Embedded Services for Medical Devices
A leading medical devices company was undergoing a significant challenge. They manufacture embedded devices used across the medical sector, including hospitals, clinics, and research facilities. However, the complexity of their products and the high-stakes nature of their use led to a critical business problem: exhaustive and time-consuming manual testing.
Their device had to go through rigorous testing procedures to ensure accurate, reliable, and consistent functioning. Given the essential nature of these devices in preserving and saving human lives, each one must function flawlessly. This testing process included various functionality checks, performance analysis, and safety measures, making it a lengthy and expensive endeavour.
Additionally, as a part of the medical sector, company’s products had to adhere to strict regulatory standards. Authorities like the Food and Drug Administration (FDA) and European Medicines Agency (EMA) demand thorough testing and documentation, further increasing the strain on the testing team and lengthening the product’s time-to-market.
The manual nature of these testing procedures was causing several inefficiencies, such as:
- Human error — despite best efforts, manual testing carried a risk of human error, impacting the reliability of the results
- Slower time-to-market — lengthy testing procedures resulted in significant delays in product releases
- High costs — extensive manual labour resulted in increased costs of quality assurance.
- Scalability issues — as company expanded its product range, the current manual testing procedures couldn’t scale effectively
Companies needed a solution that could streamline their testing procedures, reduce errors, lower costs, and get their products to market faster, all while maintaining the highest standards of quality and compliance.
Understanding the complexities of the company’s problem, we proposed an automation testing solution designed specifically for embedded devices in the medical sector.
Our team developed a custom automation testing framework, utilising cutting-edge technologies like Machine Learning (ML) and Artificial Intelligence (AI). This framework was capable of running thousands of test cases simultaneously, significantly reducing testing times and human error.
To cater to company’s specific requirements, we integrated special features into the framework:
- Regulatory Compliance Automation — understanding the need for regulatory compliance, we incorporated automated report generation for regulatory bodies like the FDA and EMA. The reports generated were comprehensive, accurate, and adhered to the specific format required by these agencies
- Risk-based Testing — we adopted a risk-based approach to prioritise high-risk areas in the testing process, ensuring efficient use of resources and focusing on areas most critical to patient safety
- Scalability and Flexibility — the automation testing framework was built to be scalable and flexible to accommodate the company’s growing product line. The tests could be easily adjusted to fit new or modified devices
Through thorough training sessions, we equipped the company’s team to effectively use the automation testing system and interpret the results correctly. We also ensured the system was integrated smoothly into their existing workflow to minimise disruption.
Our engagement revolutionised their testing procedures. By shifting from manual to automation testing, they achieved significant improvements in testing speed, accuracy, and cost-efficiency.
- Improved Efficiency and Accuracy — the automation testing system reduced the overall testing time by 60%, allowing them to expedite their time-to-market. With the reduction of human error, the reliability of testing results also increased
- Cost-Effective — the new system reduced labour costs associated with manual testing and decreased the financial impact of delays in product releases
- Regulatory Compliance — automated report generation simplified the regulatory compliance process, ensuring smooth and timely product approvals
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