Integrating Ideas

Integrating Ideas

New product development technologies advance speed,accuracy and performance.

Mark Crawford
Contributing Writer

Commercial success requires every piece of the puzzle to be in place. But even the best practices—supply chain management, compliance, and time to market—won’t really do much for your market share if the product isn’t solid. The best way to be a leader in your field is to have a fantastic product—one that meets the often-shifting needs of the highly demanding end user. Orthopedics is a relatively small marketplace, too; success or failure of a new device launch may be influenced greatly by the first positive or negative reviews that circulate through hospitals and physician practices. Physicians can be a finicky lot, often stuck in their ways and not prone to change.

Getting that next great idea before the competition often depends on maintaining a robust, cutting-edge product development practice. Having a go-to team in place (whether it is in house or outsourced) that can build and commercialize new products quickly as well as come up with the ideas, is critical to a company’s long-term success.

“Our goal is to partner with our customers for mutual success in the marketplace,” said Daniel Anderson, global manager of prototyping for Greatbatch Medical Inc., a designer and manufacturer of orthopedic implants, instruments and delivery systems in Warsaw, Ind. “We offer comprehensive and experienced skill sets to design, develop, and manufacture a full range of orthopedic devices.”

An increasing trend for orthopedic OEMs is to outsource the design and development of its new products, and even the idea-making, to trusted partners in order to reduce costs, streamline efficiencies, share risk, and focus more on business development.

“We find we are being asked by our clients to more fully integrate into their development processes,” said Peter Bayer, a product developmentengineer and project leader for Orchid Design, a contract orthopedic product development firm in Shelton, Conn. “We’re being asked more frequently to propose and complete full turnkey projects, in some cases to the extent that we train on our clients’ processes and perform all our work under their quality systems, including integration into their product data management (PDM) systems.”

As OEMs move more toward this kind of collaboration with preferred suppliers and manufacturers, they tend to let go of their in-house development staff through attrition and termination—once-vital employees who know everything about research and development (R&D). The upside is that these are “great opportunities for companies like ours to team up with former OEM employees with decades of experience and leverage their talents to serve our customers,” said Anderson.

What OEMs Want

With outsourcing, OEMs want to becertain the product development work is being done with high precision and accuracy in a compliant manner; the next priorities are quick turnaround time and speed to market. With these high expectations, most outsourcing is sent to well-established domestic partners, or more rarely to near-shore partners, where talent levels consistently are high, communication is immediate, and production facilities are easily accessible for visits and audits.

“Certainly, the greatest risk perceived by OEMs is the loss of visibility and control in a development project,” said Bayer. “The outsourced team is remote and not under the same control as an internal development team would be. We mitigate both the perception and reality of this risk by jointly setting clear roles and responsibilities, goals, and deliverables with our clients. We follow this up with responsive, open communication throughout the project, so that our clients aren’t left feeling out of the loop.”

Controlling cost is paramount to OEMs, which are under pressure from their customers to provide less-expensive (but higher-quality) products.

“A big trend in orthopedic R&D is efficiency,” said Laura Whitsitt, senior vice president of research and innovation for Smith & Nephew Inc.’s Orthopaedic Reconstruction and Trauma unit in Memphis, Tenn. “Many companies and R&D groups are looking for ways to reduce costs to the healthcare system.”

In order to do this, OEMs are placing greater emphasis on cost-effectiveness throughout the entire development cycle—design cost, prototyping cost and production cost.

“In the past,” Bayer said, “the focus was primarily on product innovation and secondarily on cost; lately these priorities have reversed. We work with clients to develop cost requirements as early as possible in the development process. Ideally we have cost goals in hand when we start concept development.”

Bayer noted that it’s not that cost control challenges are harder, but it raises the bar when your innovations take cost constraints into account. “Our innovations must be cost effective in order to have relevance and value for our clients,” he said. “It’s of no value to our client if we conceive a really slick and innovative instrument system with an estimated production cost of $10,000 per kit when our client’s instrumentation budget is $4,000 per kit. So, it’s not frustrating to innovate with cost inputs; it’s more rewarding in the end when you’ve successfully innovated while hitting cost targets.”

Demand in the orthopedic marketplace continues to increase for new and innovative spinal treatments.

“Minimally invasive treatments for spinal ailments are being showered with attention from the venture capital firms,” said Patrick Pickerell, president of Peridot Corporation, a medical device contract manufacturer in Pleasanton, Calif. “Large ortho OEMs are waiting on the fringes to gobble up those companies with promising clinical data. Interest is intense because back injuries are the number-one lost-time injury, so the insurance industry acceptance rate is high.”

Pickerell also indicated that, with the recent U.S. Food and Drug Administration (FDA) ruling that allows moderately obese individuals to qualify for stomach-reduction surgeries, bariatric companies are enjoying an infusion of funding. “Research is being conducted to develop new natural orifice transluminal surgery-based approaches to stomach reductions,” he added.

