Medical Device, Combination Drug/Device

Medical devices and combination drug/device products represent a growing area within the healthcare field.  As new material and electronic technology is developed, it is quickly applied to the creation of novel medical devices and combination drug devices.  These novel products allow for treatment of disease in ways not conceivable before.  Treatments can be designed to acutely target disease by location as well as by dosage delivery. 

Medical devices encompass a diverse range of products, from simple tools used to administer drugs such as dosing cups or syringes, to complex implantable machines such as a pacemaker.  Additionally, medical devices are being designed that also deliver a drug during use, are deemed “combination drug/device” products.  Classic examples include drug delivery heart stents, and catheters containing anti-microbial coatings to minimize infection during use. 

Medical device and combination drug/device products present unique analytical testing challenges.  Some devices are simply in contact with the patient during use, and therefore risk is associated with the transfer of harmful or toxic impurities.  Other devices contact the user during surgery, and/or are implanted into the body for therapeutic effect.  These devices must be characterized fully to ensure they are sterile and free of harmful impurities.  Lastly, combination drug/device products must be characterized for risks associated with both devices and drug products.  BA Sciences has extensive experience testing and characterizing these products.  We also have a proven track record of supporting the development of these novel products and generating supporting test data that meets regulatory requirements to ensure patient safety.  Our testing offerings include:

  • Extractable & Leachable Testing: BA Sciences has experience with E&L studies for devices and combination drug/device products.  These include syringes, catheters, surgical sets, wearable devices, insulin delivery devices, drug delivery patches, and implantables.  We stay up to date with the latest industry and regulatory guidance, including the ISO 10993 methods.
  • Microbiology: BA Sciences has experience performing microbiological evaluation of medical device and combination drug/device products, including:
    • Bioburden method validation for sterility assurance level demonstration per ISO 11737
    • Sterility
    • Endotoxin
    • Bioburden
  • Stability Studies: BA Sciences can perform stability studies for combination drug/device products.  This includes:
    • Assay and Impurity methods development and validation
    • Routine stability testing
    • Dissolution studies

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