Diagnostic Consulting Network (Carlsbad, CA)
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The LM 6000 in-line lamination system by BioDot Inc. (Irvine, CA)
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As demands on the product increase, so do demands on the manufacturing process and its machinery. A natural corollary to the development of novel technologies and applications is the development of custom manufacturing processes and machinery to produce a final product. However, customization brings unique challenges and increased risk. As a result, it is critical that manufacturing process design be performed as early as possible in the product development cycle.
The trend toward outsourcing many product development and manufacturing elements is another natural result of the increased complexity of the assay development process. The development and production of newer-generation POC devices require input from a variety of specialist disciplines. For smaller companies in particular, the range of skills required to complete the design of a complex IVD device can be difficult to access. This can also be true of larger corporations, whose focus may be in other areas.
Risk and Reward
With the outsourcing of numerous specialist disciplines comes both risk and opportunity. For manufacturing process and equipment design, the risk lies in poor communication. It is essential that the disparate disciplines and groups involved in product development understand the manufacturing issues created by their design solutions. Conversely, it is important that they comprehend the manufacturing requirements before their solutions are created and integrated into a product’s design. Good internal communication is also critical when setting manufacturing equipment performance specifications, which in turn will be vital to the success of the equipment, the process, and the product.
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The AD5000 gantry dispening platform by BioDot Inc.
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The willingness to outsource specialty tasks also presents opportunities, to the manufacturer as well as to any consultants that may be hired. One opportunity is the use of experts to identify appropriate manufacturing processes, technologies, and suppliers. Tasks such as building relationships, evaluating technology, and determining the feasibility of a manufacturing approach should be performed by agents skilled in the relevant discipline, whether this be dispensing, drying, cutting, laminating, assembly, or packaging. Including specialist expertise in difficult process design operations is essential to achieving success in the least amount of time and with the least amount of waste. This is especially true for manufacturing processes that involve the interlinking of biological and mechanical systems. To help assess risks and to aid in the design of these types of systems, specialist companies use the skills of cross-disciplinary teams of biologists and engineers, or of personnel with both sets of expertise.
Another opportunity lies in the skills of the specialist suppliers themselves. A manufacturing equipment supplier can make or break time lines, budgets, and, ultimately, products. Getting the most out of the interaction with a capital equipment supplier relies on one critical element: The quality of the relationship. Another often-ignored fact is that many specialist suppliers know a considerable amount about IVD development and manufacturing programs—expertise that can be tapped into by manufacturers.
Cultivating Relationships
Like other business relationships, the interaction between a manufacturer and a specialist equipment supplier must be carefully managed. If a few basic rules are followed, the chance for a project’s success will be greatly increased.
Use the Full Capabilities of Your Supplier. Enlist capital equipment partners early in the product design process and use their expertise. This expertise may extend to unanticipated areas, including device design, biological system interfacing, and manufacturing process design, and is quite often extremely practical. Most specialized capital equipment designers and manufacturers likely have seen processes similar to yours. They often understand the potential pitfalls of such systems.
Ask Questions. Listen to a supplier’s feedback on a proposed process design, as well as on the equipment that is being designed, which you are ordering. It is important for a manufacturer to remember that it is paying not only for the final delivered machinery, but also for a supplier’s expertise and ability to guide the manufacturer through the generation of a process that will ultimately end with a finished product.
Maintain the Relationship while Maintaining Your Options. It’s an old cliché, but true nonetheless: Treat a supplier as a partner and friend. For custom, large-capital items, in particular, the design, development, and manufacturing process may last for a while. If this process progresses successfully, and even if it does not, a manufacturer may be spending a lot of time with its suppliers in the years ahead.
Know Your Supplier Well. Be familiar with its technologies, its track record, its employees, and its capabilities. Then find a secondary supplier, if possible. If issues arise during the negotiation, production, or supply of a critical piece of capital equipment, both manufacturer and supplier may wind up in crisis. If a manufacturer is prevented from finding a second supplier due to specialized discipline or equipment, or cost or time considerations, then the IVD company should be prepared to stick with its primary supplier. In such circumstances, a supplier really does become a partner in the enterprise.
Set Specifications Carefully. Great care is necessary when setting the specifications for acceptable performance of a piece of capital equipment. A key element in setting the product specifications for capital equipment, especially in an IVD setting, is defining the difference between equipment performance and final product performance. In biologically linked systems, such as immunoassays, too many other reagent- and process-related factors are typically at play in the process of generating acceptable product performance to set final product performance as a specification for machine performance. Measuring machine function involves engineering measurement, with clearly definable and demonstrable results.
If acceptable final product performance is a specification insisted on by the customer, the equipment supplier must take into account the cost of process development and final product performance verification. Quite often, this cost will be passed on to the customer, and unless that expectation is set early, frustrations and issues can arise. The issue can be dealt with before it arises during planning. Both sides should agree that if process development and verification must be performed to guarantee product performance, in addition to measuring machine performance in terms of machine function, then there will be a cost in time and resources to do that. Setting this expectation will save a lot of time and frustration later in the process, and prevent potentially severe delays to installation and production.
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The AD1500 dispensing platform by BioDot Inc.
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Choosing suppliers that have an understanding of these potential problems and solutions is key to success. Ideally, it is good to use capital equipment suppliers that have biological science, device, or assay development expertise on board or available. Alternatively, it is advisable to use scientists, consulting or otherwise, who have manufacturing and capital equipment design expertise, to work with in defining the machine specifications and interfacing with the equipment supplier.
Use Specifications and Buy-Off Criteria to Set Expectations. Resist the urge to change specifications during the manufacture of a piece of capital equipment. Set specifications up front and do not change them. Capital equipment is designed to produce a product with a particular specification. If the specification is changed—be it related to component, performance, throughput, or product—the deal and relationship also change. This is no way to treat friends. If the terms of a deal must be altered, do so tactfully and expect repercussions in the form of cost increases, longer time lines, and occasional swearing.
To avoid this type of situation, have buy-off criteria carefully and completely defined before the equipment is ordered and the deal signed. Examine every detail of the proposed buy-off criteria and ensure that they are discussed and agreed to in full by the supplier. Misunderstandings can add severe stress, as well as months of delay and extra costs, to a project.
In many ways, the buy-off criteria for a piece of capital equipment are as important, or perhaps even more important, than the formal product specification. These criteria enable a manufacturer to judge whether the equipment will work as expected. For this reason, they should be used as a tool to set expectations, both with the equipment supplier as well as within the manufacturer’s own company.
Be Prepared for Surprises. The process of designing, developing, and producing custom capital equipment is rarely without snags. The effort spent building a strong relationship with the supplier will pay off when responding to unexpected events. In the end, machine design and product development are dynamic processes that tend to overlap. In an ideal situation, both the product and manufacturing process design would evolve together. Many times, however, when the two processes evolve separately, their meeting leads to confusion and cost. Careful management of the expectations of both the capital equipment supplier and the customer is crucial to the success of this relationship and the project.
Conclusion
The outsourcing of key elements of product development or manufacturing is, more and more, becoming a necessary element of project management. Forming strong relationships based on fairness and mutual goals is the key to making any outsourcing relationship work. The capital equipment supply relationship—particularly when it involves custom equipment with its long lead times and high ticket prices—is among the most critical relationships that an IVD manufacturer can form. In the end, if managed carefully, the outsourcing process can be positive not only for the manufacturer and supplier, but ultimately for the product and the consumer as well.
