services

NaviDx is dedicated to empowering in vitro diagnostic (IVD) and life science companies and their investors with lean, market-driven strategies that streamline the path from innovation to commercialization and deliver measurable impact.

The NaviDx Framework

We apply a consistent framework to each project, built on decades of industry experience and refined over 10 years and more than 100 client engagements.

We partner closely with our clients to ensure the framework is understood, relevant to their needs and can be used to improve performance long after project completion.

There are five elements to this framework:

1. Situation Analysis

Market intelligence using public information and organizational assessments using client documentation and NaviMAP™ organization maturity assessments identify target markets, market drivers, product-market fit, competitive differentiators and “what a winner looks like” using public information.

2. Strategy Development

Integrated or standalone strategies & business models that include business, commercial, regulatory, clinical and/or
reimbursement requirements are developed by applying our insights to the Situation Analysis.

3. Validation

Primary market research studies, pressure-test and validate recommendations and assumptions made in Strategy Development using Voice of Customer (VOC) studies, focus groups and advisory boards.

4. Insights & Synthesis

Strategic recommendations and business models are refined by incorporating learnings and our insights from Market Validation studies.

5. Implementation

“Force Multiplier” resources or fractional roles are deployed to support business development, strategic marketing, product development, commercialization, quality, regulatory, and reimbursement initiatives.

Comprehensive, integrated strategic plans are based on our deep experience, rigorous market research, customer insights, and industry intelligence.

Market Research

  • Market Landscape and Sizing
  • Customer Segmentation
  • Competitor Analysis
  • Qualitative and Quantitative Market Research Strategies
  • Market Research & Voice of Customer Studies
  • Focus Groups and Advisory Board Meetings

Strategic Planning

  • Long-Range Planning (Corporate/Product Specific)
  • Market Forecasting (PAM/TAM)
  • Product Pipeline Strategy
  • Portfolio Expansion Analysis
  • Product Life Cycle Management
  • Target Product Profile & Product-Market Fit Assessment
  • Commercialization Strategy
  • Sales & Marketing Plans
  • NaviMAP™ Organization Maturity Assessment
  • Organizational Design & Fractional Roles

Strategic Partner and Investment Readiness

  • Strategic Partner Engagement Strategy
  • Strategic Partner Identification & Engagement
  • Investment Strategy
  • Investor Pitch Decks
  • M&A Due Diligence
  • Post-Merger/Acquisition Integration Planning

Business Strategy & Market Research

Business Strategy & Market Research

Comprehensive, integrated strategic plans are based on our deep experience, rigorous market research, customer insights, and industry intelligence.

Market Research

  • Market Landscape and Sizing
  • Customer Segmentation
  • Competitor Analysis
  • Qualitative and Quantitative Market Research Strategies
  • Market Research & Voice of Customer Studies
  • Focus Groups and Advisory Board Meetings

Strategic Planning

  • Long-Range Planning (Corporate/Product Specific)
  • Market Forecasting (PAM/TAM)
  • Product Pipeline Strategy
  • Portfolio Expansion Analysis
  • Product Life Cycle Management
  • Target Product Profile & Product-Market Fit Assessment
  • Commercialization Strategy
  • Sales & Marketing Plans
  • NaviMAP™ Organization Maturity Assessment
  • Organizational Design & Fractional Roles

Strategic Partner and Investment Readiness

  • Strategic Partner Engagement Strategy
  • Strategic Partner Identification & Engagement
  • Investment Strategy
  • Investor Pitch Decks
  • M&A Due Diligence
  • Post-Merger/Acquisition Integration Planning

NaviDx provides support to accelerate market development, enhance strategic stakeholder engagement, and build robust commercial infrastructures.

