Case Study: HART Biologicals
Turning a medical device concept into software ready for clinical trials
The Challenge
Hart Biologicals is a leading reagent manufacturer and supplier that set out to expand their offering with IMPACT, their first medical device. With no internal software team, they faced the challenge of building a user-friendly, compliant system while navigating complex, country-specific regulations. Firefinch joined as an embedded partner, bringing a structured, collaborative approach to develop software from the ground up. The solution integrates with custom hardware, supports HL7 connectivity, and prioritises usability, delivering user-focused platform aligned with global regulatory standards and ready for clinical trials.
The Solution
Delivered a trial-ready software platform, fully aligned with IEC 62304 and guided by AAMI TIR45, reducing regulatory risk from the outset.
IEC 62304 compliant medical device software:
• Applied agile, sprint-based delivery to maintain momentum and adapt to evolving requirements
• Designed an intuitive, user-focused interface through collaborative UX workshops, reflecting real-world use
• Built a secure, maintainable OS optimised for long-term performance and medical-grade stability
• Supported regulatory readiness with robust documentation, traceability, and QMS alignment throughout the project lifecycle
About HART Biologicals
Hart Biologicals is a UK-based manufacturer and global supplier of reagents for haemostasis and platelet function analysis. With a strong foundation in laboratory diagnostics, the company is expanding its capabilities through the development of IMPACT, its first internally designed medical device. Drawing on deep customer insight and a commitment to innovation, Hart Biologicals aims to drive the future of point-of-care with user-friendly medical software to support future growth.
“Firefinch has been a critical partner, helping us build compliant, user-friendly software for our first medical device. Their collaborative approach, technical strength, and clear communication made the process smooth and enjoyable, and ultimately helped to deliver a great product.”
