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Device and radiopharmaceutical founders: map regulatory pathway, IP, and reimbursement early
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Summary
Luco Labs and Cancer Targeted Technology founders advised device and imaging startups to plan clinical milestones, use FDA pre‑submission, document IP strategy, and analyze CPT/reimbursement and production constraints for isotopes and imaging agents.
Carlos Castro Gonzalez, CEO of Luco Labs, and Beatrice Langton Webster, CEO of Cancer Targeted Technology, each outlined device‑ and imaging‑specific commercialization concerns that should be explicit in SBIR commercialization plans.
Castro Gonzalez said device developers should sequence clinical milestones—first‑in‑human proof‑of‑concept, feasibility/usability studies in Phase 2, and then pivotal trials—and recommended using FDA pre‑submission meetings to confirm classification and evidence requirements. He also urged teams to document IP status (provisionals vs. granted patents) and to align SBIR milestones with the evidence needed for reimbursement and market access.
Webster focused on imaging agents and radiotherapeutics: production and logistics (isotope half‑life, on‑site versus centralized manufacture, stability and transport) and whether CPT and Medicare reimbursement pathways exist for a new product. She recommended benchmarking pricing and penetration against comparable products (she referenced Polarify and Pluvicto) and gave an example of licensing that used SBIR trial data to reach a commercial partner.
Both speakers emphasized that regulatory, manufacturing and reimbursement considerations shape timelines and finance plans and advised startups to provide measurable, justifiable assumptions in proposals.
