Manufacturing dignity for patients: Safety, Standards & Compliance

Dignity Medical Solutions has developed a novel technology that helps manage incontinence in the form of a device called TIMO, which provides the benefits and convenience of a catheter without the associated complications and costs.

December 15, 2017By Michael C. Anderson

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Dignity Medical Solutions Inc. (DMS) is a group of doctors, scientists and engineers focused on developing technologies that improve the health and dignity of patients.

The company has developed a novel technology that helps manage incontinence in the form of a device called TIMO. TIMO provides the benefits and convenience of a catheter—without the associated complications and costs—while also “restoring patient dignity,” according to DMS, Los Angeles. The device is a plastic hand-held urinal attached by tubing to a pump that allows for the evacuation of urine to a reservoir, significantly improving safety and comfort for the patient.

TIMO’s main component is a small, quiet, automated vacuum device with a patented valve contained in a lightweight aluminum enclosure. The vacuum device is attached to a disposable bottle for urine collection. TIMO can be left in place for long periods of time without risk of overflow or spillage.

Manufacturing dignity for patients
The shop floor of Quest Specialty Products. Image courtesy of Quest Specialty Products.

By September, the device had been tested, approved by the Food and Drug Administration and ready for manufacture. Enter manufacturer Quest Specialty Products Inc., Bridgeton, Mo. The two companies signed an agreement that will provide DMS with the manufacturing, service and support infrastructure needed to market TIMO, along with shipping, receiving and inventory management services.

Quest, which is only 6 years old and is best-known for its work for the automotive sector, was chosen for this opportunity because of the company’s culture, said Quest’s president and founder, Dan Fitter.

“It starts with safety and organization and then quality. We preach quality every day,” he said. “We’re ISO 9001:2008-certified and have plantwide ISO training. We use a visual management board that does all of our production scheduling.”

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The company also has occasional Toyota-style 5S activities and a strong focus on continuous improvement, Fitter added.

Fitter said he acquired the assets of three separate companies and put them under one roof to form Quest in 2011. The company’s 60,000-sq.-ft. facility offers CNC machining, engineering, fabrication and assembly among its services.

“Automotive and aftermarket automotive is probably 50 percent of our business,” he said. “Alongside that, we have a close-to-equal distribution of rail, light industrial, aerospace-defense and medical.”

The company had to halt production when it moved to its current location about a year ago, but other than that pause, it’s grown every year, Fitter noted.

The TIMO project is going well, Fitter said. Many of the plastic components, including the urinal and the reservoir canister, are off-the-shelf objects one would find in the intensive care unit of most hospitals; they’re modified, not made from scratch.

TIMO is expected to be available by the end of 2017.