Combination Products: Enhancing Therapeutic Outcomes
A combination device integrates two or more components, such as a drug and a device, into one cohesive product. Conceptually, such a device has a mechanical action and a pharmacological action. The former is intended to provide a therapeutic effect derived from a physical interaction with the tissue and the latter is a response resulting from the drug. Combination products provide superior therapeutic benefits compared to traditional devices or drug biologic solutions by combining the strengths of pharmaceuticals and medical devices. These innovative products address unmet medical needs and elevate patient care through targeted treatments, improved drug delivery efficiency, and enhanced device performance.
Examples of combination products include drug-eluting stents that release medication directly to the affected area while at the same time opening the artery to facilitate blood flow and autoinjectors that precisely administer insulin at prescribed and controlled intervals. The benefits of combination products position them at the forefront of medical advancement.
Advanced materials are crucial to these complex systems, influencing drug delivery, efficacy, and patient safety. Biodegradable polymers enable controlled and sustained drug release in implantable devices, while nanomaterials facilitate the development of targeted therapies.
Developing combination products requires a deep understanding of materials science, drug delivery systems, and the regulatory landscape. Pharmaceutical scientists excel in their knowledge of active pharmaceutical compounds but may not have the same level of expertise in medical device development. OEMs with experience in medical device development may lack expertise in understanding how device materials interact with pharmaceutical compounds, or how manufacturing process conditions could impact both the polymers and the pharmaceutical compounds. The complexity of interactions between the pharmaceutical compound, medical device, and tissue environment can require in vitro simulation and release analysis that requires chromatography analysis of complex matrices.
Our team of materials scientists, chemists, and engineers possesses the expertise in FDA (Food and Drug Administration) guidelines, international standards, and emerging regulatory trends necessary to navigate these challenges and deliver innovative solutions.
We provide comprehensive support from proof-of-concept to commercialization, streamlining the development process and addressing challenges encountered throughout the lifecycle of your combination product.
Our advanced testing methodologies assess material compatibility, drug interactions, release kinetics, biocompatibility, and stability to optimize product efficacy and safety. By collaborating with our experts, you can ensure the successful development and commercialization of your drug products, leveraging our extensive knowledge and experience to achieve superior therapeutic outcomes.
Contact our experts today to combine our teams for your combination product’s success.