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Cross-Border Hardware Success: Navigating Canadian and U.S. Regulations

Insights from Hardtech Innovators Meetup on successful U.S. market entry for Canadian hardware companies

Cross-Border Hardware Success: Navigating Canadian and U.S. Regulations

This article summarizes insights from the Hardtech Innovators Meetup held in Montreal in November 2024, featuring Sam Rudolph (ecobee), Louis St-Pierre (Ora Medical), JB Congy (EY), and Alexia Magneron (Osler).

Three Critical Success Factors

  1. Understanding contract-centric U.S. business relationships
  2. Early integration of compliance into product development
  3. Strategic market entry choices

The U.S. Business Playbook

  • Contract importance: "They're not just legal documents—they're your first line of communication" (Magneron)
  • Tax complexity: Companies face obligations in up to 45 states with varying trigger points
  • Revenue thresholds: Tax compliance obligations activate at approximately $100,000 annually

Market Entry Strategies

  • dcbel's approach: Selected California as entry point to validate their model before nationwide expansion
  • Ora Medical's approach: Focused on regional partnerships and distribution networks

Resources

  • Trade Commissioner Service (TCS)
  • Investissement Québec International
  • FDA's Division of Industry and Consumer Education (DICE)
  • Consumer Technology Association (CTA)

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