There’s no getting around the reality that the lower labor costs of overseas manufacturers have challenged U.S. manufacturers to dig deep for ways to stay competitive. Perhaps not as well known is that many American manufacturers are thriving by drawing on core strengths that have not only typified U.S. manufacturing for many years, but could very well play an even bigger role as methods for countering offshore pricing challenges in the future. Virtually synonymous with the American brand, these core strengths include design, engineering, and problem-solving expertise; the ability to communicate easily with customers, understand their changing needs and requirements, and deliver on-time products and services that meet or exceed their expectations; high-level quality; and innovation.  

How important are these strengths? In addition to their intangible value, they all have the potential to impact the bottom line in a big way. Take quality, for instance. Repeatable, highest-quality parts can all but eliminate rejections, keeping per-piece costs to a minimum and saving hundreds of thousands of dollars over the course of a project. But the value of a highest-quality product is measured not just in the money it saves, but in the revenues it generates in the marketplace.  

Probably the most noticeable core strength of U.S. design, engineering, and manufacturing is innovation. From the first spark of a product design concept to a process adaptation that solves a manufacturing problem, innovation takes many forms. But whether the goal is a product that makes healthcare more affordable, or a technology that helps restore a sense of normalcy to the lives of wounded soldiers returning from Iraq and Afghanistan, the impact of an innovation rises with its success in satisfying needs that were previously unmet. And, like excellent quality, a truly innovative product has the potential to not only save costs, but also to turbo charge a company’s revenues.  

Miniature, Single-Use Medical Camera Could Lower Cost of Medical Devices

Due to their high cost, endoscopes—special instruments used by physicians to see inside the human body during routine medical procedures and surgeries—are used mostly in specialized surgical suites. But as insurance reimbursements for many healthcare procedures continue to decline, some medical device companies are attempting to introduce low-cost, single-use devices that can deliver the same results as more expensive, durable equipment. BC Tech (www.bctechinc.com), a medical product development and contract manufacturing company based in Santa Cruz, Calif., has launched a miniature single-use video camera that can be integrated into medical devices to improve safety and help reduce healthcare costs.  

“BC Tech can help medical equipment companies achieve that goal,” said Charlie Skinner, vice president of business development for BC Tech, in a statement announcing the launch. “We want to help our clients create new products that move endoscopic procedures out of the surgical suite and into the doctor’s office, where costs and risks are substantially reduced.” 

Dubbed the “Video Scout,” the mini camera is reportedly one of the smallest medical cameras in the world, measuring just three millimeters in diameter. Skinner says that medical companies can integrate the Video Scout into medical devices such as biopsy tools, ablation wands, catheters, and tissue cutters, as well as scopes and other instruments. “We’re confident this sort of low-cost imaging technology will usher in a new wave of disposable medical products with built-in video cameras,” he stated. 

Just how is BC Tech able to make parts so small? “That’s obviously been the biggest challenge of this project,” said Cassidy Clawson, marketing manager for BC Tech, in an interview with Design-2-Part. “We’re using many standard manufacturing processes that are done to extremely tight tolerances in miniaturized fashion. We also have some proprietary technologies that enable cost-effective assembly.  

“Our specialty is medical devices, and we’ve done imaging systems before,” Clawson continued. “This is definitely the most radical miniature camera system we’ve ever attempted, and we’re really at the cutting edge right now. Within the next six months, we’re going to have high-volume production running on this product.” 

Miniature camera chips provided by Santa Clara, Calif.-based OmniVision Technologies (www.ovt.com), a specialist in complementary metal oxide semiconductor (CMOS) imaging technology, are essential to the development of the Video Scout. Clawson said that BC Tech has been following CMOS technology for years, and that cell phone manufacturers have really pushed the recent improvements in CMOS sensors. “Price, size, and light sensitivity are all at the right point for these things to start making sense in medical devices,” he explained. “At current prices, they may be viable in select, single-use procedures, but over the next three years, as prices continue to fall, these cameras may be the only option for new endoscopic devices. We hope to be one of the leaders in this field.

“Right now, we’re producing low-volume evaluation units that companies can order to use in their prototyping and R & D programs, so they can see for themselves if this type of imaging system is appropriate for their products,” he continued. “We’ll be moving forward in a parallel fashion with our clients. As they’re finalizing design of their products, we will be ramping up production to supply low-cost camera modules.” 

