Medical Device Link.

Despite recent economic uncertainties, the IVD industry remains healthy and competitive. Rising diabetes rates, evolving or mutating flu viruses, and continuing corporate need for employee drug screening combine to create ever-increasing potential income for IVD manufacturers. In addition to diagnostics, in vitro testing also plays an increasing role in the regular monitoring of various medical treatments.

It is imperative that IVD producers not only choose the best equipment manufacturer for a particular project, but also understand all of the ways in which an innovative OEM can positively influence the revenue stream throughout a product’s lifecycle.

For some IVD products, standard equipment that will either work “out of the box” or with relatively minor modifications is available. However, many IVD products will require custom automation equipment built to unique and exacting specifications. In those instances, it’s especially important that an IVD manufacturer partner with an OEM that not only understands the basic challenges of the IVD industry but is also able to suggest innovative and cost-effective solutions to meet the evolving needs of the regulatory environment and the marketplace.

Special Considerations for Custom Equipment

The design and build of custom equipment offers particular and specialized challenges. Time frames can be long—sometimes several years from request for quotation to startup—and close collaboration is a given. It is important that a supplier and its OEM share an aligned vision for the project and be able to communicate effectively. An OEM partner should also have a history of projects that employ similar manufacturing processes or technologies. The “tribal knowledge” that exists within any OEM can usually be harnessed and leveraged in new and exciting ways to take a project to a previously unseen level of success.

Because custom solutions carry a high potential for cost and time overruns, a partner OEM should have a demonstrated history of exceptional project management, acknowledged resources in critical engineering and production areas, and a network of expert consultants to address any challenges beyond the OEM’s internal expertise. They should know how to mitigate risk, test critical ideas before implementation, and be able to simulate key processes or technologies before committing valuable resources to the finished machine or system.

A Phased Approach

One possible way to differentiate between manufacturers when shopping for custom equipment is to look for an OEM that offers a phased approach to meeting a supplier’s unique challenges. Rather than proposing an end-all be-all solution right out of the gate, an OEM taking a phased approach might wish to begin collaborating with the supplier as early as possible within the product development process.

This type of OEM may be able to help a supplier optimize its product design for cost savings down the line. Using historical knowledge from previous systems, they may be able to help a supplier refine its user requirements and functional specifications early on, avoiding delays in validation or even production. An OEM with a phased approach to a project may help develop and test processes in key technical risk areas or initiate formal contextual inquiries in order to design a better or more ergonomic end-user experience with a supplier’s new equipment. The OEM can assist with design of experiment (DOE) or proof of principle (POP) methodology, helping to mitigate risk and creating a much stronger system by the time the supplier begins production.

The up-front cost of this type of rigorous early involvement might seem prohibitive at first glance, but it is important to take a big-picture look at the total cost of ownership when dealing with complex manufacturing equipment or systems. Early collaboration with an OEM willing to take a phased approach to a project may require a little more effort or investment to begin with, but the rewards can be exponential.

Total Cost of Ownership: Calculating Equipment Costs

In the case of basic equipment-purchasing decisions, purchase price is the component that influences buyers the most. This type of buyer considers the equipment something of a commodity, about equal to buying pens and paper. The expectation is that results will be largely the same regardless of whom the buyers choose to supply their systems.

Manufacturing equipment for IVD applications typically has a higher cost and a higher useful life, and additional factors must be considered. Beyond the cost of the equipment itself, buyers must look at output performance and after-sale expenses such as installation, operation, maintenance, and disposition.

Historically, metrics for evaluating system performance have included mean time between failure (MTBF). This metric has tangible significance because calculating the time that the equipment went down (downtime) and came back online (uptime) is relatively simple. The difference is calculated as downtime minus uptime and represents the amount of time the equipment was operating between these two events. Over a number of failures, the mean is calculated to establish the metric. One of the key limitations to this approach is that it is event-driven and does not address the severity of the failure with respect to duration and cost of repair.

Another metric that became more widely recognized in the mid-1980s was total cost of ownership (TCO). TCO provides the foundation for a more comprehensive approach by including both direct and indirect costs in the acquisition and operation of capital equipment. TCO calculations can be applied to an individual system, a fully integrated manufacturing line, or a total facility to assess the profitability impact to the business.

A method of calculating costs that has gained traction in recent years is an offshoot of lean principles and World-Class Manufacturing philosophy. This approach to cost measurement for capital equipment is overall equipment effectiveness (OEE). OEE represents the measurement of efficiency and effectiveness. The three components used to measure OEE are availability, performance, and quality, calculated as OEE = Availability x Performance x Quality.

Availability of the equipment helps drive production and utilization by minimizing downtime. This includes equipment failures and changeover time, so a supplier that has integrated lean thinking into its system design will better minimize this loss.

