Bold Type: Reformulating MedTech Frontiers through Visionary Leadership and Unmatched Innovation

The Silicon Review

In a rapidly evolving MedTech landscape, few leaders combine scientific rigor, entrepreneurial insight, and technical mastery with the elegance of strategic foresight. Jose Bohorquez, PhD, CEO & Co-founder of Bold Type, exemplifies this rare confluence. With a doctoral background in biomedical engineering and decades of hands-on experience in medical device software and regulatory compliance, Bohorquez has cultivated a company that redefines how startups bring FDA-compliant solutions to market. Under his stewardship, Bold Type has emerged as a trusted partner for founders navigating the perilous journey from prototype to investor-ready, regulated product.

Bohorquez recognized early that medical device startups face an unforgiving environment: any misstep in regulatory adherence, cybersecurity, or documentation can delay FDA clearance, jeopardize funding, or even risk patient safety. His vision was to eliminate these barriers by creating an integrated team of medical device veterans, world-class cybersecurity experts, and AI-assisted developers allowing innovation to flourish without compromising quality or compliance.

His leadership ethos, built on transparency, technical excellence, and unrelenting pursuit of solutions, permeates every facet of Bold Type’s operations. From embedded firmware to mobile applications and cloud-connected platforms, Bohorquez has instilled a culture where compliance is embedded from day one, cybersecurity is non-negotiable, and speed is achieved without sacrificing rigor. The result is a company where medtech founders gain confidence, speed, and technical assurance, positioning Bold Type as a pioneer and an industry benchmark.

Specialization in Regulated MedTech Systems

Bold Type’s exclusive focus on regulated medical device software sets it apart in a market crowded with generic developers. The firm specializes in firmware development for embedded and wireless systems, mobile applications for iOS and Android, secure cloud platforms, and web dashboards that integrate seamlessly with connected medical devices. By concentrating solely on medtech, the team operates with fluency in standards such as IEC 62304, ISO 14971, IEC 62366, and FDA cybersecurity guidance, ensuring that every product is compliant from inception.

AI-Enhanced Development and Cybersecurity Excellence

The integration of proprietary AI coding agents allows Bold Type to accelerate repetitive coding tasks while embedding regulatory and security checks directly into workflows. The CyberMed division, led by veterans of NSA and DoD operations, provides sophisticated threat modeling, penetration testing, and post-market cybersecurity management, ensuring that devices are robust against modern digital threats. This combination of AI-driven efficiency and human expertise allows startups to reduce development timelines by 30–50 percent without compromising safety or compliance.

Compliance, Documentation, and FDA Readiness

Bold Type’s ISO 13485-certified process ensures that design controls, risk management, and device history files are fully audit-ready. Documentation is meticulously aligned with IEC 62304 software lifecycle processes, IEC 60601 hardware standards, and HIPAA-compliant data handling protocols. The company’s emphasis on integrated compliance minimizes regulatory delays, reducing the risk of prolonged 510(k) or CE submissions that can hinder funding and market entry.

Client Impact and Proven Outcomes

Clients report significant gains in speed-to-market, quality, and regulatory confidence. “Bold Type transformed our approach to medical device development. Their AI-driven workflows and cybersecurity expertise allowed us to accelerate FDA submission timelines without compromising patient safety,” says Dr. Michael Fong, CEO of Privoro. Bold Type has guided multiple startups from prototype to market launch, enabling devices such as the Leva® Pelvic Health System to achieve rapid adoption while maintaining rigorous compliance.

Vision for the Future of MedTech Development

Looking ahead, Bold Type aims to redefine the standards of medtech software development. By merging deep domain expertise, AI-enhanced coding, and uncompromising cybersecurity, the company envisions a future where startups can innovate with confidence, regulatory hurdles are minimized, and secure, compliant medical devices reach patients faster than ever. In an era where every month of delay has financial and clinical consequences, Bold Type’s integrated approach provides a blueprint for success in digital health innovation. Its leadership philosophy emphasizes not just technical excellence but mentoring and guiding medtech founders to make informed, confident, and strategic decisions that elevate the industry as a whole.

Jose Bohorquez, PhD, CEO & Co-founder