Global Integration in World Systems Theory
The content delves into the dynamics of global integration through the lens of World Systems Theory, highlighting power structures, technological advancements, labor divisions, and historical colonial influences.
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Presentation Transcript
Instructions Please fill out the template deck as completely as possible. Note that some information may not be known or applicable for your application; complete all relevant sections. Limit to no more than 15 slides excluding the title slide. You can use your company PowerPoint template, but please use the content descriptions and fill any tables that are provided in the template.
Call for proposals for evaluation of new TB diagnostics and testing strategies FEND-TB. Company Name Company Location Incorporation status Contact person and contact information Date
DETAILS OF THE ORGANIZATION Presentation of the company/institution and history/track records in the IVD field Number of employees and organization chart Executive team presentation
PRODUCT VISION FOR TB TESTING Specify the use case (triage, confirmatory diagnosis, treatment monitoring), target analytes, including resistance markers and sample type Stage of development and main barriers toward product launch Development roadmap and target market entry date
TECHNOLOGY Underlying technology principle Sample processing: technology and integration (e.g. heating, chemical, mechanical)
USABILITY Operating conditions (e.g. temperature, humidity) Time to results: from sample to answer Built-in connectivity options such as Bluetooth, Wifi Power requirements (battery-enabled?, consumption level)
DATA (IF AVAILABLE) Analytical data (e.g. limit of detection) Clinical data
COGS (ESTIMATION BASED ON MANUFACTURING LEVEL) Assay Instrument
MANUFACTURING CAPABILITIES Please describe the current and potential expansion plans of manufacturing capacity and expertise of your organization. If manufacturing of your IVD products are outsourced, please provide details about the manufacturing partner or the plan for manufacturing at scale
QUALITY AND REGULATORY STRENGTH How mature is your quality management system (certifications, ISO, compliance, audits)? Experience in regulated environments and plans toward IVD regulatory compliance Track records of regulatory clearance/approval? Where applicable, list the number of products that have obtained regulatory approvals by stringent regulatory authorities (e.g. CE-IVD, FDA, ERPD, WHO PQ). IP considerations
DISTRIBUTION: LMIC AND GLOBAL ACCESS TERMS What is your commercial strategy and key target countries for market entry? Please, describe your current distribution capacity with a focus on LMIC if possible. Do you have any ongoing projects directed toward global health issues/targeting LMIC markets (e.g. grants from global health agencies/foundations like BMGF, RIGHT, GHIT)? Which development project would be your priority, considering possible funding availability?
