Originally Published IVD Technology October 2005
Manufacturing equipment and supplies
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| An automated work cell by Kinematic Automation Inc. (Twain Harte, CA) for the cutting and packaging of blood-glucose test strips. |
Throughout the product life cycle, an IVD manufacturer must consider several key areas when planning for the purchase of production equipment and assembly supplies. Whatever the era and the level of machine sophistication, in order to maintain competitive position—or achieve competitive advantage—the manufacturer needs equipment and supplies that represent the very best value. The value of manufacturing equipment is readily quantifiable in terms of reliability, efficiency, utility, and throughput. In fact, these are just a few of the many measures of a manufacturing system’s worth.
Now, with the increasing competition that is the result of the global economy’s continuing development, the need of manufacturers to purchase value with their production equipment is even more intense. The broad array of equipment, supplies, and emerging technologies available, taken together with the specialized knowledge required to make truly informed purchasing decisions, creates a circumstance in which making the very best decision can often be a difficult objective to fulfill.
Early Planning
During the first stage of new product development, when the manufacturer’s design team is focused on matters involving product utility, functionality, and aesthetics, planning for production scalability often is incompletely attended to.
A tendency toward myopia in the area of production planning is understandable, of course, considering the particular goals and constraints of this early phase. To plan for production scale-up while the product is still in development may even seem like misplaced effort when longer-term production forecasts are uncertain. This is especially true when near-term production requirements, which are more visibly concrete, are in a range that allows for easy satisfaction by means of hand labor. However, in order for the manufacturer to maintain production continuity throughout the product’s life cycle, manufacturing scalability should be addressed soon, while the product is in the development stage.
A key aspect of scalability planning that is commonly forgotten, but that should be integral to the product design and development process, is the efficiency-oriented concept known as design for manufacture or design for mechanized assembly. Scaling up production usually includes the introduction of more-sophisticated manufacturing systems. Early-stage ramp-up commonly involves the use of fairly simple benchtop machinery, workstations, or operator-assist devices that help a worker performing manufacturing or assembly tasks to be more efficient and productive. But at a later stage in the product’s life, when it has won market favor, the manufacturer may enjoy a level of production that justifies the acquisition of fully automated manufacturing equipment. What must be kept in mind, however, is that whether relatively small and simple or large and complex, machinery is not as forgiving as the human hand.
The manufacturer can save significant time and money by having access to a production-automation expert who can bring perspective to the project during the product design phase. Working closely with the product design team, the automation expert can suggest design features that will significantly improve the product’s ability to be manufactured via automated processes with a high level of efficiency and reliability, without compromising the product’s aesthetic and functional requirements. For FDA-regulated products, designing for automated production as early as the design phase can pay off by minimizing the need for design iterations or, worse, the need to revalidate later in the product life cycle.
An expert in automated manufacturing equipment, either an internal resource or a consultant, can also provide important input during the product design phase.
Selecting Equipment Suppliers
As a product advances from idea to full-scale production, the equipment and supplies required will naturally change, too. It would be beneficial, early in the supplier selection process, to identify the equipment suppliers that offer products and services that will satisfy those requirements as they change through each phase of ramp-up. This allows the manufacturer to form supplier relationships that can continue for many years.
Early in the relationship, a full-range equipment supplier may provide only engineering services, such as process development and product design support. For early low-volume development and production, the supplier may provide pilot-scale manufacturing systems or benchtop semiautomatic production systems. Choosing an equipment partner that can supply the appropriate level of equipment throughout the evolving development and production cycle will be advantageous to a manufacturer. As market demand for the product increases to a level that justifies changeover to fully automated production, the supplier can deliver the appropriate machinery.
Here’s an analogy to keep in mind. To help ensure consistent high quality in its own products, the IVD manufacturer should source raw materials from suppliers that demonstrate an ability to provide a material that conforms to specifications and is uniform from batch to batch, month to month, and year to year. The stability of the supplier’s production process will have an effect on every aspect of the IVD, from its functionality, to customer perception of it, to its manufacturability in the first place. Similarly, to be able to operate efficiently and reliably and generate a minimum of scrap, the IVD manufacturer’s automated production equipment has to be made of components that conform to a predefined tolerance and are uniform in features, quality, composition, and dimensions.
Custom versus Specialty Machinery
Before identifying candidate suppliers of production machinery, it is advantageous for the manufacturer to understand properly the project’s requirements and to classify them as those that are best served either by custom machinery or by specialty machinery. This is another area in which having manufacturing expertise on the team is valuable. The ability to fully appreciate this distinction will aid in narrowing the search for suppliers best suited to the project.
