About
HCIR
Founders
Senior Advisors
Medical Innovation Services
Medical Innovation Services
Early-Stage Product Concept Assessment
Pre (non)-Clinical Services
Clinical Stage Services
Pre-Approval Services
Commercialization Considerations
Mature product considerations/Product lifecycle management
Healthcare Delivery Services
Investor/Analyst Services
Value-Based Care Expertise
Contact
Early-Stage Product Concept Assessment
Technology Optimization
Technology Optimization
Provide an early assessment of the technology effectiveness, safety, and commercial scalability
Ease of use for operator to ensure market adaptation
Provide a comprehensive multi-stakeholder market assessment including competitive landscape and need for new technology
Regulatory strategy
Regulatory strategy
Establish regulatory pathway
Identify potential roadblocks to approval
What data will be needed to achieve regulatory approval
Oversight of strategy and critical review of submissions
Optimizing FDA relationship and communication
Clinically informed market research
Clinically informed market research
Define the market
Identify likely end user (OBL, ASC, or hospital)
Economic analysis of the market
Product Adoption Analysis
Identify clinical support needs from entry level community hospitals to academic institution
Competitive product analysis
Primary market research
Clinician one-on-one interviews for:
Product input
User experience
Benefits over competing products
Conduct interviews with all stakeholders: hospital administrators, service line administrators
Align desired marketing claims to testing requirements
Market access and commercialization considerations
Market access and commercialization considerations
Develop a preliminary market access, reimbursement, and commercialization strategy.
Begin considerations for Value Analysis Committee strategy and preparation.
What data or evidence will the product need to demonstrate value with clinical and economic customer segments at hospitals, ASCs, OBLs, GPOs, etc?
Cost benefit analysis.
Economic Analysis of Market
Economic Analysis of Market
What are the economic prospects of the device?
What are the potential reimbursement pathways for the product in various settings of healthcare delivery (Hospital, ASC, OBL)?
Potential future changes to reimbursement that may help or harm the device prospects?
Other economic analysis that should be considered
General Counsel Services
General Counsel Services
Entity structuring
Financing structuring
Acquisition structuring
Licensing structuring
Team building and relationship structuring
SAB structuring and compliance
Board of Directors building and management
General business/legal advisory work
Acquisition support
Diligence support
