By May 26, 2022, IVD device manufacturers who are not yet registered must be fully compliant with all changes set forth in the new regulation. Under the new IVD Regulation, device manufacturers can expect challenging timelines and a need for even further technical or regulatory documentation. Backed by robust bio-compatibility pre-testing, healthcare quality systems, and change control standards, these ‘medical grade’ concentrates and pre-color formulations can help minimize risk and avoid high costs of non-compliance.

The USee™ device will be part of the permanent collection at The Henry Ford Museum of American Innovation (Dearborn, Mich.), an IDSA partner. This award is proof that the USee™ device not only graduated but was the valedictorian. Avient’s design team assisted with the design, process analysis and production of the injection-molded plastic USee™ device, which includes a copolyester frame, medical-grade polycarbonate lenses, and acetal for the dials and gears.

The USee™ device will be part of the permanent collection at The Henry Ford Museum of American Innovation (Dearborn, Mich.), an IDSA partner. This award is proof that the USee™ device not only graduated but was the valedictorian. Avient’s design team assisted with the design, process analysis and production of the injection-molded plastic USee™ device, which includes a copolyester frame, medical-grade polycarbonate lenses, and acetal for the dials and gears.

Creating a diagnostic device that can be used to determine a person’s eyeglass prescription without the support of a doctor or vision specialist. The USee device is packaged within a kit that contains various strength lenses and conventional eyeglass frames. PHOTO CAPTION: PolyOne’s IQ Design team assisted with the design, moldfilling analysis, and production of the injection-molded USee device, which includes a copolyester frame, medical-grade polycarbonate lenses, and acetal for the dials and gears.

Compartment Cover for Medical Device Auto-Injector Housing - Medical Delivery Device A custom, impact-modified Trilliant™ HC formulation plus technical services met key needs and accelerated commercialization for a drug delivery device

Compartment Cover for Medical Device Auto-Injector Housing - Medical Delivery Device A custom, impact-modified Trilliant™ HC formulation plus technical services met key needs and accelerated commercialization for a drug delivery device

Compartment Cover for Medical Device Auto-Injector Housing - Medical Delivery Device A custom, impact-modified Trilliant™ HC formulation plus technical services met key needs and accelerated commercialization for a drug delivery device

MEDICAL DEVICE DISINFECTION—HOW TO PREVENT CRACKING AND CRAZING Understanding polymer performance is key to minimizing disinfectant-related failures DISINFECTANT-RELATED DAMAGE ON POLYMER HOUSINGS Strong chemicals used to reduce hospital- acquired infections can damage equipment and result in material failures, such as: • Stress cracking • Crazing • Discoloration CHEMICAL RESISTANCE REQUIREMENTS VARY BY ENVIRONMENT • Patient/exam rooms • Operating and radiology rooms • Reception areas • Home (patient equipment & devices) Healthcare devices must perform flawlessly in a myriad of challenging environments and engineers must be certain their devices can withstand increasingly potent disinfectants, which have begun to outstrip the performance of traditional polymers. Additionally, the wide variability of environments that medical devices might see, which can range from home to hospital, mean devices must be able to withstand varying disinfectant strengths, exposure levels and frequencies. Whether you are designing for a medical device housing or a surgical device in the operating room, we offer solutions to meet a wide variety of performance specifications and application needs.

Are Your Devices Standing Up to Disinfection? When designing a medical device, selecting a material that will last and perform well under harsh conditions has never been tougher. Versaflex™ HC thermoplastic elastomers can enhance ergonomics in medical devices by adding a soft touch and improved grip.

Through a broad portfolio of technologies, these functional polymer additives provide enhancements to healthcare, medical, cosmetic or pharmaceutical applications, including OnCap HC Plus for those that require bio- compatible solutions. In addition to advancing product performance, some OnCap HC Additives are formulated to improve manufacturing efficiency of medical parts and devices. KEY CHARACTERISTICS • Formulated specifically for healthcare product applications • Wide portfolio of polymer additive solutions, including: - Antimicrobial technology - Surface energy modification, including low retention - Authentication technology - Lasermarking - Sterilization and content protection - Processing optimization - FDA compliant resin and color changeover solutions • OnCap HC Plus certified for USP Class VI and ISO 10993 bio-compatibility requirements; includes anti-oxidant, lasermarking, antimicrobial, radiopacifier, anti-stat, and polymer and gamma stabilization performance additives OnCap™ HC & OnCap™ HC Plus Additives for Healthcare PRODUCT BULLETIN INDUSTRY SUPPORT • Supported with a broad range of technical support and services: - Restricted medical-grade raw material selection process - Sampling program - World-class FDA cGMP manufacturing facilities - Batch traceability and formulation lockdown systems - FDA Drug Master Files or Medical Device Files maintenance MARKETS AND APPLICATIONS OnCap HC and OnCap HC Plus Additives are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.