Evaluation & design of a novel drug delivery device for treating tumor-related cerebral edema

Abstract

Tumor-related cerebral edema is a debilitating medical condition that afflicts tens of thousands of newly diagnosed brain cancer patients in the U.S. each year, where the standard care of treatment indicates the systemic administration of dexamethasone sodium phosphate (DXM) and surgery. The former is associated with toxic side effects, and the latter is an ineffective option. Local drug delivery to the desired site of therapy helps to circumvent the side effects of DXM. In this paper, the design of a novel, local drug delivery device was explored as a means to treat tumor-related cerebral edema. The novel device was then evaluated based on an analysis of the market environment in which it will be sold. This included discussion of the supply chain infrastructure and the challenges associated with the medical industry, an estimate of the addressable market size, growth and valuation, and an estimate of the novel product's cost compared to current edema treatment and the device's potential competitors. The methods by which the device could be commercialized were also discussed, specifically, strategies for obtaining FDA approval, manufacturing the device on a medium scale, protecting intellectual property, integrating the device into the supply chain, and an estimation of the financial investment needed to form a startup company. Finally, the technology that enables its desired application was evaluated, which included an assessment of the barriers to drug delivery, ideal characteristics of a successful drug delivery device, possible routes and means of administration, as well as other considerations pertinent to a successful drug delivery device. After completing the first iteration of the innovation cycle, it was concluded that the device deserves further investigation and investment, as it progresses from the lab bench to the marketplace.