“Embed possess deep software engineering domain knowledge and a forward-thinking
approach that ensures their solutions are both effective and scalable.”
“LEX working with Embed, achieved the almost unachievable, enabling us
to deliver clinical studies and achieve regulatory approvals ahead of time.”
Ed Farrell | CEO at LEX Diagnostics
Client – Who are they/what do they do
A molecular diagnostics company specialising in ultra-fast PCR-based point-of-care (POC) testing systems. Their mission is to deliver lab-quality diagnostic results within minutes, enabling rapid clinical decision-making in primary care, urgent care centres and pharmacies. Their product is aimed at the US market.
Challenge – What did they need us to do
The client engaged Embed to support the productisation of their embedded firmware. Our role encompassed the following key responsibilities:
- Identify and address weaknesses in the existing firmware to enhance reliability, maintainability and performance
- Collaborate closely with the client’s internal development team and external partners to ensure alignment and effective communication across all stakeholders
- Provide project oversight to ensure appropriate resource allocation and adherence to critical timelines
- Design, develop and validate a GUI based PC application to program NFC tags for use in the production of proprietary disposable cartridges integral to the PCR test system
- Design, develop and test a GUI based PC instrument manager application to configure, control and extract diagnostic data from the PCR test system, streamlining operational workflows
- Design, develop and test a command line-based tool to process engineering logs and test records retrieved from the PCR system. This tool generates analytical insights to support the scientific team in refining the PCR algorithm
Solution – How did we solve it for the client
Facing immense time pressure for a Human Factors study in the US, Embed was contracted to perform a comprehensive review of the LEX Gen 1 product. The project was a multifaceted challenge, demanding a strategic approach to rapidly address a significant backlog of work items in JIRA. By implementing rigorous project management methodologies, Embed was able to quickly identify, plan, and prioritize the most critical tasks, while delegating effectively across both internal and external teams. This strategic triage was vital in focusing efforts on the core functionalities necessary for the study, rather than attempting to tackle the entire backlog at once. Through clear and constant communication, Embed managed stakeholder expectations and ensured all parties remained aligned on the project’s condensed timeline and objectives.
In parallel with the project management effort, Embed undertook a partial refactoring of the LEX Gen 1’s existing firmware, a strategic decision driven by the project’s severe time constraints. The initial firmware, while functional, was demonstrably unreliable, posing a significant risk to the integrity of the Human Factors study and compliance with ISO 13485. This required a deep, iterative process of design, testing, and validation to stabilize the embedded software, enhance performance, and ensure it operated reliably on the intended hardware. The partial refactoring focused on the most critical and unstable components, applying meticulous attention to detail and rigorous testing to mitigate the immediate risks within the compressed timeframe. The result was a significantly more stable and robust firmware that formed the operational core of the LEX Gen 1 product for the study.
To support the development, testing and eventual manufacture of the LEX Gen 1 product, Embed developed three new PC-based applications from scratch. These applications were essential tools for various phases of the product lifecycle, from debugging and quality assurance during development to providing vital support for manufacturing and field service. The development of these applications simultaneously with the firmware refactoring demonstrated Embed’s ability to manage parallel streams of complex, interdependent work. The successful delivery of these custom tools was crucial for enabling the entire team—including manufacturing and external partners—to effectively deliver a fully operational and compliant LEX Gen 1 system within the demanding timeframe.
