Merit Medical, explore your medical devices with Steven Weir

01 Jun 2022
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"3D CT has had a positive influence on our product development process. We can quickly characterize the geometry of prototype samples and compare it against functional performance during the product development cycle. This cuts the design iteration timeline significantly. It allows lightning-fast changes to design and/or tooling, so we can move quickly to design freeze.”"

Steven Weir, Vice President TAI Merit Medical
CT scan : Nasopharyngeal swab stick showing plastic stick (blue), adhesive (green) and fibers (yellow)
Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit Medical serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals.
 
With Steven Weir, Vice President at Merit Medical we discussed the benefits of X-ray Computed Tomography for the medical devices sector, its current challenges, and the CT systems used within the Merit Medical lab.
A few CT inspections carried out by Merit Medical US:

  • Defect detection and quantification
  • Porosity, inclusion and void analysis
  • Dimensional measurements
  • CAD comparison
X-ray Computed Tomography is a powerful technology to inspect and control even the most complex parts and materials in a non-destructive way.
The main goal is to generate data and characterize the internal components as well as the complete reconstruction of 3D models. The main applications of X-ray CT are material analysis (porosity, cracks, defect, assembly analysis…) and geometry & metrology (coordinate measurement, reverse engineering, wall thickness analysis…) for the medical devices sector. As a very innovative and challenging sector, the medical devices and components evolve constantly every year. In the role of life-critical devices, medical parts, such as pacemakers & needles, have to be reliable and their longevity is a key parameter. That’s when X-ray CT comes necessary, with valuable information on internal as well as external features, measurements, material inspection and accurate comparison between a model and the final product.

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 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 for scan molded plastic parts, in assemblies consisting of multiple parts as well as metal and electronic components is also commonplace. X-ray CT at Merit Medical is almost evenly split between supporting new production 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 cost of development, and increased 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 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.
 
  • Fixtures/Tooling: 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.
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