Before making decisions about any investment, decision makers try to compile, evaluate, and categorize as much relevant information as possible. But even in a relatively transparent market such as automated manufacturing investment goods for IVDs, there is a striking lack of symmetry in information. Every so often, decision makers see themselves at a disadvantage.

In practice, certain strategies, at least to some degree, can assist in achieving reasonable judgments in investment decisions. The investment goods sector provides suitable procedures for standardizing and objectifying data (i.e., benchmarks).

Certain index figures tend to be quite useful, such as overall equipment effectiveness (OEE), which is defined as availability × performance × quality. The values are stated as either a percentage or an absolute value between 0 and 1. The life cycle cost (LCC) values and the total cost of ownership (TCO) values calculate the total cost of a system during its life cycle. Hence, decision makers are left with the option of trying to anticipate index figures such as OEE, LCC, and TCO as best as they can. Even if the available data fails to be accurate, they suggest a general direction that provides important criteria in the decision- making process.

A very versatile machine can be adapted to new ouput and function demands without engineering efforts.

Technology and Service
Technologically speaking, what is state of the art? Not every IVD manufacturer has highly trained engineers available who can clearly answer this question. Reciprocally, the question is how well does a provider of investment goods understand the requirements and needs of IVD companies and how able is that provider to translate such knowledge into the machine manufacturing process?

This article focuses is an overview of the latest developments in machine and line manufacturing for the IVD sector. A persuasive purchase decision demands thorough research and evaluation of valuable machine data, applications, and encompassing performance issues. In addition to technological advancements, the entire scope of support holds great significance for the long-term success of an investment decision and must also be factored into a purchase decision.

Process Automation in IVDs
Due to multiple reasons, process automation, machine manufacturing, and robotics have found their way into the IVD sector. Fifteen to twenty years ago, most processes in this sector required manual intervention. But as IVD applications have become more common, such a large portion of manual work would have not only led to enormous costs in the long run but also exposed the processes to the inevitable risks when human factors are in the mix. Precision and repeatability were additional factors that called for automation. This article uses immunoassay coating processes to demonstrate this development.

The following types of manufacturing processes each have their respective markets and are useful tools in those markets. For example, certain systems are still too expensive for applications in the smallest IVD enterprises. For this reason, simple solutions will continue to exist.

The first type is process automation: regular, standardized tabletop units, typically with a dispenser and a washing function. Such devices automatically fill and wash individual carrier plates. The manual work consists of feeding the plates and removing them from the unit.

The second type refers to standard machines with integrated transport systems and possibly integrated communication functions. With regard to dimensions, such systems in their smaller versions are comparable to tabletop devices. Larger units often come with additional functions, such as destacking, stacking, printing, coding, dispensing, washing, and aspiration. Such machines are designed and customized to specific products and come with the relevant functionalities. Subsequent functional upgrades are impossible or require a lot of effort. Some of the machines are equipped with control systems.

The third type relates to custom-designed manufacturing lines, which are an exact reflection of the requirements specified by a customer. They are often based on existing machine types and components, which are adapted to match the project application. Consequently, they feature customer-specific, highly specialized functionalities that support complex, fully automated processes with high throughput and output. As a rule, such lines come with a series of control and monitoring systems that reliably recognize and reject defective products. In addition, the machines are further modified according to the specific space requirements at the IVD production site. The machines are not prepared for subsequent functional adaptations, and if modifications become necessary, they are connected with comprehensive design effort, which, however, may still be justified in view of the enormous initial investment costs.

An Alternative: the Modular Generation
Modular lines represent the fourth type of manufacturing process and take a different approach. They are an innovation for IVD immunoassay manufacturing. Their distinctive feature is the option to upgrade a small and cost-efficient system into a fully and comprehensively automated machine. The following functionalities can be added: coding, printing, coating with antibodies and/or anti-genes, incubation, washing, blocking, stabilizing, drying, and packing. If required, the lines can integrate all control functions.

Even when compared to custom-designed manufacturing lines, modular lines have no limitations to the scope of functions in a full system. This also applies to throughput/output, which may range from low to high and can be increased as required. This characteristic makes such scalable systems so attractive for both process automation launches and large projects. They are a genuine alternative in particular to standard machines with integrated transport systems and custom-designed lines, and, under certain conditions, even process automation.

Such standard modules cover all functions required for the automation of the manufacturing processes for coating micro-assays. The configuration of the simpler versions of such modular systems is uncomplicated, and the design efforts for the initial setup or later modifications are reasonable, leading to cost advantages for setup and upgrades. If a client needs special adaptations, implementing special functionalities beyond the scope of existing components or controls can be done. However, their realization falls into custom-designed lines. (I.e., the projecting and realization costs for custom-designed lines are usually higher than the modular versions.)

Mechatronic Approach
For many years, modularity has been one of the most frequently used keywords in machine engineering. Many claims currently exist in the marketplace in which suppliers have touted modular systems. Mechatronics, on the other hand, refers to the interaction between a machine’s mechanics, electronics hardware, and software. Only harmonization of these three elements makes a modern machine system—and hence process automation—work. Consequently, mechatronics defines not only the degree of a system’s modularity but also its flexibility in routine operation. 