BC Tech, started 15 years ago as a specialized engineering services firm, is an ISO 9001 and ISO 13485 certified company that guides clients from research and development to pilot manufacturing, commercial manufacturing, and assistance with regulatory submissions. The company employs a staff of 65 with experience in disciplines ranging from mechanical engineering, electronics and software engineering, and industrial design to bio research, product development, and manufacturing. 

“As we’ve grown, we’ve slowly added capabilities in each of those segments, so that we now have in-house engineering and design resources, a pilot production machine shop, a regulatory group, and a small contract manufacturing facility,” says Clawson. “A company can come to us with an idea and walk out with a finished medical product. We outsource certain functions that make sense, things like injection molding and tooling. All of our engineering resources and all of our assembly are fully vertically-integrated.” 

How well the Video Scout fares in the marketplace will ultimately hinge on more than the company’s capabilities. BC Tech is banking on the widely held belief that the American medical system is ripe for a solution that makes health care more affordable. “The health care system as a whole is starting to move away from large, durable equipment, like $50,000 HD endoscopy systems,” says Cassidy Clawson. “They’re moving toward single-use solutions where a single Medicare reimbursement will cover the total cost of the product and procedure. It makes a lot of sense for many health care providers.”  

Ben Clawson, CEO of BC Tech, sees the potential impact of the Video Scout as reaching beyond American shores to the developing nations of the world. “Millions of people in poor countries die because healthcare workers lack the equipment to properly diagnose common diseases,” said Mr. Clawson. “Procedures that are routine for Americans, like colonoscopies, are simply too expensive in many parts of the world. The Video Scout enables creation of low-cost diagnostic tools that developing countries can actually afford.”

Stamping Company Coins Cost-Effective Solutions for Critical Medical Components

By eliminating the quality issues that its customer had been experiencing with a previous supplier’s work, Connecticut Spring and Stamping reportedly reduced the customer’s per-part cost by approximately 50 percent, ultimately saving “hundreds of thousands of dollars” over the course of the year. The customer had been experiencing significant problems with the production of a stamped jaw for an endoscopic clip applier, a medical instrument that applies titanium clips to blood vessels to close them off during endoscopic surgery. The client’s supplier was stamping the jaw and then machining a groove into the stamped part, but its machining operation was unable to hold the required tolerances. The client also wasn’t able to achieve the level of surface finish required for medical parts that are inserted into a body cavity.  

“They were experiencing a 25% part rejection rate on incoming inspections, and about 12% rejection of the completed surgical instruments,” said Steve Dicke, vice president of sales and marketing at CSS (www.ctspring.com). “After initial discussions, we felt as though we could take the application and, rather than machining a groove, which is where the staples are driven from, we could actually coin the groove into the jaw. We felt it would give them a higher-quality part with tighter dimensions than they were currently getting, which would give them 100% quality for incoming inspections.”  

Produced from 420 stainless steel as a single-piece component, the stamped jaw is one of the most critical components within the clip applier, and therefore must be held to very tight tolerance requirements. Connecticut Spring and Stamping accomplished this through a combination of direct engineering involvement and design recommendations. “Together, we developed a different configuration for the component that was only capable of being produced with stamping,” said Mark Labbe, a manufacturing engineer at CSS. “We worked with them very closely, and they changed the part several times. As they added new features, we had to re-engineer it because all of the parameters changed. They had to dimensionally change the part to make it function correctly, and we had to configure it to whatever they needed.”  

Although its customer designed the jaw, CSS assisted with part design and handled the tooling design—ultimately developing sophisticated tooling to coin the part multiple times in a programmed fixture. The tooling produced a coined jaw capable of holding stack up tolerances less than 0.001 inch.  

Connecticut Spring and Stamping’s use of a coining process also enabled its customer to design into the part an enhancement that wasn’t possible with the machining process—an enclosed end that achieves better clip closure. “They couldn’t machine it in that fashion because the machining had to add the groove in from the end,” Labbe explained. “So there was an opening on the end of the part. By coining it, we could actually close up the end so that the part had a better feature. Coining is a stamping process where you cause material to flow into a shape under high pressure, similar to forging, but it’s a cold process. We started with a stamped part, but the coining allowed us to do all of the critical features in one operation.” 

