Prototyping and production are now integrated to the point of beingseparate stages of the same discipline. Here is how medical deviceOEMs can leverage those trends.
Not long ago, prototyping and production for medical devices were considered two completely separate disciplines with equally separate equipment and processes. No longer. While some jobs still are performed the traditional way, an increasing number of prototyping projects are being done with an eye toward production. They may use production equipment and employ near-production-level detail.
The disciplines are becoming inextricably linked, and OEMs need to be able to partner with suppliers who can either perform both or understand how to seamlessly transition between the two.
“Many customers are looking for suppliers that can perform both prototyping and production with a high degree of expertise,” said Ken Lisk, president of Bridgeport, Conn.-based Lacey Manufacturing Co. LLC, a division of Precision Engineered Products LLC. “Past practice would generally involve prototyping at one source and then commercializing at another. Many customers have indicated the desire for both under one roof. If done effectively, this shortens the transfer from prototyping into production, as when products move toward commercialization, much of the product-specific knowledge is already in place. This also allows for prototyping to be done with a mind toward proposed production processes, thus shortening the manufacturing technology transfer.”
The linkage has become particularly important because of speed-to-market pressures in an uncertain economy, increased expectations from the U.S. Food and Drug Administration (FDA), and advances in technology that it is crucial to leverage.
“Speed-to-market concerns mean that OEMs want to ramp up as quickly as possible from prototyping to production. Some of the same technologies are now used for them; in the past, that was completely separate,” said Mike Adelstein, president of Potomac Photonics, a microfabrication company based in Lanham, Md. “We are often asked to do prototyping on production systems. Once you can validate that process, you can just keep it going. One of the first things device companies have to ask their suppliers is how can they take a device from prototyping to production, and do they have the capacity to do it.”
Economic and Market Pressures
Speed to market is one of the biggest concerns medical device makers have. There is a huge financial advantage to being first on the market, and every day off the market costs money. Any issues that can be resolved at the prototyping stage, and any features that can be transferred easily from the prototyping stage to the production stage, potentially can accelerate a device’s development time and get it into the hands of healthcare professionals more quickly.
“Prototyping schedules and associated product development are as challenging as ever. Speed to market with new ideas has always been a driver of market share,” said Lisk. “This does not mean an ‘at all expense’ mentality exists. Whereas that was formerly the case, the challenge to make prototypes closer to end use and more thought out are more related to advances in product development and prototyping technology.”
Of course, the uncertain economy has complicated matters. Prototyping and production schedules have been affected in some cases.
“Absolutely, the economy is affecting production schedules,” said Ken Fine, president of Proven Process Medical Devices, a Mansfield, Mass.-based contract research and development and manufacturing firm. “We have seen it in a number of areas. With emerging companies just getting into production, it is difficult for them to get enough funding, which is causing delays in when they actively start both production and sales and marketing. We have not seen that so much with bigger companies, other than that low-priority projects tend to get delayed when the economy is uncertain. But we see this turning around. Since late last fall, we are seeing the resumption of a lot of projects that had been delayed by our clients.”
The funding issues, however, have accelerated prototyping schedules, according to Fine.
“For emerging companies, their plans for prototyping have become highly accelerated compared to past years, because they need to make sure that they hit milestones and secure funds,” he said. “The bigger, more established companies have been prototyping much as they have in the past.”
David Yanes, director of equipment for Interface CatheterSolutions, a Laguna Niguel, Calif.-based vertically integrated provider of outsourced solutions for balloon catheter manufacturing, agreed.
“The bottom line is that every company is looking for shorter lead times to meet or hit key product milestones, start clinical trials, and get products to market faster than expectations,” he said. “However, this seems to be more of a standard practice or way of doing business than previously seen with a few key product lines for companies. Investment capital is more difficult to obtain unless a company can show product profitability and marketability trends in advance.”
The economy also is having an effect on the back end of the production process, says Dax Strohmeyer, president of Triangle Manufacturing Co. Inc., a precision engineering and contract manufacturing firm based in Upper Saddle River, N.J.
“From our perspective, the one major thing we see is the amount of attention device companies are paying to their inventory levels. They are a lot tighter,” he said. “They are keeping inventory levels down to improve cash flow. No one wants to have dollars tied up in inventory.”
You can’t get to market in the United States without the FDA giving the go-ahead, and the regulatory hurdles are higher than they were just a few years ago.
“FDA is clearly raising the bar,” says Strohmeyer. “We are being tested to our limits as far as what we can prove and validate. That speaks to getting a better product to the patients, and better quality of healthcare.”
This has led some OEMs and their outsourcing partners to accomplish more in the prototyping phase, so that FDA reviews won’t take as long.
“The biggest impact on production schedules other than financial issues are regulatory issues that delay the start of production longer than the client had planned,” said Fine. “Almost all of our clients that are regulated by FDA have had to wait longer than they wanted to start production. One of our customers has a Class III active implantable device. They had expected to start production lots by now, but have not yet received the go-ahead from FDA. It has been a six- to seven-month delay. Another customer with a Class II device just recently got cleared for production, but they had expected it about three or four months earlier. It’s a fairly consistent pattern.”
