James Kim
Founder and CEO, 551 Consultant LLC
With over 25 years as a strategic innovation leader in the medical device field, I specialize in connecting engineering ideas with clinical and technological adoption. I've helped launch more than 30 medical devices worldwide, managing a portfolio valued at over $100 million. I take pride in navigating complex regulatory landscapes like FDA approval, employing human-centered design, and crafting commercial strategies to ensure products not only enter the market but also see active use. I had the privilege of leading a diverse team of engineers, scientists, product managers, physicians, and investors as a director overseeing a P&L. One of my most rewarding experiences was co-producing the BBC technology show “Bang Goes The Theory,” akin to MythBusters on Discovery, showcasing how wearable sensors can impact our lives. I also possess practical experience in branding, positioning, and marketing for major events such as CES, Medica, and others. At mHUB, I enjoy mentoring MedTech and hard-tech founders, helping them de-risk early stages, align product roadmaps with clinical workflows, and transition smoothly from prototypes to production. Most importantly, I serve as a background mentor, supporting their efforts to achieve their goals.
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?