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Strategic Advantage in Medical Contract Manufacturing

GUIDE TO OUTSOURCING: OUTSOURCING LANDSCAPE

Photo by iSTOCKPHOTO

The medical contract manufacturing industry has been in a period of heated evolution involving significant structural change. Over the last 15 years or so, consolidation driven by both private equity groups and strategic buyers has altered the competitive landscape. This process is far from complete.

In the face of these industry changes, suppliers have scrambled to redefine their businesses. Many companies have broadened their capabilities and associated business definitions into new messages of “one-stop shopping,” “full service,” and “total solutions.” Many focused-capability specialists have been acquired by contract manufacturers seeking to achieve breadth. This transition of the historic suppliers along with the influx of new entrants is creating a wealth of broad-line manufacturing generalists and reducing the number of focused-industry specialists.

The medical device industry is far from the first to undergo structural changes associated with an increasing shift toward contract manufacturing. Electronics, pharmaceuticals, and automotive all provide examples of how industry organization can change over time if vertically integrated original equipment manufacturers (OEMs) revise their approaches to focus more on product development and marketing than on manufacturing the products themselves. The causes for this evolution—such as OEM desire to focus on core competencies, reducing time to market, efficient utilization of capacity and access to specialized resources—have been well documented and are likely to continue for the near term.1,2

Similarly, two basic strategic frameworks provide insight into the competitive factors ultimately affecting the near-term and long-term competitive advantages of the industry's participants. To gain reasonable insight into where the industry may be headed, we can begin by examining the current state of the industry against Michael Porter's seminal work, Competitive Advantage, and associated strategy typology. We can also examine the more recent resource-based strategy theory to extrapolate the important factors required when determining long-term corporate strategy.3

Porter's Competitive Advantage

Michael Porter suggests that a firm may maximize its earning potential to achieve long-term competitive advantage by adopting one of three primary postures. The first option is to focus on becoming the low-cost producer for the industry through the use of scale advantages. Primarily, although not exclusively, by achieving a certain size, a firm should be able to spread overhead costs across its business portfolio, maintain lower unit-cost production processes not available to smaller firms, exert power over its suppliers to achieve lower purchased goods costs, and ultimately win business by using these scale advantages to provide customers with equivalent products at lower prices.

The second strategic option in Porter's framework is differentiation. Firms without low-cost production advantages may create long-term competitive advantage by producing products with distinction from others available in the market, typically with features and value beyond those offered by the low-cost producers. These players are typically smaller, catering to market subsets that value the products' features.

Figure 1. (click to enlarge) The evolution of medical device outsourcing.

Each of these two primary strategies can be matched with market focus, creating a third option. Firms may choose to focus on certain subsegments of the overall market in an effort either to enhance their differentiation or to aid in cost reduction. For example, Symmetry Medical is both focused upon the orthopedics subsegment of the device market and has worked to achieve a scale advantage in relation to its competitors. By contrast, Accellent is broadly focused, with scale as its primary differentiator. However, differentiation with or without focus necessarily implies specialization. For a firm's served market, this typically implies relatively smaller size to broad-line competitors. The combination of large low-cost producers and small differentiated players often leads to a barbell-like industry structure where being in the middle makes long-term success difficult. The representation of industry evolution in Figure 1 demonstrates this phenomenon.

Early-mover advantages in carving out market real estate should also be considered. Once a number of firms establish sufficient size and begin to occupy the larger broad-line positions, the opportunities for others to ascend to that level decrease. Not only are the consolidation plays reduced as smaller firms are absorbed by larger players, but also the relative lead that the large firms have makes it difficult to catch up.

There has been a great deal of change to industry organization in the medical device contract manufacturing industry over the last 15 years. Whereas 15 years ago it was difficult to find contract manufacturing firms with more than $100 million in revenue, today the industry has numerous players of that size and larger, and an increased population of companies between $50 million and $150 million.1 This has come from a combination of firm growth and industry consolidation.

Growth in the percentage of outsourced devices on top of growth in the device market itself has led to strong underlying economic trends and attracted much investment. Estimates for growth in the contract manufacturing market range around 15% per year as the percentage of outsourced products continues to climb.1 Private equity groups have been instrumental in building some of the industry's largest players and accelerating the restructuring of the playing field by changing the competitive order of magnitude. Notable examples of companies built through private equity capital include Accellent, Avail Medical (now part of Flextronics), The Orchid Group, Greatbatch, American Medical Instruments Holdings (now part of Angio­Tech), and Symmetry Medical.

However, not all of the investment and growth in firm size has come from the injection of outside capital. Some of the investment has come from internally generated returns from incumbent players that have sought to increase the size and scope of their operations through reinvestment. Businesses in this category represent the new mid-majors of the device manufacturing industry—not as large as the top-tier broad-line producers, but larger than the typical big players of 15 years prior.

Analyzing the current structure of the industry against the basic Porter framework, it seems clear that the evolution of the contract manufacturing competitive landscape is far from complete. Very large players like Accellent (~$490 million),4 Avail (~$250 million),5 Greatbatch (~$364 million),6 and Symmetry (~$293 million)4 appear positioned to become the low-cost producers of the future through the use of scale advantages. Symmetry currently has a commanding 70% share of the orthopedic OEM market for cases and trays, with a 24% share of instruments.7 Avail's scale allows the company to employ a global network of facilities, including low-cost production in Mexico and Asia, with 18 manufacturing sites and 3500 employees.5

As evidence of the cost-competitive nature and low-cost production destination, it is interesting that the larger companies operate on margins typically lower than historic industry norms. At the time of its sale to Flextronics, Avail's operating margins were estimated to be 4.5%.5 Accellent and Symmetry both have operated recently with EBITDA margins in the 16–18% range.4 Greatbatch's first quarter operating margin was recently estimated at 4.5%.6

But what about the rest of the industry? Take the mid-major group as an example. These businesses have recently broadened their messages to mirror the full-service, one-stop-shopping value proposition associated with the large companies. They now present a message to customers much more in line with that of Accellent or Avail.

But with relative sizes at an estimated 15–20% of Accellent in revenue (based on internal estimates and Accellent SEC disclosures), can the mid-majors succeed as generalists under the Porter framework? Can the mid-majors now view themselves as either headed toward being large players, or are they likely to be absorbed themselves by current industry giants? If Porter is right in his assertion about strategic typology, it is unlikely that companies that take a generalist path but that do not achieve the requisite scale will be able to build long-term competitive advantage.

Moreover, the number of mid-major generalists is growing. Riverside Partners' purchase of Accumet Laser, New England Precision Grinding (NEPG), J-Pac, and American Medical Instruments (AMI) appears headed toward the assembly of several dissimilar specialists into one broader mid-major generalist. While they have not publicly announced an overarching strategy and business definition for these companies, it is clear that for the previous specializations (NEPG in wire products, Accumet in laser processing, AMI in high-volume needle production, and J-Pac in packaging) to become unified, the message must get broader and thus more general.

Similarly, Kirtland Capital's investment in MicroGroup and the associated purchase of Bolt Industries appears headed toward the creation of another mid-major generalist. Where MicroGroup has long been associated with tubing supply and fabricated tubing components, Bolt Industries is certainly steps away from the definition. Even the declared acquisition focus of MicroGroup/Kirtland implies a further broadening of definition: “MicroGroup seeks to acquire companies that specialize in manufacturing components and subassemblies for medical device and analytical instrument customers that will broaden the company's current manufacturing capabilities or expand its geographic scope.”8

There are plenty of other examples, but the broader question relating to industry organization remains clear: If Porter is right about industry structure and competitive advantage, how many broad-line generalists will the industry support, and what will be the requisite scale for low-cost production as a competitive advantage?

Resource-Based Strategy

More recent than the Porter model, but also widely accepted as a strategy framework, is the resource-based view. In this framework, long-term competitive advantage of a firm is linked to whether the firm's resources are valuable, rare, inimitable, and nonsubstitutable. Resources refers to assets, capabilities, information, and knowledge under the firm's control.9 Basically put, the more enduring, valuable, and rare resources a firm has, the better the firm's long-term competitive advantage.

