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 Denver Technological Center, better known as The Denver Tech Center or DTC, is a business and economic trading center located in Colorado in the southeastern portion of the Denver Metropolitan Area, within portions of the cities of Denver, Colorado, ...

Centennial, CO Centennial is a home rule municipality located in Arapahoe County, Colorado, United States. The city population was 108,418 at the 2020 United States Census, making Centennial the 11th most populous municipality in Colorado. Centennial is a par ...

. 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 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 Colorado (, other variants) is a state in the Mountain states, Mountain West subregion of the Western United States. It encompasses most of the Southern Rocky Mountains, as well as the northeastern portion of the Colorado Plateau and the wes ...

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 A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...

diagnostics Diagnosis is the identification of the nature and cause of a certain phenomenon. Diagnosis is used in many different disciplines, with variations in the use of logic, analytics, and experience, to determine "cause and effect". In systems engineer ...

, and

therapeutics A therapy or medical treatment (often abbreviated tx, Tx, or Tx) is the attempted remediation of a health problem, usually following a medical diagnosis. As a rule, each therapy has indications and contraindications. There are many different ...

Biologics

In the field of biologics, Wi specializes in benchtop assay development and translation into disposable form factors. Past projects have integrated custom

ELISA The enzyme-linked immunosorbent assay (ELISA) (, ) is a commonly used analytical biochemistry assay, first described by Eva Engvall and Peter Perlmann in 1971. The assay uses a solid-phase type of enzyme immunoassay (EIA) to detect the presen ...

, flow cytometry, hematology and

coagulation Coagulation, also known as clotting, is the process by which blood changes from a liquid to a gel, forming a blood clot. It potentially results in hemostasis, the cessation of blood loss from a damaged vessel, followed by repair. The mechanis ...

, and PCR. Wi laboratory capabilities include

cell Cell most often refers to: * Cell (biology), the functional basic unit of life Cell may also refer to: Locations * Monastic cell, a small room, hut, or cave in which a religious recluse lives, alternatively the small precursor of a monastery ...

counting,

spectrophotometry Spectrophotometry is a branch of electromagnetic spectroscopy concerned with the quantitative measurement of the reflection or transmission properties of a material as a function of wavelength. Spectrophotometry uses photometers, known as sp ...

, and in-house

phlebotomy Phlebotomy is the process of making a puncture in a vein, usually in the arm, with a cannula for the purpose of drawing blood. The procedure itself is known as a venipuncture, which is also used for intravenous therapy. A person who performs a p ...

. 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 Clinical point of care (POC) is the point in time when clinicians deliver healthcare products and services to patients at the time of care. Clinical documentation Clinical documentation is a record of the critical thinking and judgment of a heal ...

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 Laser beam welding (LBW) is a welding technique used to join pieces of metal or thermoplastics through the use of a laser. The beam provides a concentrated heat source, allowing for narrow, deep welds and high welding rates. The process is frequen ...

, 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 Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are ...

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 IDEO () is a design and consulting firm with offices in the U.S., England, Germany, Japan, and China. It was founded in Palo Alto, California, in 1991. The company's 700 staff uses a design thinking approach to design products, services, enviro ...

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 and standard blister packs

CAD Render of a Soft Open Blister Desgin

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.

References

External links

Official site
{{DEFAULTSORT:Wi, Inc. Medical technology companies of the United States