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 this year alone. When detected early, about 90% of cases are treatable, yet approximately one in three adults over age 50 are not current on recommended colorectal cancer screening. That’s where Exact Sciences comes in. Their game-changing, noninvasive stool DNA screening test, Cologuard®, is the first FDA-approved solution for early detection of colorectal cancer. And they worked closely with our medical design, manufacturing and supply chain experts to bring it to market – even before that approval was secured.
The collaboration has been a powerful example of how customers and suppliers can work together to make a real difference in the world, and serves as a brilliant example of our new brand tagline — Bringing Possibilities to Life.
As part of our customer-focused mindset, we start with the end-user in mind and work our way backward to ensure our products are optimized in every way possible. To accomplish this, a team of cross-functional experts at Phillips-Medisize evaluate each opportunity from different perspectives. Does the new concept, product or novel medical device address an unmet market need? Is the approach to solving a problem innovative and can Phillips-Medisize add significant value? We also assess the level of commitment the prospective customer’s management team brings to the project, especially if there are potential pitfalls to navigate in driving a successful go-to-market strategy. Last, but certainly not least, we ask ourselves a lot of hard questions to determine if Phillips-Medisize is ideally suited to help this company fulfill its own vision.
In the case of Exact Sciences, a leading provider of cancer screening and diagnostic tests, all the boxes were checked quickly and decisively as we joined forces to fight colorectal cancer with both our design and precision manufacturing capabilities. We were compelled by Exact Sciences mission to help people get information faster about cancer detection and treatment, so they could make more informed decisions and act sooner—when it matters most. And we were excited to participate in helping Exact Sciences realize their product vision. Exact Sciences’ scientists worked closely with Mayo Clinic to identify signs and signals that could indicate the presence of colorectal cancer. They then translated their collective findings into a multitarget stool-DNA test that looks for DNA changes in a sample, which could point to cancer or pre-cancer. The ability to use multiple biomarkers is a clear Cologuard differentiator, along with the simplicity and convenience of at-home testing.
A Study in Collaboration
To help bring the Cologuard vision to life, Exact Sciences sought an experienced manufacturer steeped in similar principles and philosophies. Their search led to Phillips-Medisize and kicked off an amazingly productive years-long collaboration.
We knew immediately that Phillips-Medisize could help Exact Sciences as their people-first culture meshed seamlessly with ours. While Exact Sciences didn’t yet have FDA approval when we started, we were fully confident that our “one-stop shop” of advanced design and manufacturing capabilities would enable Exact Sciences to emerge as a game-changer in the healthcare industry. And the rest, as they say, is history, now chronicled in the latest Phillips-Medisize case study.
Phillips-Medisize shared Exact Sciences’ philosophies on product quality, patient-centered design and supply chain optimization. We also brought like-minded thinking to the project, along with a deep bench of experts in human-factors design, complex molding, reagent handling, finished packaging, labeling and serialization as well as volume manufacturing at ISO 13485-compliant facilities.
Cologuard is available only with a prescription and the collection kit is then sent to patients at home. This kit contains everything needed to collect a stool sample, such as a bracket and collection container with lid, probe and a collection tube, as well as DNA preservative solution. The intent was to provide clear instructions and an easy-to-use collection kit to reinforce the convenience of at-home testing for patients of all ages and abilities.
That’s where Phillips-Medisize’s human factors designers played a big role by helping Exact Sciences evaluate the level of hand strength and dexterity in individuals ranging from 45 to 90 years old. Special focus was placed on ergonomics, which led to collection-container lid refinements. Modifications also were made to the collection kit’s tube and bracket to make it easier to use while ensuring airtight closure and safeguarding against inadvertent leaks.
Together, we solved a variety of complex problems relating to form and function. Phillips-Medisize manufacturing engineers assisted in reinforcing the specifications and tolerances required to produce the highest quality product possible. Of course, close proximity between our headquarters in Hudson, Wisconsin, and Exact Sciences’ a few hours away in Madison made it easy for in-person meetings, interactive whiteboard sessions, real-time conversations and streamlined project management.
Close collaboration also played a big part in reducing supply chain risks as we leveraged our strong supplier relationships and buying power to acquire all the parts, products and raw materials needed to scale kit production. We also found alternate supply sources as needed to attain much needed resin and increased safety stock and spare parts.
Driving Manufacturing Innovation
Because Phillips-Medisize commercializes about 50 new products each year, we are adept at anticipating problems and expediting fixes. Our expertise in complex molding and plastics often leads to new combinations that improve performance. We also understand the nuances of tooling, molding, manufacturing, assembly and quality testing, which proved invaluable in ramping Cologuard manufacturing.
We started out small—initially on a manual production line before scaling to semi-automated and ultimately automated lines as momentum increased. The knowledge we gained through each transition was transferred to the next manufacturing line or facility. This is standard operating procedure in our world, where manufacturing volumes are aligned with each go-to-market step. Customers typically need hundreds of units to support clinical studies, followed by thousands as they enter broader clinical trials before securing regulatory approval to scale to millions or tens of millions of products.
All of this requires manufacturing innovation at each phase, backed by a global footprint and top-notch quality processes to match the ebb and flow of production. This same approach held true for Exact Sciences, except for the extra ebb and flow brought on by COVID-19. As physicians and clinics were redirected to address the turmoil of the pandemic, we formulated a plan with Exact Sciences to minimize disruptions and scale production up or down, as needed. During this time, we redeployed resources and adjusted production schedules while keeping Exact Sciences’ mission front-and-center in all our discussions and decisions.
As a result, both sides moved quickly and efficiently to determine what was needed to mitigate risks and seamlessly scale manufacturing once momentum was regained. We navigated the pandemic together and quickly scaled production as cancer screenings regained momentum before taking off with unprecedented velocity. Case in point: at the launch of Cologuard in Q4 2014, we delivered 4,000 collection kits. Fast forward to 2021: we now are delivering 40,000 test kits each week!
To keep pace with such rapid growth, we converted a manufacturing line at a Molex facility in Little Rock, Arkansas, to meet rigorous healthcare and regulatory requirements. This enables us to run three production lines to keep up with unprecedented demand, which to date has enabled more than six million Americans to use Cologuard for convenient and fast at-home screenings for colorectal cancer. We’re incredibly proud of our accomplishments with Exact Sciences, and excited to create more next-generation products to support patients along their cancer journey—from early detection to late-stage treatment.
Ultimately, the success of Phillips-Medisize’s relationship with Exact Sciences lies in the openness and trust we’ve placed in each other, as well as the incredible power of our collaboration to bring possibilities to life.