Blurred Lines

Rapid prototyping is about more than just speed—it has evolved to the point where this robust technology can create production-quality instruments, parts, and products in a matter of days. Design tools, software programs, multi-axis precision machining and multi-material 3-D printers allow product design companies to turn prototype implants and instruments out in days instead of weeks or even months.In addition, they can be produced at less cost compared with traditional methods.Most functional prototypes being developed today can be very close to (or in some cases already be) production-equivalent, which is a huge competitive advantage for bringing new or replacement products to market quickly.

“Advanced modeling tools like CFD (computational fluid dynamics), FEA (finite element analysis) and FSI (fluid structure interaction) are available today for use by implant companies to create a smooth, fast and streamlined workflow for implant products tailored to patients,” said Jim Schultz, executive vice president for ECA Medical Instruments, a Thousand Oaks, Calif.-based designer and manufacturer of single-procedure, torque-limiting surgical instruments and kits. “Modeling and simulation using patient-specific data from MRI or CT scans is a key step towards moving clinical trials into the virtual environment. Personal medicine, which has taken hold in biotech, is also moving into medical devices, including implants.”

Rapid prototyping largely falls into the category of additive manufacturing (AM), which includes technologies such as 3-D printing, stereolithography (SLA), selective laser melting (SLM), selective laser sintering (SLS), direct metal laser sintering (DMLS), and fused depositional modeling (FDM). The incredible buzz over 3-D printing, however, is making some companies turn to 3-D printing exclusively for rapid prototyping; the additive manufacturing community, however, is trying to educate manufacturers that 3-D printing only is a subset of AM and that other technologies may better be suited for rapid prototyping needs, depending on the project.

One of the most significant developments over the last few years is the use of AM for production versus just prototyping.Many U.S.-based companies are seeing the value of AM for production and have worked to gain approvals to produce aerospace and medical products with AM methods.

“This paradigm shift is creating a demand for AM machines that have suitable capabilities and safety features for true production use,” indicated Daniel Anderson, senior manager of prototyping and design for Greatbatch Medical, a Frisco, Texas-based designer and manufacturer of medical devices and orthopedic implants. “While the technologies themselves have shown slight—but still important—improvements in quality and speed, the transition to thinking of AM as another production option is a driving factor.”

Meeting OEM Demands
In the time/cost/quality triangle, quality is an absolute constant—without it, business dies.This leaves time and cost as the relevant variables. This is why there is such keen interest in rapid prototyping andAM—rapid prototyping significantly can reduce production and total operational costs by delivering quick-turn functional prototypes in weeks instead of months. This does, however, require a collaborative, problem-solving mindset between the contract manufacturer and the OEM.

For example, OEMs are seeking cost-effective and rapid solutions to problems they are encountering with implants, instrumentation and connecting devices. One of the biggest issues is life cycle management cost for reusable instruments. Today hundreds of millions of dollars’ worth of instruments are in the field and require constant tracking, cleaning, sterilization, recalibration, and inventory management—creating a huge cost center for OEM implant firms. These companies are starting to seriously look at reducing this cost to improve efficiency in the overall delivery model.

“Ninety percent of reusable instruments are loaners to hospitals,” said Schultz. “Loaned or consigned inventory stock is typically handled by highly paid company sales reps who manage both medical implant and instruments for their hospital and ambulatory surgical center accounts. This is costly, hard to manage, and inefficient. Hidden risks include product availability, sterility, and calibration concerns.”

As a result, companies are focusing on quality improvements, creating competitive advantages and driving down costs. Suppliers that can respond quickly with functional prototypes that compress the development cycle are in high demand. Time-to-market accelerators are becoming increasingly important as competition grows in existing markets. In some cases, development cycles can be reduced by up to 50 percent or more. “If it is a legacy issue, it can be very fast—literally within a few months,” indicated Schultz. “For a new implant, typically 12 months to 18 months is required to bring to market.”

Technology Essentials
A big time-to-market accelerator is being able to reduce the number of iterations needed to reach final design. Therefore, OEMs rely heavily on their partners to help with material selection, design for manufacturability and prototyping.

“The use of solid models is essential in any prototyping process,” said Richard Hurst, business development director for XL Precision Technologies Ltd., a United Kingdom-based manufacturer ofprecisionmicro-components for the medical sector. “It is much easier to interpret a drawing, understand the design and devise a program for a machine with CAD models.”