In the medical contract manufacturing world, resource rarity and resulting competitive advantages have changed substantially along with the industry in the last 15 years. Where business niches once existed for specific manufacturing capabilities, many of these capabilities have now become distributed and embedded in larger broad-line firms. For example, it was once possible for a firm to define itself around laser welding, medical packaging, injection molding, or stamping. These resources and capabilities are now widely distributed and are no longer rare or inimitable.

As medical device OEMs have decreased their appetite for purchasing manufacturing processes in a piecemeal fashion, the stand-alone manufacturing niches have also lost relevance. This OEM bias and its associated effect on industry structure was advanced notably by Andrew Kinross.10 Today, most of the large medical contract manufacturers either directly possess or at least control access to these capabilities, thereby making them no longer rare resources or sources of competitive advantage. This, of course, further fuels consolidation.

In the United States today, there are more than 700 stampers. That number is projected to drop by 50% through consolidation and industry rationalization.11 The manufacturing-capability-based resource advantages of the past are no longer as viable in the current environment. Resource-based advantages still exist, but they need to be rethought in the new customer and industry organization contexts.

Implications

Viewing the current state of the medical contract manufacturing industry through each of the strategy frameworks presented above leads to a few reasonably obvious conclusions.

The industry is not in its final and more-stable state of organization. In the long term—because of the need for fitting into one of the Porter strategy groups or based upon the decreasing rarity of historic resources—it is likely that generalists of varying sizes will not all be successful. Those that do achieve the size and scope required to be low-cost producers should find a permanent hold on market real estate.

The niches and specializations of tomorrow will be defined differently than those of the past, and with a few exceptions, they are unlikely to be rooted in basic manufacturing processes, which are now much more distributed.

The mid-major category is likely to be viable only while the industry sorts out its long-term structure. Companies without a differentiated focus, including scarce resources, and lacking the scales and scope of the large players should see increasing competitive pressure over time. They will neither have the cost positions of the scale players nor the focused resources of the specialists.

Companies seeking competitive advantage must either find new ways to define their businesses rooted in differentiated value for device OEMs or achieve sufficient size to become cost leaders. Developing a more evolved model of contract manufacturing is thus the primary challenge facing industry leaders. Forward-thinking business leaders in medical device manufacturing must think beyond total solutions to specific solutions. During the period when the industry is rapidly growing and opportunities are abundant, the underlying currents of industry reorganization will not be as pronounced. However, the long-term imperative remains. Those contract manufacturing specialists that succeed in identifying transformational value propositions have a compelling role to play in advancing medical device technology and healthcare. Those that do not will lose relevance and will face questionable long-term sustainability.

Peter Harris is CEO of Cadence Inc. (Staunton, VA). He can be reached at peter@specialtyblades.com.

 

References

1. BD Finn, A Strategic Review of Outsourced Manufacturing for Medical Devices (Boston: Covington Associates, 2007).

2. MB Houdek, Automotive OEM and Tier 1 Consolidation—Tip of the Iceberg (Farmington Hills, MI: Stout Risius Ross, 2003).

3. M Porter, Competitive Advantage (New York: Free Press, 1985).

4. H Reukauf, Accellent Research Report (Frankfurt: Deutsche Bank, 2008).

5. W Stein, Equity Research (Zurich: Credit Suisse, 2007).

6. J Mills, Equity Research (Vancouver: Can­accord Adams, 2008).

7. M Matson, Equity Research (Charlotte, NC: Wachovia Capital Markets, 2008).

8. Kirtland Capital Partners Web site [online], (Cleveland: Kirtland, 2008); available on the Internet: www.kirtlandcapital.com.

9. J Barney, “Firm Resources and Sustained Competitive Advantage,” Journal of Management 17, 99–120.

10. A Kinross, “As Outsourcing Increases, So Does Consolidation,” in the Guide to Outsourcing supplement to Medical Device & Diagnostic Industry 26, no 3.

11. Private Equity in the Automotive Sector (Amsterdam: KPMG, 2008).

Copyright ©2008 Medical Device & Diagnostic Industry

Fusion and the Future


The North American Spine Society (Burr Ridge, IL) describes fusion as a surgical technique in which one or more of the vertebrae of the spine are united together (fused) so that motion no longer occurs between them, thereby decreasing the pain at that segment. The concept of fusion is similar to that of industrial welding. However, spinal fusion surgery does not weld the vertebrae. The procedure uses bone grafts, with or without screws, plates, cages, or other devices. The bone grafts are placed around the problem area of the spine during surgery. As the body heals itself, the graft helps join the bones together.

Fusion does provide pain relief for many patients, but the procedure is not always successful. Back pain sometimes returns, and more than half of patients develop sciatica, a gnawing pain that runs from the lower back down the back of each leg.

While fusion currently remains the dominant surgical procedure for back pain, over time it is expected to gradually cede ground to less-invasive procedures and alternative movement preservation technologies, including disk arthroplasty (artificial disk replacement), bone graft substitutes, nucleus replacement, interspinous process spacers, posterior dynamic stabilization devices, percutaneous injection procedures (vertebroplasty and kyphoplasty), image-guided surgery, and others.

"While spinal fusion will always have a place, its share of the treatment market is expected to decline," says Patrick Driscoll, president of MedMarket Diligence (Foothill Ranch, CA). "Newer treatments such as total disk replacement and nuclear arthroplasty will erode the spinal fusion market, as these and other treatments which preserve spinal motion gain favor over the invasive and traumatic fusion of two or more spine segments."

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Experts Weigh In: Selecting the Right Surface Modification

Parylene coatings are used in a wide range of medical devices including stents, pacemakers, electrosurgical tools, and endoscopic seals. Collage courtesy of Specialty Coating Systems Inc.

When it comes to modifying the surface of a product, medical device firms have no shortage of choices. These include a number of materials that provide many different properties and perform a variety of functions. In addition to evaluating properties and performance, manufacturers must consider critical factors such as cost, application, and longevity before choosing a coating for their medical device.

Then there are the coating suppliers to consider. Do they provide access to a wide range of coating choices? Do they offer help in focusing on the right coating for a product? Can they meet tight production schedules? In this article, surface modification suppliers discuss coating options and key services offered by companies. They also offer advice on how to select a surface modification product, the right coating, and the right supplier for a device.

Coating Functions

When applied to medical devices, coatings perform a variety of important functions, notes Lonny Wolgemuth, medical market specialist for Specialty Coating Systems (Indianapolis).

Isolation and Insulation. Coatings can serve as a barrier that protects a device from its environment. For example, a coating can keep moisture, chemicals, and gases from contacting and damaging a device surface. It can also protect devices by providing thermal and dielectric insulation. Conversely, a coating barrier can protect the environment from a medical product. For instance, applying coatings to the rubber ends of syringe plungers prevents minute traces of metals that reside in the rubber from leaching out, Wolgemuth says.

Changing Surface Properties. Coatings can change a surface from hydrophobic to hydrophilic, or make a surface biocompatible so that a device won't cause harm in the body.

Keeping Device Materials in Place. Consider ferrites, which consist of iron powder that is compressed at very high temperatures and pressures to form a solid object. Coatings are applied to tie down stray metal particles from ferrite surfaces and thereby prevent them from interfering with the operation of medical devices, Wolgemuth says.

Cosmetic Improvement. Coatings can be used for decorative purposes, according to Margaret Palmer, president of Coatings2go LLC (Carlisle, MA).

Surface Modification Options

A sprayer from Boyd Coatings Research applies custom fluoropolymer coatings to a prototype medical part.

Major surface modification materials include polymers and elastomers. Metal coatings are used to make a surface conductive, improve resistance to radiation, and shield enclosure contents from radio-frequency signals. Chemically coating substances adds antibacterial properties to devices or can be used to release drugs in the bodies of patients.

