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Not only can automation save valuable time and money, but it can also keep product manufacturing inside the U.S. This exclusive report explores how automation is keeping medical devices closer to home.

Eighty percent of the manufacturing cost is built into the product in the initial design. This is why it is imperative to consider automation in the initial design stage.

AT A GLANCE

• Reasons to outsource
• Problems in Third World
• Selection guidelines
• Automation and the initial design cycle

Daniel Adlon is vice president of strategic business development at Integrated BioSciences Inc., 637 Lowther Rd., Lewisberry, PA 17339. His experience in product design and automation spans 25 years with particular expertise in the area of design for manufacturing assembly. He has been awarded 13 U.S. and international patents. IBS is an FDA-registered, ISO 9000-compliant contract manufacturer of medical devices, automated equipment, and electronics. Adlon can be reached at 866-780-7832 or dadlon@ibiosci.com.

By Daniel Adlon
Companies today turn to outsourcing to be competitive for manyreasons. Although the exact cause may vary from company to company, it is usuallyfor one of the following reasons:
1. The need for a competitive selling price.

Companies must keep their selling price competitive in order to penetrate the market and maintain a positive profit margin. Using an outside vendor can allow a company to achieve lower costs to manufacture the product.

2. The need for quick turnaround times.


Using fully automated equipment, contract manufacturers are offering a domestic solution to medical device manufacturing.
Outsourcing the manufacture of a device to a more efficient, competent company can bring the product to market more quickly and cost effectively.

3. The need for expertise.

Many companies seek an outsourcing partner who can focus on areas that do not fit within their own core competencies such as product design, sales and marketing, packaging, and automation.

4. The lack of manufacturing space.

Limited manufacturing space can force a company to outsource a project. Companies might compare the option of adding to their own facility, which increases project costs, to outsourcing the production of that product to a company with the required expertise.

In order to find an answer that addresses these four factors, companies often consider outsourcing traditional, manual assembly methods of production and then look to Third World countries, such as Mexico and China, to remain competitive. However, these "out sources" of manufacturing present several obstacles including language barriers, delivery challenges, and cultural differences.

For instance, it may be difficult logistically to manage the manufacturing, shipping, and distribution of the product. Plus, there could be extra costs associated with shipping products from Third World countries. In addition, intellectual property rights have become a critical issue when sourcing the production of devices outside the U.S. The laws governing other countries are not necessarily congruent with U.S. regulations. As a result, companies run the risk of having their product design duplicated without compensation or legal redress. Other concerns include unstable governments and terrorist activities.

An alternative to outsourcing the manufacture of a device outside the U.S. is building automation into the manufacturing process within the U.S. Automating the manufacturing process can provide the required low-cost solution.

Key To Lowering Costs

There are a few U.S.-based contract manufacturers with the capabilities to design and build the automated equipment necessary to produce a medical device and then to run that machinery in-house in a clean room environment. They provide an answer for companies looking to outsource a product or entire manufacturing capability — whether it is a piece of automation the customer sends to the firm to run for them or it is a machine that a contract manufacturer designs and builds to run within its own clean room. In addition, companies do not need to maintain a staff of technicians to service the machines or keep an inventory of spare parts, thereby saving the company money.

These medical device contract manufacturers are taking outsourcing to a new level by providing automation in addition to traditional services such as product design, prototyping, assembly, packaging, sterilization, and inventory and distribution management. When selecting an outsourcing firm to provide automation services, it's important to make sure the company is experienced in designing and building automated equipment in addition to traditional contract manufacturing services—particularly to the medical device community.

Thinking Two Steps Ahead

It's important for companies to consider the automation process in the initial product design phase because they may need to utilize this process, eventually, to remain competitive and profitable.

Many companies don't think about automation until they need to increase production. At this point, the product design may need to be modified to become "more manufacturable" for automation. However, 80 percent of the manufacturing cost is built into the product in the initial design. This is why it is imperative to consider automation in the initial design stage.

There are many methods of assembling components including gluing, snap fit, welding, and screws. Because there are varying costs associated with each method, it is critical to incorporate DFMA, or design for manufacturing assembly, into the early design stages.

Of course, automation can be implemented for mature products, but the cost reduction may not be as significant. When automation is considered in the initial design stages, there is an easier transition into automation when it's time to automate, saving not only time but also money. The key factor is knowing that the production process will be automated at some point in the future. By designing the product with this concept in mind, companies can keep the outsourcing program domestic. Projects do not need to go overseas to be competitive.

Choosing The Best Partner



This syringe manufacturing process couples automated manufacturing with some manual feed.
When reviewing contract manufacturers, a crucial consideration should be if they have automation expertise in addition to the traditional manufacturing services of an outsourcing partner.

Whether a medical product is in the early or mature phase of its lifecycle, it's important to search for a company with the ability to automate in order to increase efficiency. A significant amount of time and money can be saved by utilizing an outsourcing company that is experienced in the design and development of automation and offers the ability to run the automated equipment for the assembly of the medical device within a clean room environment. Options can range from running the automation on-site at the customer's facility or within the outsourcing company's own facility.

In addition, an experienced firm can use its automation knowledge to increase the up-time of the machines and run them at higher rates of efficiency.

It is also essential to determine the best technology or process available for the manufacture of the device. There must be a good match between the automation and the product. For instance, traditionally, the company may have had to "100 percent inspect" a product after it was produced. An automation company aware of new technology can build inspection of the device into the process of assembling the product—all done by the machine — perhaps using robotics or vision systems.

ONLINEFor additional information on the products and technologies discussed in this article, see Medical Design Technology online at www.mdtmag.com or Integrated BioSciences Inc. at www.ibiosci.com.

Trends Occurring In The Market

• Medical device companies are looking for contract manufacturers with the ability to design, develop, and/or run the automated equipment required to assemble their device — all within a clean room environment. This is particularly true for products that are reaching the mature stage of the product lifecycle.

• Medical device companies are deciding not to build, and in some cases not to expand, manufacturing facilities. They are concentrating on core competencies and want contract manufacturers to handle the manufacturing of the device.

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