The development of 3-D printing, he noted, has opened up new possibilities for prototyping and will play an increasingly important role in the near future. Minor limitations currently exist on fine precision features where features and tolerances are smaller than the layer depth; surface finishes also may require some post-processing.

“3-D printing technology can provide more polymer and metal material options today, including clear, multi-durometer, radiation shielding and high-temperature applications,” added Dana Foster, marketing manager for Thogus and JALEX-Medical, two Avon Lake, Ohio-based providers of plastic injection molding, rapid prototyping and medical device design. “Furthermore, manufacturers of 3-D printing machines are introducing larger build sizes in order to print big parts in one piece.”

As a result, the orthopedic industry is utilizing 3-D printing technology more for medical device prototypes, with the possibility of generating production-quality implants and instruments. “3-D printing allows clients to see and feel their device before going into production, often within days,” said Foster.
“This not only shortens their product development time, but allows them to understand the fit and function of the device, implant or surgical tool before spending their budget on production. 3-D printing has grown to be a prototyping technology and a technology that can quickly produce end-use parts. For example, today some instruments and tools are being produced on polymer and metal 3-D printers as the final product.”

3-D printing of orthopedic products in high-resolution polymer technology allows clients to see every angle and feature in their complex parts. Foster foresees more clients ordering the majority of their product prototypes or end-use devices on their metal and polymer 3-D printing machines. “We recently 3-D-printed a tool for an injection-molded medical device,” she said.“Our customer was on a tight deadline and quickly needed prototype tooling to get samples of its overmolded medical device.Building an aluminum tool would have taken four to six weeks; however, using 3-D printing technology, we were able to additively manufacture the tool within days.We then ran the tool on one of our injection molding machines in-house, which allowed the client to get a prototype in the same material in which it will be mass-produced—all within one week.”

ECA Medical Instruments utilizes a rapid instrument customization (RIC) approach to product development. It can produce working samples and near-production-equivalent prototypes of instruments and complete procedural kits in a few days. Essential to this process is having a deep understanding of manufacturing systems and program management—which requires extensive collaboration with the OEM team. “We bring rapid-prototyping solutions for the OEMs to consider, compared to traditional build-to-print models,” said Schultz. “When we develop custom prototypes, we can be nearly 100 percent operationally accurate and functionally compliant when we deliver the first prototypes. This allows for very fast review, testing and decision-making by the OEM.” This also saves a lot of time and money—the time it takes to complete a project can sometimes be cut in half, with cost savings in the millions of dollars per product if a legacy device, instrument or procedural kit is being replaced.

Even with the rapid development of 3-D printing for plastic and metal prototypes, prototype parts can still be made using “regular” production processes. “By investing in the right kind of production-capable technology and equipment, customers can receive prototype parts in about one to two weeks and know they can be replicated exactly in production, using the same equipment,” said Hurst.

Advantages include:

• Customers receive prototype parts in the required quick time, which are fully representative of production-standard parts, and have confidence in long-term design viability;
• Manufacturers can develop a production-ready process early in the project and have confidence in ramping up batch quantities to full product launch; and
• Both parties are establishing process and operational qualification protocols from the very beginning—an increasingly critical factor in today’s product development.

“Laser technology, EDM (electrical discharge machining) technology and flexible hard-machining processes are ideal platforms for this kind of approach,” said Hurst. “We have invested $3 million in new manufacturing technology that gives us this flexibility and provides the solutions that customers increasingly require. Dedicated prototype facilities still offer value, but many contract manufacturers rely on the production volume business. To obtain that business, they need to be able to offer best-class prototype services with a solid link to DFM and long-term production.”

Expanding Design Creativity
It can be tough to be creative when designers and engineers are limited to the same materials, designs and production processes. However, additive manufacturing and rapid prototyping vastly increase what design teams can come up with in terms of complex sizes and shapes, materials and product functionality.

“Many people are not aware that additive manufacturing allows great flexibility in design—in other words, design for function versus design for manufacturability,” confirmed Anderson. “This is true for concept development, but especially true if the end product can potentially be produced using AM.”
AM, he noted, has the ability to remove the age-old battle between the design engineer who simply wants to prove a concept, and the manufacturing engineer who needs to receive a design that is feasible for manufacturing. “AM can provide the design engineer with a way to prove—or disprove—a concept by quickly producing a concept model without having to jump through design-for-manufacturability hoops early in the process.”

