A measured approach

Jason McGlynn, commercial manager for Ireland at industrial metrology provider, The Sempre Group, explains how medical manufacturers can use metrology to solve common quality challenges and enhance their competitiveness.

According to MedTech Europe, the European medical technology market was estimated to be worth €140 billion in 2020, naming the UK as the third largest market in this area.¹ UK manufacturers are always looking for new ways to remain competitive in this growing sector, while providing the accurate and high-quality products needed by patients. 

For medical device manufacturers, the health and safety of patients is a top priority, so device quality cannot be left to chance. Despite this, metrology is often treated as a policing mechanism, only used to validate products and detect defects at the end of production. As regulations become increasingly stringent, medical device manufacturers should consider how they can better use metrology equipment to improve quality management across production. 

Accuracy

Medical devices are decreasing in size, while increasing in complexity — manufacturers are producing small, intricate parts such as polymer dental implants. As a result, manufacturers must meet much tighter tolerances; precision is key to ensure the best outcome for the patient. 

Tactile measurement may compromise the quality of these smaller components. Manufacturers therefore require nano- and micro-precision noncontact measurement equipment for accurate validation. For example, Sensofar 3D optical profilers offer three optical techniques to provide highly detailed surface inspection and analysis.²

This equipment effectively validates the accuracy of devices, so long as it is calibrated correctly. ISO 17025 accreditation and certification from the United Kingdom Accreditation Service (UKAS) demonstrates the competence and performance capabilities of organisations that provide certification, testing, inspection and calibration services. It is beneficial to work with one of the few companies able to offer UKAS calibration for optical or vision coordinate-measuring machines (CMMs), as they will ensure machine reliability.

Bottlenecks

Medical device manufacturers will often validate large numbers of parts to achieve regulatory compliance. Although this is clearly an important step for patient safety, it can slow down production in an industry where speed is critical. Manufacturers typically use measurement equipment at the end of a production line. To do so, they must first manually remove the components from the production line, thus creating costly bottlenecks while parts queue for available metrology systems.

By this stage it’s often too late to rectify any issues. If the product is found to be defective, time and energy has already been wasted on a product that could have been scrapped or saved earlier in the production process. The manufacturer has also lost the opportunity to identify the root cause of any problems that could have been addressed before it created more defective parts.

By considering the role of metrology earlier in the process, manufacturers can build a solution that becomes part of the production line, speeding up validation and avoiding any bottlenecks that can slow down production.

Data integrity

Validated measurement systems can take hundreds of measurements in seconds and generate large reports of raw data that manufacturers can use to monitor quality. How manufacturers manage and use this data is vital to provide a fully traceable audit trail. For example, manually inputting measurement data into Excel documents or other isolated files can introduce opportunities for human error to create faults in the report. Also, gaps in the reporting make finding historic data, when required, difficult. 

Opting for 21 CFR Part 11-compliant equipment will ensure security and authenticity. Automated, real-time data collection software, such as Prolink SPC Data Collection Software, otherwise known as QC-CALC, can extract real-time data from any device to enable full analysis and automated reporting.³ An easy-to-use system can provide total visibility and control of data across the entire manufacturing process. Another benefit is the ability to automatically generate password-protected reports, which makes it easy to spot any changes during production, identify where they happened and why, and take steps to investigate and fix the issue. 

A fully traceable process

When applying to regulatory bodies for approval, medical device manufacturers must document every stage of the product’s lifecycle to prove the device safely meets the intended use. Implementing a fully digitised approach to metrology from the outset enables manufacturers to automatically collect vital data that ensures full traceability and influences the success of production.

Manufacturers should consider investing in an automated quality management system (QMS) that offers an all-in-one solution for quality management, by collecting and storing data at every point, from drawing to final product. They eradicate the need for time-consuming paperwork and filing, allowing developers to easily communicate important quality information across the supply chain without the risk of human error affecting the data. 

Manufacturers can use automated systems to streamline time-consuming manual reporting processes. High QA Inspection Manager, for example, allows developers to automatically generate first article inspection (FAI) reports to verify the product’s design.⁴ The software can rapidly identify geometric dimensioning and tolerancing (GD&T) from models, outline critical dimensions and input all the data from the ballooned drawing, populating a final report. Manufacturers can automatically compare the original ballooned drawing with the new report, offering full visibility to the manufacturer. 

Medical device quality is in everyone’s best interest. By integrating metrology into the production line, manufacturers can remove expensive bottlenecks, streamline production and improve traceability, helping them to gain a competitive edge in the industry. Focusing on quality also provides patients with safe and accurate medical devices that will help them enjoy a better quality of life.