Market Research

  • Market Landscape and Sizing
  • Customer Segmentation
  • Competitor Analysis
  • Qualitative and Quantitative Market Research Strategies
  • Market Research & Voice of Customer Studies
  • Focus Groups and Advisory Board Meetings

Commercialization Strategy & Launch Planning

  • Product Launch Planning & ExecutionMarket Research & Voice of Customer Studies
  • Market Development Planning & Execution
  • Initial Sales Funnel, Specialty Sales & Marketing
  • NaviMAP™ Commercial Organization Maturity Assessment
  • Commercial Organizational Structure Design
  • Incentive Compensation Plan Development
  • Development of Internal/Customer Training Programs
  • Business Development and Strategic Partner Analysis
  • Sales Channel Strategy (PCP, Health Systems, FQHCs, Public Health, OTC)
  • Trade Show Strategy
  • Pricing/Reimbursement Strategy

Specialty Sales & Marketing

  • KOL, Stakeholder & Strategic Partner Engagement
  • Key Account Management
  • Distributor Management
  • Commercial Team Management
  • Trade Show Management
  • Marketing Communications
  • Product Launch
  • Talent Recruiting
  • Contract Negotiations

Strategic Partner and Investment Readiness

  • Strategic Partner Engagement Strategy
  • Strategic Partner Identification & Engagement
  • Investment Strategy
  • Investor Pitch Decks
  • M&A Due Diligence
  • Post-Merger/Acquisition Integration Planning

Commercial Development

Commercial Development

NaviDx provides support to accelerate market development, enhance strategic stakeholder engagement, and build robust commercial infrastructures.

Market Research

  • Market Landscape and Sizing
  • Customer Segmentation
  • Competitor Analysis
  • Qualitative and Quantitative Market Research Strategies
  • Market Research & Voice of Customer Studies
  • Focus Groups and Advisory Board Meetings

Commercialization Strategy & Launch Planning

  • Product Launch Planning & ExecutionMarket Research & Voice of Customer Studies
  • Market Development Planning & Execution
  • Initial Sales Funnel, Specialty Sales & Marketing
  • NaviMAP™ Commercial Organization Maturity Assessment
  • Commercial Organizational Structure Design
  • Incentive Compensation Plan Development
  • Development of Internal/Customer Training Programs
  • Business Development and Strategic Partner Analysis
  • Sales Channel Strategy (PCP, Health Systems, FQHCs, Public Health, OTC)
  • Trade Show Strategy
  • Pricing/Reimbursement Strategy

Specialty Sales & Marketing

  • KOL, Stakeholder & Strategic Partner Engagement
  • Key Account Management
  • Distributor Management
  • Commercial Team Management
  • Trade Show Management
  • Marketing Communications
  • Product Launch
  • Talent Recruiting
  • Contract Negotiations

Strategic Partner and Investment Readiness

  • Strategic Partner Engagement Strategy
  • Strategic Partner Identification & Engagement
  • Investment Strategy
  • Investor Pitch Decks
  • M&A Due Diligence
  • Post-Merger/Acquisition Integration Planning

With a combined expertise of hundreds of product launches in the IVD and life science research markets, we support rigorous technology assessments, target product profile development, regulatory strategy, clinical trial designs, and product-market fit evaluations, enabling your team to deliver innovative, market-relevant products.

Portfolio Management

  • Product Pipeline Strategy
  • Portfolio Expansion Analysis
  • Product Life Cycle Management
  • Target Product Profile & Product-Market Fit Assessment
  • Technology and Commercial Viability Assessments & Remediation
  • Competitive Landscape and Differentiators
  • Scientific & Medical Advisory Board creation &
    management
  • CDMO & CRO Engagement

Product Development

  • Product Development, Regulatory, V&V and Clinical Strategies
  • Target Product Profile Development, Analysis, and Recommendation
  • Product-Market Fit Assessments
  • Development Plan and R&D Team Assessments
  • Troubleshooting Product Development Delays
  • NaviMAP™ Product Development Organization Maturity Assessment
  • Study Protocol Design
  • Design Controls and Risk Management

Product and Portfolio

Product and Portfolio

With a combined expertise of hundreds of product launches in the IVD and life science research markets, we support rigorous technology assessments, target product profile development, regulatory strategy, clinical trial designs, and product-market fit evaluations, enabling your team to deliver innovative, market-relevant products.