To stay innovative today, companies must be strong in their core competencies and have powerful partnerships with adjacent industry segment players to deliver the “whole product concept” to OEMs. Increasingly, OEMs are seeking creative help from supply chain partners to design new products that can meet changing market needs, as well as deliver cost reductions in life-cycle management costs, across a wide range of instruments and support equipment.

“Innovation becomes reality when marketing and product development are combined to serve a specific customer need,” said Schultz. “Rapid prototyping and additive manufacturing are the tools that support groundbreaking creative design and development that quicklysupport the changing landscape. Huge life-cycle costs, inefficient OR operations and inventory management, the costs of cleaning and sterilizing products and calibration issues are just some of the challenges OEMs face. The supplier that wins going forward is the one that can both proactively present creative solutions for these needs, as well as quickly respond to customer requirements.”

These quick, creative solutions especially are important for meeting the unique clinical challenges offered by personalized medicine, on a patient-by-patient basis. For example, Thogus has used 3-D printing to provide surgeons with models of patient’s skulls. “Using data from the CT scan, we can print a skull that exhibits the exact location and size of the patient’s trauma,” indicated Foster.“Surgeons can then fully understand the damage that has been done to the skull and where to place the cranial mesh prior to going into surgery, thus reducing the risk of error and minimizing surgical time.”

Rapid prototyping also leads to more creative design in process improvement. The goal is to create processes that not only produce a workable prototype, but do it in a way that is more economical and repeatable. “The successful prototype shops are not only looking at the quick turn to specification prototype, but also looking down the road for ways to produce the part in a production mode and offer repeatable, well-controlled parts at an economic price,” said Hurst. “This requires flexibility within the organization and highly-skilled engineers.”

For example, a customer approached XL Precision Technologies about a laser cut to maximize the radius of a tube articulation. The company also wanted to match that with strength for better torque characteristics. “They did not have a good idea of how to approach this problem,” said Hurst. “Because of our experience in laser cutting tubes, we were able to offer three examples of quick-turn prototypes for them to consider. From those three examples, they were able to modify and improve the performance four-fold of their existing device, over and above what they originally thought they could achieve. This also opened up some new facets of performance to the existing device that they had not previously considered.”

Education Required
Many companies—both OEMs and contract manufacturers—still don’t understand enough of what they need to know about rapid prototyping and additive manufacturing to make fully-informed decisions. Contract manufacturers that are experts at rapid prototyping—through additive manufacturing techniques such as 3-D printing or innovative use of production processes—often need to educate clients about how rapid prototyping can work across a range of applications.

“This helps them develop a rapid-prototyping mentality, as well as understand and practice quality by design, best engineering and product development practices, design for manufacturability and compliance,” said Schultz. “With this capability, they become strategic extensions of the engineering and product development and marketing arms of the OEMs, which strengthens their competitiveness in the marketplace.”

There also is a vast spectrum of experience in customer engineering groups, added Hurst, which also can be tapped to create innovative rapid-prototyping methods. “For veteran engineers, the discussion across the table is the most vital aspect of the exercise,” he said. “They know what they need in material and outcome. The contract manufacturer must offer solutions immediately and work side by side with the customer engineers to achieve the goal they already have in their minds. With engineers straight out of college, it is important to guide them on materials, processes and cost drivers. Any information you can offer to keep them up to speed with their particular program is vital—it also goes a long way towards ensuring you’ll get called back for a follow-up program.”

As market cost pressures increase, customers continue to look for ways to reduce them—not just for a specific device, but also the cost to run the groups that design the next device. This often results in engineering groups that are shorthanded with myriad programs and short timelines to bring the product to market. “The more you can be there to help them with short lead times, engineering assistance and mechanical know-how, the more vital you become to that OEM as a go-to partner,” Hurst said.

Value is created when it can be measured—reduced cycle times, reduced waste, higher quality, faster speed to market and lower costs.“The saying ‘it’s not the big that eats the small, but the fast that beats the slow’ is especially true for the medical device industry,” concluded Schultz. “Suppliers who don’t adapt or cannot scale will be, over time, left behind. Time is still money. Time to market and the ability to respond to customer needs and market changes are essential for a company to grow and prosper. Rapid prototyping is a tool that will increasingly provide sustained benefits to customers—companies that cannot provide this service will eventually decline and lose enterprise value, because this is the way of the future.”

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Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. He can be reached at [email protected].