The CEO of an early-stage, novel digital therapeutic company hired Catalyst to research and create a road map to the marketplace, considering whether to seek FDA clearance or not and the reimbursement implications of this decision.
Strategy
Gathered an expert inter-regulatory team to identify the nexis of regulatory, market access, and reimbursement strategies.
Produced an executable strategy that included regulatory pathway coverage, reimbursement recommendations, a cost-effective development approach, a market entry-strategy, and business considerations outlined for informed decision making.
Impact
Client decided to go with a different approach but returned a year later to follow-up on Catalyst’s recommended strategy.