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April 30, 2026 • Maggie Nye, Isabelle Johannessen

FDA Approval and Building in Healthcare: BioticsAI's Journey

FDA Approval and Building in Healthcare: BioticsAI's Journey FDA Approval and Building in Healthcare: BioticsAI's Journey FDA Approval and Building in Healthcare: BioticsAI's Journey

FDA Approval, Fundraising, and Building in Healthcare: BioticsAI Founder's Journey

The Reality of Building in Regulated Spaces

Founders building in the healthcare space can't just build fast and break things. Timelines stretch longer, stakes are higher, and success depends on navigating systems that reward rigor over speed.

Robhy Bustami, co-founder and CEO of BioticsAI, has been operating in exactly this reality. His company is developing an AI copilot for ultrasound that helps detect fetal abnormalities, an area where misdiagnosis rates remain surprisingly high.

Building Scrappy: From $100K Prototype to FDA Approval

Key Milestones:

  • Built an early, functioning version of the product for under $100,000 (nearly unheard-of in the medical device world)
  • Won TechCrunch Startup Battlefield in 2023, bringing early visibility and credibility
  • Gained FDA approval in January 2026, enabling hospital launches and accelerated growth

Integrating Regulation from Day One

Instead of building first and figuring out regulation later, BioticsAI integrated clinical validation, regulatory strategy, and product development into a single process.

Strategic Approach:

  • Working closely with clinicians
  • Collecting large-scale datasets
  • Running structured clinical studies before submission
  • Early engagement with regulators through pre-submission meetings
  • Aligning on study design and expectations upfront

The Cultural Challenge: Keeping Teams Motivated Through Long Timelines

When the biggest milestone is years away, maintaining team motivation becomes critical.

BioticsAI's Cultural Strategy:

"Making sure everyone is completely aligned, even if it's outside of their technical scope," Bustami said, "constantly seeing wins on the R&D side."

  • Building alignment across engineers, clinicians, and researchers
  • Ensuring everyone sees incremental wins
  • Celebrating progress from clinical studies to new healthcare partnerships

What's Next: From Approval to Deployment

With FDA clearance secured, BioticsAI is entering a new phase:

  • Beginning rollout in hospitals
  • Plans to expand beyond obstetrics into broader areas of reproductive health
  • Transitioning from validation to scale

Key Takeaways for Healthcare Founders

  • Integrate regulation early: Don't build first and ask permission later
  • Engage regulators proactively: Use pre-submission meetings to align expectations
  • Build for validation: Clinical validation should be part of the product development process
  • Celebrate incremental wins: Long timelines require keeping teams motivated with visible progress
  • Accept the timeline: Healthcare is a long game that rewards patience and discipline

Building in healthcare requires patience, discipline, and a willingness to operate in uncertainty. For founders willing to take that path, the reward isn't just a successful company — it's the chance to build something that genuinely changes how care is delivered.