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
Pre-Clinical Services
In Vivo Environment
In Vivo Environment
Defining appropriate in vivo boundary conditions and device lifetime requirements
Interpret literature, clinical imaging data, and standards for relevant pressures, motions, and other factors influencing device performance
Computational Modeling
Computational Modeling
Translate in vivo conditions to meaningful computational boundary conditions
Define appropriate computational strategies to meet engineering and regulatory requirements
Benchtop Testing
Benchtop Testing
Assist client in the development and confirmation of clinically appropriate benchtop models to effectively assess efficacy of product and to communicate product efficacy to investors.
Working with our regulatory and engineering consultants to confirm boundary conditions of bench top model.
Physician confirmatory testing in bench top models
Animal Studies
Animal Studies
Selecting appropriate animal model
Defining appropriate goals for preclinical animal studies
Establishing animal protocol per regulatory recommendations
Clinical execution and procedural refinement based on findings
Technology refinement based on pre-clinical testing and user input
Technology refinement based on pre-clinical testing and user input
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
Define marketing claims matrix and supporting clinically relevant test requirements
Align desired marketing claims to testing requirements
Engineering strategy
Engineering strategy
Assist in establishing the product development process (PDP) for R&D and serve as independent design reviewers
Review key design control documents such as design inputs, specification justifications, trace matrix, etc.
Develop the device evaluation strategy
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
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 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.
Strategic insights for acquisition
Strategic insights for acquisition
What are desired new technologies and therapies?
What are the strategic partners looking for in acquistions?
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.
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