Plasma etching modifies device surfaces and improves the adhesion of a coating to a device. During the process, gas ions bombard a smooth surface to make it rough. A number of different gases can be used to etch a surface, but the right choice depends on the material.

Plasma etching can also be used to coat a product, according to John Wood, a systems engineer for Plasma Etch Inc. (Carson City, NV). Only a few molecules deep, this type of coating is sometimes used to protect an underlying coat or to reduce stiction during manufacturing processes.

Selecting a Coating

There are many factors to consider before choosing a coating for a medical device. Some of the most important factors include the following considerations.

How Well Will the Coating Perform Its Intended Function? Although this might seem obvious, there is more to making such a decision than some people might realize. “Somebody might look at the properties of PTFE and say, ‘I want to use that to protect my instrument from sterilizing solutions,'” says Donald Garcia, president of Boyd Coatings Research Company, Inc. (Hudson, MA). “PTFE will withstand sterilizing solutions, but that particular coating is porous, so a sterilizing solution will go right through the coating and get to the manufacturer's instrument.”

Has the Coating Technology Been Used Before? Potential users need to know whether a coating is a new entity or whether it has a track record, according to Charles Olson, vice president and general manager of hydrophilic technologies for SurModics Inc. (Eden Prairie, MN). Specifically, device manufacturers need to know what types of products a coating has been used on and what experiences others have had with it. This information can reduce risk for users and help them get products to market faster, Olson says.

What Is the Expected Lifetime of the Device or Application? Will the coating be used on a disposable instrument or on a longer-lasting device? If the device is a disposable instrument that will only be used a few times, an immersion coating or a one-coat system may be most appropriate, says Tracey Sherman, president of Donwell Co. (Manchester, CT). If the device will be used repeatedly over a longer period of time, a two- or three-coat system with ceramic reinforcement might be the best choice, Sherman says.

How Does the Coating Affect Device Manufacturing? Olson points out that a coating might need to be removed from consideration if the materials and processing involved can't be integrated into a cost-effective manufacturing strategy. Device companies must also consider how much time it takes to apply and cure a coating because of the effect that these processes will have on production throughput.

Will the Coating Have Unintended Effects? For example, a coating might absorb light of certain wavelengths and thereby prevent a light-generating or light-receiving device from working properly, says Wolgemuth. It could also adversely affect the sensing ability of a transducer.

Hydrophilic coatings from Surface Labs reduce friction during insertion and removal of devices. Obtaining adhesion is often difficult with low-energy surfaces such as silicone.

What Are the Conditions during and after the Coating Process? Many coatings cure at temperatures ranging from 300° to 800°F, according to Sherman. Will a device be deformed or damaged when exposed to such high temperatures? For example, a PTFE coating might cure at 750°F, a temperature high enough to soften a thin aluminum part. On the other hand, some devices may operate at temperatures that are too high for a particular coating to survive, says Wolgemuth. Potential users need to know how much expansion and contraction a coating will experience as a device moves through its functional temperature range.

How Uniform Is the Coating? A coating might be thinner in one location on a device than another, which means it's less capable in some places than in others. Users of brush-on coatings have very little control over coating thickness, according to Wolgemuth.

What Are the Space and Design Constraints? If the fit is tight in a certain spot, there might not be enough room to apply a relatively thick coating. In addition, some coating processes can't be used with certain design configurations. “You can't apply a spray coating down a 1⁄8-in.-diameter hole that's 4 in. deep,” says Sherman. “You can't spray where you can't see.” In a case like this, an immersion process can apply certain fluoropolymer coatings.

What Are the Adhesion Characteristics? Will the coating adhere well to your device? Will the coating stick to itself, or will it start to flake off and disperse particulate?

What Sterilization Method Will Be Used? If the device must be sterilized, the coating must be able to handle the sterilization method that the device will undergo.

(click to enlarge)
Parylene coatings are applied via a vapor deposition process, in which components are coated in a vacuum chamber at ambient temperatures.

What Is the Supplier's Response Time? How long will it take a supplier to modify a standard coating to meet the company's needs? According to Palmer, a supplier's response time can be affected by the difficulty of a job, as well as its size. Large jobs sometimes take precedence over smaller ones.

What Does the Coating Cost? Palmer points out that a number of companies might be able to provide a coating that meets certain needs, but they should also provide it at an affordable price. Cost always comes up in discussions between Garcia and his customers. Sometimes it's a critical part of the discussion, so it must be considered when developing a coating. “I could have a coating that's the cat's meow, but it might cost more than the price of the customer's device,” says Garcia. In that case, a company might be able to change a feature of the device or component. Other cost-saving options include changing the tolerance or location of the coating application.

Advice on Coating Selection

When selecting the right coating for an application, top suppliers offer a number of suggestions. It helps to make a list of the pros and cons of the coatings under consideration, Wolgemuth says. In addition, question vendors closely about their coatings, suggests Wood. Even product-touting salespeople will start revealing “chinks in the armor” of their products if they talk long enough, he says.

Antiblocking coatings provide hard slick surfaces to eliminate product loss caused by tacky surfaces adhering to, or sliding against each other. Photo courtesy of Surface Labs.

It's also a good idea to find out about their track record, capabilities, and method of structuring business partnerships with customers, Olson advises. Think twice about doing business with companies that sell proprietary coatings that they claim only they can apply. “I would look to companies that give you the names of the coatings they're putting on, so you're not tied to one particular coater,” Sherman says. Several suppliers also caution device firms about putting too much emphasis on cost. “There's a tendency to overspend” on surface-modification technology, according to Wood. “I think it makes everybody feel better when they have the most expensive name. But sometimes the highest-cost option isn't the best one.”

On the other hand, some device firms gravitate toward the cheapest coating option. Such a coating might work well for a short time but then wear off. A supplier of inexpensive coatings could be “a financially unstable mom-and-pop shop that might not be there the next day,” Olson says. “It all comes back to risk. You can buy some very cheap coatings, but at the end of the day, you're going to see some [downsides] associated with them.”

Along with overemphasizing cost, there are other mistakes made by medical device companies when choosing coatings. According to Wolgemuth, one of these errors is selecting a coating that provides properties that a company is looking for, but not properties that are required by the application. For example, a medical firm might choose a coating that meets a biocompatibility requirement very well, but the coating can't withstand the abrasion that it will be subjected to when the device is in use. Sometimes coatings don't meet application requirements because a company chooses a coating that was used on another device for a different purpose or in a different environment.

This is just one reason that companies unwisely skip the process of investigating surface-modification alternatives for a new product. “I see a lot of people with something carved in stone that they have to use,” Wood says. “Maybe they read an article about it, or maybe a colleague from another company recommended it, and they're not willing to hear about any other options.”

This stent has a heparin-containing coating. The heparin, which is corrosive to steel, is often coated over a passivating primer to protect the steel struts. Heparin can be bonded or quick-releasing depending on its attachment method.

According to Palmer, success with a coating on a previous project sometimes prevents device manufacturers from considering all of the coating alternatives for a new project. In other cases, a contract holds a device manufacturer to a certain coating supplier, so only that supplier's coatings are considered for the company's new products. This can severely reduce the options. “Some coating suppliers have just a few coatings that they feel comfortable with, so no matter what your application is, you're going to get one of those,” says Garcia.

Options are limited when dealing with coating manufacturers, too, Sherman says. “They're going to tell you that their coating is the best,” he says. On the other hand, coating applicators also “look at coatings from many different manufacturers and pick the one that's best for a particular application.”

Help from Suppliers

Device firms can often count on suppliers for assistance in finding the right coatings for their products. Some coating jobs, however, are too small to interest certain suppliers.
“If you're going to sell 10 widgets a year and charge $10 each for them, there are probably suppliers that won't be interested in lending a hand,” Palmer says.

If suppliers are interested in a job, they can be helpful in many ways. “Usually, the client calls us, and either I or one of my senior engineers asks them what they want the coating to do,” Garcia says. “Then we take the properties the client wants and try to marry them to a coating that provides all of those properties. But sometimes clients can't get all the properties they want because of the nature of the [coating] materials.”

