Phillips-Medisize announces it has won the Gold Award in the Diagnostic Products and Systems category at the 18th Annual Medical Design Excellence Awards (MDEA) ceremony in New York City.
June 9, 2015 (Hudson, WI) Phillips-Medisize announced today it has won the Gold Award in the Diagnostic Products and Systems category at the 18th Annual Medical Design Excellence Awards (MDEA) ceremony in New York City. The company was cited for its role as an outsourced design and manufacturing partner of Exact Sciences, Inc. of Madison, Wisconsin.
The product, Cologuard®, is the first and only FDA approved noninvasive stool DNA (sDNA) screening test for colorectal cancer (CRC) designed to help increase rates of screening compliance. Cologuard is prescribed by a physician and sent to the patient’s home. The patient collects a stool sample at home at their convenience—no medication, dietary restrictions, bowel preparation, sedation, time off of work or transportation required—and sends the Cologuard kit back to the Exact Sciences lab for testing with a pre-paid mailer. The patient receives the results from their doctor in as little as two weeks. If the test comes back positive, the patient is referred for a diagnostic colonoscopy.
Phillips-Medisize worked with Exact Sciences on design for manufacture (DFM), along with an evaluation of the user interface and closure of the collection kit. Phillips-Medisize also manufactures and assembles the patient-ready kits.
“We are excited and humbled to win this prestigious award for our work on a breakthrough product that has the capability of reducing the incidence of colorectal cancer. It is unbelievable that colorectal cancer is one of the most preventable, yet least prevented cancers in the U.S., in part due to low screening compliance. Cologuard will help reduce the rate of this deadly disease,” said Matt Jennings, Chairman and CEO of Phillips-Medisize Corporation.
“We would like to congratulate Phillips-Medisize on this recognition for their contribution to the design of the Cologuard collection kit,” said Kevin Conroy, Chairman and CEO, Exact Sciences. “Their expertise in designing and producing high quality medical products was critical to bringing this product to patients, and we are very pleased with the results of our collaboration.”
The MDEA is the medtech industry’s premier design competition committed to searching worldwide for the highest caliber finished medical devices, products, systems, or packaging available on the market. The awards program celebrates the achievements of the medical device manufacturers, their suppliers, and the many people behind the scenes— engineers, scientists, designers, and clinicians—who are responsible for the cutting-edge products that are saving lives; improving patient healthcare; and transforming medtech—one innovation at a time.
Entries in the MDEA competition are judged by an impartial panel of medtech experts. Unlike other design competitions that are merely styling contests, the MDEA jury is comprised of a balance of practicing doctors, nurses, and technicians alongside industrial designers, engineers, manufacturers, and human factors experts. MDEA jurors comprehensively review entries based on the following criteria: the
ability of the product development team to overcome all challenges so the product meets its clinical objectives; innovative use of materials, components, and processes; user-related functions improving healthcare delivery and changing traditional medical attitudes or practices; features providing enhanced benefits to the patient and end-user in relation to clinical efficacy; manufacturing cost-effectiveness and profitability; and healthcare system benefits such as improved accessibility, efficacy, or safety, in addition to providing attention to a critical unmet clinical need.
The 2015 MDEA Juror Panel selected finalists from over 100 entries, in 10 medical technology product categories.
About Phillips-Medisize Corporation
Phillips-Medisize is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics and medical device, and specialty commercial markets. The company has annual sales of over $600 million with 80% of the total revenue
coming from drug delivery, medical device, primary pharmaceutical packaging and diagnostic products such as: disposable insulin pens, glucose meters, specialty inhalation drug delivery devices, single use surgical devices and consumable diagnostic components. Phillips-Medisize Corporation features a list of blue chip medical device, pharmaceutical and commercial customers. The company partners with its customers to provide design and development services which accelerate speed to market of innovative products and then works
with its customers to deploy advanced automated assembly and quality control technologies which reduce manufacturing cost while improving quality. The company’s core advantage is the knowledge of its people to integrate design, molding, and automation to drive low cost and high quality manufacturing solutions.
Phillips-Medisize Corporation is headquartered in Hudson, WI, and employs over 3,400 people in 14 locations throughout the United States, Europe, Mexico and China. The company also has design centers in Wisconsin, California, The Netherlands and China.
About Cologuard
Cologuard is the first and only non-invasive stool DNA test approved by the FDA for colorectal cancer screening. Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer.
Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average-risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com. Rx Only.
About Exact Sciences
Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please visit the company's website at www.exactsciences.com, follow us on Twitter @ExactSciences or find us on Facebook.
About the MDEA Program
The Medical Design Excellence Awards are presented by UBM Canon, the global advanced manufacturing and medtech authority, and by Medical Device and Diagnostic Industry (MD+DI), the industry’s central source for late breaking news, information, and business intelligence. Visit www.MDEAwards.com for more info or e-mail [email protected].