What are Drug-Delivery Pumps?
Drug-delivery pumps are medical devices that release a drug product over time into the human body. Infusion pumps may be used for many purposes: from nutritional and hydrational, to management of chronic illness, to neurological treatment, to pain medication, to antibiotic control, to chemotherapy. These devices present unique challenges to development and regulatory approval because they incorporate properties of both a medical device and a pharmaceutical product. Therefore, all component materials and the drug product require thorough investigation for interactions, safety, and efficacy. Additionally, since these pumps may be implantable devices, they often require additional scrutiny because of their extended contact with the human body. Guidance for ensuring biocompatibility of drug delivery devices has been set forth in documents such as ISO 10993-1.
Drug-Delivery Pump Assessment at EKG Labs
EKG Labs leverages its knowledge of material compatibility, extractables, leachables, and ISO 10993 chemical characterization to provide analytical testing in order to help support companies developing combination products and devices for FDA approval. At EKG Labs, we have brought together industry experts in combination product development and regulatory testing. EKG has experience with both Premarket Application (PMA) and 510(k) testing. We have also helped a number of clients with drug-delivery device components to their pre-IND filing. Some of the questions we can help you answer include:
- What is the extractables and leachables profile of my infusion pump?
- Does the drug product in my pump negatively interact with the device materials?
- Is my pump delivering formulation at the expected rate and dosage?
- What catheter will be best compatible with my drug product?
- How can potential impurities in my product be identified?
- What data do I need to submit for regulatory approval of a combination device?
EKG has distinct experience with pumps and drug products used for the management and/or treatment of diabetes, epilepsy, multiple sclerosis, and other medical conditions. We have also worked with a number of IV formulations. EKG Labs has extensive expertise with wide varieties of pumps:
- commercial and novel pumps
- implantable pumps and enteral pumps
- variable flow rate and constant flow rate pumps
- large external pumps to tiny implantable pumps
- peristaltic pumps and osmotic pumps
- stationary pumps and ambulatory pumps
- syringe pumps and large volume pumps
Whether you are running an established Medtronic or Covidien pump, a novel insulin pump, or a system the market has never seen before, we can partner with you as you navigate the complex FDA regulatory process. Our capabilities include:
- Full scale GMP analytical Extractables and Leachables programs to understand how the device and the pharmaceutical product interact
- Including ISO 10993 Chemical Characterization of medical devices
- Material Compatibility
- Impurity Identification
- Method Development
- Method Validation
- And more!
Other EKG Labs Combination Product Testing Expertise
The team at EKG Labs has worked with a variety of medical device combination products including:
- Metered dose inhalers, nebulizers, and other novel inhalation technology (inhaler case study)
- Drug-eluting stents
- Dental implants and adhesives
- Wound-healing devices, including microneedling devices and hydrogels (microneedle case study)
- Filler devices
- Prefilled syringes (syringe discoloration case study)
- Pumps and other drug delivery devices (case study coming soon…)
Learn more about our specialty medical device experience