Introduction
Building a healthcare technology company is no small feat, especially when regulatory hurdles and fundraising challenges loom large. In a recent episode of Build Mode, host Isabelle Johannessen sat down with Robhy Bustami, CEO and founder of BioticsAI, to unpack the realities of navigating the complex intersection of innovation, regulation, and capital. His firsthand account offers a roadmap for other founders grappling with FDA approvals, investor skepticism, and the sheer persistence required to bring AI-driven diagnostics to market.
Navigating FDA Approval in Medtech
One of the most daunting aspects of healthcare entrepreneurship is the regulatory pathway. BioticsAI's product, a deep-learning platform for fetal ultrasound analysis, required clearance from the U.S. Food and Drug Administration (FDA). Bustami emphasized that FDA approval is not just a checkbox but a continuous process of validating safety and efficacy.
"The FDA doesn't just look at your algorithm; it examines your entire quality management system, from data collection to post-market surveillance," he explained. The company spent months gathering clinical evidence, conducting rigorous trials, and iterating on its software to meet FDA standards. This phase, according to Bustami, calls for patience, rigorous documentation, and a multidisciplinary team that includes regulatory experts, clinicians, and engineers.
A key takeaway for startups: don't underestimate the time and resources needed for regulatory submission. Bustami recommends building a relationship with the FDA early, seeking feedback through pre-submission meetings, and being transparent about limitations. That approach helped BioticsAI secure a breakthrough device designation, which expedited the review process without compromising quality.
Fundraising in a Highly Regulated Space
Raising capital for a healthcare AI company differs markedly from typical tech startups. Investors are often wary of long sales cycles, regulatory risks, and uncertain reimbursement paths. Yet, Bustami secured multiple funding rounds by focusing on clear value propositions and evidence of clinical impact.
"We didn't pitch just a cool algorithm; we showed how our tool reduces false positives in ultrasound screening and improves outcomes," he said. BioticsAI's pitch deck highlighted real-world validation studies, cost-saving potential for hospitals, and a clear go-to-market strategy. Bustami also stressed the importance of targeting the right investors—those with deep healthcare domain expertise who understand the long maturation horizon.
He noted that fundraising should be thought of as an ongoing relationship-building exercise. Even after a successful round, the CEO continued to share progress updates, setbacks, and learnings with backers. This transparency built trust and made follow-on investments smoother.
The Reality of Building in Healthcare
Beyond FDA and funding, Bustami shared candid insights about the day-to-day realities of building a healthcare company. Team motivation is critical when dealing with bureaucratic red tape and slow progress. He described how BioticsAI maintained momentum by celebrating small wins—like completing a trial milestone or receiving positive clinician feedback—and by reminding the team of the larger mission: improving maternal and fetal health.
"Healthcare moves at a different pace than consumer tech," Bustami said. "If you're in it for quick exits, you'll be disappointed. But if you're passionate about solving genuine medical problems, every step forward feels meaningful." He encouraged founders to hire people who share that mission-driven mindset and to create a culture where failures are treated as learning opportunities rather than setbacks.
Another reality: the integration challenge with existing hospital systems. BioticsAI had to ensure its software worked seamlessly with ultrasound machines and electronic health records (EHRs). This required deep partnerships with hardware vendors and IT departments—a process that often took longer than anticipated. Bustami advised startups to allocate significant resources to interoperability from day one.
Lessons for Aspiring HealthTech Founders
Drawing from his journey, Bustami distilled several actionable lessons:
- Start with a clear clinical problem – Don't build technology in search of a use case. Validate the problem with physicians and patients first.
- Invest in regulatory expertise early – Hire or consult with an FDA specialist to avoid costly pivots.
- Be transparent with investors – Share risks and mitigation plans; it builds credibility.
- Embrace the long game – Healthcare returns are slower but can be more sustainable.
- Prioritize user experience – If clinicians find the tool cumbersome, adoption will stall regardless of regulatory approval.
The Future of BioticsAI and HealthTech
BioticsAI continues to expand its platform, exploring applications beyond obstetrics, such as radiology and cardiology. With FDA clearance under its belt, the company is now focusing on commercialization and reimbursement strategies. Bustami is optimistic: "We've proven that AI can be both clinically valuable and regulatory compliant. The next frontier is scaling that impact."
As more founders venture into healthcare, the lessons from BioticsAI's journey serve as a pragmatic blueprint. It's a path marked by rigorous validation, strategic funding, and relentless commitment—but one that can ultimately transform patient care for the better.