Taking Research to the 3rd Dimension and Beyond
Clinical & Commercal Development
TGT is dedicated to providing state of the art advancing technology to transistion from the bench to the bedside. Our presence in the industry has provided us with a broad experience base to assist during the transition.
Members of ASTM:
ASTM working group F2211 formed to outline the aspects of TEMPS that will be developed as standards.
FDA Contacts:
The FDA's Center for Biologics Evaluation and Research (CBER) regulates an array of diverse and complex biological products, both investigational and licensed, including; human tissues and cellular products and xenotransplantation products.
Manufacturing Partners:
TGT works closely with local and global vendors to provide GMP certificed equipment to produce TEMP compatible products.
We utilize a stepped approach to this process to ensure design, fabrication, and production meets our customers and regulatory body requirments. We assign a full time project manager to drive inter-company communications, schedules and cost models as well as product deliverables. Click here to download a summary of TGT's Capabilities and approach to TEMPS instrumentation.
| Phase | Subphase | Description |
|---|---|---|
| Design | Discovery: Review of Exisiting Design, Initiation of Users Requirements Documents, Generation of Verification & Validation Matrix | Time and attention are spent in the front end to ensure that fabrication and eventual production is correct and meets all necessary requirments for the customer and commercial production. TGT & Customer vists are often included to share capabilities, regulatory concerns and current research protocols which need to be included in the final product. |
| Concept Development & Refinement: Generate Flow in 2D Format - Flow chart to demonstrate chamber and system process. | Further development of sketches and specifications into full fledged concepts for review by customer in preparation for engineering development. | |
| Engineering | Engineering Development & Prototype | TGT Engineers develop chosen concept into working prototypes. These may include chambers, stimulators, and other accessory components. Deliverables 1) Rapid prototypes 2) Results of verifcation testing per TGT's verification and validation matrix. |
| Delivery of Alpha System | The first system (machined or rapid prototype - not molded) is delivered to the customer for validation. | |
| Review of Alpha System | TGT & Customer review the Alpha system design and operation. TGT incorporates changes identified during validation. | |
| Production | Production Development | TGT initializes production. Tooling is fabricated and tested for disposable chamber manufacturing. |
| Production Enablement | The production network is finalized and first units off of the tooling are validated. | |
| Packaging | Packaging & Sterilization: Package design is developed, fabricated and tested. | TGT designs and initializes sterilization testing for the disposable items. Deliverables 1) Package prototype 2) Final sterile package. |
