“This very issue has pushed device manufactures to improve overall procedure times, as well as improve patient outcomes, both during and post operation,” said Chris Stevens, senior research and development engineer for Proto Labs, a Minneapolis, Minn.-based provider of digital, quick-turn manufacturing for injection molding, CNC (computer numerical control) equipment, 3D printing, and sheet metal. “This has shifted the focus to devices that take a minimal invasive style approach or use robotics for assisting in the procedures.”
Prototyping is essential for speedy orthopedic design these days—prototypes are vastly improved compared to just a few years ago. OEMs want greater detail from their prototypes regarding materials, dimensions, shapes, fit, and function. Surgeons often work closely with OEMs regarding device design, with human factors and time to market being top concerns.
The need to innovate and simplify design, yet maximize functionality, leads many orthopedic companies to rely more on additive manufacturing (AM) as the best way to optimize the design of implants and instruments, especially for making prototypes. AM helps device manufacturers finalize implant and instrument designs in a quick and efficient manner, shortening time to market.
“When designing implants and instruments, the orthopedic device industry is leveraging AM for improved design and better performance,” confirmed Gautam Gupta, vice president of global GTM for healthcare for 3D Systems, a Rock Hill, S.C.-based provider of digital manufacturing solutions, including metal 3D printers, print materials, and on-demand manufacturing services. “If we look at implants for example, AM helps optimize geometries and surface properties, which dramatically improve implant performance and fixation to host tissue. Incorporating AM into the manufacturing workflow also creates a cost-effective supply chain and enables faster turnaround.”
AM is also becoming less expensive to purchase, which broadens its availability to orthopedic designers and engineers, especially for smaller firms with fewer resources. For example, fused deposition modeling 3D printers can be purchased for less than $1,000. Having access to their own AM tools helps these design firms meet tight client time needs—such as surgeons who want products that are custom-designed to their specific needs and/or patient populations and expect super-fast iterations.
“For example, a doctor has a lab on Monday that shows his/her unique problem isn’t being addressed with existing instrumentation,” said Chris Rodriguez, senior mechanical engineer for Goddard, a Beverly, Mass.-based engineering and industrial design firm specializing in medical device development. “In many cases, engineers can design and create solutions in hours or days utilizing technologies such as direct metal laser sintering, 3D-printed metal, or rapid machining, and deliver tangible functional prototypes for the physician to evaluate in a wet lab by the end of the week.”
Additive manufacturing/3D printing (AM/3DP) is becoming an essential tool for prototyping and design. Easy accessibility to these processes gives device manufacturers the ability to design and build devices that could not be machined or built otherwise in a cost-effective manner—a capability that greatly expands engineering and design creativity. More 3D-printed parts are being used in the final device. Greater design flexibility allows surgeons to match devices with patients that do not require on-the-table adjustments, shortening the procedure and the time of recovery for the patient.
When rapid prototyping is facilitated by iterative design and AM processes, orthopedic device manufacturers can shorten the product development cycle, delivering their new products to market faster.
One of the more notable industry trends is using multiple technologies to develop a digital model of the patient, which can be used to construct a tool or bracket specifically designed for the patient’s anatomy. Stevens noted the digitalization of the patient-gathering information, as well as the manufacturing processes involved, can streamline the process from what previously would have taken many months, down to a few days, if not hours. “Custom one-off parts are becoming reasonable and attainable as compared to mass production of a product,” he said. “The key is digital platforms that can automate many of the repetitive tasks to both increase the speed and reduce the cost.”
Although the demand for quick prototyping has remained steady, Andrew Metzger, director of innovation and program management for Secant Group, a Telford, Pa.-based provider of custom textile and advanced biomaterial solutions for medical device manufacturers, indicated an emerging trend of shortened and expedited go-to-market timelines. “This translates into the need for quick iteration on new concepts, as well as high-quality standards and an increased focus on design for manufacturability,” he said. “Often, a one-off sample will be used for more than benchtop evaluation, including animal studies, so quality and repeatability are key for project success.”
What OEMs Want
Outpatient procedures are gaining popularity in the healthcare industry. With today’s aging population that remains fairly active, healthcare facilities are eager to get patients out of the hospital and back to their daily routines as quickly as possible. To help accomplish this, OEMs are creating more compact implants and devices that enable patients to regain normal function as comfortably and quickly as possible. These tools include minimally invasive surgical equipment, which is increasingly guided by sophisticated robotic controls.
Of course, whatever saves time and money, without sacrificing quality, is at the top of the OEM list. For example, although new materials can improve overall device performance and functionality, OEMs prefer using well-tested “standard” materials, which make it easier and faster to move from single prototype to full-on production.
For products with smaller, more intricate designs and tighter tolerances, more manufacturers are investing in design for manufacturing (DFM) to identify the best and most cost-effective manufacturing process. “Customers are particularly fond of proactive DFM at the prototype stage to identify and work out any design flaws, as early as possible,” said Francois Samson, head of marketing for Intech, a Memphis, Tenn.-based global contract manufacturer of surgical instruments, implants, cases and trays, and silicone handles.
