The Significance of Color as a Functional Property of Critical Medical Devices Len Czuba, Czuba Enterprises, Inc.
In a world where color is used to enhance the cosmetic appeal of products from cars to toothbrushes, the fact that product color can be a functional part of a medical device often comes as a surprise to many. But the importance of color, both from a quality and appearance perspective but also as a way to distinguish differences in size or functionality of the device has provided the healthcare industry assurance of acceptable products as well as ease of use designations. The color can indicate the size of a cannula or needle or even show which connector should go into the proper mating connection. This presentation will show how color has added to the ease of use, improving quality of care and given the healthcare community a way to better serve the needs of patients.
Mattifying Surface Coatings with Excimer UV Curing Jennifer Heathcote, GEW Inc.
UV cured materials naturally appear glossy, shiny, and reflective. While this is a desirable property for many end use products, other markets require matte surfaces with gloss levels that are challenging for broadband mercury and UVA LED systems to achieve. To produce UV cured matte surfaces, formulators add mattifying agents to coatings. While this is a viable solution, doing so makes coatings increasingly difficult to apply. There are also limits on the lowest gloss levels that are possible. Another solution is to use excimer UV curing which enables gloss units to be further reduced without the use of any mattifying agents. The benefit to manufacturers is consistent UV cured surfaces that are anti-reflective, anti-fingerprint, and anti-glare. This paper explains the science behind excimer UV lamps, how excimer UV output produces matte surfaces, and how the technology is integrated into production lines.
Functional Inks for In-Mold Electronics (IME) on Automotive Interiors Ken Araujo, NAMICS Technologies, Inc.
In-Mold Electronics (IME) parts for smart surfaces are becoming a growing trend in the automotive industry. IME parts offer a 70 percent lower part weight with higher reliability and increased design possibilities. To meet these next generation designs, a set of functional inks are needed for applications such as flexible touch sensors, strain sensors and heaters. These inks used in in-mold electronics (IME) need to offer low resistance, excellent thermoforming properties and compatible with several decorative inks. This presentation will show the latest in functional inks for IME applications, silver conductive inks, carbon conductive inks, dielectric inks, and conductive bonding adhesives for component attach.
UV Lasers: The newest asset for medical device manufacturers to innovate in plastic decoration and anti-counterfeiting Faycal Benayad-Cherif Ph.D, FOBA
Where infrared lasers require additives in plastics to create contrasted marks, UV lasers have the unique property to react with many additive-free plastic materials. The use of additive-free materials significantly reduces the need for periodic material validations and minimizes adverse health effects. Combined with excellent repeatability, a spot size on the order of 20um and image processing tools, UV lasers can accomplish permanent and highly accurate contrasted eye-popping graphics on materials like Lexan and UHMWPE (Ultra-high-molecular-weight polyethylene) used in implants. Their unique wavelength and spot size allow UV lasers to create unnoticeable digital and counterfeiting signatures like the UDI (Unique Device Identifier). An introduction of the UV laser technology and its use in the decoration and traceability of medical devices will be presented.
Next Level Decoration – Advance Film Transfer Technologies Scott Tacosik, Kurz Transfer Products, L.P.
Numerous innovative decoration options for plastic surfaces are available. New metallizations, interactive Shy Tech designs or tactile effects can be realized. This presentation will discuss these technologies as well as IMD Haptic solutions and other advanced processes.
Scratch Resistant Coatings: High Performance, Economic Solutions for High Quality Low Gloss Finishes Eric Sammet, Red Spot Coatings
Low gloss finishes (≤2 GU at 60°) are a demand across a variety of industries. These low gloss finishes must provide scratch, mar, and burnish resistance to maintain physical and visual integrity over the lifespan of a product. This can present unique challenges within interior automotive and other similar applications, where low gloss finishes are expected to provide luxurious aesthetic characteristics as well as support the need for anti-glare applications. The high traffic of automotive cabins requires the low gloss finishes to be highly resistant to chemical and abrasion resistance throughout the lifetime of the vehicle. Continuous evolution in the methods used to evaluate interior automotive materials has led to the development of new, innovative coating technologies that exceed previous scratch and chemical resistance expectations for interior finishes. The performance capabilities of new coating technologies and the supplemental benefits they bring enable designers to achieve low gloss, quality finishes that exceed Original Equipment Manufacturer (OEM) testing demands for performance and quality while remaining cost-effective.
Testing Decorated Plastic Parts: Understanding and Applying Testing to Ensure Success Paul Uglum, Uglum Consulting
Testing is a critical part of understanding if our choices in decorating products are appropriate and will succeed in the field. If standards are set too high, cost is added and if too low the products fail to satisfy the customer. When testing fails to ensure success, it is often because either the wrong tests were chosen or were incorrectly applied. This presentation will review how market and environmental changes have impacted the choice of appropriate testing as well as review common mistakes made in everyday testing to evaluate end use and control process. New risks such as additional cleaning, UV-C exposure, emerging technologies and where to find the information needed to make appropriate choices will be reviewed.
Navigating the Complexities for Successful Decoration of Medical Components Chris DeMell, ITW IDS
Medical applications often introduce a full gamut of additional considerations when decoration of the part is needed. Whether the decorator is a molder, contract manufacturer, or an OEM, medical regulations require an expanded awareness of unique variables that must be dealt with. Consumables often must meet specific FDA guidelines such as Medical Class VI and can also be subject to testing such as Toxicology and Migratory studies. The consumables may also have to survive harsh sterilization from autoclaves or radiation in addition to the standard adhesion and durability requirements. The operating environment may also affect the choice of technologies as the systems may be operating in a clean room environment or similar situation. All equipment is subject to validation protocols of IQ, OQ, PQ which require experience and knowledge to plan accordingly to successfully implement. Automation is often required to meet the volume demands as well. In this instance several additional considerations such as CFR 21 11, URS expertise, FMEA tests, contact surface requirements and many others must be fully understood for successful implementation. While this process can be more detail oriented than others, proper execution will result in successful decoration!
