|Polyimide combs with 25- micron-wide teeth are pictured above. Processes capable of producing features as small as 2 microns in many polymers are now capabilities prototyping and production house can offer to customers. Photo courtesy of Potomac-Laser.|
In an industry in which days can mean the difference between a successful product launch and being beaten to the punch by a competitor, medical device prototyping and production providers are setting their sights on one overriding goal: delivering more complex prototypes more quickly at lower costs.
A few years ago, depending on the process used, it could take several weeks to several months to create a prototype. Today, in many cases, that time has been cut to days, or in some instances, hours. Design changes can now be made nearly instantaneously. And some companies are finding that their per-part production costs have fallen by more than half because of better designs and manufacturability that resulted from better prototypes. In fact, it appears that both suppliers and OEMs are focusing more on the role that prototyping can play in ensuring a successful product debut.
The Power of Prototyping
The Power of Prototyping
In the past, “the prototype was often an undervalued and overlooked asset in the development cycle of a component, medical instrument or surgical device,” noted Debra Van Sickle, vice president of sales and marketing for Peridot Corp. in Pleasanton, CA. “The beauty of the prototype is that it allows us to closely evaluate and validate our clients’ ideas and visions without committing to large expenditures in capital, time and resources. Moreover, it allows us to view, with a critical eye, the pitfalls of a particular design and steer our client toward DfM (design for manufacturability), often resulting in lower costs and superior products.”
Zev Asch, vice president of marketing and sales for Popper & Sons, Inc. in New Hyde Park, NY, elaborated: “The biggest challenge for OEMs is not only developing a great idea or solution, but one that can withstand the test of tight budget and pricing limitations. What looks great ‘on paper’ during the design stage may not pass the manufacturability test.”
Asch noted that the manufacturability test comprises four elements:
|•||Can the product be made at all?|
|•||Are the tolerances reasonable or do they place unrealistic expectations on materials or equipment?|
|•||Is the material to be used readily available? Will it require long delivery lead times, unique suppliers or other challenges?|
|•||Can the product be manufactured at a ‘sellable’ cost? “One can design the perfect device, but if it costs $100 for one unit, it will not fly,” Asch explained.|
While traditional prototyping focused primarily on ensuring a device would function according to the OEM’s vision, these days material selection, component and assembly features and tolerances, and manufacturing processes are also considered during this phase. As a result, more risk is transferred to the beginning of a product’s development cycle, allowing for faster ramp-up times and fewer costly surprises on the back end.
Indeed, companies have found that by scrutinizing some of their customers’ planned manufacturing processes during the prototyping stage, they are able to suggest changes that result in dramatic savings.
Potomac Photonics in Lanham, MD helped one client shave its per-part cost by nearly 88%, from $1.20 to 15 cents; another customer saved 91%. New Britain, CT-based Okay Industries Inc. noted that a client developing complex components had planned to use metal injection molding. However, Okay’s engineering, R&D and project management experts suggested using a metal stamping process that allowed the company to make the product at one-fifth of the original estimated cost.
Suppliers also are reassessing their offerings and enhancing or complementing current capabilities to better serve OEMs’ needs. For example, Okay developed Production Proven Prototyping. As the name suggests, prototypes are created using the same tooling concepts, sequence of operations and grain direction that will be used during the stamping manufacturing process. Component strength, cracking, surface finish, burrs/edge condition and feature tolerance capability are all assessed at this point, said Jason Howey, business development manager for Okay Industries. The process uses laser blanks and universal, off-the-shelf prototype forming and production tooling to cut costs, Howey said.
“Before, prototyping was more piecemeal—we’d make a tool for one particular application. Now, proprietary processes with standardized tooling enable us to offer our customers a high degree of flexibility for a wide range of complex products.”
Howey pointed out that vendors, like their customers, learn from the prototyping process about the characteristics of the device in relation to the materials, processes and machines used to make it. As a result, suppliers don’t have to overly re-engineer, and both parties benefit in the end.
Certainly, the knowledge gained during prototyping a product is invaluable, and OEMs are increasingly inclined to having just one supplier handle a project from concept to marketplace delivery.
