​
Richard Peluso
Product leader specializing in IVD, immunoassay, and diagnostic innovation—dedicated to advancing clinical tools that improve patient outcomes.
(704) 941-5913
About
MY BACKGROUND
Rick Peluso is a diagnostics and med-tech strategy advisor with more than 15 years of experience guiding products from early concept through regulatory approval and into successful market adoption.
He works at the intersection of science, regulation, and commercialization—helping organizations navigate complexity and make decisions that drive real-world outcomes.
Rick’s expertise spans FDA regulatory pathways (510k, PMA, De Novo), product strategy, and data-driven commercialization, with deep experience across clinical and molecular diagnostics, emergency medicine, and laboratory operations.
His background includes work across a broad range of diagnostic domains, including clinical and special chemistry, serology and autoimmune diagnostics, tick-borne and infectious disease testing, neuronal autoantibody diagnostics, and molecular platforms such as PCR and RT-PCR, including point-of-care and bench-top systems.
He also brings strong working knowledge of clinical laboratory environments and compliance frameworks, including CLIA, CAP, COLA, OSHA, and JCAHO, along with a practical understanding of how diagnostic products are implemented, evaluated, and adopted in real-world settings.
What differentiates Rick is his ability to connect regulatory strategy, product development, and market execution. He helps organizations move beyond approval to achieve meaningful clinical adoption, commercial traction, and sustainable growth.
Throughout his career, Rick has partnered with leading healthcare institutions and organizations including Mount Sinai Medical Center, Johns Hopkins, Columbia Presbyterian, Mayo Clinic Laboratories, LabCorp, Quest Diagnostics, Rutgers University, and Ithaca College.
He is currently engaged with diagnostics and med-tech companies seeking strategic clarity across regulatory, product, and commercial functions, and is available for advisory, consulting, and fractional leadership engagements.
​
Rick focuses on one core objective: helping innovative healthcare technologies not only reach the market, but succeed within it.
Core Competencies
COMMERCIALIZATION & MARKET STRATEGY
-
Go-to-market and launch execution
-
Market intelligence & competitive analysis
-
Customer segmentation and targeting
-
Positioning, messaging, and pricing strategy
-
Adoption strategy across labs and clinical settings
DIAGNOSTIC & CLINICAL EXPERTISE
-
Clinical & special chemistry
-
Serology and autoimmune diagnostics
-
Tick-borne & infectious disease testing
-
Neuronal autoantibody (AAB)
-
Molecular diagnostics (PCR, RT-PCR)
-
Point-of-care & bench-top platforms
-
Emergency medicine & trauma applications
REGULATORY & COMPLIANCE STRATEGY
-
FDA pathways: 510(k), PMA, De Novo
-
CLIA, CAP, COLA, OSHA, JCAHO alignment
-
Pre-submissions, regulatory planning, risk mitigation
-
Lab compliance and operational readiness
-
Integrating regulatory strategy with product and commercial goals
Diagnostics & Medical Device Roles
CLINICAL OPERATIONS & IMPLEMENTATION
-
Laboratory workflow integration & optimization
-
Mock regulatory surveys & POC
-
Policy & procedure manuals
-
Practice management and real-world usability
-
Lab setup, consolidation, and expansion
-
Cross-functional alignment (clinical, regulatory, commercial)
-
Process improvement driving efficiency and cost savings
DIAGNOSTIC & CLINICAL EXPERTISE
-
Clinical & special chemistry
-
Serology and autoimmune diagnostics
-
Tick-borne & infectious disease testing
-
Neuronal autoantibody (AAB)
-
Molecular diagnostics (PCR, RT-PCR)
-
Point-of-care & bench-top platforms
-
Emergency medicine & trauma applications
Recognition
WHERE I'VE MADE AN IMPACT
Recognized for transforming clinical insights into innovative diagnostic solutions, strengthening product performance, and empowering healthcare teams through clear communication, strategic vision, and hands-on partnership. (AACC Disruptor award 1st place 2017)
Interests
OUTSIDE THE BOARDROOM
Traveling
Culinary Adventures
Vol. Firefighter
Hunting
Fishing
Fitness
Reading
Cultural Immersion