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
Clinical Stage Services
Technology Refinement
Technology Refinement
Clinical translation: Synthesizing procedural and user feedback to improve technology
Root cause analysis to investigate any device failures at this stage.
Clinically Informed Market Research
Clinically Informed Market Research
Define the market
Identify likely end user (OBL, ASC, or hospital)
Economic analysis of the market
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
Pricing strategy
Regulatory Strategy
Regulatory Strategy
Establish or continued evaluation of regulatory pathway
Oversight of strategy and critical review of submissions
Optimizing FDA relationship and communication including preparation for meetings with the FDA
Preparation for FDA panel meetings
Basic regulatory training for a company on the various paths to get to market
Expert witness services
Quality Management System
Quality Management System
Assist in implementation of a quality management system.
Assist in development of design control strategies.
Market Access and Commercialization Considerations
Market Access and Commercialization Considerations
Develop reimbursement strategy.
Develop Value Analysis Committee strategy
Strategy: “Getting your product on the shelf”
Develop value proposition for product or service that is consistent with requirements of Hospital/Healthcare Systems
Strategic Insights for Acquisition
Strategic Insights for Acquisition
What are desired new technologies and therapies?
Portfolio analysis of major players
Strategy acquirers: Brainstorming/wargaming to identify likely acquirers
Business analysis preparation for due-diligence conversations
Pipeline and product portfolio planning (including assistance in IP and white-space analysis)
Maximize potential pool of acquiring partners
Clinical Affairs
Clinical Affairs
Clinical study objectives
Regulatory
Market adoption
Clinical environment strategy
Hospital
Outpatient surgery
ASC/OBL
Medical Community Primary and Secondary Considerations
Medical Community Primary and Secondary Considerations
Specialties for the procedure/device
Clinical Study Design
Clinical Study Design
Creative considerations of primary and secondary endpoints
Mechanism of action
Least burdensome/optimal chance for successful study design
Strategic considerations for data collection
To meet endpoints
For marketing claims
To prove cost-benefit analysis
Adjudication of Clinical Events
Adjudication of Clinical Events
Models for Case Support
Models for Case Support
Technical considerations (trunk stock, etc)
Enrollment considerations
Model for education and maintenance of expertise of clinical support
KOL Outreach
KOL Outreach
KOL strategy development & outreach
Introduction to KOLs and relationship building
Clinical Marketing
Clinical Marketing
Podium & Publication strategy and execution
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