Common knowledge in information technology also applies to machine engineering. Peak technology in modular machinery building ten years ago is standard or even obsolete today. Ideally, state-of-the-art modular machine systems should currently offer the following features.

•    The manufacturing line’s functionality is adaptable to current requirements. A supplier offers components that not only work individually but also can easily be assembled into a complex and fully automated system.
•    The manufacturing line’s output and throughput (capacity) can be upgraded and adjusted to changing market requirements. Depending on budgets and market demands, manual intervention is reduced to a minimum, and the quality is improved by automation and control functions.
•    The previously listed item requires a decentralized control of the individual modules. The design of such decentralized controls includes their capacity to communicate with other modules, superior software, and/or a transport system.
•    Manufacturers can carry out the upgrades or modifications themselves and do not need rewiring or software modifications in the process.
•    In an ideal approach, assembly of the modules into a complete system and/or modifications and upgrades do not require additional engineering. Such an integrated system is capable of mastering complex tasks.

Flexible machine solutions feature the following key characteristics:

•    Format changeover (flexibility) is carried out at the push of a button at the manufacturing line’s human-machine interface. Stored parameters for each product (recipes) combined with servo motors trigger the correct positioning of the modules and their format parts. The subsequent stored parameters and servo motor triggers modify the movement curves for acceleration and deceleration, immersion depths, and lifting heights.
•    Multiple dispenser algorithms can be stored in the recipes and adjusted to the processing products and components.
•    The manufacturing line offers a broad selection range with regard not only to formats but also machine speed.
•    If required, the machine control masters parallel batch processing, including automatic control of codes and optical and sensor controls.

Market, Flexibility, and Modularity
Interrelationships exist among modularity, flexibility, process automation, and the IVD market. IVDs are considered a growth market, and an increase in demand for IVDs is expected, in particular in the healthcare sector. People living in industrialized nations have increased life expectancies, while many such nations are being confronted with the demographic problem of an aging society. Medical care in developing countries is improving and getting more expensive and comprehensive. Nonetheless, healthcare must remain affordable. New application possibilities, sometimes with small lot sizes, can also result in increasing cost pressures in the IVD industry.

At the same time, there are the demands of IVD manufacturers. An investment has to suit their requirements (i.e., size of their enterprise, product output, or scope of product variants). The ability to predict the last two factors over a five-year time period is a daunting task.

An investment will always involve certain risks, due to either external factors such as cost pressures from the market or internal factors such as the launch of product introductions on the market. Each manufacturing line’s modularity must be able to provide appropriate responses to such swiftly changing circumstances. Once frame conditions change, a modular machine type certainly offers optimum conditions for adaptations.

Another factor is flexibility in daily operations, such as changes to product output or the number of product variants. Wherever machine configurations are fast, it is usually the direct outcome of smartly applied mechatronics that has been essential with regard to exchange, extension, or relocation of machine functions. Another critical point of consideration is a manufacturing line’s capacity to process multiple batches simultaneously. The smaller the batch size, the more important this aspect is for efficient line operation.

Technical Advice, Project Management, and Service
The success of an investment project becomes apparent long before a manufacturing line is commissioned. Even at the beginning of the consulting phase, a supplier reveals its degree of understanding of a customer’s needs, communication skills, and capacity for generating proactive solutions. If a contract is awarded, such strengths will be carried forward during the entire project. Transparency about the progress of a manufacturing line not only provides customers with a good feeling but also is indispensable with regard to the planning stages for production startup.

Internal coordination and cooperation are further key elements for a project’s success, especially for mechatronic projects that are designed and tailored to a manufacturer’s specific requirements. Mechanics, electronics, and software have to be developed in parallel, which in practice represents an enormous organizational challenge.
Suppliers of modular manufacturing lines will already have completed the major part of the mechatronics development in the preparatory phase. For them, the focus during project implementation is rather on adapting and combining the various function modules.

Test Lab and After-Sales Service
During a project’s development phase, a test lab is a valuable asset for testing individual functions or entire processes under real-life conditions. It also allows for the optimal development of automation processes and defining process parameters.

Setup and certification offer a manufacturing line supplier the opportunity to demonstrate its service orientation and expertise. During the practical phase, it is determined by demonstration if a project will succeed. Then, the index figures regarding output, reliability, and quality (OEE) are taken into account as much as cost considerations of TCO and LCC, and after-sales service.

Service offers after the commission and start of routine operations are equally important. This fact alone can have a significant impact on the decision process with clear differentiation among suppliers. An example of a question to take into consideration would be whether a customer can be assured of staff availability for operator training or continued support until the best possible parameters are reached and the machine controls are set. There are differences in machine reliability, but no supplier can guarantee that system failures will never happen. Therefore, every machine supplier should have a service staff on call. Spare parts inventory is an additional decisive criterion, and teleservice options can be a useful tool when time is of the essence.

Conclusion
This article intended to provide an overview of the performance levels and technological developments of current machine engineering. It further intended to help even out the information gap between manufacturing line suppliers and IVD manufacturers.—Jürgen Feyerherd, managing director, Medicon GmbH (Schwäbisch Hall, Germany)