Remaining data compliant in the world of medtech
Mike John, technical director of industrial metrology specialist The Sempre Group, explains how manufacturers in medtech can automate data collection to streamline compliance reporting and gain insights.
In the world of medical technology and healthcare, quality management is key. Manufacturers must comply with increasingly stringent regulations, such as ISO 13485: 2016 and ISO 17025 and be able to provide a fully traceable report that proves quality throughout the product’s lifecycle. Whether the device is a wearable blood pressure monitor or a drug delivery system like a metered dose inhaler (MDIs), ensuring reliability and safety is critical.
The world of medical devices is just as stringent. Manufacturers must be 21 CFR Part 11 compliant, which means ensuring that all electronically generated information is fully traceable and free of gaps where human error can occur in data collection and introduce untraceable faults. This means keeping a trail of where data is amended, stored, transferred, or accessed.
The future is automated
Manual data collection is time consuming and lacks complete traceability, increasing the risk of human error because there is no guarantee that operators input data from one source to another accurately. By reviewing incorrect data operators risk adjusting machinery unnecessarily, stopping production or allowing lower quality parts to pass inspection. Consequently, production levels are damaged, and parts become non-compliant, harming the manufacturer’s reputation.
The production and quality process can never be fully traceable unless there is a digital thread connecting drawing to product to report. For example, a medtech developer could take notes of measurements in a first article inspection (FAI) report and input the dimensions into an isolated Excel file that isn’t linked to the original ballooned drawing or future quality checks, making it difficult to guarantee that all parts meet specifications.
Instead, the operator uses fully traceable automated data collection systems, such as High QA, to streamline FAI reporting. Another example is the Prolink SPC Data Collection Software, which, as well as being 21 CFR Part 11 compliant, allows manufacturers to extract real-time data from any device to enable full analysis and reporting. By using High QA, developers can scan entire drawings, or multiple pages, and extract the geometric dimensioning and tolerancing (GD&T) data and critical dimensions, with all the tolerances automatically allocated. Using this data, they can generate FAI, Production Part Approval Process (PPAP) and other reports, and store future measurement data in the same centralised system.
A reformed industry
By using automated, real-time data collection software, those in the medtech industry can extract real-time data from any device to enable full analysis and reporting. Without relying on isolated documents, manufacturers can communicate important quality information to stakeholders and reduce the time needed for compliance reporting.
Analysing the reports provides medtech developers with full visibility over production quality processes, so they can demonstrate and identify areas for improvement. For example, if they notice that parts on a wearable device are not compliant, the report will say when the fault occurred and help them resolve the issue. Over time this will decrease the number of defective products, reduce material waste, and improve productivity so that healthcare facilities and other customers receive fully compliant parts and devices sooner.
Medtech and medical device manufacturers can also use software and data to make proactive changes during production. For example, if a part does not meet specification, software like Reaction Plan Manager will instruct the operator on how to adjust the machine to correct the issue without needing a specialised engineer to assess the process. By adjusting tooling as soon as an issue is spotted, engineers can ensure that fewer parts are manufactured out of tolerance, reducing scrap.
As the amount of data usage continues to grow exponentially, we need to understand how to make the best use of it. The same can be said for the highly regulated medtech industry — by analysing reports acting on the results, manufacturers can make the informed decisions that will improve efficiency, reduce costs, and ensure compliance.
The Sempre Group will be exhibiting at Med-Tech Innovation Expo on Stand D13 on 8th-9th June at the NEC, Birmingham. For more information visit www.med-techexpo.com.