|Regulations & Standards|
From IVD Technology's 2011-2012 Buyers Guide
The good news is that in a stagnant economy, the $37 billion global IVD market continues to grow at a compound rate, which is expected to approach 9% through 2012. The challenging news is that IVD manufacturers encounter a myriad of obstacles when considering their manufacturing solutions. IVD testing devices are much more sensitive and complex than in the past. Not only is the technology more complex, stringent per-piece pricing adds to that complexity. There is an ever-constant need to reduce waste, utilize staff more efficiently, and comply with regulatory and validation requirements.
In order to maintain a competitive edge and ensure their businesses are meeting current and future demands, IVD manufacturers must optimize their manufacturing methods. Regular inventories of both equipment and processes must be taken to make sure they have what is necessary to meet the demands of growing markets. The objective of this article is to inform IVD manufacturers about some of the tools that could simplify the new-equipment decision-making process.
When considering a machine purchase or equipment upgrade, IVD manufacturers should perform a self-
analysis. A clear and concise customer requirement specifications (CRS) document is often the first step in determining the validity of the purchase of a new machine. The self-analysis that includes, but is not limited to, forecasts for production and sales volumes, time to market, internal staff resources, and overall equipment effectiveness of current equipment contributes to defining an IVD company’s required financial payback and specific customer requirements document.
Overall Equipment Effectiveness
Measuring overall equipment effectiveness (OEE) is a valuable tool for not only assessing an IVD manufacturer’s current equipment but also justifying the cost of a machine addition or upgrade. OEE formulas help IVD companies analyze their entire manufacturing and packaging line, not just their equipment. The OEE tool evaluates availability, performance, and quality in combination to measure effectiveness.
• Machine availability (MA) is defined as the actual time the machine ran versus the time the machine was expected to run. The time the machine was expected to run does not include the startup time associated with new rolls or splices, or the time lost from non-machine problems such as those caused by bad product. MA for acceptance runs is often set at a minimum of 95%.
• Quality rate (QR) is defined as the quantity of acceptable products or the quantity of total parts produced. QR for acceptance runs is often set at a minimum of 95%.
• Performance (P) is defined as the time it should take to produce or the time it actually took to produce. P for acceptance runs is often set at a minimum of 95%.
• OEE = MA (0.95) × QR (0.95) × P (0.95) = 85%. OEE for acceptance runs is generally set at a minimum of 85%, with each individual component set at least 95%.
All of these details should be factored into the equation when measuring the effectiveness of an IVD manufacturer’s current equipment and processes. A variety of software options and consulting firms can help with determining OEE.
Manufacturing Process-Specific Challenges
Once the OEE of the current equipment has been defined and it has been determined that a new piece of equipment is in fact going to increase productivity, improve quality, and ultimately save money, IVD manufacturers should begin to answer and document the following product- and process-specific questions:
• What parts of the current manufacturing processes are successful?
• What are the major throughput thieves (i.e., setup, cleanup, material changes, and process waste)?
• What internal resources are available for process design, implementation, and validation?
• How much equipment flexibility and expandability is required for the present process and future processes?
• What is the time to market?
• What are the critical parameters of the process (e.g., tolerances, speed, etc.)?
• What is the initial investment cost of the equipment or upgrade versus the operational cost?
• Is remote service support desired? What internal hardware and IT support is required to facilitate this type of service?
In addition to including answers to these questions in the CRS document, IVD manufacturers may also want to consider the following specific process challenges. Even though not all of these challenges may apply to an IVD manufacturer’s specific parts, these types of concerns do emerge in the product design and customer requirement planning phases.
Lamination and Cutting Challenges. To process successfully fluid samples that result in multiple accurate diagnoses, today’s tests often require tighter registration of the various die-cut layers. These films, membranes, metals, and absorbent materials are ever more delicate, and if they are manufactured in web form, they require very precisely controlled tensions. Computer-controlled, servomotor-assisted modules make up one solution to meet that specific device requirement.
IVD devices requiring channels for fluid flow are also common product design specifications. Currently, those features may be made by using flatbed punch presses, rotary die-cut presses, or lasers. Recently, these channels have been designed to even narrower tolerances to accommodate smaller finished products and fluid samples. Most toolmakers can build engraved rotary dies with die blades as close together as 0.0625 in. (~1.6 mm). Today’s intricate channels often require narrower gaps than this. Some companies have responded by offering laser-cutting capabilities in their systems. Laser modules can perform cutting and edge sealing to form narrow channels. Today’s lasers can also cut materials running continuously under their moving beams. Naturally, there are many considerations when exploring the laser option for web converting.
Laser type, strength, field of view, beam width, etc. are important aspects to consider when specifying this cutting method. While the cost of this technology can be relatively high when compared to conventional engraved die cutting (replacing a die station with a laser can add $100,000 or more to a machine’s price), lasers offer another advantage: tool-less changeovers. The purchase and maintenance cost of steel die tooling and the time required to change these tools between projects can be significant. Lasers offer convenience in this area by eliminating all tooling costs and minimizing the time required to perform a changeover between parts.
