Ideation → Creation

Rapid prototyping gets a product concept into end-users’ hands quicker than ever.

Jennifer Whitney
Editor

While winning the lottery may only take “a dollar and a dream,” as the slogan goes, actualizing the next great invention takes more than a little of both. In orthopedics, with recent double-digit growth rates in certain sectors cooling a bit over the past year, it’s no surprise that manufacturers are looking for the next great innovation that can produce a windfall.

Rapid prototyping of instruments and implants helps reduce time and costs to get to market while helping to optimize manufacturability. Photo courtesy of Gauthier Biomedical.

It’s not just about a great idea, though. To bring a concept to market, a team of engineers, marketing experts and others first need to be able to test their idea—to see it, feel it and touch it—to make sure that the Next Great Idea will be effective, safe to use and well designed for manufacturability.

Hence, the need for a working prototype.

Rapid prototyping is a process used to build a physical model directly from 3-D CAD data. The part or product can be made from plastic, liquid, metal or powdered or sheet materials, based on the computer model.

While any inventor wants to see his or her idea come to life as quickly as possible, the race to get to market ahead of competitors is essential in orthopedics. Ask any supplier working with orthopedic OEMs to cite the most common request from its customers, and you are likely to hear “rapid turnaround.”

As such, providers of rapid prototyping services have evolved in their approach to customers’ needs. Although prototyping services aren’t new to the industry, the term “rapid prototyping” encompasses a model that uses different methodologies than are employed in the traditional approach. Whereas model shops once used rudimentary techniques such as soldering and employing wood patterns—with human hands being the primary mechanism used to get the job done—now they use techniques such as sintering, layer deposition, sculpting and stereolithography to get the prototype made quicker and more closely resemble the final product.

Gauthier Biomedical, a Grafton, WI-based full-service provider of surgical instrumentation to orthopedic OEMs, has been prototyping for as long as it’s been in business, but it really kicked its efforts into gear in the past three to four years, according to President Michael Gauthier. “We’ve made an emphasis on streamlining the process, making deliveries and offering a rapid turnaround,” he reported. “As the business has evolved and our customers become more sophisticated, it’s necessitated this.”

And it’s worked. The rapid prototype service has had a huge impact on Gauthier’s business, he said, because many of the instruments he offers aren’t commodity-type products and, thus, customers don’t just order them sight-unseen—rather, many of the instruments are custom made to the customer’s preferences.

“They might have a handle we make for them but want it on a different instrument, or a different shaft or thru-hold,” Gauthier explained. “Everyone wants a different color, length, connector…whatever it is, they want to differentiate themselves. We take the requests and create a rapid prototype so the customers can see it.”

A factory floor at Accellent’s Wheeling, IL location. Accellent’s broad array of equipment and technology allows the company to provide complete manufacturing under one roof. Photo courtesy of Accellent.

Customers aren’t the only beneficiaries. “That secures business for us in the long term. It separates us from competitors in terms of the turnaround we can offer and shows we’re flexible. When someone throws down a challenge to us, we take pride in trying to meet their need exactly. It shows we want to do business with them, and it secures orders going forward,” Gauthier said.

Since the industry trend is for contract manufacturers to work with customers more often from the design phase all the way through to production, it makes sense that many companies have devoted space specifically for rapid prototyping. Symmetry Medical, for example, has been ramping up its co-development and design work with customers, and having rapid prototyping services available to them adds value to the partnership.

“Taking drawings or concept plots to a design meeting isn’t quite as official,” said Kevin Hayes, director of research and development for Symmetry, which is based in Warsaw, IN. A working prototype allows everyone to “get that tactile feel and give immediate feedback,” he added, which can be crucial to meeting timelines and getting to market sooner.

Accellent, one of the largest contract manufacturers in the field, has dedicated several working cells and systems specifically for rapid prototyping that are set up independently of the production area. The Wilmington, MA-based company has five locations that offer rapid prototype services, and at each one the goal is the same–evaluate time, scale and capacity.

“We’re not stopping manufacturing runs to make a prototype anymore,” said Dean Schauer, senior vice president, engineering, for Accellent. “A lot of times we get products to manufacture that we’ve never seen before. It’s critical for us to offer rapid prototyping of ideas to see if they’re feasible before any launch effort is made. In orthopedics, product launch quantities are pretty limited runs [as opposed to other device segments that might be more high-volume, low-mix runs]. Therefore, the customer has to be absolutely sure the design is correct and be sure the product will function as it was intended.”

A Most Beneficial Service Offering

Prototypes offer manufacturers many advantages during the development process: an opportunity to implement radiuses, determine how to best fixture a part, tolerance requirements and material usage, as well as evaluate ergonomics and function. Prototyping also takes certain risks out of timelines, since engineers can find out—early in the developmental process—where challenges may arise, so they can tackle them right away and not have to stop everything later down the line to restart the process for improvements. Furthermore, the process proffers the ability to determine if the product can be made efficiently and cost effectively.

