Development of a Rapid Point-of-Care PCR Testing System with Integrated Hardware and Software Platform

The client requires a comprehensive solution to perform rapid and highly accurate PCR testing at on-demand locations, such as point-of-care settings, addressing the need for reliable diagnostics outside traditional healthcare facilities. Existing processes lack integration between hardware components, software management, and user interfaces, impacting test throughput and usability during critical periods like pandemics.

A mid-sized innovation-driven diagnostics company specializing in high-precision molecular testing solutions seeking to enable fast, accurate testing outside traditional healthcare environments.

• Design and develop an integrated hardware-software system capable of ultrafast PCR tests with accurate detection of target pathogens.
• Create a user-friendly Windows-based application to manage PCR processes, facilitate data communication among system components, and enable seamless operational workflows.
• Build a communication protocol to ensure robust data transmission between hardware, software, and user interfaces.
• Ensure the solution meets relevant certification standards and has the capacity for future protocol and test expansion.
• Deliver a scalable platform that improves testing speed, reliability, and user experience in point-of-care environments.

• Hardware component: A PCR reader utilizing PCR cards for thermocycling and optical detection to conduct ultrafast tests.
• Point-of-care device: A portable testing unit connected to the PCR reader for use by medical personnel at on-demand testing sites.
• Software platform: A Windows-based application that manages testing workflows, monitors system status, and facilitates user interaction.
• Communication system: A protocol enabling data exchange between hardware components and the application, ensuring real-time status updates and test results.
• Simulator tool: A hardware emulator for software development and testing prior to hardware deployment.
• Workflow optimization: Minimized user interaction and streamlined testing procedures for maximum operational efficiency.
• Certification compliance: System designed to meet industry standards relevant for medical device software, including IEC 62304.

• Hardware communication interfaces between PCR reader and control software
• Point-of-care device connection with the PCR reader
• Data transmission protocols for system components
• Cloud data services for storage and analysis
• External testing algorithms and diagnostic modules as necessary

• System performance: Capable of ultrafast testing cycles with high reliability
• Scalability: Modular architecture permitting addition of new diagnostic protocols
• Security: Data encryption and user authentication to ensure patient and test data privacy
• Compliance: Meets industry standards and medical device regulatory requirements
• Usability: Intuitive user interface minimizing operator interactions and training

The implementation of this integrated point-of-care PCR testing platform will significantly enhance testing capacity and speed, enabling rapid diagnostics in diverse environments. The system aims to improve operational efficiency, meet certification standards, and facilitate future protocol expansion, thereby supporting timely disease detection and pandemic response efforts, ultimately leading to improved patient outcomes and public health management.