"We leverage more than 200 years of collective expertise in a wide variety of functional disciplines to provide client partners with strategic and tactical guidance based on practical experience." - Scott Bruder, MD, PhD 

Optimize Product Portfolio Management
  • Valuation of Discrete Projects and Programs 

  • Proprietary Analytical and Heat Mapping Tools

  • Market Opportunity Assessment and Return-On-Investment Metrics

  • Objective Analysis Drives Critical Thinking and Insightful Dialogue

  • Streamline Decision-Making and Efficient Resource Deployment

Solve Diverse Clinical Challenges
  • Orthopaedic Surgery, Sports Medicine, Trauma & Extremities

  • Spine and Neurosurgery, General Surgery, Plastic & Reconstructive Surgery 

  • Ophthalmology, Urology and Women's Health, Wound Healing 

  • Diabetes & Metabolic Disorders, Neurology, Immunology, Cardiology

  • In Vitro Molecular- and Immuno-Diagnostics, Point-of-Care Diagnostics

Accelerate Product Development
  • Target Product Profile Design, Development Risk Mitigation

  • Pre-clinical Model Development, Animal and Laboratory Bench Testing

  • Clinical Development Strategy, Trial Design and Site Identification

  • Statistical Analysis and Review, Bayesian and Adaptive Trial Designs

  • KOL Identification & Development, Establishment of CRO Partnerships

  • Physician Surveys (n=5 to 1,000), Animal & Cadaver Lab Organization

Navigate Regulatory and Quality Requirements
  • FDA Submission Strategy for 510(k), IDE, PMA, IND, NDA and BLA pathways

  • HUD/HDE, De Novo and 513(g) Negotiation

  • FDA Meeting Representation, Senior Level Involvement at FDA

  • On-label and Off-label Guidance, HCP Compliance Review

  • Quality System Review, Design Control, MDR, CAPA

Utilize the Latest Technologies
  • Implantable Devices, Combination Products, Regenerative Medicine

  • Cell Therapy, Orthobiologics, Tissue Engineering

  • Biomaterials, Recombinant Proteins, Biopolymers

  • Minimally Invasive Surgery, Imaging Modalities

  • Oligonucleotide Drugs, Immuno & Molecular Diagnostics

Design Commercialization Strategies​​
  • Strategic & Quantitative Marketing Surveys - 30 to 300 physicians

  • Market Landscape Review, Competitive Intelligence & Product Positioning

  • Reimbursement Approach, Coding, Coverage and Payment Analysis

  • Clinical and Health Economic Studies, Manuscript Preparation / Review

  • Commercial Launch Planning, Distribution Channels and Contacts

Shaking Hands
Support and Execute Business Development Transactions​​
  • Inbound and Outbound Asset Evaluation & Due Diligence 

  • Product Development, License and Distribution Agreements 

  • Asset Identification and Investment Support for PE and VC Firms

  • Focused Diligence and Strategic Business Development Guidance for Public and Private MedTech, Biotech and Pharmaceutical Firms

  • Successful Track Record for Acquisitions from $50 to $500 Million

Maximize Product Reimbursement
  • Coding, Coverage and Payment Analysis

  • Benchmarking for Reference Products

  • Database and Literature Review

  • Strategic Reimbursement Planning

  • Clinical and Health Economic Studies