When products become more innovative, they also typically are more challenging to design and manufacture. Miniaturization especially is driving innovation today—the continual quest for smaller devices and implants that are stronger, more functional and often equipped with sensors or microelectronics, which must be manufactured to very high tolerances. Advances in 3-D computer-generated models and animation rapidly are leading to the development of smaller and more complex devices that could not have been made just a few years ago. Advances in prototyping and production technologies and best practices regarding prototyping/production flow allow for the rapid transition from drawings and models to fully functional prototypes. The speed that comes from being able to move quickly from prototype to production also helps ensure manufacturability and gain approvals more smoothly.
“We are focused on rapid prototyping approaches that incorporate fast-start, fast-fail and fast-improvement methods,” said Siddharth Desai, vice president of research and development and engineering for Pro-Dex Inc., an Irvine, Calif.-based designer, developer and manufacturer of powered surgical instruments primarily for the orthopedic market. “Fast start involves quick assessment of users’ unmet needs and rapid prototyping for evaluation. Fast fail implies that the early prototype represents an idea that will require further changes. Fast improvement means learning from the prototyping process and the improvements made from conception through prototyping. This iterative process enhances customer involvement through continuous feedback and rapid product refinement through the prototyping process.”
Rapid prototyping is not just for big orders, either. Technology has advanced enough with rapid prototyping and 3-D printing to drive down costs, making these processes more affordable—which then can make prototyping for smaller orders more feasible, with less financial risk if the product doesn’t make it to market.
“The use of rapid prototyping to support limited production has shown success and is projected to grow,” said Randy Calvert, director of sales and marketing for Infinity Plastics Group, a Mt. Vernon, Ind.-based custom plastics injection molder/contract manufacturer of medical device components and assemblies. “The ability to create parts from a CAD file, compared to investing in a steel injection mold, can be a very cost-effective alternative for the client.”
“We recently received a request for feasibility for a five-part run, followed by a good manufacturing practice-compliant process for the next 100 parts,” said Diwakar Ramanathan, business development manager for Resonetics, a Nashua, N.H.-based provider of laser micro-machined polymer components for the life-sciences industry. “This was practically unheard of just three to four years ago.”
Certain market segments especially are hot and well-funded for research and development.
“Novel new spinal treatments continue to attract venture capital funding,” said Patrick Pickerell, president of Peridot Corporation, a Pleasanton, Calif.-based medical device contract manufacturer. “Back injuries are the number-one lost-time injury in the country. Insurance companies are busy writing codes to underwrite the use of these procedures to decrease injured worker recovery time. Natural orifice surgeries are still hot. Trans-esophageal approaches to what were mostly laparoscopic procedures are beginning to hit the clinical cycle and will be ubiquitous in a few years. Gall bladder, gastrointestinal reflux disease and obesity treatments are all headed for natural-orifice procedures. This further drives the demand for smaller devices and components.”
Desai pointed out the key to successful product development is to fully understand the voice of the customer.
“While there may be several clinical opinions from key opinion leaders,” he said, “we tend to develop an 80-percent solution, meaning 80 percent of the general clinical population at large should be able to use the product.”
During early prototyping, Pro-Dex looks for initial functionality and conducts human factors (HF) analysis. Human factors are critical to the development of the product. The U.S. Food and Drug Administration also is focusing more on HF to minimize medical errors and expects medical device manufacturers to know human factors in their development processes.
“Human factors involvement is not simply a box to check in a product development and planning process,” added Desai. “It is an essential element of the early product development process.”
JunoPacific Inc., a Soquel, Calif.-based provider of product design, prototyping and volume manufacturing for medical device OEMs, increasingly is being asked by its customers to participate more in component and process design to create next-generation devices, or to assist with identification and implementation of cost reduction strategies. Recently a major medical OEM client asked the manufacturer to reduce the price point of a product by more than 50 percent due to competitive market pressures. JunoPacific engineers reviewed the entire manufacturing process and focused on the major cost drivers of the product.
“One of the drivers we identified was a lengthy manual step,” said Kern Bhugra, president of JunoPacific. “Alternatives were investigated, pilot studies designed and completed, and based on the data results the customer approved the recommended process change, which provided a dramatic cost reduction.”
The change involved replacing the manual step with a batch process that leveraged cryogenically deburring the parts with very specifically sized polycarbonate beads. This process adjustment, combined with other cost savings identified by the team, achieved the price reduction goals of the OEM.
Technology continuously is being refined—either by the equipment manufacturer or the prototyper and/or medical device manufacturer. New materials also can be a challenge to existing prototyping and production operations that have been considered standard for many years. The push for smaller components and devices also can unrealistically challenge manufacturability and R&D budgets.
“It’s easy to make one of something, but making a production part out of it is a different story,” said Scott Herbert, president of Rapidwerks Inc., a Pleasonton, Calif.-based precision micro-molder. “There are some companies that claim the smallest part in the world, but how valuable is that accomplishment if there is no production?” Dimensions that Rapidwerks can produce are as small as 0.100 x .004-inch rounded parts with .003-inch wall thickness and .002-inch spacing at a .050-inch depth or smaller.
