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Lean Startup in a Regulated Environment
Mureen Allen
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Lean Startup in a Regulated Environment
Mureen Allen, MD, MS, MA, FACPSVP, Clinical & Affordability Lead
Friday, April 7, 2023
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The Lone Intrepreneur
How do you follow the principles of lean startup in a highly matrixed and regulated environment?
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Project Trajectory Bumps on the Road
Customer Discovery
Customer Validation
Minimal Viable Product
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Finding Your Customer• Customer Discovery
– Family, friend, co-worker– Internet disease forums– Online website– Adult day Care– Goggle advertisements– Craig’s list
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Finding Your Customer• Key Barriers to Success
– Timing – Networking– Restrictions to online
medical content– Think outside the
corporate box
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Validating Your Idea• Customer Validation:
– Summarize initial idea or concept– Validate with interviews– Update thinking
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Validating Your Idea• Key Barriers to Success :
– Not truly validating your idea– Not understanding the market– Not updating thinking
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Your Minimum Viable Product• Use the data collected from
customer discovery and validation
• Scale the MVP• Iterative development and design• Set expectations
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Your Minimum Viable Product• Key Barriers to Success
– Corporate sponsor– Network for adoption– Forget timelines
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Major Barriers to Success!• Legal Oversight & Compliance
– Customer Discovery and Validation• Confidentiality• Compensation • Existing customers
– HIPAA • Privacy & security• Medical history
– Medical fora• Providing medical advice
– Website• Online disclosure• Public solicitation
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Current Status• 6 months later:
– Legal review of agreements– Piloting with a larger application– Customer deployment
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Conclusion• Difficulties and challenges in adopting LS
principles especially a lone intrepreneur• Lessons learned
– Be bold!– Think outside the corporate box!– Legal from day one!– Timelines – Really?
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Contact Information
Mureen Allen, MD, MS, MA, FACPSVP, Clinical & Affordability Lead
908.696.2875