® earns its place.
MMC Medical: boutique, rapid-execution first-in-human device CRO, reportedly founded 1992, Laguna Beach, California; reported 70+ device studies since 2019 and 15–18 concurrent per a published case study; operations described across four continents, with early non-U.S. work through Paraguay, Lithuania, and New Zealand.
bioaccess®: geography-neutral first-in-human CRO founded 2010, headquartered in Miami; honest U.S.-vs-LATAM recommendation; U.S. regulatory strategy anchored in Miami; first-in-human and early feasibility execution across 19 Latin American and Caribbean countries; Miami cardiovascular site where the device and study fit; 12-month protocol-to-last-patient-last-visit written guarantee.
Read the full head-to-head: bioaccess® vs. MMC Medical.
It depends on what is still undecided. If your geography is settled and you want a long-tenured rapid-execution specialist, MMC Medical itself is a credible choice. If the geography question is still open — U.S. Early Feasibility Study or Latin American first-in-human — bioaccess® is the geography-neutral alternative: an honest U.S.-vs-LATAM assessment, FDA strategy anchored in Miami, 19-country Latin American execution or a Miami cardiovascular site where the study fits, and a 12-month written timeline guarantee.
The central difference is the geography question. MMC Medical is a boutique rapid-execution FIH device CRO with decades of early-stage device experience. bioaccess® is a geography-neutral FIH CRO: we advise honestly on whether the program belongs in the United States or Latin America, anchor the program to FDA strategy from Miami, execute across 19 Latin American and Caribbean countries, and put a 12-month protocol-to-last-patient-last-visit guarantee in writing.
The roles do not overlap cleanly — both firms run first-in-human work — so sponsors typically pick one. What does happen: a sponsor runs the FIH with bioaccess® in Latin America and returns to a U.S. or Europe pivotal afterward, or enrolls a U.S. Early Feasibility cohort first on our recommendation and then takes the program abroad.
Yes. Julio G. Martinez-Clark, co-founder and CEO of bioaccess®, interviewed Laura Minarsch on the Global Trial Accelerators podcast (Season 2, Episode 4, October 26, 2019) and for Med Device Online in 2019 for an article on the EU Medical Device Regulation. She was re-invited to the podcast in September 2026.
Tell us where your program stands — preclinical, bench, or ready for protocol. We will tell you honestly whether your first-in-human belongs in a U.S. Early Feasibility Study or a Latin American first-in-human, and what the timeline and budget look like either way. Book your free 30-min strategy call.
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