The FDA’s review cycle has been much more conservative recently than in past years, Fine explained.
“As a result, more established companies have been looking to confirm and verify proof of concept more thoroughly than they did in the past, so that they can be more efficient with their resources,” he said. “There have been more customers trying to verify on the prototype some of the more production-based characteristics of the product. They are trying to expedite regulatory submissions based on what they are verifying in the prototypes, versus what they would be verifying during pilot manufacturing.”
Strohmeyer agreed that FDA expectations have contributed greatly to changes in how prototyping has been done.
“There is more pressure being put on device companies by FDA to validate their processes and equipment. That means OEMs have started looking for suppliers who can team up with them to get involved in risk management,” he said. “There is definitely more interest in what we can do at the prototyping level than there was three or four years ago. A lot of prototypes have been looking more and more like a production product, because companies want more issues answered at earlier stages of development. So prototypes can become more expensive and complicated, depending on how you run your business. In between prototyping and production, there is the pre-production zone. That is where a lot of things have to be validated, prior to FDA inspectors coming in. In some cases, some things that were done there are now being done in prototyping, which then is no longer just about whether the product works.”
OEMs should not expect that the strategy of doing more at the prototyping stage will always work, though, Fine added.
“In my experience, this has not usually had the desired effect,” he said. “It’s a ‘pay me now or pay me later’ type of environment. Prototyping is an important tool for weeding out design flaws or concept flaws that would not have been observed until there was a physical representation of the product. But adding more expectations onto the prototyping process complicates the verification process, and creates more deviations or exemptions that need to be verified. And that leads to more discussions with regulatory bodies about more issues raised in the prototyping stage.”
What that means, Strohmeyer said, is that OEMs and suppliers must work closely together so that concerns can be addressed quickly and production delays can be minimized or prevented.
“When you get into pre-production, more OEMs want to have validated processes by that point, because they don’t want to be prohibited from going from pre-production to full production when they’re ready,” he said. “So a lot of that is more linked to what went on in the early stages of development than it ever was before. We do our best to help them streamline the process, by doing our homework up front and getting it right the first time. We engage our customers early on to draw out any potential pitfalls prior to casting anything. That way, once we get on to making components, we have it right. We go into prototyping with production in mind.”
One of the most compelling arguments for the closer integration of prototyping and production is that the technology to do so efficiently and cost-effectively now exists at a reasonable price.
“Expectations for prototyping jobs have changed based on advances in technology,” according to Lisk. “Instead of producing prototypes that are machined, there are many technologies that are fast, efficient and more closely mirror actual production techniques, thus allowing development engineers additional technological evaluation capabilities.”
Diversity of technological options is key to a more streamlined process. If a supplier has more technologies at its disposal, it is more likely to be able to produce prototypes quickly and make them look as close to a finished part as possible, said Kenny Mazzarese, director of balloon extrusion and balloons for Interface Catheter Solutions.
“Being a contract manufacturing company and having a wide variety of in-house capabilities, such as mold and die fabrication, provides for quick turnaround for prototyping and quicker time to production,” he said. “Also, having an extensive inventory of extrusion and balloon tooling allows for quick turnaround without sacrificing the quality.”
“There is now a broad range of technology available for use in prototyping, especially because their costs have continued to come down,” he said. “We take a hybrid approach, whereas before we just used lasers. We still use lasers for smaller parts that need tighter tolerances, but we also look at CNC and other technologies for other jobs. That allows us to produce at much tighter tolerances, even to the sub-micron level. It also allows for sub-micron-level positional accuracy on certain metals. All of this is becoming more cost-effective, so we can charge the customers less and they receive a lot more. It’s a win-win situation for everybody.”
Yanes said rapid prototyping and advance preparations for manufacturing a finished product are completed almost simultaneously.He works with customers on the design and prototype while developing the tooling and equipment to manufacture anticipated quantities in advance.“Prototypes are viewed as a manufactured or finished product with all necessary tooling, materials and sizing prepared in advance,” he said.
Better prototyping technology has contributed to better customer research, noted Fine.
“On the mechanical side, the cost of 3-D modeling and 3-D printers has come down,” he said. “That has allowed us to do more iterations earlier. On the software side, a variety of rapid prototyping programs are available now. That has accelerated our ability to do trial sets because we can do graphical user interfaces so fast. That means voice-of-the-customer research has become much easier. You can go out into the field with an attractive-looking user interface, which makes it easier to explain how the device is supposed to work. That research has also benefited from our ability to rapid-prototype complex electrical systems. That makes iterations faster and more professional looking.
That’s a big help in validating initial concepts.”
Advances in how prototyping is done also are enabling OEMs to make design changes faster, which ultimately can get the product to market sooner.