Machining continues to adapt for smaller parts and features. Pickerell said that five- and seven-axis machining centers are coming down in price and becoming easier to program.
“The elimination of secondary operations by employing these multi-axis machines can improve quality and reduce costs by 20 to 50 percent,” he said. Pickerell also is considering investing in a direct metal laser sintering system for manufacturing 3-D printed implantable parts. “This process can create very complex 3-D shapes that would be impossible to machine otherwise,” he added. “As the process continues to develop I think we will see a wider range of applications for this technology in the near term.”
The rapid advance of minimally invasive surgical techniques also challenges traditional precision fabrication techniques and requires new technology and innovation—including lasers.
“For example,” said Pickerell, “emerging femto and pico lasers are being developed to create nanoscale holes and slots and other features these devices demand. This new class of laser equipment is very expensive and requires a much more skilled operator and programmer level compared to flashlamp-pulsed YAG systems. Similarly, in wire electrical discharge machining (EDM) work, we are seeing increasing demand for fine wire—for features as small as 0.1 mm. These features cannot be made with conventional ‘chip-based’ machining. Gone are the days when we had all five of our wire EDMs strung with the standard 0.25 mm diameter EDM wire.”
Resonetics provides a comprehensive applications laboratory that includes all the laser types used with polymers, including fluoropolymers such as perfluoronated ethylene-propylene copolymer (EFEP) and bioresorbable materials. “EFEP is a new ethylene tetrafluoroethylene (ETFE)-based fluoropolymer that is being worked on by various extruders,” said Ramanathan.
“Primary advantages appear to be excellent lubricity without the delamination concerns that polytetrafluoroethylene and ETFE have. We expect this material to be a great match for our ultrafast laser technology for drilling and cutting applications.”
Challenges for bioresorbable materials include the need to be stored and machined in an oxygen-deprived environment. In addition, localized and bulk heating of the material are much more deleterious because of loss of molecular weight and subsequent impact on the resorbable properties.
Other laser applications include selective removal of one layer from coextruded or multi-layer components, drilling/cutting/skiving polymer-coated metal braided shafts where both metal and polymer are laser machined with pristine edge quality and drilling tapered holes with precise profiles that provide different flow characteristics.
Laser welding ultra-miniature and dissimilar components also can be highly challenging, where the “art” often is in the work holding.
“For example, with our in-house tool-making capabilities we can make jig and fixture applications that allow us to laser-weld a 0.1 mm-diameter PTFE-coated wire to a 0.5 mm-thick titanium sheet for pacemaker applications,” said Pickerell.
Needle Specialty Products Corporation, a Boyle, Miss.-based medical device contract manufacturer that specializes in needle parts, is receiving more requests to prototype various types of ground tubing and wire with different types of point geometries, especially small length and small gauge cannula—a result of increased focus on smaller devices and less invasive procedures. The biggest production challenge this creates is process and part fixturing.
“We use specially designed fixturing that captures the parts in different manufacturing processes,” said Michael Belenchia, president and CEO of Needle Specialty Products (NSP). “As the parts get smaller, fixturing is not as readily available. We sometimes have to build fixturing, or substitute something for the appropriate fixturing, to make the R&D parts.”
Belenchia also pointed out that it is very costly to make special fixturing just to do a prototype run, without any assurances that the parts being prototyped will ever make it to production.
Being a Valued Partner
Over the last two years, several large OEMs with diverse product offerings, large customer bases and markets worldwide, have moved some of their needle product lines to Needle Specialty Products for manufacturing. After reviewing their products, NSP recommended changes to their current part requirements that will benefit the manufacturing process, or enhance the quality of the product.
“These customers have had supplier issues in the past with supply and quality,” said Belenchia. “The previous suppliers did not seem to know or feel it very important that these types of recommendations to the part/process requirements would allow for more efficient and consistent manufacturing and a higher-quality product. These changes also allow us to maintain a very tight rein on our costs and allow us to charge as little as possible to these customers for their products.”
Belenchia noted that more OEMs are looking for value-added partners whose services and high quality would allow OEMs to bring product back to the United States that currently is made overseas. “We may never be as cheaply priced as some of the non-domestic manufacturers, but our dependability, effective communication, shorter lead times, low-as-possible manufacturing costs and greater quality will bring more overseas product back to the United States,” he said.
ASI (formerly known as Advanced Scientifics Inc.), a Millersburg, Pa.-based contract manufacturer for the bio-pharmaceutical, medical device, diagnostic and drug-delivery markets, evaluates manufacturability and return on investment for all of its projects, including a careful evaluation of manual production versus automation. ASI conducts a detailed cost analysis to determine whether components or complete products should be manufactured through an automated system or a manual system.
