Securing tomorrow’s Care: Bold Type Masters Medical Device Software Integrity

In an era where healthcare is increasingly dependent on software-driven innovation, Bold Type has emerged as a vital partner for both medical device startups and original equipment manufacturers. The firm specializes in developing and securing apps, embedded systems, and cloud-connected platforms that power regulated medical devices. With the U.S. Food and Drug Administration’s 2024 updates—particularly the new Section 524B guidelines on cybersecurity—Bold Type’s unique integration of usability, compliance, and cybersecurity has positioned it as a leader in this high-stakes space. Built on the foundational belief that software integrity is inseparable from patient safety, Bold Type has architected a development model that blends engineering discipline, regulatory fluency, and design clarity. At the heart of this approach lies the firm’s proprietary App Foundation—a code-complete software scaffold that includes wireless connectivity, secure authentication, and over-the-air update capabilities. This framework enables clients to launch compliant, connected products up to 50% faster. Every project is executed under the governance of an ISO 13485-certified quality management system, ensuring that design history files, threat models, and FDA documentation are fully synchronized and audit-ready.

Bridging Complex Regulatory, Usability, and Security Needs

What sets Bold Type apart is its ability to unify the traditionally siloed domains of regulatory compliance, usability engineering, and cybersecurity into one streamlined offering. This harmonized model ensures that software development for medical devices doesn’t require coordination among multiple consultants or fragmented vendors. Instead, clients work with a single partner that understands the nuances and interdependencies across these critical areas. On the regulatory front, Bold Type brings decades of experience navigating FDA frameworks. This enables the company to embed documentation readiness—such as design controls, risk assessments, and design history file generation—into the software lifecycle from day one. As a result, developers aren’t scrambling to retroactively assemble documentation before submission.

App Foundation: A Fast-Track to FDA Readiness

At the core of Bold Type’s efficiency is its proprietary App Foundation—a robust software base that’s purpose-built for regulated medical environments. Rather than building from scratch, clients begin with a development-ready framework that includes wireless communication protocols such as BLE, Wi-Fi, or cellular; secure login systems; cloud synchronization; over-the-air update mechanisms; and standardized UI components along with compliant data logging capabilities. This starting point allows teams to cut development timelines by nearly half while maintaining flexibility to tailor the user interface, application logic, and device integrations to their specific needs. Importantly, the App Foundation isn’t just a productivity booster—it’s also documentation-ready. As the software is developed, regulatory artifacts are generated in parallel, aligning product engineering with FDA requirements in real time. This synchronization helps ensure that both code and compliance files are complete at the time of submission, dramatically reducing the risk of delays.

CyberMed: Meeting New Cybersecurity Mandates

Cybersecurity in the medical device space is no longer an afterthought—it’s a requirement. With the release of Section 524B guidance, the FDA now expects developers to take a proactive, lifecycle-based approach to software security. Bold Type’s CyberMed team is designed to meet and exceed these expectations. CyberMed services begin with FDA-aligned threat modeling and architectural risk assessments that identify potential vulnerabilities early. This is followed by rigorous penetration and fuzz testing to validate system resilience against real-world threats. Software Bills of Materials (SBOMs) are generated as part of the development workflow, ensuring that all third-party and open-source components are fully accounted for—a key requirement under new regulatory rules. Post-market, the team offers monitoring support and incident response planning, giving clients a complete toolkit for maintaining compliance after release.

Specialized Engagement Models: From Full Build to Validation

Understanding that no two clients are alike, Bold Type offers engagement models tailored to a company’s stage, structure, and needs. For startups without in-house software expertise, the firm provides complete, end-to-end development—from architecture to submission. For mid-sized companies with engineering teams, Bold Type offers targeted consulting to inject domain-specific knowledge around regulatory or cybersecurity matters. For organizations that already possess internal capabilities but require independent validation to meet FDA guidelines, CyberMed delivers standalone testing, review, and documentation services. Whether a client is building from the ground up or just needs expert oversight before submission, Bold Type provides a right-sized solution to match the moment.

The Road Ahead: Proactive Cybersecurity, AI-Assisted Development

Looking forward, Bold Type is preparing for the next wave of medtech innovation and regulation. Recognizing the increasing complexity of connected health systems, the company is investing in AI-powered cybersecurity tools designed to automate threat modeling, anomaly detection, and code validation. These capabilities will allow for faster revalidation cycles and more robust post-market surveillance. Other roadmap initiatives include enhanced monitoring systems for telehealth platforms, expanded App Foundation modules to cover more device types, and tighter integration of compliance checkpoints within continuous development pipelines. The firm is also exploring generative AI applications to accelerate documentation and reduce friction in regulatory workflows. These future-focused developments underscore Bold Type’s mission to stay ahead of regulatory evolution while supporting clients with the most advanced, scalable, and secure tools in the industry.

Jose Bohorquez, PhD, President

"We build software that safeguards both patients and devices—before the FDA even asks for it." — Mahesh Jethani, Co‑Founder & CEO, Bold Type