Drug-Device Combination Products Combine Various Aspects of Medical Diagnosis and Treatment and Are Developed Mainly Through a Process of Deep Research

 Drug-device combination products are developed and used all over the world, especially in regions such as the US, UK, and Italy. Drug-device combination products can be therapeutic and diagnostic products that combine different drugs, diagnostic devices, and/or biological products, resulting in safer and more effective therapies thanks to precise and efficient drug targeting, precise local administration, and personalized treatment. A number of companies produce drug-device combination products for the treatment of cancer, arthritis, and other diseases and conditions. There are various ways through which combination products may be introduced into the market. Most of these methods include the use of pressurized steam, microwave or laser infusion, tablet or capsule preparation, administration via droplets, intramuscular or subcutaneous injection, and orally.

In clinical trials, drug-device combination products may be introduced either as single drugs or as a combination of one to two biological agents. Single drug combination products and biological drug combination products involve only one drug with one regulatory requirement. On the other hand, pMOA (pharmacological Modular Approach) involves the introduction of a single DNA molecule or gene-targeted regulatory molecule into the body of an animal or cell. The animal is then treated using the pMOA drug. In regions such as the United States, the prevalence of several pharmaceutical companies has increased the production of drug-device combination products. For instance, according to Pharmaceutical Research and Manufacturers of America, there are over 449 public and 2336 private biotechnology companies in the US.

Drug-device combination products used in the field of the medical device should be evaluated by the FDA to ensure their safety and effectiveness before they are released into the market. Such evaluation includes determining whether the combination product is capable of causing URT (urinary tract infections) and CV (ventilatory colitis) symptoms in patients and whether the clinical trial participants will be protected from the manufacturer's failure to comply with warnings, indications, contraindications, and qualification requirements. Manufacturers are required to inform the FDA about the method of manufacturing the devices and drugs involved in the combination products. There are also manufacturers who have signed agreements with the FDA to provide post-market monitoring services, such as post-market surveillance and recall activities.