Although changing to another manufacturing process was key, the resulting design improvement was expedited by CSS’s close interaction with its customer. “I think the product design improvement came about through a collaboration with the customer, and the fact that they didn’t realize how tight we could hold the tolerances, and that we could fold up the end as consistently as we did,” Dicke maintained. “They recognized the improvement to their design and made the modifications based upon the collaboration. They would have been happy without the product design improvements, so it came as an additional benefit.”  

By the time they were through, CSS had helped its customer go from a 25% part rejection rate to zero rejections, while significantly reducing the cost of the parts by using a stamping process. “The tooling cost is not necessarily less, but the per-piece cost goes down significantly when you go from a machined part to a stamped part,” said Dicke. “Processing time is much slower when you’re machining it, so the stamping process saved them time and money in the long run.”

“We saved them hundreds of thousands of dollars with the parts we made for them in one year, if you consider the cost of the part times the volume of the parts,” Dicke added proudly. “Each finished instrument costs several hundred dollars, so it was very expensive to dispose of the other supplier’s rejected instruments.”

For more on Connecticut Spring and Stamping, see Quality, Cost Savings Are Stamps of Recognition for Connecticut Manufacturer.

Design and Engineering Firm Developing Advanced Prosthetic Arm for DARPA Program 

If its development continues on track, one technology that’s still in the research and development stages could one day make a huge difference in the lives of amputee soldiers. Evanston, Illinois-based Kinea Design, a research and engineering design firm specializing in Human Interactive Mechatronics, is developing innovative biomechatronic technology intended to give arm amputees dexterous control of a prosthetic hand and a sense of touch. Kinea Design is developing the innovations as part of the multinational Revolutionizing Prosthetics 2009 (RP 2009) team sponsored by the Defense Advanced Research Projects Agency (DARPA) and led by Johns Hopkins University Applied Physics Laboratory.

The prosthetic hand is connected to the patient’s nervous system, which sends control signals that allow the patient to move his or her fingers and joints. It uses either neural implants or neural electrodes that connect to peripheral nerves remaining in the area of the amputation, enabling thought-controlled movement of an artificial limb that mimics the sensory-motor capabilities of a natural hand and arm. The innovations of this new biomechatronic technology—controlling the movement of a hand simply by thinking, and recapturing a sense of touch—are said to overcome the key limitations of conventional mechanical prostheses, which are typically simple grippers that are unable to experience tactile feeling. 

 “What makes this hand innovative or unique is that it has more active joints than any hand out there,” said Julio Santos-Munne, director of operations at Kinea Design, in an interview. “Our hand has four motors on the thumb, two motors per finger, and two motors inside the palm that are used to splay the fingers, for something like grabbing a sphere. It has a lot of controls and a lot of flexibility, which you would want in order to control an arm using electrodes. I’m not aware of any other prosthetic hand that has this high level of functionality.” 

The motivation behind the development of the technology, according to Santos-Munne, was a desire to provide amputee soldiers returning from Iraq and Afghanistan with an arm capable of functioning as well as their natural arm. “We wanted it to be as easy to control as their own, so hopefully they could do it by just thinking,” he said. “There’s no switching or using the chin to get in and out of different modes; they just think about what they want, and it will happen.”

Part of Kinea’s work on the project involved the development of a novel tactile, or haptic, fingertip sensor that enables an arm amputee to explore and interact with his or her environment using the sense of touch. Combining numerous sensing capabilities, the Kinea Design Fingertip Sensor reportedly provides users with a broad array of sensory information, including temperature, texture, pressure, friction, and vibration. It can sense heat flux, for example, and feed the information back to the patient. It can also sense three axes of force—pressure on the fingertip in any of three directions—and four different points of contact.  

In addition to developing the fingertip sensor, Kinea designed a Modular Finger System and a Palm Module. The modular finger system, with three articulated joints driven by a single motor, provides the ability to curl in a natural motion and conform around an object. The Palm Module is the principal electromechanical interface for the fingers and wrist; it also serves as the enclosure for the hand’s electronic components. 

Santos-Munne said that Kinea recently finished Phase Two of the R & D project, which included conceptualization, design, and creation of a prototype. Johns Hopkins is currently in talks with DARPA, he said, concerning the next stage of the project, which, if all goes well, could take at least two more years.