To prevent coating selection errors, the coating provider should ask its customers detailed questions before coating selection. “We have to ask these questions up front,” says Wolgemuth. Once coating suppliers have a good idea of a customer's requirements, they should be willing to coat some sample materials, parts, or devices to see whether the coating actually works. Suppliers can apply different coating thicknesses, formulations with slightly different performance characteristics, or entirely different coatings to substrates for evaluation. Samples are often exchanged a number of times between a coating supplier and a device manufacturer, as different coating options are tested, until the customer is finally satisfied. Suppliers can also produce data that show how its coatings compare with competing products.

Conclusion

Medical device companies have a range of choices when it comes to modifying the surface of a product. Not only are material properties important, but also factors such as cost, application, and longevity. It is essential to address all considerations before putting the coating on the product.

Copyright ©2008 Medical Device & Diagnostic Industry

12 Key Questions for Selecting a Supplier

GUIDE TO OUTSOURCING: SUPPLIER SELECTION


Device companies should look for suppliers with a medical manufacturing culture. Photo courtesy of The MedTech Group.

Few decisions are as important to medical device companies as the choice of an outsourcing supplier. These suppliers, which take on critical jobs once handled by OEMs, have both an immediate and long-lasting effect on the fortunes of their customers.

OEM-supplier relationships “tend to go on for a long time. When you choose a supplier, you're probably making a three- to five-year decision,” says Jeff Somple, president of northern operations for Mack Molding Co. (Arlington, VT).

So, how does a company choose the right outsourcing supplier? The keys to making a sound decision include understanding each of the following: the needs for a specific project, what work will be outsourced, and the suppliers vying for the job. How the selection process is developed and implemented are also crucial.

To help companies become better shoppers for outsourcing services, this article poses a dozen questions that should be answered before signing on with a supplier.

1. What Am I Looking For?

A company should define what is wants from a supplier, advises Dirk Smith, vice president of business development for Minnetronix Inc. (St. Paul, MN). The document can be as detailed as a request for proposal, or it can simply be a general statement of what the company expects from an outsourcing partner.

Once a company has a document stating its requirements, it can begin the search for a supplier. “Many companies say they do medical device design and manufacturing, but that can mean a lot of different things,” says Smith. “You have to do some work up front to narrow down your list of prospective outsourcing providers to those that actually do what you're looking for.”

After identifying a number of vendors, a company must find out which of them have the specific competencies required by the project, according to Bill Ellerkamp, CEO of ExtruMed (Placentia, CA). For example, the product may require a degree of tolerance control that can only be provided by certain suppliers.

2. What Phase Is the Project In?

According to Ellerkamp, there are four major factors to consider when evaluating a supplier—cost, quality, speed to market, and volume, or capacity. The importance of each of these factors depends on the phase in the product life cycle in which the supplier will be getting involved. Ellerkamp breaks up the product life cycle into the following five phases.

Design. At this stage, don't focus on a supplier's capacity or production cost. Instead, a company should be concerned about speed to market and how well the supplier can comply with quality requirements.

Development. Speed to market and quality is a primary concern at this stage. Cost is beginning to matter, but volume does not yet.

Manufacturing. Quality will probably jump to the top of the list. Cost and volume also become more important, but speed to market becomes less of a factor.

Maturity. At this point, the product's sales growth has probably peaked, and cost becomes the OEM's top concern. “When you've got two or three competing products on the market, it's all about who can sell the product at a lower price and still get a good margin out of it,” Ellerkamp says. Quality and volume remain important in the maturity phase.

End of Life. There's still enough of a market for the product to make it worthwhile to produce, but the OEM is no longer putting any focus on it. Although quality is still important, cost is now the major factor. Therefore, the OEM may be thinking about moving manufacturing offshore to cut costs even further. “Today, there are products on the market that may have reached the end-of-life stage 10 years ago but were moved to Mexico and found new life, because they're manufactured at a cost-competitive level,” says Ellerkamp.

Some integrated suppliers can handle all five phases of the product life cycle. There are also many suppliers that only assist OEMs in one phase. Therefore, products sometimes shift from one supplier to another as they move through their life cycles.

3. Who Will Size Up Suppliers?

Potential outsourcing partners should be evaluated by people from a number of different departments of the OEM's firm, advises Robert Scott, vice president of manufacturing operations and information technology for Possis Medical Inc. (Minneapolis). In addition to manufacturing, departments that should be represented during the selection of a manufacturing supplier include these four:

Engineering, the group that knows the product best.

Quality, the department that ensures that quality standards are achieved.

Documentation, that makes sure the document systems used by the OEM and the supplier are compatible.

Finance, the group that ensures any deal with the supplier is a sound financial move.

4. How's the Fit?

A view of a portion of Minnetronix's production floor.

Is a supplier a good fit for a particular job? To answer this question, the OEM must make judgments about several areas.

Experience. Has the supplier handled jobs like yours before? It's not necessary for a potential outsourcing partner to have experience with exactly the same type of product as yours, Smith says. Having experience with making devices that have the same level of complexity and are produced in the same types of volumes are more important considerations.

“If you've got a design and you're looking for someone that can build the device, I think it's more important to look for expertise in executing on manufacturing—and not necessarily expertise in the technology of an IV pump or whatever the product might be,” Smith says.

Volume. Does the supplier have the volume capabilities to handle the product when it goes into full production? If it can't, and this is discovered after the supplier has been given the job, the OEM is forced to switch suppliers. The OEM must then requalify the new supplier to meet FDA requirements, says Lonny Wolgemuth, medical market specialist for Specialty Coating Systems (Indianapolis).

In addition, the supplier must be able to handle any increases in volume requirements when necessary. John Grecco, senior designer for knee engineering for Stryker Orthopaedics (Mahwah, NJ), says his company expects its suppliers to be able to keep up with Stryker's growth.

Scope of Services. Smith says his company specializes in providing a complete package of services for medical device manufacturing. However, in some cases, “people come to us [and] want a module or component of a system, and they don't need our quality system and our complete documentation package,” says Smith. “So, we point out that we may not be the best fit for that type of project, because they don't need all of the services we provide.”

Assembling a combination product at Mack Molding.

Cultural. Make sure the corporate culture is in sync with that of a potential supplier, advises Somple. The OEM and supplier should have similar views on key matters such as corporate values and the treatment of employees.

Somple cites a case when four of his customer's engineers were basically living at Mack for the better part of six months. “In that kind of situation, they almost become a part of your team, and you become part of their team,” says Somple. “If your team directives are different—for example, if one group comes from a quality culture and the other comes from a profit culture—there are going to be some clashes.”

Good cultural fit is particularly important during a product launch, when decisions must be made as a team. “When you and your supplier are culturally the same or close to it, you're making decisions based on the same kind of criteria,” says Somple. “But if you're always arguing about what's most important, you find you're spending most of your time wrestling with each other rather than trying to solve problems.”

5. What Else Does the Supplier Bring to the Table?

Many attributes and capabilities can affect the performance of suppliers and the satisfaction of their customers.

Medical Expertise. According to Somple, medical device firms must make sure that potential suppliers understand process validation. The supplier's quality system is crucial as well. “You'll probably want your suppliers to adhere to ISO 13485,” he says. “That puts a lot of emphasis on recordkeeping and processes that suppliers don't necessarily have to do in normal day-to-day operation, but are required in the medical field.”

When a supplier focuses on the medical industry, “it engenders a culture,” explains Gil Reich, vice president of sales and marketing for The MedTech Group (South Plainfield, NJ). Medical device companies should look for suppliers with a medical manufacturing culture. “When you're talking about things like bioburden and pyrogenicity, you should be talking to a supplier that doesn't have to look those terms up in a dictionary,” Reich says.

