Key Development To Commercialization Considerations For Drug-Device Combination Products In Rare Diseases

By Bill Welch, Executive Director of Market Development, PCI

Developing drug-device combination products for rare diseases can be a challenge, but it also offers a great opportunity for biopharmaceutical companies. These products combine a drug and a device into one treatment, which can be particularly helpful for patients with rare diseases. The combination may improve how well the treatment works, make it easier for patients to stick to their treatment plan, and ultimately improve their quality of life.

However, creating these products is a complex process. Companies need to carefully consider several factors, including regulatory requirements, technical feasibility, clinical efficacy, and patient-centered design.