Performance addresses speed loss where the goal is to have the equipment perform to specified production rates. An equipment supplier who designs for robust process control can offer better equipment performance that may even exceed contractual requirements of units per minute.

Finally, the quality measurement addresses the goal of making product that falls within the specifications. OEE calculations leverage tangible data that is segmented to best identify opportunities for improvement within the business enterprise.

Regardless of the method used for calculating true equipment cost, it is important to remember that buying custom capital equipment is very different from making a simple commodity purchase. Additional up-front costs may seem daunting or even prohibitive, but can create a more robust and durable revenue stream for many years. The better a system runs, and the longer it stays running, the more profitable it will ultimately be.

Special Considerations of FDA-Compliant Solutions

Many of the integrated systems used to manufacture product for the IVD market need to be compliant with FDA requirements. Generally, these requirements fall under the term “validation,” which provides a high level of assurance that the processes are under control during the manufacture and packaging of a product, to ensure uniform quality.

When applying this controlled approach to IVD manufacturing equipment, process validation answers questions about system installation and documentation, compliance with the buyers’ user requirement specifications (URS), and how the equipment integrates with the business systems in the factory.

It is important that the OEM have stringent controls and tools in place to ensure that equipment is validated in a timely manner. Failure to do so can result in increased costs and risk to the schedule. Risk to the schedule, if it delays start of production or the introduction of the product to the marketplace, can add significant hidden costs well into the project lifecycle. Choosing an OEM with prior regulatory experience and an established quality program (ISO certified or otherwise) can be invaluable.

The first step to the successful design and build of any manufacturing equipment is the development of a thorough, well-defined set of URS. These specifications serve as something of a project Bible, providing the OEM with everything it needs to consider when designing a machine or system. The URS can also function as an early warning system from which an OEM with extensive regulatory or validation experience can determine potential problem areas within the project before any of the “heavy lifting” begins.

OEMs with validation experience will know how to make equipment easier to clean. They will understand the ergonomic considerations necessary to make the equipment safe for operators and easy to use and maintain. They will design to URS but understand the impact of specifications on basic process control elements like repeatability and consistency of performance and output.

The best OEM partners will know the right questions to ask and the areas in which the URS might need further definition up-front in order to produce equipment that not only operates the way it is supposed to, but also meets all regulatory-compliance guidelines. An experienced OEM will have prior experience working within those guidelines and will have in place clearly defined systems and processes to help smooth the validation process throughout the entire design and build phases of the equipment.

One example of the type of invaluable tool an OEM can bring to the validation table is a structured and experienced approach to traceability. Traceability is a core concept of good automated manufacturing practice (GAMP), and the approach an OEM takes to traceability monitoring can provide excellent additional value by decreasing time and complexity of the final regulatory compliance process.

An OEM partner will most likely use a traceability document or matrix that ties directly to the supplier’s URS and provides line-by-line traceability and ultimately closure to each specification. This kind of detailed “as you go” analysis makes it easy to track design and process decisions; document codes, standards, and regulations with which the equipment must comply; and provides an overall map for the entire project team on how to get from initial idea to validation and, finally, to production.

The Importance of Service After the Purchase

Capital equipment is often daunting to design and expensive to produce. It is important to keep a system running at peak performance levels for many years beyond the initial purchase, especially since it will often be operating under extremely demanding conditions. Choosing an OEM that understands the life of the machine after the sale can add substantial value to the partnership and help create a much more enjoyable purchasing experience overall.

The benefits of after-sale support from the OEM can be both short-term and long-term. Initially, the OEM can help with things like installation, startup, and training, making sure that the equipment is running properly in its permanent location and that all operators and maintenance technicians are familiar with the machine, comfortable with the processes in which they are involved, and aware of any and all safety considerations.

Later, the OEM will be able to help maintain the system’s optimal performance with new parts, expert preventative maintenance and field service support, and technology upgrades that extend system life to maintain or even expand profitability far down the road. A knowledgeable OEM with a “tiger team” program will be able to provide on-site diagnostic support for equipment, system, or process issues influencing efficiency, consistency, and profitability.

Summing Up

The economy will no doubt remain volatile for some time yet, but the IVD market seems to have nowhere to go but up. IVD manufacturers must be able to deliver a quality, validated product consistently, cost-effectively, and in a timely manner.

A great first step to accomplishing this is to partner with a knowledgeable, innovative OEM that can help turn an IVD manufacturer’s vision into reality. In the case of custom equipment for a unique application, product, or process, the right OEM can even help take that vision to a level not previously anticipated. With a great IVD product and the right OEM partner, the future truly is bright and wide open.