Converting Quarterly 2015 Quarter 3 : Page 42

MEDICAL & PHARMA MA TERIALS R2R Converting Converting platforms for the production of disposable, medical diagnostic devices By John Dillon, vice president of marketing; and Paul Johnson, rotary applications engineer, Preco, Inc. Introduction arket demand for instant-result and low-cost in-vitro medical, disposable diagnostic devices continues to grow rapidly – and for good reason. Self-monitoring, near-care and point-of-care medical diagnostic devices offer the ability to quickly diagnose and provide actionable information to the patient or health care provider in minimal time. In addition to existing diagnostic test strips, advanced technology micro-fluidic devices can perform complex sample preparation and provide the results without the need of a central laboratory (see Figure 1). These new devices offer many advantages by providing remote diagnostic capabilities – such as in an ambulance, clinic, emergency room or even in a retail environment – without sending the sample to a central lab for analysis. The ability to quickly diagnose a condition assures immediate and effective medical care in a minimal amount of time, saving valuable health care costs. This article will highlight the role of the narrow-web converting industry in producing the existing and new devices, focused on the production of highly complex micro-fluidic devices that are entering the market. M Disposable diagnostic devices For the purposes of this article, a disposable diagnostic device is typically used with a handheld or tabletop reader. The disposable device is a single-use platform designed to accept a sample (blood, tissue, sputum, urine, etc.), which results in a signal designed to be read by the portable reader. Disposable diagnostics offer many advantages to the patient and health care provider. Chief among these is the ability to rapidly capture a small sample for testing and get an actionable result in a matter of minutes. This new technology – referred to as a Lab-on-a-Chip (LoaC) – is capable of preparing samples using techniques such as molecular diagnostics designed to isolate biomarkers in the sample and then amplify them to allow a reading to take place, usually in less than 30 minutes (see Figure 2). The ability to diagnose an infectious disease in minimal time in a clinic or emergency room without the need for a central lab is extraordinary in itself. LoaC technology is a new development, but a range of products is advancing toward FDA clinical approvals, with market introductions on the horizon. After FDA approval, the next step to market acceptance is the cost of the test. While there are numerous advantages to this technology, there are already established insurance and government reimbursement rates for these tests as they are already performed by the clinical lab. The use of roll-based polyesters, acrylic adhesives and other polymers to produce these LoaC devices are well-known to the converting industry, making these devices a candidate for roll-to-roll (R2R) or roll-to-part converting on narrow web (13 in. or less), servo-controlled rotary-converting systems. However, the complexity and accuracy required to produce these devices is challenging. This presents an opportunity in the converting market to develop equipment, processes FIGURE 1. Next-generation medical diagnostic devices can replace central laboratory installations with a small remote reader and Lab-on-a-Chip disposable devices. (Courtesy Ativa Medical) FIGURE 2. A Lab-on-a-Chip is inserted into a portable reader for analysis. (Courtesy Ativa Medical) continued on page 42 u 40 • 2015 Quarter 3

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