Jason McGlynn, commercial manager at industrial metrology specialist The Sempre Group, shares his thoughts on measurement in Ireland’s medtech market and explains how the company’s new Dublin facility will support local manufacturers.
What are the current measurement and quality trends in Irish medtech?
There is a growing shift towards connected metrology systems, which provide manufacturers with a digital thread connecting initial product drawings right through to final quality reports.
Ireland’s medtech sector is expanding, and so is the spotlight on production processes. Manufacturers may already have multiple measurement systems and software on site, but, if these are working in isolation, vital data can be misplaced. However, manufacturers can now integrate their various measurement systems and connect them with the necessary software, tying them together with one unified electronic quality management system (EQMS) that enables them to access the necessary data.
One example is 21 CFR Part 11 compliance. Quality engineers must ensure the manufacturing process is fully traceable and connecting their systems and software can help medtech businesses meet this standard. At our new Balbriggan site, we offer a wide portfolio of metrology systems as well as automated, real-time data collection software. Therefore, we’re enabling local medtech firms to improve their productivity and quality by helping them improve measurement accuracy and traceability.
What measurement challenges is the Irish medtech industry facing?
The main challenge is device complexity. Medical devices everywhere are becoming more sophisticated as designs evolve with functionality. For example, glucose monitors for diabetics, catheters and orthopaedic instruments all have tight geometries, which can make measurement a challenge. The medical industry demands the highest standards, which can mean measuring down to nanometres.
Manufacturers can overcome measurement hurdles when working with bone screws, drill bits or any precise other components by finding an experienced metrology partner that can provide flexible support and help them find the right solution. This means understanding the specific measurement challenges and needs, and what it takes to remain compliant with the necessary standards.
What inspired Sempre to open an Irish facility? What does it offer?
Ireland is one of Europe’s largest medtech hubs, so opening a site where we can support local manufacturers was a no-brainer. Medical device companies care about two things — speed and getting their products to market. Unless they have a metrology partner nearby, manufacturers and quality engineers must wait for parts to be shipped so they can be measured. This means they can lose valuable time in transportation delays.
At the new site, we provide local metrology support to help medtech companies speed up their time to market. We’re already getting a lot of demand for contract measurement because we offer quick turnarounds, and we’re continuing to grow our product portfolio at the site. For instance, we’ve just introduced the RX Solutions EasyTom CT scanner, which is available for both purchase at an affordable cost and for contract scanning services.
Branching out into Ireland is a great opportunity to expand our global reach. A lot of companies here are US-based firms using Ireland as their manufacturing hub, and we can offer local partnerships like we’ve already been doing in the UK.
What do you expect the future of measurement in Irish medtech to look like?
Data integrity will be critical, no question. Measuring an implant or a particular instrument or component is one thing, but this information is only useful if the manufacturer can demonstrate validity and confidence. Is the data traceable? Who measured the part, and when? These are all questions that medtech companies must ask themselves.
Data integrity is already a hot topic with the industry facing increasingly stringent regulations, and its importance will only increase. The number one priority must be finding a reliable metrology partner that can support with a credible data collection platform, such as Prolink SPC Data Collection Software.