Suppliers are listening. In 2003, Specialized Medical Devices, in Lancaster, PA created a dedicated prototyping department. Before, prototype work was channeled through its production department.
“We saw that a lot of our future growth would come in prototyping,” reported Jack Fulton, vice president of sales and marketing. “To be in a position to win production jobs in the future, I think you’ll have to be in on the ground floor. Five years ago, OEMs did their prototyping in-house or with a prototyping group. Production was done elsewhere and added time to the process because the production house had to learn the whole program. Today, everything is out of house and in one place. Prototyping and production work hand-in-hand so that the best materials, design and manufacturing processes are determined and put into place from the very beginning.”
OEMs, seeking to reduce their supply chains, also are searching for one-stop shops. Therefore, prototype and production providers are adding more capabilities to their portfolios.
“We’re seeing OEMs coming to us with a concept and wanting us to do more than mold the parts,” noted Ken Brandl, quoting manager for Scientific Molding Corp. in Somerset, WI. “They want us to do a lot more of the secondary operations—subassembly work, testing, packaging, distribution and marketing. They used to want just tools and parts. Today it’s design assistance, product development and sterilization.”
In addition, suppliers are innovating like never before. “Today’s clients come looking for expertise and technology you have available off-the-shelf,” said Steve Maylish, director of business development for Aubrey Group Inc. in Irvine, CA. “Ten years ago, clients expected you to develop technologies from the ground up. Now, they look for specific outsourcers with developed technology.”
Having the technology in-house not only adds to a supplier’s areas of expertise, it also can speed the entire prototyping and production process. For example, Aubrey Group, which specializes in developing state-of-the-art graphical user interfaces (GUIs), has a library of tools from which to construct GUIs.
Rather than starting from scratch with each project, company officials review current offerings to see if time and expense can be saved by incorporating or modifying an existing tool rather than custom designing and building a new one.
Bob Park, engineering manager for Micro Group in Medway, MA, added that suppliers that have broad-based offerings also can better match processes to OEM goals. “Both EDMs and lasers can put a slot in a material, but if you don’t have both options, you may be forced to use the less desirable option for a particular application,” he noted.
“Bringing technologies in-house allows us to provide the services we and our customers expect. Often, having additional technologies and services in-house lets us offer faster and more economical prototypes,” said Van Sickle, explaining another reason why many suppliers are developing capabilities in new areas rather than simply building a network with other firms.
And for OEMs who need to explain a supplier’s technology or service offerings to a board of directors or to a VC firm, some suppliers offer help in that area as well. Potomac Photonics has prepared both videotapes and personal presentations, which have been shared with numerous audiences.
Just as suppliers’ offerings have changed, OEMs’ approach to product development has evolved as well. Fulton and other industry experts noted that five or 10 years ago, medical device manufacturers’ R&D departments had numerous projects in various stages of development. Many of those projects never made it to market. Today, they devote little time to speculative projects. Instead, many medical devices are based on tested technologies or advances that have a reasonable chance of reaching the marketplace before those of competitors.
Previously, OEMs may have had 18-24 months to get a product to market. That window has shrunk to six to nine months. As a result, every step of the process is compressed—from prototype turnaround times to production cycles.
“Five years ago, two weeks’ turnaround time for prototypes was good, and three weeks was the norm,” Van Sickle said. “Now almost all are done within two weeks, and many are done within a week.”
Mike Adelstein, vice president of Potomac Photonics, noted that his company can take customer drawings and develop prototypes within 24 to 48 hours using its proprietary CAD-to-Fab process. In one scenario, a glucose sensor manufacturer who previously had parts cut with a tool die typically waited four to six weeks to get new designs. Potomac Photonics imported the drawings into its customized AutoCAD file, which then delivered work instructions to the laser equipment. This process allowed eight new iterations to be created over the same period.
“In production it may be cheaper to use a tool die, but with prototypes, a laser’s accuracy, resolution and speed can make a difference in getting through clinicals and into the market much faster,” he said. “Our laser system’s positional accuracy is also better—it’s within a few microns. With a tool die, you’re limited to 12-, 15-, 20-micron accuracy.”