Manufacturers often try to maintain a balance between using traditional methods and newer manufacturing processes. For example, DFM doesn’t always mean AM—depending on the project, CNC machining or injection molding gets the nod. Additive manufacturing can be problematic at times—for instance, strength issues with the final product or cost-effective production for higher volumes.
When it comes to final decision making, speed often wins out.
“It is always the lead time that concerns our OEMs the most,” said Matthew Hsu, business account manager for Intai Technology Corporation, a Taichung, Taiwan-based contract manufacturer of medical devices. “Since their main focus is to launch the product as soon as possible, or prototype for a validation purpose, they want the shortest lead times possible.”
“Our customers expect fast turnaround times with the ability to quickly iterate on design concepts to reach design freeze in the shortest amount of time,” added Metzger. “These expedited timelines often coincide with upcoming surgeon demos or recently approved animal studies. Ultimately, manufacturing partners need to offer choice and flexibility in design options and have the talent, processes, and equipment to accommodate OEM requirements.”
Iterative design versus a single prototype is often a discussion OEMs have with their contract manufacturers. “We often hear both sides—should the design be held until all aspects are verified before moving to prototype/production tooling, or can an iterative design approach better identify design, manufacturing, and assembly challenges early, saving time and cost in the long run?” said Stevens.
For NN Life Sciences, a Charlotte, N.C.-based manufacturer of high-precision metal and plastic components and assemblies for the medical device industry, depending on the timeline, “some clients are using phases or multiple rounds of prototypes to ensure production-ready product, in order to meet short time-to-market requirements,” said Dan Owens, director of the NN Life Sciences’ advanced manufacturing group.
ECA Medical Instruments manufactures single-use instruments such as torque limiters and complete surgical procedure sets that provide precise fixation of orthopedic implants. For OEMs that want to take market share or enter a vertical segment like the ambulatory surgery center market, creating a cost-effective solution quickly is critically important.
“Our collaborative and iterative process, which includes instrument and kit modeling, 3D printing, rapid mold development, VoC [voice of customer] testing, and feedback loop, allows us to bring products to market in months versus years,” said James B. Schultz, vice president of customer solutions for ECA Medical Instruments, a Thousand Oaks, Calif.-based designer and manufacturer of single-use instrumentation for the medical device implant market. “This means huge cost and time savings. A broad platform of standard and validated products can be easily optimized and tailored for customers seeking a single-use alternative to traditional reusable case and tray approach.”
A constant requirement by OEMs is medical device certifications, which have always been at the center of quality discussions; however, in recent years, the quality demands on supply chain partners have increased dramatically, giving contract manufacturers a bigger stake (and shared risk) in the development process. “With designs increasing in complexity, timelines getting shorter, quality expectations growing, and supply chains being stressed, the focus around risk reduction is growing on multiple fronts,” said Stevens.
Advanced Technologies and Processes
AM/3DP is now widely used among top orthopedic device makers that want to take advantage of the shorter lead times and faster design feedback it provides. AM/3DP design and production is steadily capturing more of the orthopedic implant market share—for example, as the cost of this equipment drops, more do-it-yourself additive manufacturing happens in-house, such as top OEMs launching their own 3D-printed implant cages. “In response, conventional CNC machining shops must convert their focus to other types of implant manufacturing in order to survive,” said Hsu. “Fortunately, 3D printing cannot yet compete with the turned implant, or the blank for hip and knee implants, which require wax casting.”
Rather than a flow of new tools coming into the industry, Gupta sees an increasing level of sophistication in using existing tools for prototyping and design. In particular, software is playing a much-expanded role in the medical device design and manufacturing process. “Companies are much more knowledgeable—and open—about using sophisticated software packages such as 3D Systems’ 3DXpert to optimize not only their designs, but also their supply chain,” said Gupta. “Such software tools are very specialized in designing for metal additive manufacturing and combine the additive and subtractive workflows in ways not previously possible.” Companies are also utilizing design for additive manufacturing (DfAM) in their product development cycles from the beginning.
Automation also has an expanding role in orthopedic prototyping and design. Improvements in automation allow companies to create more complex components within shorter timeframes. “This aligns with OEM goals to seek out less costly components that can be developed quickly,” said Dan Treusch, business development director for Secant Group. “It doesn’t stop at cost and time, either—OEMs want to see the performance data behind the components.”
Automation capabilities, combined with more sophisticated delivery systems, also enable OEMs to make minor revisions to devices over time, which improves therapy outcomes and keeps component costs down. “Essentially, automation eliminates bottlenecking, thereby allowing devices to get to market more quickly,” Treusch added.
ECA has also invested in automated equipment for product development and testing including automated torque testing systems, which helps reduce time to market and provides critical data for validations and the design history file needed for market adoption and a CE mark.
Since time to market is such a high priority among medical device companies, Intech has embedded a “Prototype Garage” within each of its facilities, with prototype-dedicated cells that “provide a fast-track lane to rapidly produce prototypes that are run on production-equivalent CNC equipment,” said Samson.
