Market Access & Healthcare Strategy
Market Access & Healthcare Strategy
Duba & Partners helps healthcare and medical-device companies align regulatory requirements, clinical evidence, market intelligence, pricing, and reimbursement to prepare for the United States and European markets.
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(01)
(What)
© 2026
(01)
(What)
Real-world evidence and data strategy
Pricing and reimbursement strategy
Stakeholder and market entry planning
Regulatory pathway planning
Market opportunity assessment
Evidence and value strategy
Healthcare strategy and market access that guide innovation to adoption
Real-world evidence and data strategy
Stakeholder and market entry planning
Regulatory pathway planning
Market opportunity assessment
Evidence and value strategy
Pricing and reimbursement strategy
Healthcare strategy and market access that guide innovation to adoption
Healthcare strategy and market access that guide innovation to adoption
Real-world evidence and data strategy
Regulatory pathway planning
Market opportunity assessment
Evidence and value strategy
Pricing and reimbursement strategy
Stakeholder and market entry planning
Real-world evidence and data strategy
Pricing and reimbursement strategy
Stakeholder and market entry planning
Regulatory pathway planning
Market opportunity assessment
Evidence and value strategy
Healthcare strategy and market access that guide innovation to adoption
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(Our approach)
© 2026
Navigating complex healthcare markets
01
Regulatory Strategy
Define the appropriate regulatory pathway and prepare the requirements needed to bring a medical device to the US and European market.
FDA Marketing Authorization
EU MDR & CE Marking
Device Classification
Regulatory Feasibility
Premarket Approval
MDUFA Fee Processing
Statements & Amendments
02
Clinical and Real-World Evidence
Plan and support the clinical and real-world evidence required to demonstrate product safety, performance, and value.
Clinical Study Strategy
Premarket Clinical Studies
Investigational Device Exemptions
Real-World Evidence
Post-Market Studies
Patient Registries
03
Market Entry Readiness
Build a clear understanding of the market and translate it into a commercially grounded strategy for the United States and Europe.
Market Research
Commercial Potential
Competitive Landscape
Market Risks & Barriers
Price Sensitivity
Pricing Strategy
Reimbursement Assessment
US & EU Business Planning
04
Market Establishment & Representation
Establish the relationships, local presence, and practical support required to enter and operate within the target healthcare market.
Healthcare Providers
Key Opinion Leaders
Research Institutions
Insurance Companies
Distribution Partners
US Representation
Local Market Support
Strategic support for growth-focused teams
Regulatory Strategy
Define the appropriate regulatory pathway and prepare the requirements needed to bring a medical device to the US or European market.
FDA Marketing Authorization
EU MDR & CE Marking
Device Classification
Regulatory Feasibility
Premarket Approval
MDUFA Fee Processing
Statements & Amendments
Clinical and Real-World Evidence
Plan and support the clinical and real-world evidence required to demonstrate product safety, performance, and value.
Clinical Study Strategy
Premarket Clinical Studies
Investigational Device Exemptions
Real-World Evidence
Post-Market Studies
Patient Registries
Market Entry Readiness
Build a clear understanding of the market and translate it into a commercially grounded strategy for the United States or Europe.
Market Research
Commercial Potential
Competitive Landscape
Market Risks & Barriers
Price Sensitivity
Pricing Strategy
Reimbursement Assessment
US & EU Business Planning
Market Establishment & Representation
Establish the relationships, local presence, and practical support required to enter and operate within the target healthcare market.
Healthcare Providers
Key Opinion Leaders
Research Institutions
Insurance Companies
Distribution Partners
US Representation
Local Market Support
Strategic support for growth-focused teams
Regulatory Strategy
Define the appropriate regulatory pathway and prepare the requirements needed to bring a medical device to the US or European market.
FDA Marketing Authorization
EU MDR & CE Marking
Device Classification
Regulatory Feasibility
Premarket Approval
MDUFA Fee Processing
Statements & Amendments
Clinical and Real-World Evidence
Plan and support the clinical and real-world evidence required to demonstrate product safety, performance, and value.
