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