Why is this important? When a supplier is focused on the medical industry, the OEM doesn't have to spend a lot of time bringing that supplier up to the standards of medical manufacturing, Reich says. For example, a medically focused manufacturing supplier will know that raw materials must have the proper certification and that devices must be made in a controlled environment with low bioburden.

Corporate Systems. What systems does the supplier use to govern how it conducts business? Examples include quality systems such as ISO 9001 and 13485, Ellerkamp notes.

Design and Development Capabilities. These include design for manufacturability and prototype production. “Since most [medical device firms] are instrument designers and marketing companies rather than manufacturers, they look for a company that can do up front development work,” says Frank Jankoski, director of technical services for Micro Medical Technologies (Somerset, NJ).

A Wide Range of Manufacturing Services. The more technologies and operations a single supplier can handle in-house, the less risk that is run by its customers, according to Chuck Edwards, executive vice president of Micro Medical. “If [a contract manufacturer] is buying five different components from five different suppliers and then putting them together to make an instrument, the chances of variability in those processes are much greater than if the manufacturer has the five different operations running in-house, where he has control over them.”

Using a single supplier with many manufacturing capabilities, makes things easier for OEMs when problems arise. Consider a situation where a medical device company is getting components from 10 different vendors and then putting them into a complex medical device. If a quality issue arises, it might not be easily traced back to its source. “Imagine the finger pointing that goes on between the 10 vendors,” says Al Carolonza, Micro Medical's director of marketing. If the company has all of the component manufacturing under one roof, any quality issue “is our problem, and the customer goes to one place to get it resolved,” says Carolonza.

A Special Wrinkle. Does the supplier have a unique capability that will give its customers a competitive advantage? For example, Carolonza points to a patented technology developed by his company that halved the cost of a component in a customer's instrument, thereby helping the instrument gain market share.

Long-Term Engineering Resources. Although OEMs pay plenty of attention to the engineering staff that a supplier initially assigns to the development and launch of a product, they also need to think about the future. “Who's going to be managing your project two years down the road?” asks Jankoski. “Does the supplier have a staff that's going to be working on continuous improvement? Often, I don't think medical device companies look at what the supplier's engineering staff will provide over the long term.”

Engineering Service Capability. Consider a manufacturing supplier that has the technical expertise to service its products during the warranty period.

Financial Stability. Unlike products in other industries that have launch times measured in months, it takes years to roll out medical products. Medical device companies need to know that their suppliers won't be going bankrupt in the middle of the lengthy process of getting their products to market. During that time, suppliers must have “the financial resources to invest in the people and everything else needed to make sure your product is successful,” says Somple.

6. How Was the Visit?

Suppliers can say anything over the phone or in a written questionnaire, so it's imperative for medical device firms to visit the facilities of the suppliers they're considering, Jankoski says. OEMs will see whether the facility is clean and well organized and whether the supplier is working on other medical devices.

Other things to look for during supplier visits include:

Prototype lab. If development work must be done, a company should see an actual prototype lab, not just a few scattered employees who are identified as people who work on prototypes, says Jankoski.
Validation package. This package, which includes device and design history records, shows that the supplier understands validation methods.

Your team. Somple suggests asking the supplier to identify the people who will be working on the project. This includes getting their resumes, if possible. “The team that's assigned to you can be just as important as the company you pick,” he says. “If the supplier assigns you the B or C team, you could be in a lot of trouble.”

Questions from the supplier. During a supplier visit, try to determine how well that supplier will listen while you're working together on a project. Although this can be hard to assess, meeting with the supplier's personnel can provide some clues. For example, are they quick to reach conclusions about the project? “I think technical people have a tendency to jump in and provide solutions, so it's important that they take a step back and ask questions,” Smith says.

7. What Did the References Say?

A chat with references can be a big help in assessing a supplier. “You want to go into this relationship knowing that you're not a guinea pig—that the supplier has worked on similar products and has been successful in helping get them to market,” Somple says.

Of course, suppliers will always provide their best references, Scott notes. “But surprisingly, we get good, frank information from some of them,” he says. He and his colleagues ask references a number of questions about their suppliers, including:

Did they provide on-time delivery?

Did they try to solve quality-related problems themselves, or did they bring the customer in on the solution? The latter is preferable. “If there are any quality issues that may be looming out there, you're not blindsided by them later on,” says Scott.

How did they handle pricing? Did the customer get a lowball estimate but end up paying more?

Do you know anyone else who used the supplier or anyone who may have had a bad experience with the firm?

Where do you think the supplier can improve? This question can elicit very honest feedback. “Everybody can improve somewhere,” says Scott. “If [the reference] doesn't come up with any place where the supplier can improve, you have to question the integrity of the person responding.”

8. Do You Want to Go Offshore?

Many factors go into the decision of whether to seek a supplier with offshore facilities, including the following:

Product volume and complexity. High-volume, low-complexity products are the best candidates for low-cost offshore manufacturing.

Product size. Big, bulky products are costly to ship.

Communications. There are natural communications hurdles that must be overcome when manufacturing is farmed out to foreign facilities.

Intellectual property (IP). Does production of your device involve valuable IP? IP protection can't be counted on in some countries, Scott says.

Market location. If all of the company's products manufactured outside the United States are manufactured in a certain country, it would be prudent to look for a supplier with a facility in that country, says Reich.

While offshore suppliers can slash manufacturing costs, local suppliers have advantages of their own. For example, Scott and his colleagues have enjoyed the convenience of having their manufacturing supplier close by. “We can just hop in the car and be there in a matter of minutes,” he says. “It's hard to oversell that.”

9. Is the Low Bidder Really the Best Option?

Many times, the process of picking a supplier is guided by price. Other important factors in making the selection “are often overlooked when people are under pressure to meet certain economic criteria,” Ellerkamp says. “It's easy to say, ‘I'm going with Supplier A rather than B, because A is $800,000 cheaper per year.'”

There are many reasons not to necessarily opt for the low bidder. In some cases, suppliers with low cost estimates don't provide all of the services required by projects, Smith says. They might assume that the customer will be handling some of these items, or they might have simply missed them.

Another possibility is that low-bidding suppliers will handle certain tasks but not bring them to the necessary level of completion. For instance, they might produce design documentation as agreed, but that documentation might not be suitable for inclusion in an FDA submission, Smith says.

10. Is the Supplier You're Looking For the One You've Already Got?

Edwards urges OEMs not to undervalue long-term relationships with outsourcing suppliers. “People at some companies are always looking for the next low-priced or sexy outsourcing supplier to come down the road,” he says. “It's a mistake for them not to develop these partnerships long term and make the outsourcing supplier an extension of themselves.”

Why? Once design teams are disbanded, Edwards says, the outsourcing supplier is often the only remaining link back to the early stages of a project. “So, if you have that supplier as a continuous part of the team, that tribal knowledge is maintained and grows over the years.”

In addition, there's a learning curve for a new supplier, resulting in mistakes that wouldn't have been made by a supplier that has previously worked with a company. “You don't want to keep changing suppliers for the same reason you don't change the jobs of your internal people every couple of years,” says Edwards. “Instead, you allow them to grow and learn and bring their accumulated knowledge to every new project.”

11. How Do You Evaluate All of the Information?

When all of the information about a group of potential suppliers is in, it's time to make a choice. In their effort to select the best supplier for a job, Scott and his colleagues weight the different factors that go into the decision. For example, is quality more important than experience or technical staffing capabilities? Is cultural fit as important or more important than quality?

However, Scott warns that these exercises can lead to overanalysis that renders a company unable to reach a decision. Although analytical tools and techniques are useful, “there will always be a certain inherent amount of intuitiveness that will drive you to your final decision,” Scott says.

12. Did You Take Enough Time to Make the Right Choice?

An informal product planning meeting near the production floor (photo from Minnetronix).

In the end, a company might still conclude that it isn't totally comfortable with any of the finalists. Nevertheless, it might feel obliged to choose one of them because of the time and effort invested in the selection process. In a case like this, however, Scott believes companies should resist the natural urge to bring the process to an end and declare, “We don't need to go with any of these companies. Let's look a little longer.”

