Sustainability for Melanoma Diagnosis Disease State from Patient Samples Using Photoacoustic Flow Cytometry
Product Proposal
AutoAssay Diagnostic Device
2020
Duquesne University
This is a Fusion 360 model of the AutoAssay device.
The details and specifics of the AutoAssay can be found in supplementary materials.
This is a Fusion 360 model of the AutoAssay device.
Combining knowledge gained from two graduate- level classes, Biotech Product Development and Regulatory Aspects of Medical Devices, fellow classmates and I worked all semester long to develop a hypothetical product. Together, we combined all aspects of the product development process to assemble a product proposal to be presented in front of a Board of Directors at the end of the cycle. Topics included in the proposal are:
Project Timeline Regulatory Strategy
Budget US Regulations
Manufacturing Good Laboratory Practices (GLP)
Technology Risk Management
Device Documentation Usability
Communication Standards
Quality & Quality Systems Human Clinical Trials
Reimbursement Labeling
Product Launch European Union Product Approval
Each topic, learned in each of the two classes, was applied to group project proposal to be presented to the board of directors. Using all of this information, a budget and project timeline were estimated and included in the presentation. A company name, AIA Technologies, along with a product name and product specifications were all created, simulating a real- case scenario. The presentation and accompanying documents are included below.