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RFP for Single Dose, Prefilled, Dual Chamber Injection Device

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Application: Request for Proposal for Single-Dose, Prefilled, Dual Chamber Injection Device

Open Date: May 21, 2018 12pm PST

Applications Due: Tuesday, July 10, 2018 5pm PST

Please note: Concept memos may be up to 2 pages in length excluding general information page.

 

Overview

This project is to design and build an initial prototype of a dual-chamber, prefilled, single-dose injection device. These devices will be required in the global health space to enable simple, intuitive reconstitution and injection of drug products that require storage in the dry state (powder or cakes) in remote in-home settings. This Request for Proposal outlines two use cases for the device: administration of measles-rubella vaccine in house-to-house campaigns by low skilled healthcare workers and self-administration of next-generation, long-acting, injectable contraceptives by patients, themselves, in a home or other non-clinical setting. The device should enable safe injection outside of traditional healthcare facilities and meet minimum requirements for one of the two use cases outlined. Ideally, proposed devices will meet and exceed minimum requirements for both use cases.

In order to meet the use cases, these devices would need to meet several key requirements:

  • Lightweight, rugged and compact for shipping, storing and use, including last-mile settings such as house-to-house campaigns in remote locations
  • Simple and intuitive to use for low-skilled healthcare workers and/or self-injection
  • Ensure accurate reconstitution and administration of freeze-dried or powdered drug or vaccine products to patients
  • Consist of materials that are compatible with a wide range of sterile injectables, including drugs, biologics and vaccines
  • Compatible with filling under aseptic conditions and capable of maintaining product sterility during storage, reconstitution and administration
  • Contain built-in safeguards to prevent reuse of the device, including the needle
  • Low-cost to manufacture and fill to enable wide spread adoption within the global health community

The focus of the Request for Proposal will be on early research and creation of prototype devices for human factor study. It is anticipated that ~3-5 awards will be made in January 2019 and range from $100K - $250K per award. Target grant duration is about 6 months.

This is intended to be a first phase of funding – successful prototypes may be further supported for user acceptance testing, pilot scale production, and further development.

 

Timeline

Request Announced: Monday May 21th, 2018 at 12 pm PST

Q&A Teleconference: Wednesday, June 13th, 2018 from 12pm to 1pm PST (Dial-in info: +1 (855) 507-1600, Conference ID: 86301239)

Deadline for Round 1 Concept Memorandum submissions: Tuesday, July 10th, 2018 at 5 pm PST

All applicants notified of their status, finalists will be asked to submit a full proposal: Monday, August 6th by 5pm PST

Full proposals due from finalists from Round 1: Monday, September 17th by 5pm PST

Grants executed: January, 2019

 

How to Apply

Please submit all documents directly to dualchamberrfp@gatesfoundation.org. Your submission should include only the completed Concept Memorandum. Other attachments, including cover letters and supplemental information will not be accepted or reviewed.

Additional Information

Please contact dualchamberrfp@gatesfoundation.org with any additional questions. Questions received through the RFP mailbox will be responded to in writing at the end of the week in which they are received.

 

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