Medical Manufacturing Stays Strong in the U.S.

Founded in 1886 as a supplier of metal findings to the jewelry trade, Rhode Island-based ATW Companies now specializes in a lot more. Today, they offer the development, prototyping, and manufacturing of rigid and flexible microwave tubing and components; custom seamless tubing; coined and drawn stamped metal components; laser fabrication and welding of small diameter tubes; computer numerical controlled (CNC) machining of metallic and non metallic materials; and manufacturing of metal injection molded (MIM) parts. The majority of ATW’s products are used in medical applications.

As a U.S.-based manufacturer, ATW differentiates itself in the medical market primarily by its skill in designing for manufacturability (DFM), using engineering support and fast turnaround prototyping capabilities. In addition, its proprietary metal injection molding (MIM) technology facilitates miniaturization of surgical devices and lowered costs for healthcare equipment.

Lean manufacturing initiatives and vertical integration are a few other strategies ATW is using to drive down costs and remain competitive in the face of low cost offshore competition. Finally, the company’s all-important ability to execute complex designs better than overseas factories that specialize in high volume production gives medical device manufacturers the peace of mind they need as they unveil a new generation of medical instruments and devices.

Design for Manufacturability
Manufacturability is the factor that can make or break the economic viability of a particular product, and nowhere is this more evident than the medical device industry and, in particular, minimally invasive surgery.

Device designers may already have specifications on drawings, but frequently there are ways to make modifications to get to an end product that is easier to build, economically producible in volume, repeatable, and highly reliable. Obtaining good surface finishes, tight dimensional tolerances, and going from a prototype to an economically producible volume that may number into the tens of thousands is challenging.

Judson Smith, which manufactures custom and precision tubing products and is one of the most highly specialized tube fabricators and machined component manufacturers, supplies metal tubing used in tools for minimally invasive surgery. In the crowded field, Judson differentiates itself by honing in on ways to reduce manufacturing costs before the design is even finalized.

“The more complex the design, the more value there is in onshore manufacturing,” says John Shields, Judson’s sales and marketing manager. “This is because of the shear amount of communication that has to take place between the customer and the vendor before we ever begin making the instrument.”

At the earliest stages of a project, when the design may be more conceptual than finished, working with an on-shore manufacturer allows designers to develop numerous iterations and prototypes quickly and efficiently, and get quick feedback. This enables them to make necessary changes, reducing overall development costs.

Parmatech’s MIM components are used in articulation gear for varying the direction of the working end of the device, as shown in the above example.For example, one major orthopedic device OEM uncovered a design issue associated with a component of a new instrument’s assembly, and wanted to change the heat treating process it would use to manufacture the instrument. Judson was able to make the change and send them the new finished component within a day.

Changing design parameters is quicker and smoother when the designer and engineer are in the same time zone.
“When developing new products, designers often have a long wish list of features for a particular component,” says Robert Kelly, Judson Smith’s engineering manager. “Using the DFM process results in a component or assembly that has the desired features but can be manufactured cost-effectively. Using the DFM process to maximize cost benefits is far more feasible with a U.S.-based firm.”

Parmatech’s work on MIM parts used in manufacturing bariatric and laparoscopic instruments, as well as orthodontic brackets, is a good example of DFM in the medical device industry.

MIM provides for complex shapes in a high volume manufacturing process, and supports the drive towards miniaturization of surgical devices and lowered costs for healthcare equipment. As a result of the trend towards miniaturization, most of the parts made with MIM technology weigh less than 50g, and can be additionally lightened by adding holes or pockets without sacrificing strength.

“Manufacturing of metal components using MIM technology has enabled U.S. companies to stay within the United States for sourcing components, due to MIM’s high manufacturing capability and competitive pricing,” says Parmatech sales manager Dan Lauck. “MIM offers onshore capability that is a substantial savings over more costly machining options, fighting effectively against machining off-shore by offering MIM capability on-shore.”

