In the medical industry, a “combination product” is a term used to describe a product that is composed of two or more of the following: drug, device, and biological product. In recent years there continues to be increasing overlap between devices and drug therapies, leading to combination devices that more effectively deliver drugs and treatments to patients. This article will focus on the powerful combination of drug-eluting products and medical devices!

A drug-eluting device is a product that gradually releases a medicinal treatment over time. Generally, drug-eluting products are implanted into the body but there are some examples of external products such as drug-eluting wound dressings. For drug-eluting implantables, the exterior of the device can be coated with the drug, or the drug can be impregnated within the device during manufacturing.

Benefits and Examples of Drug-Eluting Medical Devices

Drug-eluting medical devices perform a variety of functions. One of the most common is vascular stents used to preserve and maintain blood flow in the heart. The stent is implanted in the patient’s artery and the device slowly releases the desired drug over time to target the care exactly where it is needed! Other examples of drug-eluting products include electrostimulation devices that regulate heart rhythm or block spurious signals in the brain, catheters with antimicrobial coating to prevent infections, and orthopedic devices that mechanically reinforce the spine or restore range of motion of hips and knees.

Drug-eluting medical products provide a great benefit to patients over conventional dosage methods. As noted above, these devices provide site specific drug administration where it is most needed – this targeted treatment often allows for lower doses since the drug does not have to spread throughout the entire body – resulting in fewer and less severe side effects. Drug-eluting implants are able to maintain the desired level of the drug, often referred to as the Active Pharmaceutical Ingredient (API), in the patient much more consistently and over a longer period of time than both pills and injections. For these reasons, the level of the API in the patient’s body remains inside the therapeutic window for a much longer duration. Additionally, drug-eluting medical devices are less burdensome to the patient and there is no risk of the patient forgetting to take a dose!

Recent Advances in Drug-Eluting Devices

Combining the power of medical devices and drug-eluting products is an exciting opportunity, and this field continues to be a focus area for research and development. One recent advancement is using a novel drug-eluting coating to reduce infections. Infection is often problematic with implants and it is estimated that up to 15% of hospital infections may be caused by internal medical devices! Bacteria often collect on the surface of an implant and form what is called a biofilm layer that makes it very difficult to fully remove the bacteria; in fact, in many cases, the implant must be removed, the bacteria treated via anti-biotics, and the device reimplanted – which is definitely not an ideal treatment plan! A cutting edge drug-eluting medical device in the form of a special coating was recently developed and will slowly release a drug that will combat the formation of a biofilm layer by the bacteria. The result is expected to yield fewer patient infections due to an implant as well as fewer procedures required to remove and reinstall implants when an infection does occur!

Traditionally, the field of medical devices has focused on palliative treatments, which try to manage a condition by improving quality of life and preventing the given problem from getting worse. But with the combination of medical devices and drug-eluting treatments, there is an opportunity to think broader than palliative treatments and shift toward treatments that potentially erase the damage from a prior medical event, such as a heart attack or stroke. And thinking even broader, these combination devices can potentially treat Alzheimer’s, Parkinson’s, or other diseases that are impacted by tissue or organ breakdowns – seeking to repair the tissue or organ and restore the patient to his/her original health. The sky is the limit when medical devices and drug-eluting products are combined!

ProMed Pharma’s Capabilities

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components, such as drug-eluting products. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics.

We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics – including Liquid Silicone Rubber (LSR) that is an excellent option for drug-eluting medical products! We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.

Summary
Combining the Power of Medical Devices and Drug-Eluting Products
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Combining the Power of Medical Devices and Drug-Eluting Products
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Benefits and examples of the power of combining medical devices and drug-eluting products as well as recent advances and innovations in this field.
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ProMed Molding
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