Abstract
The purpose of this article is to report the translational process of an implantable microdevice platform with an emphasis on the technical and engineering adaptations for patient use, regulatory advances, and successful integration into clinical workflow. We developed design adaptations for implantation and retrieval, established ongoing monitoring and testing, and facilitated regulatory advances that enabled the administration and examination of a large set of cancer therapies simultaneously in individual patients. Six applications for oncology studies have successfully proceeded to patient trials, with future applications in progress. First-in-human translation required engineering design changes to enable implantation and retrieval that fit with existing clinical workflows, a regulatory strategy that enabled both delivery and response measurement of up to 20 agents in a single patient, and establishment of novel testing and quality control processes for a drug/device combination product without clear precedents. This manuscript provides a real-world account and roadmap on how to advance from animal proof-of-concept into the clinic, confronting the question of how to use research to benefit patients.
Highlights
Implantable microdevices (IMD) is retrieved from the patient tumor with surrounding tissue by minimally invasive biopsy or surgical means [6]
The IMD platform consists of a micro-implant, roughly the clinical workflows, a regulatory strategy that enabled both delivery and response measurement of up to 20 agents in a single patient, and establishment of novel testing and quality control processes for a drug/device combination product without clear precedents
Up to 3 days later, the IMD is retrieved from the patient tumor with surrounding tissue by minimally invasive biopsy or surgical means [6]
Summary
IMD is retrieved from the patient tumor with surrounding tissue by minimally invasive biopsy or surgical means [6]. A to characterize drug response in the tissue, ranging from translate developments made in the preclinical realm into standard histopathology to cutting-edge spatial transcriptomics, metabolomics, or highly multiplexed immunofluorescence [7], the patient setting. This translational process involves two major areas, one being the regulatory review (primarily by the U.S Food and Drug Administration (FDA) in the United States, and institutional review boards) and two, the clinical translation process, consisting mainly of engineering design and testing to integrate the novel technology into existing clinical workflow and to reduce risks to the patient to a point where a potentially beneficial yet unproven intervention is justified. Bhagavatula et al, “An interventional imagetrauma, orthopedic, and spinal implants,”
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