SQA2 Case Studies: Health Tech
Overview
A healthcare startup in the oncology sector set out to create a Software as a Medical Device (SaMD) solution for real-time patient monitoring and deterioration prevention. Starting from scratch with no existing QA processes, they partnered with us to ensure compliance, quality, and reliability. Through a comprehensive QA strategy that included automation, HIPAA-compliant data security, and a cost-effective blended QA model, we delivered exceptional results. Our work ensured the successful delivery of their MVP, safeguarded patient safety, and strengthened operational efficiency.
Client Background
The client operates in the healthcare industry, focusing on oncology patient care through Software as a Medical Device (SaMD) solutions. Their offerings include a mobile application for patients and a web-based dashboard designed for nurses and doctors to monitor vital signs and detect patient deterioration in real time. Initially, the client collaborated with two QA companies but ultimately chose to retain our services due to our superior quality coverage, fast turnaround times, and expertise in compliance.
Project Objectives
The project objectives were to build a minimum viable product (MVP) that integrated two medical devices with a mobile application, cloud storage, and a nurse/doctor dashboard. Another key goal was to ensure the real-time accuracy of the patient deterioration algorithm. Additionally, the project aimed to meet FDA compliance requirements while maintaining robust data security in adherence to HIPAA regulations.
Challenges
- Lack of Existing QA Processes: No prior QA function, requiring QA practices to be built from the ground up.
- Algorithm Complexity: The deterioration detection algorithm had to process vast amounts of real-time data for multiple patients without error.
- Patient Data Security: Ensuring HIPAA compliance for protected health information (PHI), including encryption, secure storage, and restricted access.
- Resource Constraints: Testing medical device integrations and algorithm performance within tight deadlines.
Our Approach to Success
- Establishing QA Foundations:
- Designed test cases and test suites for manual and automated testing.
- Introduced Zephyr for test case management and built an automation framework in Java with Ivy.
- Comprehensive Testing Strategy:
- Conducted functional, API, and integration testing to ensure interoperability across medical devices and cloud systems.
- Automated the algorithm’s critical functionality to ensure data was processed accurately and in real time.
- Compliance and Data Security:
- Verified API encryption using Auth0 tools to ensure SAML requests and JWTs were valid and secure.
- Ensured PHI remained protected by preventing traceability in databases and restricting user access to personal information only.
- Blended QA Model:
- Deployed one embedded QA lead and multiple SQaaS resources to balance cost-efficiency with scalability.
- SQaaS resources focused on regression and smoke testing while contributing to automation development.
- Iterative Development Phases:
- Supported the Alpha, Beta, and MVP phases, adapting to changing requirements and ensuring timely delivery of all milestones.
Key Impact and Results
- Error-Free MVP Launch: Delivered a defect-free MVP with an accurate algorithm capable of detecting patient deterioration and triggering alerts in real time.
- Automation Success: Automated critical workflows, reducing manual testing efforts and accelerating deployment timelines.
- HIPAA Compliance: Safeguarded patient data through robust encryption and secure storage practices, meeting all regulatory requirements.
- Scalability Achieved: Grew the QA team from one embedded member and two SQaaS resources to a total of four SQaaS resources, allowing seamless handling of increasing workload demands.
- Recognized Excellence: Our ability to detect and resolve a critical flaw in the algorithm’s functionality during testing garnered praise from the CTO and development team, ensuring system reliability.
A Defining Moment
During the functional testing phase, our team uncovered a critical flaw in the deterioration detection algorithm when processing data for multiple patients simultaneously. While the algorithm functioned correctly for a single patient, it failed under the load of three concurrent users. By leveraging automation and well-designed testing scenarios, we identified and reported the flaw early, enabling the development team to implement a fix within two days. This discovery was pivotal in ensuring the algorithm’s robustness and earned recognition from the client’s leadership.
Client Feedback and Long-Term Value
- The client leadership team frequently commended our dedication and expertise, with the CEO providing a glowing testimonial.
- Our QA lead was entrusted to demo the product to potential partners and played a vital role in the FDA patient testing process.
- The CTO was so impressed by our work that they brought us into new projects after leaving the company, underscoring the value of our relationship-driven approach.
Lessons Learned and Best Practices
- Start QA Early: Introducing QA from the beginning of the project ensures processes are established and integrated into the development lifecycle.
- Tailored Testing Scenarios: Partnering with industry experts, such as nurses and doctors, ensures that testing scenarios align with real-world use cases.
- Automation for Complex Systems: Automating critical workflows not only accelerates timelines but also ensures accuracy in data-intensive systems.
Contact Us
If you’re developing life-saving healthcare solutions and need a QA partner with expertise in automation, compliance, and scalability, contact us today. Our proven track record in delivering high-quality solutions for healthcare startups makes us the perfect partner for your next big project. Let’s build a world-class product together!