“Designers create a product with function in mind, with DFMA [design for manufacturability and assembly] an afterthought. Until you put it on the machine, it’s only then you find out the challenges,” Schauer said. The timeline in a development stage has improved dramatically with the advent of rapid turnaround, as any OEM who has sought to beat the competition to market may have noticed in recent years. “Most rapid prototyping has historically been done in production so they could run parts quickly for a customer,” Schauer noted, adding that the trend toward Lean manufacturing has significantly changed the approach to prototyping.

Since providers of rapid prototyping most often work from designs made with CAD software (as opposed to the simple blueprints of times past), what once took weeks or months to make now may be completed in a matter of days or a couple of weeks. A part can be prototyped now in a matter of hours or days, shaving anywhere from two to 10 weeks off the timeline, and the cost of using plastic in the prototype may cost only a few hundred dollars, whereas metal machined prototypes could run in the thousands, Hayes said.

“We can get a quick look at a concept part rather than machining it in metal and waiting weeks,” Hayes said. “We’re producing a representation of the actual parts so they can test-fit them into cases and trays and make sure the cavities and brackets will fit properly. Historically, you developed all the instruments and made prototypes, then designed case trays later. Now we work collaboratively in concert with our other divisions. This saves iterations down the road for all components.”

Mack Prototype, based in Gardner, MA, similarly has found that rapid prototyping can allow for more design iterations in a quick timeframe that helps OEMs get to launch sooner. For example, in one recent project, the company was charged with creating a prototype of a hammer used in hip replacement procedures. According to President Ric Perry, “We were able to do four or five different styles to really refine the design to give it the weight and feel the surgeon was looking for. Where you may have produced one or two design iterations or prototypes of a certain style in the past, you’re now seeing a higher number of  prototypes requested to refine the design for ergonomics, to make a more refined product.”

Along with expanded opportunities for more design iterations, the rapid prototype process enables an OEM to amend its product line with new extensions in a quicker timeframe. In another example from Mack Prototype, a customer wanted to add a new product line that was based on an existing line. Instead of building an entire new set of tools, Mack Prototype worked with the customer’s engineers to use a good portion of the existing tooling to produce the new line, and at the same time, still be able to mold the existing product line. “[We] were able to achieve the flexibility of molding both ‘old’ and ‘new’ with the same basic set of tools, while saving the customer approximately $1.3 million based on the cost of the original tool package,” Perry said. “How? By building new cavities for the 72 new part configurations only, and by using sub-inserts for the cores to accommodate the part variations.” Of course, all parts, both existing and new, had been prototyped.

“One of the things we’re always looking for is manufacturability at the production level. In an injection molding operation, before [the customer] goes and spends big money on a mold, they [now] have proven it’s what they’re looking for,” he added.

What’s the Hurry?

Rapid prototyping essentially is all about shortening the time to market. However, it’s also about meeting various deadlines that come up within the time between concept and the product’s launch—for example, it could be that an inventor needs a working prototype to show investors to secure additional funding.

Requests for rapidly built prototypes often are due to an OEM’s upcoming training session for surgeon customers. “They might have a beta launch, sending out a few instruments for evaluation,” Gauthier explained. Alternatively, an OEM may be looking to get a new product into a potential surgeon customer’s hands quickly so the company can get feedback and refine the product, if needed, so it can be ideally suited for the market.

Schauer recalled one developer of spine products that needed prototypes for a “very challenging application” for biological material deployment. The customer requested 10 functioning prototypes for use in a cadaver lab by potential surgical customers. “We had to work our tails off. We not only had to design it, but make the prototype,” Schauer recalled. “The cadaver lab and surgeon panel had a date in place, and we had to meet the date regardless of what it took [to do so].

Since trade shows are a well-known opportunity for orthopedic manufacturers to show off their wares, OEMs also often approach their outsourcing partner with a need for an extremely quick turnaround to get a prototype that looks and feels much like the intended finished product ready in time for display.

“When we hear that, it’s an absolute drop-dead date,” Perry said. “The marketing department will want something to do pre-sales and will need something in hand. They will get real feedback from customers and, before they go and finish the product, they can take orders for the unit. It’s a big part of prototyping—putting the prototype in the hands of end-users.”


If there was one message providers of rapid prototyping could give to their customers, it might be that, although the strides made in this industry certainly can be hailed as remarkable, one should not expect miracles. “The term rapid is fast, not instantaneous,” Perry said. That said, he and others said they always give it their best shot to get a project done as…umm, well…rapidly as possible. “In product development, we’re always going to try to push the envelope,” Perry concluded.

And the value of getting a prototype made in such fashion is priceless, according to the experts. As Gauthier said, “If a picture is worth a thousand words, a prototype is worth a million words.”