Startups

Early Stage Medical Device Company Assistance

Complete support packages, regulatory affairs consultation and general business and strategic advices for medical device companies throughout the entire product life cycle (from concept, through development, clinical trials and into Manufacturing):

  • Opportunity (Opportunity identification and analysis)
  • Concept Development (Medical device concept rendering, brainstorming, conceptual refinement)
  • Business Plan (Medical device startup companies, early stage firms)
  • Funding Options (VC-Venture Capitalists, Angel/Private Investors, etc)
  • User Requirements
    • Evaluation/Validation of User Requirements
    • Comparison to Device
    • Design Modifications (If Required)
  • Design Phase:
    • Prototype Design
    • User Requirements
    • Regulations
    • Design Controls
    • Design Validation Requirements (Confirm this is the correct device)
    • Device Verification Requirements (Confirm the device has been correctly built)
  • Testing and Clinical Trials
  • Modification
  • Production/Manufacturing
    • ISO 13485:2003 Quality Management System
    • Risk Management
    • Surveillance
  • Process Validation Requirements

Business Strategy

  • Strategic planning, from concept, through design, market and manufacturing
  • Marketing
    • Reimbursement (Reimbursement Code, Hospital and Insurance Payment, Medicare Reimbursements, etc)
    • Pricing Strategies
    • Overseas Marketing
  • Domestic and Overseas Distribution
  • Manufacturing: In-house or OEM, Domestic or Overseas, etc.

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