3 Ways to Improve Your Medical Device Testing Data Quality

The development of safe and effective medical devices is of utmost importance, considering the impact they have on the health and safety of patients. To meet the stringent requirements of applicable regulations such as ISO 13485 and US QSR (21 CFR 820), companies in the medical device industry face the challenge of improving the quality of their test data.

To ensure the quality and integrity of their data, it is highly recommended that these companies establish a comprehensive data governance framework. Such a framework defines data ownership and responsibilities, classifies data for their intended use, and defines data criticality. By implementing a data governance framework alongside the three key steps outlined in this article, companies can significantly improve the quality of their medical device test data. A source to elaborate on this would be Robert S. Seiner “Non-Invasive Data Governance: The Path of Least Resistance and Greatest Success”

This approach not only enhances data quality but also plays a crucial role in increasing patient safety, ensuring compliance with regulations such as ISO 13485 and 21 CFR Part 11, and streamlining the development process. Effective data governance is essential for maintaining data accuracy, consistency, and security throughout the product development lifecycle.

• Clear requirements with controlled change management

To develop a safe medical device, it is critical to begin development with a well-documented description of all the requirements and specifications that the product must meet. These serve as a blueprint for the development process and ensure that the device meets the required safety standards. Any changes to these requirements during the development process should also be carefully documented and explained to ensure overall traceability. Once the medical device has been developed, the next step should be to create test plans based on the current documented requirements. After the test plans have been prepared and the corresponding documented execution of these, it is evaluated whether the results of the tests are accepted and meet the requirements, or whether further adjustments are necessary. This evaluation and the results are also documented.

By implementing a controlled change management system, companies can avoid long discussion loops during development and ensure that each iteration of the device meets the latest requirements. It also ensures proper functionality and that all changes are reviewed and assessed for their risks. This applies not only to hardware aspects but also to any changes to the software component of the device. In addition, implementing a quality management system, adhering to established standards such as ISO 13485, and following the requirements of 21 CFR Part 11 serves as a solid foundation and is a must-have for manufacturing high-quality medical devices.

• Internalizing critical thinking and patient health awareness

Many companies involved in medical device development may not have fully internalized the mindset for a risk-based approach as described in ISO 14971. This mindset is essential for identifying potential risks and ensuring patient safety. To develop safe medical devices, it is critical to proactively identify potential hazards and address them at every stage of development. To ensure this a documented risk assessment should be initiated as soon as the first requirements are documented. The risk assessment Based on the risk assessment new requirements such as material, secure energy supply, or easy handling should be identified.

By adopting the critical thinking of the pharmaceutical industry, and incorporating Computer Software Assurance from the Center for Devices and Radiological Health (CDRH), companies can better assess the potential impact of their medical devices, including software components, on patient health and safety. In addition to critical thinking and software assurance, it is also relevant that every employee is aware that their actions can affect the health of patients. Therefore, it is beneficial to build a quality culture that puts patient safety first and to make employees aware of this when identifying risks.

• Introduce a system for user feedback.

Feedback from users and healthcare professionals is a valuable resource for improving medical devices. However, without a well-structured and standardized feedback program, it can be difficult to collect, evaluate and use this feedback. To improve data quality, companies need to develop a system that ensures valuable information is collected and analyzed effectively.

To obtain feedback from different users that is as comparable as possible, the user feedback system should be designed with clear and standardized questions. In addition, the user interface should be user-friendly and intuitive to encourage participation and facilitate the submission of feedback. This can positively influence that all information necessary for device development is reported back in a statistically significant amount. This data provides the basis for further improvement of medical devices.

High-quality medical device test data is critical to developing safe and effective products that positively impact patients’ lives. Companies involved in medical device development should prioritize compliance, think critically, and establish standardized user feedback systems. In this way, they can streamline their development process, improve data quality, and enhance patient safety. Internalizing the pharmaceutical mindset and valuing user feedback will ultimately lead to the development of innovative and reliable medical devices that meet both market demands and, more importantly, the needs of the patients they serve.

If you have any questions on the topics discussed here or you need support in implementing these requirements, do not hesitate to contact us.