Phillips-Medisize, a Molex company and leader in drug delivery, diagnostic and MedTech devices, has completed a successful collaboration with Exact Sciences, a leader in cancer diagnostics, to advance early cancer detection.
 
Fueled by a relentless pursuit for smarter, earlier life-changing answers about cancer, Exact Sciences developed Cologuard, the first and only FDA-approved noninvasive stool DNA screening test for colorectal cancer. This mission aligned seamlessly with Phillips-Medisize’s decades of innovation and world-class product design, development and manufacturing capabilities. 
 
“We offered Exact Sciences a one-stop shop of advanced manufacturing,” said Paul Chaffin, president, Medical and Pharmaceutical Solutions, Molex. “From human-factors design, complex molding and reagent handling to volume manufacturing, finished packaging, as well as labeling and serialization, we have everything they needed to bring this innovative product to market. We brought a powerful mix of capabilities and expertise to help Exact Sciences change the game in the fight against colorectal cancer.” 
 
According to the American Cancer Society, colorectal cancer is the second most common cause of death in women and men combined in the U.S., resulting in about 53,000 fatalities in 2021. When detected early, about 90% of stage I or stage II cases are treatable, yet one in three adults over age 50 are late on recommended colorectal cancer screening. Concurrently, new cases of colorectal cancer are increasing among young and middle-aged adults, which prompted the United States Preventive Services Task Force (USPSTF) to recommend screenings starting at age 45. 
 

Patient-Focused Product Design 

Thanks to transparent teamwork between Exact Sciences and Phillips-Medisize, Cologuard is poised to help transform how Americans think about colorectal cancer screening. Together, the companies ensured every aspect of product performance met stringent usability and quality requirements.
 
“Our focus and mission is really on the patient experience,” said Tammy Turek-Etienne, VP of operations at Exact Sciences. “Everything we do is around quality and that end-user, so we can ensure they have a really great experience with the products.” 
 
Because the simplicity and convenience of at-home testing are clear Cologuard differentiators, the collective group embraced human-factors design principles to prove patients of all ages and abilities could effectively open and close the different components within the collection kit. Phillips-Medisize developed new tooling to safeguard against inadvertent leaks while meeting specifications and tolerances required to produce the highest levels of product quality. 
 

Reducing Supply Chain Risk

Unprecedented levels of supply chain flexibility enabled Exact Sciences to acquire all the parts, products and raw materials needed to rapidly scale kit production. Phillips-Medisize located and validated alternate supply sources, conducted risk assessments and forecasting, as well as sourcing and procurement plans to protect against unplanned disruptions. The organization’s ability to increase safety stock, hold spare parts and leverage its buying power helped Exact Sciences attain much-needed supplies and raw materials to meet rapidly increasing demand, such as resin.
 
During the pandemic, colorectal cancer screening rates plummeted as large swaths of the population postponed annual doctor’s visits and regular screenings. Resources were redeployed and production schedules were readjusted to accommodate volume changes and avoid overstocking.
 

Scaling for Rapid Growth

In supporting sustained growth while mitigating risk, Phillips-Medisize diversified its manufacturing footprint by transitioning a former Molex manufacturing site in Little Rock, Ark., to complement its medical manufacturing sites in Wisconsin.
 
Phillips-Medisize now operates three production lines at U.S.-based manufacturing facilities in Wisconsin and Arkansas where a combination of manual, semi-manual and highly automated manufacturing is used to produce 40,000 screening test kits each week. As a result, more than six million Americans have used Cologuard for convenient screening and early cancer detection.