Bold Type

Bold Type is a specialized medical device development firm that provides end-to-end software and electronics engineering for regulated medical devices. The company focuses on startups and emerging medtech companies navigating FDA clearance, offering services that span embedded firmware, wireless connectivity, mobile applications, cloud platforms, and electronics design under ISO 13485-certified processes.

The firm operates CyberMed, a dedicated medical device cybersecurity division led by FIPS-certified experts with NSA/DoD backgrounds. This division provides threat modeling, penetration testing, SBOM generation, and post-market cybersecurity monitoring specifically designed for FDA requirements. Bold Type's technical capabilities cover the full technology stack for connected medical devices, including BLE, Wi-Fi, and cellular protocols, with expertise in IEC 62304, ISO 14971, and FDA cybersecurity guidance.

The leadership team includes MIT-trained engineers and medical device veterans with over 20 years of experience in medtech software development and multiple FDA clearances. The company emphasizes AI-assisted development to accelerate timelines while maintaining regulatory compliance, claiming 30-50% faster development cycles without compromising audit-ready quality.

Choose Bold Type when you need a single partner who can handle both the technical complexity of connected medical device development and the regulatory requirements for FDA clearance. The integrated approach eliminates coordination issues between separate firmware, mobile, and cloud vendors while ensuring cybersecurity is architected from day one rather than retrofitted.

The firm's value proposition is strongest for startups facing tight timelines and funding milestones where delays in FDA submission could jeopardize market entry or next funding rounds. The combination of ISO 13485 certification, dedicated cybersecurity expertise, and AI-accelerated development targets the specific challenges of resource-constrained medtech companies.

Bold Type exclusively serves the medical device sector with specific focus on FDA-regulated connected devices. The company's entire service offering is built around medical device standards including IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 62366 (usability engineering), and FDA cybersecurity guidance. The CyberMed division specifically addresses medical device cybersecurity requirements that became more stringent with FDA's 2023 updated guidance.

Client testimonials reference specific medical device applications including the Leva Pelvic Health System (Axena Health) and work with medical device companies like TIDI Products and Hexoskin. The company's documentation follows dozens of FDA guidance documents and medical device-specific standards, indicating deep specialization in this vertical rather than broader healthcare software.

The ideal client is a medtech startup or Series A/B company developing a connected medical device (wearable, implant, or monitoring system) that requires FDA 510(k) clearance. The best-fit client has secured seed funding but needs to demonstrate regulatory progress for next-round fundraising, requires expertise across multiple technology domains (firmware, wireless, mobile, cloud), and recognizes cybersecurity as a critical path item for FDA submission rather than an afterthought.