This blog is a contributory post from NI submitted to the NeuronicWorks Blog as an informational piece.
New technologies regularly enable a more efficient and economical manufacturing process. Companies seek to incorporate tightly integrated test systems into their processes, reducing the time-to-market schedule for new products and costs.
This article explores effective manufacturing test strategies that impact manufacturing operations, their advantages, how to implement them, and what steps you can take to ensure your company achieves optimal performance.
Medical Devices are Critical to Patient Healthcare
Successfully testing medical devices is critical to patient safety, as they are used in hospitals and other healthcare facilities to diagnose, monitor, and treat patients.
Because the FDA has strict regulations regarding the safety and effectiveness of their products, manufacturers must ensure their products meet the highest standards of quality and reliability to prevent injuries or deaths due to faulty and/or malfunctioning devices.
Here is a list of some commonly applied US FDA consensus standards for electronics/electrical Medical devices:
1. ANSI AAMI 60601-1:23005/A1:2012/A2:2012/AMD2:2021 (Medical electrical equipment - Part 1: General Requirements for basic safety and essential performance)
2. IEC 60601-1-2 Edition 4.1 September 2020 (Medical electrical equipment - Part 1-2: Collateral Standards: Electromagnetic disturbances - Requirements and tests)
3. IEC 60601-1-6 Ed. 3.2 July 2020: (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability)
4. IEC 60601‐1‐8: ‐Ed.2.2 July 2020: Part 1‐8: (Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems)
5. IEC 60601-1-11 Ed. 2.1 July 2020: Part 1-11: (Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
6. IEC 62304-1 Ed. 1.1 June 2015: (Medical device software: Software life cycle processes)
These regulations cover all aspects of the production process, from design through to testing and validation. They are designed to ensure that products meet the appropriate standards of quality and safety while minimizing any risk that could cause patient injury or death. If a medical devices manufacturer fails to follow the FDA’s regulations, it can be held liable if its products cause injuries or deaths.
Quality Assurance Testing
Quality assurance (QA) testing is a process of identifying, assessing, correcting, and monitoring important aspects of medical devices to ensure they are safe for use.
As the name suggests, quality assurance is a crucial part of quality control; it is a critical step in ensuring that your medical device meets all regulatory requirements and provides consumers with a safe product experience.
A robust testing strategy begins with creating a test plan that defines what needs to be tested and how to evaluate the outcome. This plan is created by an experienced team with a deep understanding of device standards and requirements. Likewise, this team will be responsible for executing the testing strategy and communicating their findings all throughout the process.
Integrated Systems
To meet regulatory requirements, prevent workflow and timeline issues, produce safe products, and keep within budget, engineers need hardware to do the testing and software to record test results.
An integrated systems approach is the best way to meet these objectives. The system provides a single source of records and ensures that data is always available to engineers, regulatory staff, and management.
Additionally, this system helps engineers track test results and make changes to the device based on those findings. As a result, the team avoids spending time searching for information or troubleshooting issues later in development or production.
NI's products, technologies, and services set the standard for automated tests and measurement. NI combines the right equipment with proven methodologies to help you find any potential defects faster and, ultimately, design better products.
Advantages of Integrated Manufacturing Test Systems
Manufacturing test systems of an integrated nature provide the following advantages:
Teams can use integrated test systems to test many types of products. They are especially useful for medical devices because they allow you to ensure that your products meet the quality standards required by FDA regulations.
Integrated systems can also help to reduce risk, lower costs, and increase customer satisfaction by addressing problems earlier in the process.
The system can also help with compliance by recording test results and generating reports that meet regulatory requirements. These reports can be used by the manufacturer, regulatory staff, and management to monitor production and make decisions about how to move forward.
In addition, testing integrated systems generate a detailed history of each product. As a result, engineers won’t have to start from scratch when investigating a problem one presents itself down the line.
Reduced Risk of FDA Non-Compliance
Medical device manufacturers are required to adhere to several FDA regulations, including the Quality System (QS) Regulation.
Manufacturing test systems allow for medical device manufacturers to comply with regulations by documenting the design process, developing quality plans and procedures, and ensuring that products meet specified requirements throughout manufacturing.
