Bring customized point-of-care diagnostics and diagnostic kits to market quickly and efficiently. Engaging Phillips-Medisize gives you access to our specialized capabilities in reagents, lateral flow testing, electronic systems and many other areas. Find innovative solutions for your capital investment, regulatory, and quality challenges at every stage of development. With millions of products manufactured each year, you can trust us to reduce your go-to-market risks.
We design, develop and manufacture diagnostic consumables (disposable or reusable) that are customizable, scalable and high quality — with continuous improvement built into our process.
Capabilities that support fast, accurate and affordable point-of-care tests to streamline diagnosis.
Two-shot molding expertise enables uniform assembly of clinical and home tests such as glucose monitors.
Development of cancer, pregnancy, fertility and other women’s health testing needs.
Expertise for lab tests that deliver immediate, accurate test results.
Specialized reagent handling supports accurate in-home collection.
Design and manufacturing of high-quality testing for effective brachytherapy.
Phillips-Medisize helped pioneer a noninvasive, at-home stool DNA screening test for colorectal cancer. More than 5 million people have been screened by the Cologuard test.
Rapid COVID-19 Test
We supported development of a first-of-its-kind molecular diagnostic test for SARS-CoV-2 that can be administered, instrument free, from anywhere. Delivers results in less than 10 minutes.
Our expertise in lateral flow testing is a critical part of rapid, high accurate pregnancy detection.
Extensive quality management processes and regulatory certifications reduce risk and increase peace of mind.
- Rigorous ISO9001, ISO13485, 21 CFR 820 and TS16949 controls
- Integrated medical certifications and regulatory standards compliances
- National and international medical regulation and certification expertise
Phillips-Medisize offers the benefits of a single, trusted integrated solution at every phase of the product lifecycle, from front-end innovation to post-launch services.
- World-class mold-making partnerships and suppliers. Specialized injection molding capabilities (multi-shot, multi-materials, thermo plastic, micro molding)
- Reagent handling shortens the supply chain for customers
- Deep experience with lateral flow testing
- Competency in electronics, microfluids, optics
- Hundreds of design and innovation technical staff
- Deep expertise in medical product development
- Apply industry-leading rapid innovation and engineering expertise
- Diagnostic innovation portfolio with patented positions
- Diagnostic research insights
- Diagnostic feasibility analysis
- China-ready capabilities
- Large manufacturing footprint of 20+ fully equipped sites
- Processes integrated with front-end design and development
- Manufacturing strategy expertise
- Cycle-time reduction strategies
- Transparent, digital supply chain and network optimization
- Automation and testing expertise
- Serialization and final packaging solutions and traceability
- Cleanroom production facilities, FDA-registered class 7 & 8
- Dedicated, single-line manufacturing suites at global locations
- Drug and reagent handling across markets deepens our regulatory experience
- Robust risk management and quality programs
- Global regulatory knowledge across all sites