Debkishora Mitra and John Waldeisen are the co-founders of Lucira Health. Lucira Health, which was originally founded as Diassess, is the first company to get an FDA approval for at-home PCR based test for COVID. We talk about the story of Lucira from its founding stage to raising; the technological and market based pivots; raising over $250M (including an IPO); COVID; leadership transition; regulatory affairs; ups and downs of the journey; FDA approval of at-home flu and covid test and the unfortunate bankruptcy. Shownotes: - https://www.lucirahealth.com - Educational backgrounds of the founders & how they met - Market exploration in search of billion dollar markets: markets for diseases like Malaria not big enough (~$50M) - Technology development: Disposable RT PCR; Passive Fluid actuation; Colorimetric PCR- Visible DNA amplification - Deborah Dean, MD, UCSF - Running PCR in the second bedroom at home; struggling to pay rent - Raising seed round - Visa struggles- Detour to deal with immigration struggles - Growing the team; mistakes - Transparency, radical candor - Ego - Fundraising: Kissing the frogs; building soft circles - Diagnostics market is super hard - Non-dilutive funding; mental models - Venture capital: Lessons learned - Pivots: Technological and market driven (STD, flu, COVID) - Challenges: Regulatory, customer centric thinking, scalability (manufacturing, distribution) - Deep dive into regulatory challenges: Issues with comparing with predicates - "In the diagnostic space, 'you don't want to be the first in the market" - Selecting an advisor to provide regulatory guidance for a startup - Deep dive into product development - Understanding the value of luck: Having a plan B - Evolution of the "Go to market" strategy - Government policies: Macroeconomic factors that affect pricing for startups - Create options as the CEO - Building the narrative - Leadership transition; journey towards IPO - VCs tie your personality to your startup- something to keep in mind for founders - Highs and the lows