Another challenging trend for manufacturers is a preference for miniaturized devices, which are typically more complex, utilize advanced materials or unusual combinations of materials, and require higher tolerances. “The greatest challenge we face in R&D is the overall miniaturization of components in minimally invasive devices,” said Pickerell. “We are constantly forced to upgrade machinery and processes to handle the ever-shrinking sizes of parts.”

Mark Lowe, vice president of sensor business at Tekscan Inc., a manufacturer of tactile pressure and force measurement systems and sensors in Boston, Mass., observed that customers are asking for smaller, less-expensive sensors with more connection options.

“Now, in addition to the traditional pin connection, Tekscan is offering a lower-cost termination method to enable OEM customers to utilize a low-profile connection such as a ZIF (zero insertion force) connector,” he said. “It also allows easier connection directly to printed circuit boards and flex circuits via conductive epoxies, tapes or mechanical means.”

This provides more options to OEM customers for the design of smaller products, including portable, wearable medical devices such as drug delivery pumps.

“In these types of applications, space is at a premium,” said Lowe. “This new ZIF-compatible termination option provides more flexibility in such product designs, which cannot always accommodate the larger area required for pin connections.”

In order to provide this lower-cost alternate connection option to its OEM customers, Tekscan developed a more streamlined, lower-cost process that involves screen-printing the conductive adhesive during the actual manufacturing process.

“This was challenging to do as we had to incorporate improvements into our standard production process, as opposed to just adding in the process at the end,” said Lowe.

The traditional pin termination is still available to OEM customers who have more available space in their product for electronic connections. Pin connectors also can be an advantage when a product will be subjected to rougher handling conditions and a more secure connection to the board is required.

Meeting Customer Expectations

Many orthopedic manufacturers, especially startups, rely on companies such Orchid Design for R&D. They get involved up front with developing user needs by working with surgeons and planning the project and performing concept development.

“Concept development is one of the highest-value services we offer,” said Bayer. “Our concept development is a healthy mix of brainstorming, individual ideation, and simple and rapid prototyping. Lately we’ve been experimenting with the C-K (concept to knowledge) approach, which encourages early simple prototyping within concept development. Many times it’s proven very valuable for helping clients define the initial design and product requirements for a new product. It then makes it much easier and less risky to move into development.”

Customers also expect FDA compliance and having proper design controls in place. Design control is required by FDA—because the kinds of medical devices are so varied, the FDA has established the framework that manufacturers must use when developing and implementing design controls, but leaves the selection of the actual practices up to the OEM. This gives OEMs the flexibility they need to develop compliant design controls that are most appropriate for their own design and development processes.

However, some OEMs have too many steps in the process. “Larger OEMs are more and more sensitive to the possible consequences of not having proper design controls and there has been a tendency to react with overly complex product development processes that tend to slow product development to a non-competitive pace,” said Anderson.

Design control procedures consist of establishing a project core team, phases, testing, failure mode and effects analysis (FMEA) for design and process, and approvals at multiple stages.

“It is not really a complex process, but it’s not easy and it requires a lot of documentation,” added Anderson. “Unfortunately, the trend to overcomplicate the process makes it very difficult to move product development forward. The system we implement has all the necessary and critical elements, but is not so complicated. Our orthopedic team spent a considerable amount of time assembling a design control process that manages all the necessary phases—steps, testing and documentation—and nothing more.”

Acquiring this sort of advanced technology and processes requires significant capital investment. For example, Peridot has invested nearly $1 million in new state-of-the-art equipment in the current fiscal year to meet these growing research and development demands.

Last year, Greatbatch Medical opened its Technology Development Center. The facility is equipped with the latest rapid-prototyping technologies and continues to add expertise to its staff. As a result, the company has accepted new development projects in minimally invasive surgery, resurfacing, and lateral access spinal surgery.

“We are working with customers to accelerate their projects by providing proof of concept parts, test pieces, and items for verification,” said Anderson. “For example, a customer recently needed a metal prototype of a bone plate that had several threaded holes in it. It was a very small plate, about the size of a quarter, and the holes were only about 4 mm in diameter. We were able to produce the plates with enough thread to secure bone screws in less than two days, at a fraction of the cost of metal removal. Lead times for metal removal were about four to six weeks by comparison.”

Advanced Technologies

The orthopedic market continues to push for lower production costs and more speed in bringing new products to market. A good way to accomplish this is using the most advanced and efficient technologies available for prototyping and production. Two of the hottest trends in product development are using femtosecond laser technology and direct-metal fabrication (DMF) in the earliest stages of concept andproduct development.

Femtosecond laser technology uses ultra-short laser pulses that evaporate material from a workpiece before the heat can significantly penetrate the material. Essentially, this “cold” ablation process eliminates unwanted heat transfer to the part. The technique is extremely promising for high-precision procedures that require machining accuracy down to the nanometer scale. Femtosecond lasers are being used to form stents with smaller web widths and wall thicknesses, with very little secondary processing required. It works well with a variety of materials, including tantalum, precious metals, shape memory alloys, and bioabsorbable plastics, which tend to have low melting points and large heat affected zones, making them difficult to machine with traditional cutting lasers.