MIM parts can cost about 30% of a machined part, with high production rates and no individual part handling once stacked from molding. By using DFM early in the design process, designers can incorporate features that lend themselves to the benefits enjoyed by MIM.

In a recent example, medical engineers were seeking to build a next generation bariatric surgery device with a more robust platform. Joint design reviews and discussions centered on design intent of the components, and the detailed manufacturing process needed to fabricate these components. Detailed discussions focused not only on the MIM parts themselves, but also on ways to control elements of the manufacturing process pertinent to subsequent steps in the process. “DFM takes into account elements that are critical to the manufacturing process as well as those critical to the overall product design,” Lauck says.

In another example, a company sought ways to significantly reduce costs when the estimated production volume for a brand new product was sharply reduced.  Numerous iterations were developed to make the device more functional and flexible at lower costs. “It is much harder to make these frequent and rapid changes offshore, since feedback would be delayed by many days,” Lauck explains. “As an on-shore manufacturing company, this is our lifeblood; since once we engage in prototyping and development the production will stay with us.”

Shields agrees, saying, “If we are successful at finalizing the design with our protoypes, we are likely to be awarded production, at least initially.” Acknowledging the challenges for U.S.-based firms, Shields adds that high volume medical instruments are frequently put out to bid after initial production runs, to obtain lower costs.

Judson’s laser technology offers precise tube cutting capabilities.The bottom line is that the more highly engineered a product, the more caution there is in manufacturing the instrument off-shore, especially if this will be the first exposure to the market. “In addition to design for manufacturing, on-shore companies trade on their skill in executing projects to differentiate themselves from low-cost overseas competition,” Shields says.

Lean Manufacturing
Adopting lean manufacturing techniques, and continuously improving operational efficiencies, is one way U.S. firms are remaining competitive. Cost savings achieved by continuous improvements are frequently shared with customers.

For Judson, lean manufacturing reductions have not been made in any one product line in particular, but throughout the entire Boyertown, PA facility. This includes improvements to cleaning lines, work cell organization, product flow from one process to another, and scrap initiatives that have already yielded 5% to 10% in improvements.

At Parmatech, specific lean processes have yielded major improvements in particular products. For example, the company completely redesigned the process for a 15-year-old product, saving in molding and stacking costs, increasing profitability by 10% – with a large portion of these savings being passed on to the customer in the form of price reductions.

Another technique utilized to reduce costs is vertical integration, bringing in-house processes that may have been outsourced a few years ago, where it makes sense and manufacturing space is available.

For example, Judson Smith Co. recently brought laser marking, pad printing, and heat treating processes in-house to reduce costs. These processes are used in the production of a variety of medical instruments, including a circular stapler, endoscopic cutting and coagulation instrument, and a battery canister for an insulin pump.

Overall Intangibles of On-Shore Manufacturing
Many of ATW’s customers in the medical device field recognize that there is risk to off-shoring raw materials for their products. Not wanting to jeopardize the overall quality of an instrument or engine, they are willing to pay a higher price for a component or assembly, in exchange for a greater degree of confidence in the product delivery and quality. For these customers, the tight tolerance, high quality components that go into products that affect life and death are worth paying for.

Others in the medical device industry know that calculating the total cost is trickier than just looking at the piece cost of an item. Delays in communication, ability to get a product quickly, the unrecognized value of face to face time with a design team, and the ability to get on a plane and be in front of your customer quickly, are just a few of the less quantifiable aspects that should be part of the cost equation.


Judson A. Smith Co.
Boyertown, PA
judsonsmith.com

Parmatech Corp.
Petaluma, CA
parmatech.com

Parmatech Proform
East Providence, RI
parmatech.com

A. T. Wall Co.
Warwick, RI.
atwall.com

ATW Companies is the parent company of Judson A. Smith Co., Boyertown, PA; Parmatech Corp., Petaluma, CA; Parmatech Proform, East Providence, RI; and A. T. Wall Co., Warwick, RI.