Center for High-Throughput Minimally-Invasive Radiation Biodosimetry

Center for High-Throughput
Minimally-Invasive Radiation Biodosimetry

Product Development Core

Core Leader: Frederic Zenhausern, Arizona State University

Overview

The Product Development Core (PDC) is focused on facilitating the product development activities of the three major projects of the Center, and by extension, the services and work performed by the other Cores. The PDC will accomplish this through effective implementation of processes and infrastructure that includes training at every site for all Projects and Cores of the Center.

The Specific Aims for the PDC involving all participating sites of the Center are:

Implementation of a product development process with well-defined milestones denoting transition points within the process that include concept, feasibility, development, manufacturing, and clinical validation.

Establishment of a Consortium Program Management Committee with representation from all Projects and Cores to guide and manage at a high level all projects within the program.

Establishment of Project Development Teams comprised of individuals who are stakeholders in each project.

Project management implementation using Microsoft Project software as the standard for facile use and access to project plans with associated timelines, milestone/task deliverables, resource allocations, and project budget planning and monitoring.

Implementation of Six Sigma tools for quality product development (Value Stream Mapping, Design of Experiment, and Statistical Process Control).

Electronic document standardization for the entire program.

Centralized document control using a SQL database that is accessed through a business process management software package for secure revision control, electronic signatures, tracking operational and performance metrics, and auditing for corporate review and regulatory compliance.

Coordinate the product development process as well as the emerging "device(s)" with perspective of Regulatory Guidance. Determine FDA Office liaison and begin communication on pathways to commercialization with proper regulatory clearances. Submit pre-IDE's where appropriate.

In short, the PDC will provide significant benefit to the Center’s program by ensuring timely delivery of high quality products. In addition, the implemented quality systems will greatly facilitate the transfer of the developed diagnostic devices to manufacturers in a form that can be easily adapted to their manufacturing processes and that is ready for submission for FDA registration.

References

Pre-IDE Information Packet: Office of In Vitro Diagnostic Device Evaluation and Safety.

Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays.

Device Advice: Premarket Notification 510(k)

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing).

Collaborating Institutions

Center for Applied Nanobioscience, Arizona State University