OEMs might also feel it's necessary to choose a supplier relatively quickly in order to keep a project on schedule. These companies must remember the importance of making a good choice and the consequences of getting it wrong. “With all the documentation and validation involved, it's very hard to change horses in midstream,” Somple says. “So you have to take the extra time to make sure you pick the right horse at the beginning of the race.”

Conclusion

How do medical OEMs pick the right supplier? As we've seen, there's no easy answer to that question. But asking and answering the 12 key questions above should help medical firms identify their own needs and an outsourcing partner that can meet them.

Copyright ©2008 Medical Device & Diagnostic Industry

UV Micromachining: Shorter Pulses or Shorter Wavelength?

DPSS ultraviolet lasers are characterized by their compact platform and are now available with a choice of output wavelengths and pulse widths.

For manufacturers of medical devices, particularly disposables, pulsed all-solid-state ultraviolet lasers are the established tools of choice in many micromachining applications. The high reliability and compact size of these diode-pumped solid-state (DPSS) lasers enable systems tool builders and end-users alike to view the focused laser beam as just another high-precision tool piece, albeit with smaller dimensions than any other physical tool type. Current applications—which involve machining plastic, metal, ceramic, and glass substrates—range from drilling holes in catheters to machining stents and other tiny implants.

Until recently, the majority of these applications have been well serviced by widely available lasers with an output wavelength of 355 nm and a typical pulse duration of 40–60 nano­seconds or more. The need for increased miniaturization and the concomitant requirement for even better edge quality are now pushing the limits for these lasers. Superior resolution and edge quality can be achieved by switching to lasers with shorter wavelengths (266 nm), but this can increase processing costs in several ways. In many materials, similar results can be obtained simply by using a 355-nm laser with shorter (~20 nanoseconds) output pulses. Manufacturers need to understand the relationship between the process and the materials involved. This article discusses materials for which 266-nm lasers may be a better option, notwithstanding the higher-per-unit machining costs.

Micromachining: Pulsed UV Lasers


Sidebar:
Ultrafast Lasers: A Peek at the Future

The ultraviolet (UV) region of the spectrum encompasses wavelengths shorter than 400 nm. UV lasers offer two distinct advantages over longer-wavelength laser sources. The first is superior spatial resolution, i.e., tool size. The minimum spot size of a focused laser beam increases with wavelength and poor beam quality. Conversely, minimum spot size decreases with smaller wavelength and better beam quality. This spatial resolution is due to an inescapable optical effect called diffraction. Only perfect beams can be focused down to the theoretical limit. As a result, only UV lasers with high beam quality are capable of machining at the micron and submicron scale.

The second advantage of UV lasers is cold processing. Infrared and visible lasers machine materials solely by acting as an intense, highly localized spot of heat, essentially removing material by boiling it off. However, heat spreads, and this leads to unwanted peripheral thermal effects such as charring, melting, cracking, and the deposition of recast material. This is referred to as the heat-affected zone (HAZ).

In many plastics and some other nonmetals, UV light directly breaks molecular bonds. The process, called photo­ablation, is a relatively cold process that produces a very small HAZ, if at all. Photoablation enables the production of sharper, cleaner edges and the creation of tiny features that would be melted away by thermal processing.

Figure 1. (click to enlarge) Pulsed laser output delivers high peak power compared with the average laser power.

In laser micromachining, it is important to use a pulsed laser rather than a continuous-wave laser, because heat dissipation takes time. If the pulse width is shorter than the time it takes for the heat to dissipate into the surrounding material, most of the pulse energy causes photoablation, avoiding destructive cumulative heating effects. In addition, pulsed output maximizes the peak power for a given average power (see Figure 1).

The laser's processing power also depends on the peak power. Ideally, pulsed output means that most of the power is delivered above the processing threshold for the target material, with just a small amount of the laser pulse at a power level at which it only causes undesirable thermal effects. This benefit is maximized in specialized micromachining lasers in which the optics and electronics have been optimized to produce pulses with very fast rise and fall times (less than 20 nanoseconds).

Shorter Wavelengths or Shorter Pulses

The key to producing smaller features and clean edges in delicate and thin materials with focused laser beams is to limit thermal effects. Thermal effects can be limited by using a laser that produces short wavelengths and short pulses with high beam quality. As already stated, this need has been met for several years by lasers with an output wavelength of 355 nm and typical pulse duration of 40–60 nanoseconds. But to produce holes and slots smaller than 10 µm, or to produce cuts with very smooth edges, as with some stents, these lasers are not always the best option. Clean edges with minimized debris can also provide the benefit of not requiring postprocessing cleaning in some cases.

Figure 2. (click to enlarge) Longer wavelength lasers process material by a thermal mechanism, essentially boiling material. In the UV, lasers remove material by a mechanism called ablation in which the laser photons directly break the interatomic bonds in a relatively cold process.

Material removal with pulsed laser beams is caused by a combination of both thermal processing and photo­ablation. The latter becomes more dominant at shorter wavelengths (see Figure 2). Consequently, some applications have started to use a new generation of DPSS lasers with output in the deep UV, at 266 nm. The results can be excellent, but this approach is not without its drawbacks (see Figure 3).

Figure 3. Shorter wavelengths can deliver excellent results, but often at higher unit cost. This bioabsorbable stent has been machined on a ceramic mandrel with a 266-nm laser.

The 266-nm lasers are only available at power levels that are a fraction of their 355-nm predecessors. Throughput is generally slower, and applications are limited to very thin materials (i.e., 250 µm in ceramics and other hard materials, and 500 µm in plastics). In addition, the cost per watt is much higher, so the laser-cost-per-unit produced increases. And equally important is that some glasses start to absorb at this wavelength, requiring the use of silica beam-delivery and focusing lenses and lowering the lifetime of the entire beam-delivery system.

Extensive studies have shown that, in many materials, comparable results can be obtained by using a laser designed to produce shorter pulse widths with high beam quality. Specifically, our studies have found that at around a 20-nanosecond­ pulse width or lower, and an M2 lower than 1.3, peripheral thermal effects drop off significantly in these materials. M2 is the measure for beam quality; a perfect beam has an M2 of 1. The key is to have a reliable laser with such a short pulse width and high beam quality.

Although one way to get shorter pulse widths is to lower the pulse repetition rate, this would slow the throughput for many machining processes. Alternatively, shorter pulse widths can be reached by building a physically shorter laser in which the components are pushed much closer together. In addition, shorter pulse widths can be achieved by pumping more energy into the laser crystal. To do this while maintaining stable energy output is a simple adjustment for laser manufacturers.

Choosing the Optimal Laser for Specific Materials

The type of laser selected depends on the characteristics of the material being machined and the desired results such as hole size and edge quality. As a first requirement, successful micromachining of a material necessitates that the material efficiently absorbs light at the laser output wavelength. As a rule, successful micromachining requires that 50% of the laser pulse be completely absorbed within 0.1 µm depth below the surface.

a.
b.
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Figure 4. These Kapton samples were machined with (a) a 355-nm longer pulse laser, (b) a 266-nm laser, and (c) a 355 nm short-pulse laser.

Plastics. Several polymer materials commonly used in medical devices absorb strongly at 355 nm. A standout example is Kapton, which is an excellent candidate for a short-pulse 355-nm laser. Figure 4 shows typical results on identical Kapton samples that have been micromachined with a short-pulse 355-nm laser, a longer-pulse 355-nm laser, and a 266-nm laser. The economic 355-nm approach delivers indistinguishable results and would therefore be the best choice. Mylar absorbs less strongly, but the short-pulse 355-nm laser can still deliver almost the same results as a 266-nm laser (see Figure 5.)

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b.
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Figure 5. Mylar is a material used extensively in medical device fabrication. This figure shows the edge quality of Mylar cut using the same three lasers as Figure 4: (a) 355-nm long pulse laser, (b) 266 nm laser, and (c) 355-nm short pulse laser. Good-quality results are obtained with the 355-nm short-pulse laser, even with the lower absorption of Mylar with respect to Kapton.

