SBIR Phase I: Development of a connected implantable vascular access port to facilitate oncology drug delivery and AI-data analytics for personalized cancer care

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project includes the potential to improve survival and quality of life outcomes in cancer care while decreasing treatment costs. Each year, 1.7 million people in the US are diagnosed with cancer. National expenditures on cancer care are projected to reach $156 billion by 2020. Cancer treatment is delivered mostly in an outpatient setting, leaving patients unmonitored at home while at high risk of complications that can lead to high utilization of emergency services and associated hospitalizations. Early detection of complications can trigger rapid intervention when most effective, leading to improved outcomes and lower costs. A linked implantable vascular access port will provide sterile means of cancer drug delivery and physiologic monitoring. Advanced analytics will identify patients showing the earliest signs of common complications. Finally, aggregated data will provide valuable insights for hospitals to better understand outcomes and costs, serving as a valuable research tool for industry and academic researchers developing next-generation cancer therapies.This Small Business Innovation Research (SBIR) Phase I project will advance technology development toward a linked implantable vascular access port (VAP) capable of intravenous drug delivery and patient monitoring. The proposed research will focus on risk in technology development and clinically important endpoints. For ease of use, the linked implantable VAP will communicate with the patient’s mobile device via secure Bluetooth wireless. Aim #1 focuses on establishing a front-end mobile application to control the collection and transport of ‎multiple sensor inputs and associated metadata. This mobile application will provide a critical link between the implanted sensor technology and the cloud database for analytics. As an implantable medical device, replacing the power supply would carry unacceptable risks and costs. Therefore, Aim #2 focuses on power supply characterization, selection, and optimization. In Aim #2 power requirements for 12 months of active patient monitoring will be identified based on clinical needs and used to identify a power supply compatible with implantation. Most cancer patients require radiation therapy as part of their treatment. It is therefore critical to understand the effect of ionizing radiation on any device implanted in cancer patients. Aim #3 addresses this need through in vitro irradiation of the device.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.