Disposable medical device to prevent sexually transmitted infections
Manufacturing run of 2,100 packaged units was successfully completed in July, 2025 using production tooling in a FDA Certified ISO 13485 facility in the USA. We proved that the product can be made in the USA at low cost.
The FDA was very supportive of our efforts and suggested a 510K path to compliance. Per FDA Q-Submission, testing protocol was established consisting of Human Factors Study, Bench Testing, and Bio-Sensitivity Testing.
We are currently in Phase 1 (Human Factors / Usability) testing.
About Technical Products Inc.
Technical Products Inc., doing business as TPI Source, is a provider of engineered and custom-manufactured components based in the United States. Established in 1996, the company specializes in a diverse range of manufacturing capabilities, including custom machining for metals and plastics, fourslide and progressive die stampings, wire forms, and injection molding. They also provide aluminum die castings, impact extrusions, and specialized seal rings using engineered materials such as PEEK, Vespel, and Inconel. TPI Source emphasizes its ability to provide engineering assistance, including design and reverse engineering services, to deliver custom solutions for various industrial applications. By leveraging a network of ISO-certified manufacturing facilities, TPI Source supplies critical components such as spring-loaded contacts, pogo pins, and electrical connectors to sectors including aerospace, defense, medical, and electronics. Their service model focuses on prototype development through to high-volume production, utilizing in-house tooling and contract assembly to meet specific customer requirements for complex or precision parts.
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