With organic polymers, UV absorption depends on the bond structure. Materials with double bonds (such as Kapton) absorb at longer wavelengths, including 355 nm. The absorption of highly saturated polymers is limited to shorter wavelengths, so these would require a 266-nm laser.

The ultimate example is Teflon. The pure material is difficult to machine even at 266 nm. Fortunately, most medical device applications use Teflon with additives, and often these are colored additives with absorption even in the visible spectrum. In this case, the short-pulse 355-nm laser can deliver great results. The bottom line with Teflon is that the optimal laser choice strongly depends on what additives are present.

Metals. Most metals absorb 355-nm wavelengths quite well, so results with the short-pulse 355-nm laser are almost as good as with a 266-nm laser (see Figure 6). The fact that the 266-nm results are slightly better is probably due to the high thermal conductivity of metal negating some of the heat-reduction benefits of a short-pulse approach. In most cases, this marginal difference is not critical. Therefore, most metal-foil applications can be well serviced with a short-pulse 355-nm laser.

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b.
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Figure 6. Stainless steel is another commonly used material in medical device fabrication. Thin stainless steel and most other metals can be quickly and cleanly cut using UV lasers, the choice of which depends on the exact application at hand. Shown here is (a) 355-nm long pulse laser, (b) 266 nm laser, and (c) 355-nm short pulse laser.

Glass. Except for colored glass, most glass materials do not absorb much light at 355 nm. Consequently, these can only be machined successfully with a shorter-wavelength laser, and this often means a laser with a wavelength even shorter than 266 nm. An even better, although costlier, solution may be to use one of the new picosecond lasers.

Ceramics. Ceramics react similarly to metals in that they are hard materials. The thermal conductivity of metals is better than that of ceramics, and the nature of the ceramic bonding is nonmetallic, so chipping and cracking are potential problems for a ceramic. In any case, ceramics respond well to 355-nm laser light, and the shorter pulse length can greatly improve processing conditions. In addition, Emulsitone is frequently used to keep the process clean and can easily be washed off in a simple postlaser process.

Conclusion

Laser manufacturers, tool builders, and contract manufacturers continue to develop new tools and techniques to support the drive for increased miniaturization in medical devices. These developments focus on processing costs as well as processing results. The advent of short-pulse 355-nm lasers enables improved results in many applications without increasing unit costs.

However, these lasers are not a panacea for micromachining needs in this industry. It is vitally important to explore all possible options before committing to a particular processing strategy. A laser or system vendor can often test samples of your material in advance to establish optimal processing parameters that help meet target costs.

Ronald Schaeffer is CEO of Photo-Machining Inc. (Pelham, NH). He can be reached at rschaeffer@photomachining.com. Tobias Pflanz is product marketing manager at Coherent Inc. (Santa Clara, CA).

Copyright ©2008 Medical Device & Diagnostic Industry

Striking a Balance in Medical Molding

GUIDE TO OUTSOURCING: MOLDING


Developing complex medical devices requires a balance among design, quality and cost. Shown here are Grieshaber Revolution DSP microforceps and scissors from Alcon Grieshaber AG, which feature Makrolon polycarbonate.

Three basic issues usually play a dominant role in the molding of medical parts: design, quality, and cost. The design informs the functionality and aesthetics of the device and is often at the core of the device's competitive advantage. But design can also play a major role in molded part quality and cost. Design features influence factors such as mechanical performance, dimensional control, cosmetics, mold cost, and part moldability.

Part quality not only has a direct bearing on device performance and potential liability, but it can also influence the perception of device quality and consumer confidence in the brand—two critical qualifiers for medical parts. Quality requirements can restrict part design and add to molding and quality control costs. In addition, efforts to reduce costs are often at odds with efforts to maximize part performance and quality. Because design, quality, and cost are related, the optimal molded part must strike the best balance among the three.

Design

The term molded medical parts refers to a broad family of device components as diverse as tubing connectors, blood oxygenators, monitoring equipment housings, face masks, and home healthcare devices—each with its own design criteria and challenges. For example, aside from the need to withstand periodic disinfection, housings for monitoring equipment hardly differ in basic design functionality compared with housings for typical consumer products. As a result, standard design guidelines are typically easy to apply.

Unique medical applications, such as blood-contact devices, often place very specific and demanding limitations on the part geometry, and they can be much more difficult to design in accordance with good molding and design practices. Understandably, many design efforts focus primarily on functional performance, while molding and manufacturing considerations take a backseat. However, functionality optimization can drive designers to violate good design practice.

Part design guidelines, as published in resin supplier literature, are often established based on decades of molding observation and experience. Designs that adhere to such guidelines typically experience fewer molding problems, retain better material performance, and mold more efficiently. Common violations of design fundamentals in medical parts include nonuniform wall thickness, sharp corners, and inadequate draft.

Adhering to established design guidelines helps minimize molding problems for devices, such as the INJEX injection system from Rösch AG Medizintechnik.

Good molding practice calls for the nominal wall thickness of a part to vary no more than 25%. As thermoplastics cool and shrink in the mold, thinner wall sections tend to solidify first and undergo less shrinkage than sections with thicker walls. These varied solidification times and shrinkage levels create stresses within the part, particularly at the boundary between two thicknesses. Elevated stresses can reduce chemical resistance and mechanical performance and can lead to premature part failure.

Shrinkage-induced stresses along the boundaries of long thickness transitions can cause a component to warp and distort. Small, isolated areas of increased thickness can be difficult to pack during molding, and they may exhibit sinks or voids. This is especially true if the location of the thick feature and gate result in thin-to-thick filling, in which flow from the gate must pass through restrictive thin sections before reaching the thick feature. Process adjustments to correct thickness-related problems can narrow the processing window and lengthen the molding cycle time and cost. The common solution is to maintain a uniform wall thickness.

Sharp inside corners act as stress concentrators and can dramatically reduce mechanical properties such as impact strength and fatigue resistance. Polycarbonate, for example, is often chosen for its superior toughness and impact performance. To retain its toughness, design guidelines call for inside corners to have a 0.01-in. minimum radius, particularly for corners subjected to impact or fatigue loads. Drawings that call out a maximum permitted radius are insufficient because they allow the mold maker not to add a radius. When no radius is added, inside corners typically end up with a radius of 0.005 in. or less. The radius should be called out as a range, such as 0.010–0.015 in.

Draft is the angle or taper added to the mold steel to allow the part to be removed from the mold without excessive force or damage. Allowance for this draft must be incorporated into the part design. Inadequate draft can lower part quality and molding efficiency.

This cardiotomy reservoir from Jostra is molded of polycarbonate.

As the part is separated from the mold, dragging of the part surface along insufficiently drafted cores can induce surface stresses and lead to stress cracking during sterilization or in-use exposure to chemical agents and applied stresses. Ejection damage due to inadequate draft adds to scrap and quality control costs. In addition, steps to reduce ejection stresses, such as adjusting ejection speed, material, or cycle time, can increase part cost. From a performance standpoint, draft is often not desirable; but to facilitate efficient molding, provisions should be made for at least some small amount of draft.

Medical part molding presents design challenges beyond those covered by the standard guidelines. Core shift, weld joint design, and long-term loading issues, for example, are particularly problematic in medical design. Options to improve moldability are often overlooked because the costs associated with poor moldability are difficult to quantify. However, if the true costs were known, more-informed decisions could be made.

Quality

Quality priorities vary by application. Complex, fluid flow–based medical devices, such as blood oxygenators, pumps, and filters, rely heavily on design to achieve proper flow dynamics and performance efficiency. Quality efforts in such devices must include shape optimization. Tight tolerances may be more critical to function in other devices. Because appearance is often perceived to be a reflection of part or device quality, aesthetic attributes such as uniform gloss, clarity, fit, and finish can be important quality concerns.