Some machine builders have designed modularity in their lasers to maximize manufacturing process flexibility. If the manufacturing processes demand that the laser-cutting function move from station to station depending on the parts being produced, IVD manufacturers could consider a machine designed to accommodate the laser’s mobility.
Quality Verification and Validation Challenges. Human eyes are quickly becoming obsolete tools for many inspection activities. In recent years, machine vision has become a flexible, robust, high-performance, and affordable tool for ensuring that an IVD manufacturing process results in good products.
Minimizing nonconforming products and maximizing uptime are critical elements of successful IVD device manufacturing. Advances in in-line inspection methods have made it possible and affordable to implement sensors and vision systems. Equipment for producing IVD devices can be designed to detect, adjust for, and identify variances in product quality. Adding software and optics to a converting or device assembly system can help to make these tasks easier.
Both camera–lamp assemblies and sensors provide ways to see products as they pass by. Sensors are often used to detect splices, edge alignment, and registration features. In addition, IVD manufacturers use sensors to detect material thickness, color contrast, and many other attributes. Machine vision systems add still more detection capabilities. More complex converting and assembly systems use cameras to measure dimensional tolerance, determine part presence and position, read print accuracy, analyze colors, and conduct many other tasks.
Once these tools perform their tasks and detect possible problems, it is up to the operator or assembly equipment to act on those detections. In a manual system, rejects are marked and removed offline from the manufacturing process. In a fully automated and servo-controlled converting or assembly system, visions systems and sensors can provide a two-step quality verification process. First, the inspection devices may adjust process parameters in real time to correct errors (i.e., correct die roller position in a web-based system). Second, the inspection devices may identify the remaining rejected parts. The parts that are identified as failures may either be marked with an ink or punch system and manually removed, or tracked in the system software and removed automatically via reject conveyors. Reject conveyors provide the option of one or many reject gates to isolate the failed parts in the system.
Material Waste Reduction and Sustainability Challenges. Many IVD device designs contain exotic and expensive materials that can dramatically increase an IVD manufacturer’s finished cost. Such materials often improve the device’s performance, so they are seen as necessary to the product design. Machine builders have developed technologies to minimize the quantity of waste of these materials while maintaining manufacturing process speed and quality.
If flexible circuits, precious metals, custom adhesives and absorbent materials do not cover the entire surface of a device, IVD manufacturers should consider using one of various pick-and-place modules. Machine builders can include robotic arms, bullnose parts transfer mechanisms, and other tools to minimize the amount of waste of these materials.
Manufacturing Solutions Providers
Having the above information well thought out will help make the search for the best manufacturing solutions provider that much easier. It is important that qualified equipment vendors offer a total solution rather than just machines. While IVD manufacturers typically employ their own engineers for developing and testing their products, it is at the mass production stage where additional expertise can be a monumental benefit. Finding a company that already has experience in the IVD industry employs a significant number of engineers and high-level technical staff, and is willing to become a partner, is worth the extra money a manufacturing solution may cost. An ideal manufacturing solutions provider will relieve some of the risk and offer a fully supported system that ultimately shortens time to market.
Expert engineering is necessary in the designing of manufacturing and packaging solutions for complex IVD parts. Finalizing any confidentiality/non-disclosure agreements and actually meeting with design engineers up front is one of the most important parts of this process. This will give an opportunity to discuss all the features for the IVD products that are needed at the present moment and explore additional options for the future.
Design engineers offer a wealth of knowledge and creativity. They can reveal the latest manufacturing options available in the field and perhaps shed some light on the latest technologies that are effective in other industries as well. While price and delivery may initially be the primary concerns, company culture, experience, quality, and support should also be considered. Given the risk involved with some new products, IVD manufacturers should consider breaking down the manufacturing process and working with equipment providers to provide a proof of principle of the most critical aspects of the manufacturing process. This step will save both time and money in the large scale aspects of the project.
Precision performance should be a priority when choosing IVD manufacturing equipment. Manufacturing IVD components often requires advanced manufacturing techniques that allow for accurate parts placement, lamination, die cuts, multiple in-line inspection systems, quick process adjustments, and machine security, just to name a few. Choosing a manufacturing solution that minimizes material waste and reduces downtime while offering precision and technical support will be a huge benefit as the business grows. It is also important to choose an equipment supplier that can help with FDA and validation requirements. While equipment suppliers may not be able to divulge the names of their other customers in the field due to confidentiality, they should be able to describe products with which they have experience in developing or manufacturing processes they have assisted in validating.
Service is another important criteria for selecting a manufacturing solutions provider. When evaluating provider options, IVD manufacturers should ask about training, service, and technical-support offerings. Many equipment companies that have high-level engineering departments have the ability to offer remote services. They may be able to log on to a system via the Internet to troubleshoot and make simple adjustments in a matter of minutes versus a service call two days later.
The IVD industry encompasses a huge variety of product parts and manufacturing processes. The number of products is enormous, as are the numbers of manufacturing process solutions. Evaluating and choosing the best manufacturing solution takes time and research. While this article only scratches the surface regarding factors that IVD manufacturers should consider when evaluating manufacturing equipment for their operations, it has provided some tools to help simplify the decision-making process.—Mike Wagner, business development, and Wendy Stromberg, design engineering and sales, Delta Industrial Services (Minneapolis)