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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. 

Plant

Get in Touch

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