“It’s not uncommon to have OEMs request prototypes be done in days now,” Park added, noting that prototype tolerances, like their timelines, are also tightening. “We often see prototype applications where the client wants to hold a tolerance to +/- .002 inch.”
Asch added that much more is possible in creating prototypes today. “Five years ago when a customer asked us to take a 0.004-inch ID tube, bend it and put a tiny hole in it, we wouldn’t quote the job,” he said. “Today, the material is readily available, and our laser technology products can easily handle 0.002-inch to 0.004-inch holes in a tube.”
Faster turnaround times, tighter tolerances and lower costs mean that OEMs can lower their liability risks by building more prototypes and prototypes that are more sophisticated. Consider GUIs, for instance.
“It used to take a few months to deliver a simple, functional prototype with a basic GUI. Ten years ago, that GUI would have shown a seven-digit display and had a bunch of knobs and switches. Now, in the same period of time, we can deliver full color, sophisticated VGA displays that feature touch-screen input and computer graphics that can be changed easily and speak numerous languages. They also are reprogrammable so we can use the same hardware, reprogram it and change the software and make iterations in hours. Because the prototype is so easy to change, OEMs can be more adventurous the first time out,” explained Vytas Pazemenas, Aubrey Group’s president and founder.
Aubrey Group can make quick GUI iterations because rather than designing and building special circuit boards, the company uses internally developed technology and GUI modeling software.
|Advances in the tools used to make prototype have helped to speed up the process. Pictured above are samples that Scientific Molding Corp. made for one client. Photo courtesy of SMC.|
Software Pulls It Together
Software Pulls It Together
Software plays a vital role in increased speed of prototypes throughout the industry. “The biggest thing is that everything is networked now, which saves a lot of time and communication,” said Jim Meier, vice president of marketing for Scientific Molding Corp. OEMs e-mail design files to suppliers, who then download the files into their prototyping and production systems, which are interconnected as well so no information slips through the cracks.
Fulton noted that improvements in three-dimensional modeling allow software to perform some functions, such as some initial product testing and assembly, on-screen. “Technology has advanced to the point where today we can do things that previously weren’t possible,” Fulton explained. “Some initial testing on a part can be conducted with software rather than on a separate prototype, so it helps you eliminate one of the prototyping steps.”
Okay Industries’ engineering database translates work instructions for the wire EDM machines and CNC machines, incorporating many details in minutes as opposed to the six to eight hours it used to take to manually program the machines. The company also customized its CAD software to design off-the-shelf tooling components that could be used for multiple projects with minimal modification. Further, 30-40% of the prototyping tools are then used in production, saving additional time and expense.
Equipment has continued to enjoy advances as well. Wire EDM and CNC machines are faster and more accurate than ever. The same can be said for stereolithographics (SLAs). Many machines also are able to perform more functions, eliminating the time needed to perform change-outs.
Adelstein noted that Potomac Photonics is now using lasers not only to machine parts but also to deposit materials. “We can deposit a substance, like silver or other metals, onto the electronics portion of a product, or we can machine it into an item like a high-density interconnect,” he said. “By machining materials and depositing materials concurrently, customers don’t have to lose time waiting for multiple steps to be performed.”
Flexibility is key. Suppliers are well aware that OEMs need their product in the marketplace ASAP, so they’ve created systems to offer both speed and cost efficiency. “Once we have a design finalized through the prototype phase, and marketing has determined the volume run, we can do an interim phase of soft tooling,” Van Sickle said. “We use blanking dies for production of up to 5,000 parts. More secondary labor is involved, but we get parts much faster, and it bridges the gap until the final stamping die is ready. We simultaneously are building the full-blown stamping die so that we can then accommodate larger scale production of up to 50,000-plus pieces.”
Suppliers say that the prototyping business is booming, and they’re bullish on the future. Technology will continue to help drive the number and quality of prototypes produced.
“Advances in three-dimensional printing, stereolithography and other technologies are opening the door as wide as can be for future advancements in medical devices,” said Micro Group’s Park. “Tomorrow’s advances will allow even quicker turnaround times and more sophisticated prototypes. Forget the limits you’ve faced in the past. Technology is making more possible every day.”
Stacey L. Bell is a freelance writer who specializes in business and marketing issues. She is based in Tampa, FL.