Exploring the Role of Interferometry in Medical Device Manufacturing
The ability to produce high-quality products that meet the stringent requirements of the FDA and other regulatory bodies is critical for all medical device manufacturers. To create products with the highest possible quality, advancements in product testing during production are essential. This need has resulted in the use of optical metrology in medical device testing, which offers significant advantages over traditional methods.
The Lumetriscan® 360 provides an example of the capabilities of cutting-edge optical technology to provide high-precision, non-destructive, repeatable, real-time medical device measurements. The instrument is engineered for the testing of medical device thickness measurements and the dimensional measurement of medical balloons, blood bags, and other medical device components with objective, non-destructive, dimensional measurements.
Non-contact optical measurement provides accuracy and advantage in a wide array of production scenarios. To achieve higher quality outputs and efficiencies in medical device production, it is necessary to be able to obtain measurements of wall thickness, concentricity, and ovality which all contribute to the critical operation of the medical balloon. In addition, it allows measurement of another key variable in medical balloon quality, the condition of the tubing used in its manufacture. These types of non-contact measurements cannot be achieved using typical quality assurance methods.
OPTICAL THICKNESS MEASUREMENT OF CORONARY BALLOONS AND MEDICAL TUBING
Read our app note to learn more about how our technology overcomes the limitations of traditional medical device inspection methods.
The application of interferometry in medical device testing can also extend to the seal integrity on blood bags and IV bags. The same degree of advanced accuracy is also necessary for bioresorbable stents when collecting dimensional measurements during the manufacturing process.
The advantages of using optical non-contact measurement instead of traditional methodologies include the fact that these alternatives are high-precision, non-destructive, repeatable, and accomplished in real-time. The following summarizes practical use examples of the capabilities of the Lumetriscan 360 in a variety of medical device testing scenarios:
- Dimensional testing of wall thickness across a medical balloon, including the body and the proximal and distal ends.
- Medical device measurement solutions from simple lab devices to fully automated robotic systems.
- Measurement for products with a diverse range of properties such as clear, coated, or encased in wire mesh.
- Advanced catheter and balloon measurement with consistent, NIST traceable, real-time measurement in the production process.
Beyond the tactical capabilities of optical interferometry systems, they offer the ability for production management and quality assurance team members to gather data to maximize the throughput and output of medical device lines. Data integration is made possible with software such as the Lumetrics Data Relay and the OCC Software Toolkit. It is the ability to proactively pinpoint errors in the production process and subpar product quality that creates true value in the medical device field.
This is why the selection of the appropriate and most accurate measurement instruments is critical. Partnering with an experienced and innovative provider of these advanced optical measurement solutions is the first step in the process of leveraging more advanced measurement capabilities to maximize return on investment and quality.
Compared to traditional measurement methods in the medical device field, optical interferometry like that performed by the Lumetriscan 360 simplifies processes, reduces waste and user errors while saving time and money.
To learn more, download the Lumetriscan 360 Fact Sheet.Source: https://www.qualitymag.com/articles/96694-simplifying-metrology-system-selection-for-medical-applications
Want to explore how our non-contact measurement solutions optimize your production? Talk to an engineer!