Healthcare Innovation Catalysts

Healthcare Innovation Catalysts (HIC) is a boutique advisory firm specializing in regulatory strategy, clinical development, quality systems, and market access for medical products. Founded by industry executives and FDA veterans, the firm supports pharmaceutical, biotech, medical device, diagnostic, and digital health companies throughout the product lifecycle from early development through commercialization.

HIC's service portfolio spans regulatory roadmaps and FDA submissions, clinical trial design and biostatistical analysis, quality system development and GxP audit support, and reimbursement planning including Military Health System and VA market access. The firm emphasizes a "Goldilocks approach" to deliver right-sized solutions that balance technical rigor with practical implementation, avoiding both overly generic recommendations and unnecessarily complex strategies.

The firm serves clients ranging from startups to multinational corporations, offering flexible engagement models including interim staffing, inspection support, and strategic advisory services. HIC's team brings combined expertise from government regulatory agencies, industry, academia, and the military health system.

Choose Healthcare Innovation Catalysts when you need specialized regulatory and clinical expertise delivered with practical, implementation-focused guidance rather than generic consulting frameworks. The firm excels in situations requiring FDA regulatory strategy, inspection readiness, or clinical trial optimization where direct agency experience provides tangible value.

Companies can expect tailored solutions scaled to their stage and needs, whether navigating first-time submissions, remediating compliance issues, or accessing specialized pathways like military health systems. The boutique structure enables partner-level attention with flexible engagement terms.

Healthcare Innovation Catalysts operates exclusively within the medical product sector, serving pharmaceutical, biotech, medical device, diagnostic, and digital health companies. The firm's healthcare focus extends beyond commercial markets to include specialized expertise in federal healthcare systems, supporting clients with BARDA funding applications, Military Health System access strategies, and VA market entry.

All services address healthcare-specific regulatory requirements including FDA compliance, GMP/GCP standards, clinical trial regulations, and healthcare reimbursement coding and coverage analysis through CMS and private payers.

Medical product companies at any stage from early development through commercialization that require specialized regulatory, clinical, or quality expertise. Particularly suited for organizations seeking strategic guidance on FDA pathways, companies facing compliance challenges or inspection preparation, and those pursuing government healthcare markets including DoD and VA systems.