Expertise and Mission
Note from the Managing Partner
LADUCA RCA, LLC was established following a successful 30+ year career in senior management in medical devices and in vitro diagnostic devices (IVDD). As a globally recognized expert in point of care testing (POCT), it was apparent that the skills and techniques developed over this tenure were applicable to many medical device organizations, from start-ups to major corporations. The leadership practice employed throughout this career and which is a cornerstone of LADUCA RCA is to assemble high caliber, "Best in Class" teams who are committed to work diligently and cooperatively to achieve focused results and corporate success. Included in the significant "Achievements" found on this website, are examples of numerous contributions to more than two-dozen clients over the initial four years of operations.
Diagnostic medicine encompasses non-invasive and invasive products of which IVDDs are the backbone of medical care and a greater than 70 billion (USD) world-wide business. POCT which had its start as "bedside testing" has evolved to applications in specialty hospital units such as surgery suite, critical care, out-patient clinics catering to ambulatory patients, physician office labs (POLs), health screening centers, corporate wellness and pharmacy based primary healthcare. In these diagnostic areas, teams under my direction have developed novel products, designed and implemented compliant quality management systems, achieved numerous US FDA product approvals and global product registrations, established product value through clinical study and publication and when required resolved compliance situations which threatened the company's freedom to operate.
LADUCA RCA, LLC brings to clients an unparalleled expertise in regulatory, quality, compliance and technical expertise which is applicable across the full spectrum of medical device businesses. With regards to IVDDs, lab based testing, POCT and molecular diagnostics, clients have leveraged this expertise to define and create strategic planning and product development portfolios supporting corporate growth. Our mission in support of the client's business includes protection of the stakeholder's investments.
Thank you for visiting our website and for consideration of the use of our services.
Frank M. LaDuca, Ph.D., FAHA
OUR MISSION
LADUCA RCA, LLC is committed to providing a high quality and technically sound approach to addressing the scientific, regulatory and compliance needs of our medical device and diagnostic device partners. A "roll up the sleeves" approach is the benchmark of our advisory and consultant mission and we address any task with ownership and a commitment to success while cognizant of our clients' needs and objectives.
