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Commercial Product Prototyping

Active

SBIR / STTR

Response Deadline04/06/2027, 04:00:00 AM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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This subcontract opportunity with the Department of Health and Human Services focuses on the supply and manufacture of early stage prototypes and proof of concept hardware for prime contractors working on NIH, CDC, and FDA research and development projects. The scope of work includes rapid prototyping, 3D printing, CNC machining, and PCB design, specifically utilizing biocompatible materials and medical grade plastics to deliver functional models of commercial products. The contract is designated as a total small business set aside under NAICS code 339113, requiring firms to have fewer than 500 employees. A critical requirement for eligibility is ISO 13485 certification for medical devices. Interested parties must submit their responses by April 6, 2027.

General Info

HHS subcontract for medical prototype manufacturing; ISO 13485 required; deadline April 6, 2027.

Agency

Department of Health and Human Services

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

Not specified

Set-Aside

SBA

Documents

This scope was carved out of PA-27-100.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)

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Timeline

PostedMay 28

subcontract

Response DeadlineApr 6

Submission deadline

Response Deadline

04/06/2027, 04:00:00 AM UTCin 5 months

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Organization & Contact Information

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AgencyDepartment of Health and Human Services

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment of Health and Human Services

Office AddressN/A

ContactsNo contact information available

Full Description

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Supplies and manufactures early-stage prototypes and proof-of-concept hardware for prime contractors on NIH, CDC, and FDA R&D projects. Performs rapid prototyping, 3D printing, CNC machining, and PCB design using medical-grade plastics and biocompatible materials. Requires ISO 13485 certification for medical devices. Delivers a physical prototype or functional model of the commercial product.

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