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:
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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
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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.
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