Medical Device Quality Assurance

X-ray inspection provides the information medical device manufacturers need to elevate quality assurance.

Medical Device Quality Assurance

Medical professionals’ ability to help patients is a function of both the information and technology they have access to. Medical device manufacturers contribute significantly to the technology available to caregivers, and the quality of those devices are critical.  At Creative Electron, a dedicated subset of our engineering department is continually examining the factors that contribute to quality manufacturing outcomes in medical devices. Medical manufacturers are after all, among our largest partners in the X-ray industry. One conclusion we have reached is that information about technology is a critical function of how helpful a manufacturer can be to medical professional and in turn, their patients. 

  • Placement
  • Presence/absence
  • Dose/fill level

Injectables like Epi-Pens depend on proper assembly and mechanical function to deliver their sometimes lifesaving medication.  Failure of these devices to deploy the needed medication can result in serious injury or death.  X-ray inspection can prevent some of the most common defects, things like missing, damaged or nested springs, from ever reaching consumers.  In most cases, even finished product in its sterile packaging can be validated. 

AI driven X-ray detection of the presence and placement of a critical spring in an epi-pen.

X-ray systems are particularly well suited for verifying parts presence or absence. Negative patient outcomes can easily be avoided with automated X-ray validation.  Surgeons, for example, rely on surgical kits to be complete every time.  A single missing component can cause delays to critical emergency care. 

AI enabled software quickly identifies missing components

Not only do autoinjectors need to function perfectly every time, but it is essential that they deliver the required dose of medication.  Validating fill level of injectable medications is another task that is easily accomplished with automated X-ray inspection.  Ensuring the proper dose is done quickly and accurately, avoiding the potential adverse effects of under dosing a patient. 

Automated volumetric measurements can detect dangerous voids or overfills. 

Medical devices of all types benefit from X-ray inspection.  Automated inspection supported with AI enabled software quickly and efficiently improves quality outcome.  It is far more reliable than fallible human inspectors in identifying problems, resulting in fewer defective products reaching patients.  X-ray systems are utilized to validate components, sub-assemblies, finished and even packaged goods. 

November 17, 2022

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