Increased Yields
When implemented properly, manufacturing test systems can help manufacturers reduce scrap rates and increase the output of production while maintaining quality levels during each phase of the manufacturing process.
This increases overall production efficiency by minimizing rework time and reducing downtime due to errors or defects in products that need to be rectified before the product reaches customers.
Improved Customer Satisfaction
Manufacturing test systems can help medical devices manufacturers reduce the number of defects in products at every stage of production, which helps to maintain high product quality standards. This enables healthcare organizations to provide customers with reliable and effective solutions that meet their needs.
With proper systems in place, implementing manufacturing test systems enables organizations to improve customer satisfaction scores by reducing complaints about product quality following launch. Let’s discuss the different test strategies available to manufacturers within this field.
Social Test and Measurement Network
Test and measurement is an interdisciplinary, cross-functional network that involves interweaving people, processes, and technologies toward a common end. The result is a highly social and scalable process that supports rapid innovation while creating high-quality products and cost-effective delivery.
As measurement technologies become increasingly complex, production test teams must develop a culture of collaboration and continuous improvement. Cloud-based solutions provide the opportunity to build a collaborative platform that allows teams to share best practices, record performance benchmarks, and share information to enhance their measurement capabilities.
Scalable QA Testing
There is a growing demand for test data to be used for more than just measuring product performance and compliance with standards. This list includes functions in supporting new types of testing, improving test automation, and reducing the time it takes for new features to be deployed.
This creates an opportunity for test teams to leverage measurement data in new ways.
Using cloud-based solutions, test teams can build scalable QA test environments that provide a more efficient and effective way to run their quality assurance workloads. One particular function this can help with is facet testing, which is likely to increase in significance over time in the field of healthcare device manufacturing.
Facet Testing in Healthcare
Facet testing is a technique for identifying interactions between variables in a data set. Specifically, it can be used to identify specific combinations of factors that affect the quality of test data. This it useful when trying to determine if your tests are stable and reliable enough to use in production.
Facet testing for medical devices is particularly important because of the need to ensure that each device or product is safe, effective, and serves its intended purpose.
The following are samples of facet testing in the medical device industry. They show how NI’s LabVIEW software can be used to capture, analyze, and report on the data generated during a facet test. We can help you achieve better data quality in less time and with less effort, which results in more reliable tests and higher confidence when making decisions about medical device development and safety.
Functional Validation
Functional validation of the software and hardware components of a device is critical to ensuring that it will work as expected in the real world. Functional validation involves testing each component individually, then testing them together as an integrated system.
As a result, this type of validation ensures that all software modules interact properly with each other and that the system as a whole behaves according to its specifications.
Device Interoperability
The interoperability of devices and clinical systems is a key driver for innovation in the field of healthcare. Connected devices and applications allow patients and providers to access valuable health data for treatment planning, monitoring progress, and engaging with care teams.
As applications and devices become more complex, it’s not enough to verify that each piece works independently. The data from these devices must be able to seamlessly flow freely between devices and applications without compromising security or privacy.
Usability Testing
Usability testing is a type of quality assurance that focuses on how easy it is for users to interact with software. It can be particularly important when developing applications that require complicated data entry or manipulation, including those used by medical professionals who may lack up-to-date software training.
Application Security
Security of applications and their data is also critical. Security validation ensures that the device cannot be hacked or compromised by malicious actors, and that its users have appropriate access to only those resources they need to perform their jobs.
Productivity and Implementation Testing
This testing technique is necessary because it helps ensure that the product works well outside a production environment.
Once a product has been developed and tested, it is important to make sure that the item works in its typical use environment. This type of QA test demonstrates that your product works as it should and that people in the real world will be able to use it effectively and efficiently.
Conclusion
With the increasing demands of the healthcare industry and the growing number of new products entering the market, companies must design manufacturing test strategies for products from the beginning stages. Quality assurance tests allow for a more efficient and cost-effective manufacturing process that meets all regulatory requirements.
About Author
Daniel is a community manager for NI (formerly National Instruments), where they create the tools needed for companies to Engineer Ambitiously™. His current interests are at the intersection of software engineering and DevOps. Outside of work, he is a marathon runner and is working on his first novel.