“Our evaluation also includes U.S. production or offshore production and re-shoring products that are currently done overseas,” said Rudy Pavlik, product development manager for ASI. “We have delivered savings to our customers who have re-shored a product to ASI once the raw materials, taxes, shipping and quality have all been taken into account. With the rise in oversees shipping and current foreign taxes as well as potential future taxes, U.S. production is a very competitive or better option in many cases. Of course, whenever a product is manufactured closer to home, it can be monitored more closely, with prototypes done more quickly and speed to process often improved.”
Sometimes collaboration with a partner involves designing brand-new equipment to make production and commercialization a success. For example, a customer approached Resonetics regarding a complex embolic filter project.
“We needed to hold the part and maintain its structure while manipulating it spatially so that all surfaces were laser drilled with a consistent hole size,” said Ramanathan. “The main challenges were 80 percent material volume removal, plus or minus 10-micron tolerance, complex conical part geometry and a part that has a wall thickness of 0.0005 inches.”
Resonetics designed and patented an opto-mechanical system to move the part and control the laser with nine axes, which include X, Y, Z, theta, pitch and yaw. It also used a mask projection method to simultaneously drill more than 100 holes to keep the cost under control. The team also filled the part with a biocompatible material to help maintain the shape during the machining process and then removed it. Today the product is being produced in high volumes in a dedicated manufacturing cell in a Class 8 environment.
Investing in the Future
ASI continues to track and monitor every raw material and component necessary for production. The system is integrated from prototype/design phase to production, sterilization and delivery, allowing designers and engineers to anticipate raw materials in the early stages. Automated software and monitoring systems provide customers with extended production and quality information on their product each time it is produced.
“This greatly speeds up the production process because we often use raw materials from a large selection that we have already validated and have in stock during the early stages,” said Pavlik. “If approved, this takes us to production much more quickly. If a custom material is needed, we still do the rigorous testing and documentation; if it passes, we will stock a ready supply and regularly test the incoming materials against the quality documentation ensuring that the supply remains consistent to the validations/quality documents.”
Infinity Plastics has integrated a 3-D printer with its CAD system to better communicate manufacturability issues with its clients. This allows the design team to provide a physical demonstration of engineering changes that will strengthen the chance of production success without compromising design intent.
“If the prototype is to be used for limited production or for physical testing, there are newer technologies such as fused deposition modeling and PolyJet modeling that can mimic some production materials,” Calvert said. “We would recommend one of these technologies for creating a more robust prototype.”
Even though the ability to make money on prototyping is not as good or reliable as mature product lines, Needle Specialty Products has embraced the prototyping business because it gives the company a competitive edge in being able to manufacture the next grand discovery in the medical device industry—whatever it might be.
Rapidwerks has developed complex tooling for bioresorbable materials that can be leveraged across multiple applications, making the process fast and cost-effective for easy revisions.
“Bioresorbable materials are very sensitive to heat, moisture, and other factors,” said Herbert. “Because they degrade quickly, control and speed of process is critically important. Having a tool that produces a prototype, and can then be adapted to other revisions, or even be the production tool itself once the part is verified and functional, is a great production advantage. Because the tool that made the prototype also makes the production part, there is no additional validation required, which saves time and cost.”
“Most companies in our business shy away from prototype requests because of time, labor and technology required, combined with a lack of confidence that the products being prototyped will succeed moving forward,” said Belenchia. “We look at it as an opportunity to make money if we do it smartly and pick up enough of this type of work. If you can throw in some new idea or development during the R&D process that later benefits your current business or methods of manufacturing, you have profited.” The key, he added, is thoroughly understanding what the customer is trying to achieve, the environment in which the part will be used and the physical test specifications that will be enforced.
Prototyping and production solutions increasingly involve complex component designs and assembly processes, along with electronics. Desai noted that key considerations include:
Manufacturability—rapid prototyping is essential for determining material performance, tolerances, and assembly methods;
Sterilization—do the components and finished device meet steam sterilization and Sterrad sterilization requirements? Do these processes impact product function?
Electronics packaging—“Since we are dealing with small sizes and complex electronics, we have to develop a form factor that can be accommodated by our handpiece design,” Desai said.
Fiscal impact—conduct a thorough financial analysis to ensure the customer and the manufacturer will make satisfactory financial returns on the project.
Pro-Dex recently embarked on a project to develop a brand new system. The company conducted in-depth interviews to understand the clinical needs of the product and developed early prototypes with off-the-shelf components and in-house 3-D printing, machining and electronics design capabilities. After meeting with two key customers and demonstrating the early prototypes, there was enough enthusiasm to move forward and develop the next version of the prototypes.
“It took us a total of two months to develop the early stage prototypes and we are intending to develop the next-generation prototype in an additional two months, followed by the design control process,” said Desai.
Using the prototype as a way to “fail fast” and make iterative changes and improvements speeds the design and development process and allows companies to deliver a better end result to the OEM client.
“This focus on speed-to-market is key to our value-add and a major differentiator when it comes to promoting our services to the medical device market,” said Desai.
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at firstname.lastname@example.org.