“Customers are looking for technology that enables them to make design changes quickly. Our customers are engineers, and they’re looking for a way to do this over the Internet, right at their desks,” Adelstein said. “That’s why we have set up an online toolbox for engineers. They can go on, experiment with designs right on the site, and upload drawings for us. They can get quick answers in a very seamless fashion. We have had a huge uptick in customers from overseas, especially Europe, and especially for electronics. Part of that is because we know have a way for engineers to sit at their console and design a product, then quickly come up with a plan for it, prototype it, and produce it. We can take that information and build it into a whole process, build it into the workflow. Now, you can submit something on the site, and get a prototype back within 48-72 hours, in some cases, even 24 hours.”
The increased use of direct metal laser sintering (DMLS) also has made the prototyping process more efficient, according to Tim Ruffner, vice president of new business development and marketing manager for Lake Bluff, Ill.-based GPI Prototype & Manufacturing Services Inc.
“DMLS has been a spectacular tool for designers and medical device companies. This is because the part can be created in just a matter of days to meet the exact needs for the customer,” he said. “A good example would be that DMLS offers a stainless steel called PH1, in which case can be hardened and solution annealed to be used in surgery. No longer do you have to do a plastic prototype and then move into production for one-offs. Now you can literally create a usable device in just a matter of days. This drastically reduces time and cost. I see more and more metal components used in surgery that are created with the DMLS technology. DMLS parts are not just for prototyping anymore, they can be used for custom surgical devices created in just a matter of days.”
Charles Griswold, project manager of Trinity Orthopedics LLC, a spine-focused company based in San Diego, Calif., and a customer of GPI, agreed.
“Direct metal laser sintering is a remarkable tool. It’s a way to obtain one-off metal parts in a week’s time,” he said. “They have had the technology since 1990, when I was in college, but it has become affordable and commonplace.”
DMLS also has been able to make prototyping jobs look more like production jobs, Ruffner added.
“Ever since the introduction of DMLS in the U.S., customers can now create a prototype in the actual metal used in production, and if the prototype works they can use that part as their part in surgery,” he said. “With additive manufacturing becoming the norm for highly geometric shapes and quick turns, it allows freedom of design.”
The same is true on the production side, according to Griswold.
“CNC machinery and rapid prototyping has reduced the cost and speed of fabrication. Smaller-volume production has really decreased in price, making many items affordable that were not once considered viable,” he said.
OEMs should make sure that their suppliers have the technology in place to reduce production cycle times or to streamline manufacturing, said Yanes. “Fast cycle times with immediate detailed visual and data reporting make the equipment ideal for production and research and development.”
Fisk says the use of the latest technology has been invaluable.
“Camera, robotics and high-speed processors have all advanced and impacted production jobs,” he said. “The rate of technological advance quickly brings the cost of effective technologies down into competitive ranges. In the interest of reducing labor content in order to compete, capital equipment using these advanced technologies has a shorter payback and positively impacts costs so as to remain competitive.”
Automation also is crucial to this process, according to Brett Freeman, vice president of operations, Providence Enterprise LLC, a Newport Beach, Calif.-based full-service contract designer and manufacturer.
“Even though we are in a low-cost country for production (China), increasing labor costs and requirements for improved efficiency have driven us to further invest in semi and full automation,” he said.
A Good Place to Start
In order for all of these advances to produce the desired result, however, OEMs and suppliers must work together early on to make sure that manufacturing issues are incorporated into the design process. If they are not, no amount of success with prototyping and production is going to get the product to market any faster.
“To achieve optimal results, you have to address issues early on and employ design for manufacturing,” said Strohmeyer. “We have an operations team that engages early on with clients to work on Lean concepts, Six Sigma issues, and so on. There are a lot of opportunities to get things as streamlined as they possibly can be before production is launched.”
Fine agreed. “OEMs are paying more attention to design for manufacturing, so as to reduce complexity and costs,” he added. “From our viewpoint, we are looking at the design phase as well as the production phase for things like automated assembly and testing, and waste-reduction processes.”
Ruffner said that engineers at OEMs have become more comfortable with taking prototyping and manufacturing technology into account early on.
“I would say that the demands for prototyping of medical devices have changed, mainly because the technology is getting better and designers are working closely with the technology in order to meet the demands,” he said. “For instance, in previous years you would have to create an SLA (stereolithography) part for fit, feel and function. Now, you can almost create the prototype in the exact material quickly and cost-effectively to meet the demands. Expectations do grow larger as the technology gains, most designers now look for parts to be right on tolerance or with a specific surface finish to meet their needs.”
Materials selection must be part of this process, said Andre Noronha, Interface’s director of medical extrusion sales.
“Medical extrusion-standard raw materials are purchased in advance and bulk to keep rising materials costs down and prevent pass-through to customers. More customers are now more likely to agree to contractual arrangements in order to lock in their product pricing,” he said.
It is at the early stages that OEMs need to consider all the technologies available to them for prototyping and production, said Adelstein.
“It’s important to look at technologies that machine differently and more efficiently,” he said. “We advise customers on what materials might be best for a particular job if they don’t have a list already. We have a list of what is biocompatible for which applications. That helps in prototyping and in design for manufacturing. There’s no sense to doing something in prototyping if you can’t do it cost-effectively in production.”
Erik Swain is a freelance writer based in Phillipsburg, N.J. He hascovered the medical device industry for 13 years.