Portfolio Management

  • Product Pipeline Strategy
  • Portfolio Expansion Analysis
  • Product Life Cycle Management
  • Target Product Profile & Product-Market Fit Assessment
  • Technology and Commercial Viability Assessments & Remediation
  • Competitive Landscape and Differentiators
  • Scientific & Medical Advisory Board creation &
    management
  • CDMO & CRO Engagement

Product Development

  • Product Development, Regulatory, V&V and Clinical Strategies
  • Target Product Profile Development, Analysis, and Recommendation
  • Product-Market Fit Assessments
  • Development Plan and R&D Team Assessments
  • Troubleshooting Product Development Delays
  • NaviMAP™ Product Development Organization Maturity Assessment
  • Study Protocol Design
  • Design Controls and Risk Management

With hundreds of FDA submissions and deep reimbursement expertise we support you from early strategic planning through to global regulatory submissions, FDA interactions, and comprehensive reimbursement strategies.

Regulatory

  • Regulatory and Clinical Strategies
  • Pre-Submission Document Preparation & Review
  • Regulatory Filings and FDA Interactions
  • Clinical Study Design and Protocol Review
  • Responses to FDA reviews

Market Access

  • Reimbursement and Market Access Strategies
  • Policy Monitoring and Impact Assessment
  • Health Economic Studies
  • Dossier Preparation and Submission for Payer Decision-Making

Regulatory and Reimbursement

Regulatory and Reimbursement

With hundreds of FDA submissions and deep reimbursement expertise we support you from early strategic planning through to global regulatory submissions, FDA interactions, and comprehensive reimbursement strategies.

Regulatory

  • Regulatory and Clinical Strategies
  • Pre-Submission Document Preparation & Review
  • Regulatory Filings and FDA Interactions
  • Clinical Study Design and Protocol Review
  • Responses to FDA reviews

Market Access

  • Reimbursement and Market Access Strategies
  • Policy Monitoring and Impact Assessment
  • Health Economic Studies
  • Dossier Preparation and Submission for Payer Decision-Making

We elevate product quality and operational performance by designing, implementing and optimizing quality management systems, streamlining regulatory compliance and auditing, and improving operational efficiency.

Quality

  • QMS/eQMS Strategy and Implementation
  • eQMS Platform Selection
  • IVDR QMS Compliance
  • Certifications ISO 13485, ISO 9001, ISO 17025, MDSAP, IVDR
  • Registrar and Notified Body Selection
  • Internal Quality Audit Management (IQA)
  • CAPA Management and Audit Remediation
  • FDA Warning Letter Support and Remediation
  • Product Recalls and Withdrawal
  • CLIA Lab QMS Accreditation
  • Manufacturing facility inspections

Operational Excellence

  • NaviMap™ Organization Maturity Assessment
  • Organization Remediation Plan

Quality and Operational Excellence

Quality and Operational Excellence

We elevate product quality and operational performance by designing, implementing and optimizing quality management systems, streamlining regulatory compliance and auditing, and improving operational efficiency.

Quality

  • QMS/eQMS Strategy and Implementation
  • eQMS Platform Selection
  • IVDR QMS Compliance
  • Certifications ISO 13485, ISO 9001, ISO 17025, MDSAP, IVDR
  • Registrar and Notified Body Selection
  • Internal Quality Audit Management (IQA)
  • CAPA Management and Audit Remediation
  • FDA Warning Letter Support and Remediation
  • Product Recalls and Withdrawal
  • CLIA Lab QMS Accreditation
  • Manufacturing facility inspections

Operational Excellence

  • NaviMap™ Organization Maturity Assessment
  • Organization Remediation Plan

sound like a good fit?

Reach out today and see how we can help you.

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