Case Study from RX Solutions

X-ray Computed Tomography for Medical Devices

"X-ray CT has influenced our product development process in a positive way - we are able to quickly characterize the geometry of prototype samples and compare them against functional performance during the product development cycle. This cuts the design iteration timeline significantly. This allows for lightning-fast changes to design and/or tooling allowing us to accelerate quickly to design freeze."

- Steven Weir, Vice President TAI at Merit Medical

About The Company  - Merit Medical

Merit Medical is a top manufacturer and marketer of unique disposable medical devices utilized in interventional, diagnostic, and therapeutic procedures, especially in cardiology, radiology, oncology, critical care, and endoscopy. Merit Medical caters to hospitals globally with a sales force and clinical support team, both domestic and international, comprising over 5000 members.

In a conversation with Steven Weir, Vice President TAI at Merit Medical, RX Solutions explored the advantages of X-ray Computed Tomography for the medical devices industry, the current challenges it faces, and the CT systems implemented in the Merit Medical lab.
Image Source: Merit Medical,

What is X-Ray Computed Tomography?

X-ray Computed Tomography is a powerful tool for inspecting and controlling even the most intricate parts and materials in a non-destructive way. Its primary objective is to generate data and characterize internal components, as well as to completely reconstruct 3D models. In the medical devices sector, the main applications of X-ray CT include material analysis (such as porosity, cracks, defects, and assembly analysis) and geometry & metrology (including coordinate measurement, reverse engineering, and wall thickness analysis). Given the continuous innovation and evolution in medical devices and components each year, ensuring the reliability and longevity of life-critical devices, like pacemakers and needles, is crucial. X-ray CT becomes essential in providing valuable information on both internal and external features, measurements, material inspection, and precise comparisons between a model and the final product.

Some CT inspections carried out by Merit Medical 

  • Detection & quantification of hidden defects
  • Porosity, inclusion, and cavities analyses 
  • Coordinate measurement
  • Real part and CAD comparison
Voids in a nitinol wire after being laser welded to a nitinol tube
Nasopharyngael swabstick showing plastic stick (blue), adhesive (green) and fibers (yellow)

What Are the Main Medical Devices for Which You Regularly Use X-Ray CT?

Merit Medical has a broad range of product offerings including tens of thousands of products. X-ray CT has been used on almost every product family at Merit over the past several years in some respect either to support manufacturing, design improvements, or investigations.

Has X-Ray CT Influenced Your Product Development/Improvement Processes? If Yes, Could You Explain Us How?

Absolutely in a positive way. We are able to quickly characterize the geometry of prototype samples and compare them against functional performance during the product development cycle. This cuts the design iteration timeline significantly. This allows for lightning-fast changes to design and/or tooling allowing us to accelerate quickly to design freeze.

What Are the Main Applications of X-Ray CT at Merit Medical?

Primarily we use CT to scan molded plastic parts, in assemblies consisting of multiple parts as well as metal and electronic components are also commonplace. X-ray CT at Merit Medical is almost evenly split between supporting new product development in R&D and supporting current production and quality functions. We also scan in 3D printed parts during development to understand how geometry impacts function.

What Are the Main Benefits of X-Ray CT in the Analysis of Medical Devices?

Root Cause Investigation: Being able to 3D examine parts and assemblies in a non-destruction manner assists in determining the true root cause of complex issues without losing geometrical evidence from sample disassembly.
Research & Development: Improving new device speed to market, lowering the cost of development, and increasing quality of new designs at launch.

Are There Any Current Challenges That the Medical Devices Sector Encounters for Which X-Ray CT Could Be Useful?

Complaint Samples
X-ray CT can be used in the analysis of returned or complaint samples in order to non-destructively ascertain if a problem exists with the device. For example, one may be able to confirm a complaint on a complicated assembly by 3D viewing the inside of the assembly prior to taking the device apart, which in many cases destroys the evidence.
X-ray CT doesn’t have to be limited to the medical devices themselves. We have used it for studying interactions between devices and production fixtures, fixture development, and other production tools such as tipping dies and even parts of metal molds used to produce plastic parts.
Process Control
X-ray CT can be used to generate a database of full part geometries so that future parts can be compared to historical parts, such as when making material changes/new material lots, generating new tooling, mold changes/fixes, new core pins, etc. A historical baseline of part geometry can be extremely valuable. Better to have it and not use it than need it and not have it.

What CT System Do You Use at the Merit Medical Lab?

Merit Medical first purchased the DeskTom CT system (now EasyTom S) and then the EasyTom.

Merit Medical Images from CT Scans

Glass fiber orientation in a plastic molded part
Cross section of a curved electronic trace with cracking and delamination of 1 micron gold coating. Easytom 0.35 micron scan.

Adhesive cracks between two tubes that are glued (outer tube removed)

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