Also, due to the nonlinear absorption of light, the ultrashort pulse laser is ideal for marking optically transparent materials such as quart glass. Unlike other glass marking methods, femtosecond lasers do not induce microcracks, flaking, or unwanted material changes.

“Femtosecond lasers have finally become commercially viable at the job-shop level, but are quite expensive,” Pickerell told Orthopedic Design & Technology. This athermal laser technology is definitely changing stent manufacturing and polymer lasering in very interesting ways.”

DMF is a process that fuses metal particles together to build a part, rather than using standard metal removal processes to carve a part from a block of material.

“We use a DMF technology called direct-metal laser sintering that uses a laser to fuse metal powder into a part in 20-40 micron layer thicknesses,” said Anderson.

“Direct laser metal sintering is an additive process in which metal parts are built up layer by layer,” added Bayer. “It is conceptually similar to 3-D printing, but metal parts are produced with characteristics that are almost as good as machined parts.”

Laser-sintering allows medical designers to craft products from both metal and plastic that are custom-designed for doctors and patients using 3-D data generated by MRI, CT, or CAD.
DMLS-produced parts and instruments include surgical drill guides customized to reflect patient geometry, bone rasps, and stainless-steel surgical tools. Modern data preparation software is then used to program the DLMS equipment to create complex geometries, porous surfaces for osteointegration, and lightweight structures and implants. Researchers also are working with DMLS technology to produce customized PEEK implants.

Although DMLS is becoming more popular, the vast majority of orthopedic companies do not have the technology.“OEMs are beginning to understand the value of this technology beyond the obvious ability to just create show-and-tell parts,” said Anderson. “Instruments produced with DMLS are being reviewed in metal earlier in the process and are being tested in cadaver labs and, in some cases, live surgeries. Prototypes are generally critical-path items so DMLS provides an avenue to prototype faster and/or with more iteration in a given timeframe. Of course it varies by situation, but there are times when DMLS can produce a product overnight that would take days or weeks to produce with standard metal removal technologies. In product development, time is money—how much time and money depends on the customers’ needs.”

Being able to produce customized surgical devices that can be used on a case-by-case basis is a huge competitive edge for an orthopedic OEM. “What makes DMLS so great is a surgery can be scheduled and parts created and shipped within just a few days, unlike CNC which can take several weeks,” said Tim Ruffner, marketing manager for GPI Prototype & Manufacturing Services Inc., a Chicago, Ill.-based provider of prototyping and manufacturing services. “Parts are fully dense stainless steel and can be citrus passivated. DMLS can do complex geometries in just a few days that would be very difficult and time-consuming

to machine.”

“We’ve had good success with DMLS going beyond prototyping and have used it to fabricate clinical instruments that would have been difficult to make using conventional processes,” Bayer told ODT. “We’re actively exploring additive processes in general and it’s very interesting to see how they’re evolving from the prototyping phase into clinical production.”

Morris Technologies Inc. will file a 510(k) premarket notification with the FDA for the first-ever DMLS-generated titanium implant. The company, a Cincinnati, Ohio-based provider of fabrication processes, is in the final mechanical and biocompatible testing stages with a Ti 64 ELI implant and will submit its application this spring.

The new DMLS machine uses an argon atmosphere to run titanium grades Ti-64 and Ti64ELI. Ten months of test runs have produced complex geometries out of titanium powder for the aerospace andmedical industries.

“Yearly demand for laser-sintering services has increased and we expect interest in titanium parts to follow the same strong demand curve” said Greg Morris, CEO and chief operating officer ofMorris Technologies.

EOS, a global manufacturer of DMLS equipment, recently announced its new EOSINT M 280 system, which features a three-inch-taller Z height and an optional 400 watt laser, which improves surface finish and speed of the process. A big attraction with this system is that it laser-sinters aluminum, a first in the industry and a capability that companies have wanted

for years.

“The M 280 has a dual mode for nitrogen and argon atmosphere, so it can do all the alloys in one machine,” said Ruffner. “Previously a company had to have the M 270 extended or it couldn’t do all the materials. The dual mode is an option for older systems as well.”

So what does a DMLS cost and what is the estimated return on investment (ROI)?

Pricing is contingent on system configuration, the materials being processed and the nature of the application, among other factors.

“In addition to the DMLS you would also need additional items like electrical, temperature-controlled environment, materials, software, computers, vacuum, etc., which would bump your initial investment to about $750,000,” said Ruffner. “We specifically built two rooms for EOS machines and our total cost was around $1 million. Our ROI was a few years, but there is a three- to six-month learning curve that could extend thatROI for companies that have noDMLS experience.”

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 such as Kohler. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at [email protected].