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James Kim

Founder and CEO, 551 Consultant LLC

I’m the Founder and CEO of 551 Consultant LLC, with over 25 years of experience bringing medical devices from concept to global market. I’ve launched more than 30 devices and specialize in regulatory strategy, clinical adoption, and commercialization. I help founders de-risk development, align with clinical workflows, and successfully transition from prototype to scalable product.

 

QUESTIONS I CAN ANSWER

  • How do I validate my product within real clinical workflows?
  • What milestones are needed to reach commercialization?
  • How do I navigate regulatory and go-to-market challenges in MedTech?

Questions:

  • How can I validate that my engineering concept fits into a real-world clinical workflow before finalizing the design?
  • What are the key commercial milestones I need to reach to transform this prototype into a scalable, market-ready medical device?
  • Who are the potential commercial partners I should explore to develop my go-to-market strategy and ensure successful execution?