U.S Based Medical Device & IVD Contract Manufacturing
Tensentric’s sweet spot for manufacturing is high-complexity systems which require small to medium volumes of validated products built under quality controls for initial market introduction or to support clinical trials. This makes us uniquely suited for the cell and gene therapy space, which can require high-complexity bioprocessing instruments and consumables that may never reach the volume threshold to be seriously considered by traditional large contract manufacturers, who typically prefer to wait until the product lifecycle is mature with established and consistent demand.
Tensentric offers a complete product development solution for new medical devices, IVD, or systems supporting advanced therapies. We have the team and expertise to support products from early concept development to detailed design, formal design verification, and manufacturing from New Product Introduction (NPI) to volume production.
Our manufacturing capabilities are focused on high level assembly of complex electro-mechanical and electro-optical instruments and complex consumables. We offer Design for Manufacturability (DfM) Assessments and will engage with clients on limited NPI or long-term volume manufacturing contracts.
In addition, we’ve added reagent blister manufacturing capabilities including automated production capacity of 15M+ blisters annually for point-of-care IVD and advanced therapy consumables.
Tensentric now offers both standard and self-piercing blisters off-the-shelf with fill volumes ranging from 100uL to 1.2mL.
Tensentric also has significant experience with custom reagent blister design integrated with complex microfluidic consumables. Tensentric can fill the blisters with DI Water and various buffers including salts and alcohols such as EtOH and IPA, or any custom buffer needed with appropriate material compatibility testing.
Tensentric uses advanced material science to select and optimize forming and lidding materials to ensure compatibility with microfluidic applications, regulatory requirements, shelf-life and stability. Potential linings include Polypropylene, Polyethylene, and Polyvinyl Chloride.
Production Manufacturing
Tensentric can scale production from small runs (e.g., a few dozen or hundreds of blisters) to high volumes (10M-15M+ units per year), supporting clients from early prototyping to full commercial rollout. We have full depot level repair capabilities, fulfillment services, and two clean rooms for consumable assembly.
If you’re looking for U.S. based medical device or IVD manufacturing, please contact fred.mitchell@tensentric.com
