Market access for SaMD and AI devices
Market access for SaMD and AI devices
We help maximize product value, accelerate reimbursement, and expand market access for SaMD and AI devices.
We help maximize product value, accelerate reimbursement, and expand market access for SaMD and AI devices.
We help SaMD and AI medical device clients scope, design, and execute projects that guide critical strategic decisions. From early development through to market entry and post-market success, we ensure products are aligned with clinical needs, backed by strong evidence, and positioned for sustainable growth.
Expertise
- Integrated products and beyond-the-pill solutions
- Precision and personalized medicine
- Innovative diagnostics
- Digital Health
- Therapeutics
Problem-solving approach
Problem-solving approach
We’ve developed and adapted methodologies that fit the needs and reality of diagnostic and digital health products and also mid-sized companies.
Early Development
Opportunity assessment
Evaluate the opportunity for a product, indication, or market to inform a decision for investment or a milestone.
Landscaping or mapping
Understand the disease, competitive, and access landscape to formulate a better strategy for the product. Evidence needs to evaluate the best plan for evidence development depending on objectives and align them across the brand team.
Global access strategy
Define the best access strategy for navigating both established and innovative reimbursement and funding pathways.
Launch Preparation
Value propositions
Formulate and target the value proposition to different markets, customer segments, and patient populations.
Pricing, innovative agreements, and negotiation
Define the best price positioning, choose applicable agreement options, and train for negotiation.
Access readiness
Adapt the global strategy to the reality of different countries, preparing and empowering local teams.
Product Growth
Access expansion
Assess untapped potential in some markets and leverage new segments (e.g., private market).
Product innovation & differentiation
Manage a specific product or competitive challenges with the patient or HCP add-on services and technology.
Partnership
Mapping for partner evaluation and selection (service, diagnostic, or digital health).
Early Development
Opportunity assessment
Evaluate the opportunity for a product, indication, or market to inform a decision for investment or a milestone.
Landscaping or mapping
Understand the disease, competitive, and access landscape to formulate a better strategy for the product. Evidence needs to evaluate the best plan for evidence development depending on objectives and align them across the brand team.
Global access strategy
Define the best access strategy for navigating both established and innovative reimbursement and funding pathways.
Launch Preparation
Value propositions
Formulate and target the value proposition to different markets, customer segments, and patient populations.
Pricing, innovative agreements, and negotiation
Define the best price positioning, choose applicable agreement options, and train for negotiation.
Access readiness
Adapt the global strategy to the reality of different countries, preparing and empowering local teams.
Product Growth
Access expansion
Assess untapped potential in some markets and leverage new segments (e.g., private market).
Product innovation & differentiation
Manage a specific product or competitive challenges with the patient or HCP add-on services and technology.
Partnership
Mapping for partner evaluation and selection (service, diagnostic, or digital health).