Areas of Expertise
Our expertise touches each point of the patient experience. We advise on coverage, data strategy, market access, product design, quality measurement, federal agency regulation, and more.
Coverage
-
Engagement in developing a strategy to obtain coverage for novel devices and drugs including both local and national coverage decision processes with CMS.
-
Strategies for integration into value-based contracting.
-
Evidence generation for product coverage by both private and public payors in managed care and fee-for service payor arrangements.
-
Assistance in developing evidence-development studies and use of real-world evidence.
-
Strategies around coverage of artificial intelligence (AI) -enhanced devices and Software as a Medical Device (SaMD)
Data Strategy
-
Integration of data into corporate or organizational strategic planning.
-
Development of organizational strategies for optimizing use of data, including data infrastructure, interoperability, platforms, and visualization/analysis tools.
-
Evaluation of the use of artificial intelligence and its implications for product development, coverage determination, and healthcare delivery or financing.
-
Assessment of analytic approaches and methodologies for leveraging real world data and evidence.
-
Evaluation of data commercialization opportunities and ‘data as a product’ within the broader healthcare ecosystem.
Market Access
-
Value-assessment and communication strategy for product diffusion in both the private and public marketplace.
-
Identification of market barriers and strategic access points.
-
Product generation and identification of gaps in marketplace for growth opportunities.
-
Development of studies to expand novel real-world data approaches.
Product Design and Development
-
Design strategy development encompassing user (patient/provider) experience, aesthetics, and functionality to enhance products or services.
-
Usability and design research to understand needs, preferences, and behaviors of target users, usability testing and evaluation to gather real-world feedback and data, and comparative product analysis for physical and digital products.
-
Evaluation and visualization of shape and form, content, layout, and patient/provider experience; systematic analysis of physical and digital interfaces to optimize usability and acceptance.
-
Integration of design objectives for production/manufacturing, marketing, and distribution.
Quality Measurement and Reporting
-
Quality measurement development and incorporation into programs by federal agencies.
-
Reporting requirements and regulation around the collection and utilization of quality measurement data including its use in outreach and regulatory strategies.
-
Development of patient-reported outcome measures (PROMs) into quality programs.
-
Development of report cards for hospitals/health systems .
Federal Agency
Regulation
-
Strategizing around federal government engagement including best-practices, storyboarding, utility, and priority mapping.
-
Advising around regulation of novel technologies including device, AI, digital therapeutics, pharmaceuticals, and vendor infrastructure.
-
Educating around federal processes and procedures.