Dedicated prototype cells allow engineers to rapidly stack processes back to back, from 5-axis sculpting to wire electrical discharge machining. “The benefit of using dedicated production-equivalent machines is that we can leverage multi-axis machines from prototype to large-scale production,” Samson added.
In the spine industry, companies are adopting AM to introduce innovative products that can promote bone ingrowth and improve implant fixation to host bone. The 3D printing of these devices also reduces the number of manufacturing steps, thereby making the additive process more cost effective in several cases. For example, NuVasive Inc. capitalized on the advantages of AM, going from design to market in just over one year with the 2017 launch of the Modulus line—titanium implants designed through a proprietary optimization algorithm that balances porosity, load sharing, and radiolucency.
“This was achieved through topological optimization, an algorithm-based design strategy that removes excess material that serves no structural or functional purpose,” said Gupta. “A component that has been topologically optimized is lighter weight with no adverse impact on strength. In the case of the Modulus line, topological optimization also facilitates better imaging characteristics across all shapes and sizes of implants, giving surgeons a better view into bone fusion during follow up. In addition, an optimized lattice structure provides a fully porous architecture that creates an environment conducive for bone in-growth.”
ECA Medical Instruments’ new second-generation TruTORQ precision torque limiting products, from 0.4 Nm to 13 Nm and for hand or surgical power tools, are being developed using contemporary software tools for 3D modeling, mold development and optimization, and rapid prototyping, including 3D printing and automated torque testing equipment. “Combined, these design and development tools offer a powerful and cost-effective solution to creating new products and optimizing existing ones,” said Schultz.
AM/3DP is a rapidly advancing science and has, therefore, drawn an increased level of scrutiny from regulatory bodies when used for production. The FDA and other agencies have looked to industry leaders such as ASTM for guidance and development of best practices when using AM/3DP technologies for the manufacture of medical devices.
To differentiate themselves in a crowded market, orthopedic device manufacturers must design and make one-of-a-kind products that meet orthopedic challenges and improve the surgeon and patient experience—quickly. This is typically accomplished using AM/3DP, especially for prototyping. With entry costs becoming much more affordable, even startups can jump in with creative and differentiating designs and grab a share of the market.
Also, data security continues to be a top regulatory concern, especially for “smart” devices that collect and transmit data. “With continued threats of security breaches, regulatory bodies will continue to keep a close eye on what companies are doing to be sure the security of their connected devices is up to date and the information secure,” said Stevens.
Now, more than ever before, the speed at which a product gets to market is as critical as the product quality. Product developers who have the greatest success are those that leverage manufacturing technologies beyond the prototyping phase, through production and product launch, minimizing the large capital investment before generating product sales. “Using digitally-enabled injection molding, CNC machining, 3D printing, or sheet metal fabrication technologies for low-volume production is key to getting to market faster and opening the opportunity to capture significant market share,” added Stevens. “Advancements in the digital process have allowed for lower costs without sacrificing quality, opening the door for use of low-volume tooling or bridge tooling to support regulatory and launch strategies.”
OEMs are always looking for innovative solutions at every stage of their product design and development needs—sometimes even pushing beyond the established limits of material and equipment performance. Because of staff, budget, or infrastructure limitations, more OEMs are outsourcing prototyping and design to contract manufacturers that are more experienced in using digital tools and methodologies. This is especially true for complex software such as 3DXpert or ADaM, an anatomical data mining product from Materialise. Software is also playing a key role in surgical planning to create very complex, patient-specific implants, guides, and instruments. Virtual reality or augmented reality tools can produce incredibly detailed models of the human anatomy, allowing designers to better understand the anatomical complexities and, thereby, create more effective orthopedic implants and tools that take these variations into account.
Medical device engineers must also design products to meet evolving regulatory requirements, “which have become very market specific,” noted Rodriguez. “For example, a few years ago, it was much easier to launch an orthopedic product internationally with a CE mark and follow shortly thereafter with a U.S. launch after the 510(k) clearance has been granted. This is not always the case today and many European countries have become as challenging as the U.S. for getting clearance.”
In addition, early in the design stage, product managers must plan for the regulatory markets in which their products will be sold. “This allows the product development team to work with international internal and external stakeholders to deliver a product into that market as soon as possible,” said Rodriguez. “For example, an anterior cruciate ligament fixation device requires vastly different testing to launch in Japan versus the U.S.”
Then, of course, there is the impact of COVID-19.
“Never before have we had a single large event that has reshaped the entire healthcare industry,” said Stevens. “The move to telehealth was forcefully adopted overnight, creating an entirely new segment that previously lacked traction and willingness to adopt. This rings true for any and all medical segments that are moving toward digitally-enabled devices and doctors.”
Ultimately, with the ravages of COVID-19, geopolitical issues, and trade wars, it has never been more evident that having deep digital manufacturing capabilities is absolutely essential for survival and quick adjustment to market forces. “As device manufacturers find new norms and work through a high level of uncertainty for what is to come, they will require highly flexible development teams and supply chains in order to win,” said Stevens.
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.