Strategic planning for market readiness

• A delivered Strategic Plan document
• Mission Development (if needed)
• Roadmap to where the company is going, and directions on how to get there - business and operational analyses
• Adapted to today’s healthcare environment
  • With flexibility scenarios
  • Availability of experts in reimbursement (private and federal and state government)
  • Insurance programs w/ Local access measures
• Measures of key performance indicators and guideposts to determine success
• Communication Strategies to reach internal employees and external key constituents

Regulatory requirements for US submissions of health IT products and services

• Pre 510(k) submission gap analysis and requirements evaluation
• Review of your overall regulatory strategy and determination of how the project will align with your business objectives
• Presentation of HIPAA and state privacy laws (in conjunction with legal) State Professional board requirements
• State Professional board requirements

Early Reimbursement Planning

• Early stage analysis
• Pre-commercial products
• Dossier preparation
• VBP modeling
• Clinical/Quality outcomes analysis

Clinical Study Design

• Financial and Clinical Outcomes
• Statistical and Actuarial methods and data analyses
• Ease of IT integration with feedback from MDs, nurses, patients and consumers
• Review by payors and other key stakeholders for requirements

Clinical Market Expertise

• Consumer-driven healthcare
• Telehealth product and service launch
• Distribution channels
• Collaborations and partnership for successful product and service launch
• Expert National Advisors available

Placement of Board of Directors and Advisory Board Development

• Product subject matter expertise
• Identification of channels for regulatory, reimbursement or sales
• Ability to provide expertise and access to capital to CEO and management
• Deep network of experts who can work with companies as consultants or provide openings to new hire