Specialty suppliers focus on a particular industry niche. For example, a specialty machinery supplier may serve the diagnostics industry and concentrate on providing fluid-handling machinery or production machinery for lateral-flow rapid tests. By specializing, such a supplier strengthens core competencies in its chosen area of expertise. Specialization allows this kind of machinery supplier to provide manufacturing equipment that is fundamentally very similar to—perhaps even identical to—equipment that it has supplied to customers over and over for a number of years.
This is an advantage to the IVD manufacturer. Since specialty machinery has typically been developed and perfected over several years, it is usually more efficient, more reliable, less expensive, and less risky to purchase than custom machinery. It is also usually available with a shorter delivery time than a fully custom system. Often, the specialty supplier offers a line of standard products as well. And—another advantage for the IVD manufacturer—since the specialty machinery supplier has substantive knowledge of the manufacturer’s area of product technology, the supplier can be an excellent source of information and guidance.
Suppliers of custom automation, on the other hand, generally provide machinery for projects that are not well served by suppliers of specialty or standard equipment. Custom machinery is conceptualized and designed for projects with unique requirements. It is common for the supplier of custom automation to provide one-of-a-kind machines. While the specialty machinery supplier may have considerable expertise in a chosen area, the custom automation company usually has broad experience, sometimes spanning several industries.
The IVD manufacturer should keep in mind that the distinction between a custom solution and a standard one often is blurry. That is, most standard or specialty machinery is customized to some degree in order to satisfy the manufacturer’s particular requirements precisely. And though custom machines necessarily involve engineering, design, and development, they are designed to employ standard components and technologies wherever possible.
When to Begin
In many cases, the IVD manufacturer should initiate discussions with suppliers long before it needs supplies. This is especially true with regard to the procurement of specialty and custom manufacturing equipment. The manufacturer may have a tendency to wait until it knows all the facts before starting to talk. Developments in the product design or in the production process itself may be under consideration. Similarly, the manufacturer may be considering a materials change or a change to the way raw materials are received. However, when market release milestones are looming, or when demand is forecasted to outstrip capacity in the near future, lacking this information may not justify delay. Even if the manufacturer feels that its project is well specified, the process of quoting complex machinery can be lengthy and iterative. An early start to discussions will help ensure that an adequate amount of time is allotted for this important part of the process.
Early discussions with suppliers will also help the manufacturer determine the validity of budget and delivery lead-time expectations (the latter is roughly estimated before the project is specified). Although budget information is always important, lead time can be critical when planning project milestones and project management.
Depending on what is purchased, when it is a purchased, and where it is stocked, an off-the-shelf standard component or simple benchtop machine can be delivered with a short lead time of several weeks. Many larger standard products are not stocked; they are built to order, which can take much longer for delivery. When equipment has to be conceptualized, engineered, and designed, as with customized specialty or custom machinery, the lead time for delivery can be so long as to surprise the inexperienced purchaser.
The Relationship
Successful manufacturing equipment suppliers do not design and fabricate in a vacuum. The IVD manufacturer should view its relationship with the equipment supplier as one of teamwork and interdependence, particularly when the manufacturer has contracted the supplier to provide large specialty and custom machines with developmental aspects. The best equipment suppliers seek to collaborate closely and communicate often with the manufacturer’s project team.
For projects that will require close collaboration, the manufacturer should identify suppliers equipped with proven systems and tools to ensure regular and clear communication. Modern technologies have made it easier than ever for companies to communicate, and to respond quickly, even if supplier and manufacturer are on opposite sides of the globe.
The manufacturer that needs suppliers who can offer validation support will find that the level of support offered varies from supplier to supplier. The company should allot some extra sourcing time to locate a supplier that has the experience and the ability to provide the support required. Some equipment suppliers have developed sophisticated documentation procedures and templates that closely match those needed for the manufacturer’s validation efforts. If in-process inspections, part tracking, and secure control systems are necessary, then the manufacturer should be sure to source suppliers that can offer the requisite level of support capability.
It is common practice for manufacturers and their suppliers to engage in the negotiation of various types of nondisclosure agreements. The equipment supplier simply has to know and understand certain proprietary project details, especially when the project requires the design and fabrication of sophisticated manufacturing equipment. If a nondisclosure agreement must be in place before beginning the necessary discussions regarding machinery needs and requirements, the IVD manufacturer should consider getting the negotiating process under way early in order to prevent delays in project progress.
Signing agreements alone is not enough. The manufacturer should also verify that the supplier has systems in place to safeguard proprietary information throughout the project.
Conclusion
An IVD manufacturer’s ability to maintain competitive position or achieve competitive advantage depends in part on planning and on the ability to consistently arrive at the best decision. Never is this more true than with respect to production equipment and automation. To make the correct decisions in this crucial aspect of IVD manufacturing requires expertise, taken from wherever it is available—from in-house staff, from the equipment supplier, or from a qualified consultant.
Guy Parenti, Mosaic Business Development LLC (Derry, NH)
Copyright ©2005 IVD Technology