Clinical Study Strategy
Premarket Clinical Studies
Investigational Device Exemptions
Real-World Evidence
Post-Market Studies
Patient Registries
Market Entry Readiness
Build a clear understanding of the market and translate it into a commercially grounded strategy for the United States or Europe.
Market Research
Commercial Potential
Competitive Landscape
Market Risks & Barriers
Price Sensitivity
Pricing Strategy
Reimbursement Assessment
US & EU Business Planning
Market Establishment & Representation
Establish the relationships, local presence, and practical support required to enter and operate within the target healthcare market.
Healthcare Providers
Key Opinion Leaders
Research Institutions
Insurance Companies
Distribution Partners
US Representation
Local Market Support
Navigating complex healthcare markets
01
Regulatory Strategy
Define the appropriate regulatory pathway and prepare the requirements needed to bring a medical device to the US and European market.
FDA Marketing Authorization
EU MDR & CE Marking
Device Classification
Regulatory Feasibility
Premarket Approval
MDUFA Fee Processing
Statements & Amendments
02
Clinical and Real-World Evidence
Plan and support the clinical and real-world evidence required to demonstrate product safety, performance, and value.
Clinical Study Strategy
Premarket Clinical Studies
Investigational Device Exemptions
Real-World Evidence
Post-Market Studies
Patient Registries
03
Market Entry Readiness
Build a clear understanding of the market and translate it into a commercially grounded strategy for the United States and Europe.
Market Research
Commercial Potential
Competitive Landscape
Market Risks & Barriers
Price Sensitivity
Pricing Strategy
Reimbursement Assessment
US & EU Business Planning
04
Market Establishment & Representation
Establish the relationships, local presence, and practical support required to enter and operate within the target healthcare market.
Healthcare Providers
Key Opinion Leaders
Research Institutions
Insurance Companies
Distribution Partners
US Representation
Local Market Support
(03)
(Clients)
© 2026
(03)
(Clients)
When clients engage Duba & Partners
When clients engage Duba & Partners
Regulatory authorization, clinical evidence, real-world evidence, market readiness, pricing, and reimbursement all influence one another. Duba & Partners connects these workstreams from the beginning, ensuring that every decision supports the same market-entry strategy.
Regulatory authorization, clinical evidence, real-world evidence, market readiness, pricing, and reimbursement all influence one another. Duba & Partners connects these workstreams from the beginning, ensuring that every decision supports the same market-entry strategy.
(04)
(How)
© 2026
(04)
(How)
How We Work
How We Work
Duba & Partners combines healthcare expertise, data intelligence, and technology to help organisations understand complexity, make better decisions, and turn those decisions into action.
Duba & Partners combines healthcare expertise, data intelligence, and technology to help organisations understand complexity, make better decisions, and turn those decisions into action.
Understand the product and objective
We begin by understanding the product, its intended use, available evidence, current regulatory status, target market, and the organisation’s commercial objectives.
Understand the product and objective
We begin by understanding the product, its intended use, available evidence, current regulatory status, target market, and the organisation’s commercial objectives.
Assess feasibility and requirements
We evaluate the regulatory, clinical, market, and access requirements that may shape the product’s path into the selected market.
Assess feasibility and requirements
We evaluate the regulatory, clinical, market, and access requirements that may shape the product’s path into the selected market.
Define the strategy
We connect regulatory authorization, evidence generation, market readiness, pricing, and reimbursement into one practical strategy.
Define the strategy
We connect regulatory authorization, evidence generation, market readiness, pricing, and reimbursement into one practical strategy.
Build the roadmap
We translate the strategy into specific workstreams, priorities, responsibilities, evidence requirements, deliverables, and decision points.
Build the roadmap
We translate the strategy into specific workstreams, priorities, responsibilities, evidence requirements, deliverables, and decision points.
Prepare and deliver
We support the preparation of submissions, evidence programmes, market analyses, access strategies, and other work required to advance the product.
Prepare and deliver
We support the preparation of submissions, evidence programmes, market analyses, access strategies, and other work required to advance the product.
Review and adapt
We refine the strategy as regulatory feedback, new evidence, and changing market conditions shape the decisions ahead.
Review and adapt
We refine the strategy as regulatory feedback, new evidence, and changing market conditions shape the decisions ahead.