Wi, Inc.

Wi, Inc. (pronounced as an initialism, "double-u i.") is an American medical device development corporation incorporated and headquartered outside of the Denver Tech Center in Centennial, CO. Wi's contract design and manufacturing services focus on commercialization of in-vitro diagnostic microfluidic disposable cartridges and instrumentation, as well as an array of therapeutic and other medical devices. Wi programs have achieved significant industry success and recognition, notably with the LifePort Kidney Transporter a 2004 Gold Winner and GenMark's ePlex platform a 2017 Silver Winner of the Medical Design Excellence Awards.
History.
Wi, Inc. was founded by David W. Wright in 2001 in Englewood, Colorado.
Facilities.
Wi, Inc. started out in a building and has grown to a location, including class 10,000 clean room, a BSL-2 Bio-Safety lab, device and process development labs, and a prototype machine shop.
Products.
Wi's program history covers a broad spectrum of medical device development efforts, focused primarily in the areas of biologics, diagnostics, and therapeutics.
Biologics.
In the field of biologics, Wi specializes in benchtop assay development and translation into disposable form factors. Past projects have integrated custom ELISA, flow cytometry, hematology and coagulation, and PCR. Wi laboratory capabilities include cell counting, spectrophotometry, and in-house phlebotomy. In microscopy, Wi utilizes benchtop and point-of-care cellular imaging and fluorescence for enhanced quantitative evaluations of assays.
Diagnostics.
Wi's core competency is development of diagnostic hardware and consumable platforms optimized for regulatory approved Point-of-Care applications. Wi leverages in-house mechanical, biomedical, microfluidic, electrical, and industrial engineering resources working within ISO-13485 certified development and manufacturing programs. Standard manufacturing processes include membrane sealing, clean laser welding, thermal staking, die and laser cutting, and reagent blister packaging. Examples of past projects include the GenMark ePlex, a multiplexed molecular diagnostic platform for which Wi performed primary engineering and manufacturing services, the LabNow CD4 quantification point-of-care test, and turnkey solutions for Operating Room imaging carts.
Therapeutics.
Therapeutics make up a large part of Wi's work, ranging from extracorporeal system design to surgical devices and critical component interfaces. In 2003, Wi brought the LifePort Kidney Transporter, a therapeutic system designed to support out-of-body kidneys for transplants, to market. Wi designed and scaled-up both hardware and disposables components, as well as executed verification and validation of the product in preparation for regulatory approvals and a successful market launch. This device was unique in that it perfused a nutrient-rich solution while maintaining precise thermal stability, thus extending organ viability for up to 72 hours. The device significantly reduces the risk of Delayed Graft Function, even in DCD (donation after cardiac death) organs. Wi, along with IDEO and Zevex, received a Medical Device Excellence Award "Gold Award" in 2004 for the platform. Another Wi therapeutic device, the LumaWave employs ultrasonic waves to soothe pain. Wi ushered development of the core technology from initial concepts through qualified production that integrated ultrasonic welding systems, proprietary flex-circuit overmolds, and produced several utility patents.
Custom & Standard Blister Packs.
 Wi manufactures both industry-standard and proprietary "Blister Packs" to package and dispense diagnostic reagents and drug therapies within the point-of-care consumable form-factor. Wi offers a line of standard "off-the-shelf" solutions ranging from 50 to 1,000 µL that employ the company's trademarked Soft Open™ Blister opening and controlled dispensing methodology. Soft Open™ Blister Packs, accompanied by appropriate custom actuators, allow precise metering of dispensed fluids, thus emulating the performance of pipettes and syringes without the need for endpoint user input. Through a dedicated manufacturing process engineering team, Wi is also able to create blister packaging of virtually any practical fluid volume.