HomeMaintaining Team Morale Amid Uncertain FDA Approval
# Build Mode
# BioticsAI
# Build Mode Video
# medtech
# Startup Battlefield
# startup battlefield winner
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Enduring the lengthy path to FDA approval involves more than creating groundbreaking technology. It's about sustaining your team's drive, identifying supportive investors, and adapting to operate effectively despite unpredictable schedules.
This week on Build Mode, Isabelle Johannessen is joined by Robhy Bustami, co-founder and CEO of BioticsAI, a Startup Battlefield champion. The company builds an AI copilot for ultrasound technology designed to detect fetal abnormalities. Bustami shares insights from developing a $100,000 prototype to achieving FDA clearance, outlining the real challenges of innovating within one of the globe's most stringent regulatory environments.
This episode delves into the authentic experience of launching a medtech startup, where you cannot simply "move fast and break things." Each milestone demands considerable time, careful coordination, and unwavering trust.
This conversation covers:
How to maintain motivation and ensure team alignment when FDA approval is not a certainty. What founders must understand about navigating the FDA regulatory process from the very beginning.How to attract investors who appreciate the slower pace and high-risk profile of the medtech industry.Why cross-functional collaboration—involving engineers, clinicians, and researchers—is essential for success.The importance of advisors and why engaged, active industry experts often outweigh well-known names.How to build progress and recognize achievements throughout long periods of uncertainty.
Subscribe to Build Mode on Apple Podcasts, Spotify, or your preferred podcast platform. Watch full video episodes on YouTube. New Build Mode episodes are released every Thursday. Hosted by Isabelle Johannessen. Produced and edited by Maggie Nye. Audience development led by Morgan Little. Special thanks to the Foundry and Cheddar video teams.
Apply to Startup Battlefield: We are seeking early-stage companies with a Minimum Viable Product (MVP). Nominate a founder—or yourself—for consideration. Please mention that you heard about Startup Battlefield on the Build Mode podcast. Apply here.
TechCrunch Disrupt 2026: Join us for TechCrunch Disrupt from October 13 to 15 in San Francisco, where the Startup Battlefield 200 will compete. Come to support the competitors or to network with thousands of founders, venture capitalists, and technology enthusiasts. Get your tickets now.
Use codebuildmode15 for 15% off any ticket type.
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Loading the player…
Enduring the lengthy path to FDA approval involves more than creating groundbreaking technology. It's about sustaining your team's drive, identifying supportive investors, and adapting to operate effectively despite unpredictable schedules.
This week on Build Mode, Isabelle Johannessen is joined by Robhy Bustami, co-founder and CEO of BioticsAI, a Startup Battlefield champion. The company builds an AI copilot for ultrasound technology designed to detect fetal abnormalities. Bustami shares insights from developing a $100,000 prototype to achieving FDA clearance, outlining the real challenges of innovating within one of the globe's most stringent regulatory environments.
This episode delves into the authentic experience of launching a medtech startup, where you cannot simply "move fast and break things." Each milestone demands considerable time, careful coordination, and unwavering trust.
This conversation covers:
How to maintain motivation and ensure team alignment when FDA approval is not a certainty. What founders must understand about navigating the FDA regulatory process from the very beginning.How to attract investors who appreciate the slower pace and high-risk profile of the medtech industry.Why cross-functional collaboration—involving engineers, clinicians, and researchers—is essential for success.The importance of advisors and why engaged, active industry experts often outweigh well-known names.How to build progress and recognize achievements throughout long periods of uncertainty.Subscribe to Build Mode on Apple Podcasts, Spotify, or your preferred podcast platform. Watch full video episodes on YouTube. New Build Mode episodes are released every Thursday. Hosted by Isabelle Johannessen. Produced and edited by Maggie Nye. Audience development led by Morgan Little. Special thanks to the Foundry and Cheddar video teams.
Apply to Startup Battlefield: We are seeking early-stage companies with a Minimum Viable Product (MVP). Nominate a founder—or yourself—for consideration. Please mention that you heard about Startup Battlefield on the Build Mode podcast. Apply here.
TechCrunch Disrupt 2026: Join us for TechCrunch Disrupt from October 13 to 15 in San Francisco, where the Startup Battlefield 200 will compete. Come to support the competitors or to network with thousands of founders, venture capitalists, and technology enthusiasts. Get your tickets now.
Use codebuildmode15 for 15% off any ticket type.
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