Polyurethanes as Biomaterials

What is a Combination Product?

“Combination product” is a term used in the medical industry that refers to a product composed of two or more of the following: drug, device, and biological product. For over a decade there has been an increasing convergence between devices and drug therapies, leading to combination devices that more effectively deliver drugs and treatments to patients. Implantable medical devices are a common pharmaceutical combination product that provide a variety of functions from vascular stents that preserve blood flow to electrostimulation devices that regulate heart rhythm or block spurious signals in the brain, to orthopedic devices that mechanically reinforce the spine or restore range of motion of hips and knees. Other examples of combination products include inhalers and insulin pumps.

Pharmaceutical combination products, in particular implantables, provide a great benefit to patients over conventional dosage methods. For example, implantable devices provide site specific drug administration where the drug is most needed – this targeted treatment often allows for lower doses, reducing side effects. Additionally, this form of drug dosage is less burdensome to the patient. For these reasons, the trend toward combination products is expected to continue as demand grows for patient-centric drug delivery and self-administration of healthcare.

Silicone – the Perfect Match for Combination Products

Silicone has long been a popular material for medical device manufacturers due to its durability, ease of molding by many methods, wide useful temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. But the key characteristic that makes silicone the perfect match for combination products is its biocompatibility. Silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth. Additionally, medical-grade silicones have undergone stringent purity and biocompatibility testing that make them suitable for use in long-term implants.

LSR is a specific type of silicone used in combination products. The low viscosity of LSR makes it a great silicone material for making medical devices via injection molding, since the LSR can easily flow into and completely fill molds with relatively low injection pressures, even those with intricate and small features. Furthermore, the temperatures needed to vulcanize LSR are usually low enough that significant degradation of compounded substances like Active Pharmaceutical Ingredients (APIs) can be avoided.

One application where medical-grade silicones, such as LSR, really shine is drug-eluting implantable devices. Before molding, silicones can be compounded with APIs such as cancer drugs or hormones which can then be steadily released into a targeted area of the patient’s body over time once that molded implant is inserted. Drug-eluting implants are able to maintain the desired level of the API in the patient much more consistently and over a longer period of time than both pills and injections. Also, since the implant can usually be inserted near the targeted organ or tissue, lower total amounts of API are needed because that API doesn’t need to spread throughout the entire body before reaching the targeted area. As a result, the level of the API in the patient’s body remains inside the therapeutic window for a much longer duration.

ProMed’s Combination Product Capabilities

At ProMed, we combine industry-leading medical-grade LSR expertise with the latest developments in silicone materials and technology. From helping OEMs incorporate the latest medical-grade LSR formulations into their designs to delivering rapid silicone prototypes, we serve as a premier silicone molding contract manufacturer for medical device OEMs.

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components. Working with both established and early-stage medical device and pharmaceutical companies, ProMed develops 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. 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.