Ireland is one of the largest exporters of medical products in Europe, with annual exports of 12.6 billion euros. Medical device manufacturers in Ireland are constantly looking for new ways to enhance competitiveness, improve productivity and generate new growth in the area – could metrology make a real difference? Jason McGlynn, commercial manager for Ireland at industrial metrology specialist, The Sempre Group explores three factors to consider when searching for a metrology supplier and equipment for medical applications.
The goal of medical device manufacturing is to produce exactly what the patient needs. As such, manufacturers should consider how they will validate the process to ensure this is the case. However, metrology is often an afterthought in the product’s lifecycle and is simply used to validate products and detect defects at the end of production. With regulatory requirements becoming increasingly stringent, there is added emphasis on proving safety and quality throughout every step of the product’s lifecycle. For metrology specifically, ISO 13485 lays out how to maintain an effective quality management system specific to the medical device industry, covering every stage of product lifecycle from design to disposal.
Precision is key when manufacturing any medical device to ensure the best outcome for the patient. Take an insulin pen as an example – if any dimensions are slightly incorrect it could lead to false deployment, overdosing or underdosing putting the user at risk.
Manufacturers can invest in nano and micro precision measurement equipment to validate a variety of parameters, from dimensions to surface characterisation. This equipment can effectively validate the accuracy of devices, so long as it is calibrated correctly. So, when looking for a metrology supplier, medical manufacturers should check that a supplier’s equipment and services meet relevant standards.
ISO 17025 accreditation and certification demonstrates competence and performance capabilities of organisations that provide certification, testing, inspection and calibration services.
When applying to regulatory bodies for approval, medical device manufacturers need evidence to prove that the device safely and effectively meets its intended use. Proving compliance requires manufacturers to document every stage of the process – so improving traceability should be a priority.
Investing in automated, real-time data collection software, such as the Prolink SPC Data Collection Software, will help manufacturers spot any changes that occur during production and identify where they happen and why. It extracts result data from any device or machine and enables full analysis and reporting, providing total visibility and control across the entire process and reduces the risk of human error that comes with paper documentation. When choosing a software, medical manufacturers should also ensure it is 21 CFR Part 11 compliant, as it assures that any electronic documents generated are authentic.
The full package
The earlier that manufacturers involve metrology specialists in a project, the more successful it will be. Finding a supplier early in the process means that the metrology company can provide everything manufacturers need to improve quality at every stage of the product’s lifecycle, ensuring ISO 13485 compliance.
Smaller businesses can also benefit from involving metrology specialists early on so that they can build a solution that grows at the same rate as the project. The supplier can build bespoke systems to meet the needs of the application and upscale the solution as the medical manufacturer scales up production, ensuring that the solution will always meet production requirements.
Medical device manufacturers know that metrology is needed to ensure a device operates to design intent and safety requirements. By considering metrology as a higher priority and investing in a fully integrated approach to quality, medical manufacturers can gain the competitive edge required in such a large industry.
For more information: www.thesempregroup.com