The prevention of part failure stemming from issues such as mechanical loads, molding deficiencies, or environmental exposure is a priority for every molded medical part. Most medical devices also require part-to-part consistency and the absence of defects, however they may be defined.

Optimizing functional performance is at the heart of quality and design efforts for complex medical devices, and it can define the market position of a device in a competitive marketplace. Trying to attain peak performance can also place excessive strain on the molding and manufacturing processes to consistently produce parts and assemblies that meet other quality requirements. The result can be a high-performance device that fails to reach full business potential because of quality-related production costs and delays. Ideally, manufacturers should consider and anticipate potential quality problems at the earliest stages of product development when corrective adjustments are easier and cheaper to implement.

Quality problems first become apparent when concepts and ideas finally take form as molded parts. Because the problems show up during molding, molding is often erroneously identified as the cause of problems. As mentioned earlier, design choices can reduce moldability and introduce quality issues. Mold design and construction directly influence molded-part quality. A good mold produces parts to specification under normal production conditions, over a broad processing range, and over the intended life of the mold. Plastic can penetrate gaps between poorly fitting mold components and leave a thin web of unwanted material, called flash, along parting lines and mold lines. Likewise, inadequate wear management in moving components of the mold can lead to misalignment and flash.

Runner systems in multicavity molds need to be balanced to reduce cavity-to-cavity part variations. Hot runners can contribute to molding and quality problems if they are not designed appropriately for the material being used. Molded medical parts, especially transparent medical parts such as filter housings, syringes, and dialysis canisters, require hot-runner systems that are free of stagnant flow pockets where material can linger and degrade. High-temperature plastics such as polycarbonate work best with externally heated hot runners with flow channel diameters sized to avoid excessive pressure drop. Many potential quality problems can be avoided by soliciting input from various sources such as the molder, the hot-runner manufacturer, the quality control department, and the resin supplier.

Figure 1. (click to enlarge) The notched Izod impact strength (1⁄8 in. at 23°C) of selected medical materials.

Resin selection determines many of the key quality and performance characteristics of molded medical parts. Basic material characteristics, such as toughness, clarity, and shrink rate, are important for many medical devices. Mechanical toughness and impact resistance are also key material properties for many medical devices. Figure 1 shows the broad range of Izod impact performance for a variety of common medical plastics.

Plastics in many medical devices must also meet special medical criteria such as those related to biocompatibility, sterilization, and resistance to medical chemical agents. Biocompatibility testing is expensive and time-consuming, so it is often prudent to choose a resin grade with a proven history of biocompatibility. Compatibility with various sterilization methods is also important. For example, gamma sterilization tends to yellow or color-shift many plastics. For this reason, special medical grades of polycarbonate resin, for instance, have been developed that shift from a transparent purple tint to a pleasing smoked tint after sterilization. In addition to avoiding yellowing, the color change also can function as a quality control to identify those devices that have undergone gamma sterilization. Selection of the right material is critical to maintaining molded-part quality.

Figure 2. Viewed between polarizing filters, these center-gated polycarbonate samples reveal a birefringence pattern that can be used to calculate internal stress levels.

Excessive molded-in stresses can reduce material performance and lead to part failure. Experimental techniques, such as solvent stress testing and photoelastic strain measurement, provide ways to check relative stress levels in molded polycarbonate. In solvent stress testing, sample parts are immersed for a set time in solutions that have been calibrated to generate stress cracks when surface tensile stresses exceed a known stress threshold. Experience or experimentation dictates the maximum stress that the part may have to endure to avoid premature failure over the intended part life. The effects of annealing, a postmold heating method used to relax stresses in molded parts, are often verified with such testing. Photoelastic techniques take advantage of polycarbonate's tendency to exhibit double refraction when under stress. When viewed between polarizing filters, the part reveals color bands that can be interpreted to determine stress levels throughout the part (see Figure 2). Plastics that work with such techniques offer valuable tools for verifying material and molded-part quality.

Cost

Various direct and indirect costs contribute to the true cost of molded medical parts. The obvious direct cost is a molder's quoted piece price, which is largely influenced by a part's design and quality specifications. The part cost also includes components tied to material, mold, and molder costs. These elements can spawn indirect costs. Although often difficult to quantify, these indirect costs are real and often quite significant.

The direct cost contributors are relatively easy to identify. The part design determines the volume of material per part and the complexity and size of the mold cavity. It can also limit the material and molder options. As such, part design directly affects the material, mold, and molding components of cost. The molding resin cost per part represents a direct cost. Accountants may differ in the way they handle mold costs, but mold cost is really a direct cost that adds a fixed amount to the cost of every part. Molder direct costs include press rate and profit, as well as costs associated with quality control, material handling, and secondary operations. These easily quantified direct costs are the most common targets for cost reduction.

Indirect costs tend to result from interactions with other cost elements and are more difficult to isolate. Choices made in part design, material selection, mold design and construction, and molder selection can affect part quality and molding efficiency, which in turn affects part and device cost. For example, a plastic that exhibits low levels of molding shrinkage, short mold-cooling time, and compatibility with various welding and bonding methods (e.g., polycarbonate) can be more cost-effective overall than a cheaper plastic that molds less efficiently, incurs higher quality-related costs, and is more expensive to weld or bond (e.g., polypropylene). Additional money spent on improved mold quality, better mold cooling, and hot-runner systems can improve molding efficiencies and reduce overall part costs.

Orqis Medical Corp.'s Cancion system uses molded polycarbonate in key components, including the connectors pictured here.

Hot-runner systems, which deliver molten material directly to the part cavity, add to the initial mold cost. However, they eliminate regrind and scrap costs associated with conventional cold-runner systems. Mold cooling enhancements, such as high-conductivity inserts and cooling channel designs that closely conform to the part shape, add mold cost but can reduce the mold cycle time and reduce costs overall. Investment in a well-constructed mold can yield more parts over the life of a mold with fewer rejects and production delays. The cost-optimization process must consider not only the separate initial costs, but also the influence of the initial cost choices on the overall program cost over time.

Beyond such normal indirect costs are the more serious and less-tangible costs associated with the choices that influence medical part molding. The cost to cover warranty repairs or liability expenses, though difficult to predict, is easy to measure. Damage to the reputation of a product or company is much tougher to quantify, yet can be much more costly. In the medical industry, where the cost of failure is particularly high, a premium is placed on quality, reputation, and reliability. Cost-cutting measures that jeopardize these important attributes are risky. Failure to protect intellectual property can also be costly. A savings in mold or molding costs may not compensate for the loss of know-how or market edge.

Figure 3. (click to enlarge) Topology optimization software removed 11% of the material from this component while increasing stiffness in bending and torsion by 5% and 23%, respectively.

In medical device molding, it is usually wiser to cut molded-part costs in ways that do not sacrifice quality or productivity. Instead of substituting a cheaper, lower-performance molding resin, computer-aided engineering (CAE) methods can be used to optimize wall thickness and remove unneeded material (see Figure 3).

Part-design consolidation and standardization can reduce mold and assembly costs. Investments in high-quality molds with advanced mold cooling and hot-runner systems can cut costs by reducing cycle time and material usage, and such investments can also reduce quality-related costs. CAE simulation techniques can save money by optimizing the part and mold design and by correcting potential problems. Selecting a reputable medical molder with the proper facilities, molding equipment, inspection equipment, processing expertise, and quality control procedures can save money in the long run by reducing quality problems, downtime, and delayed deliveries. These kinds of cost savings can actually improve part quality.

Conclusion

Competition and pricing pressures make it increasingly important for molded medical parts to strike the best balance among design, quality, and cost. This is best accomplished when the relationships among the three are considered at all stages of part and design development. Too often, design elements progress one after another, with molding and fabrication considered late in the development process when opportunities to correct problems and optimize the system are limited. To prevent this, the first step should be to pull together a team knowledgeable in the capabilities, limitations, and costs associated with molding for medical devices. Such elements are critical to the performance, reliability, and manufacturability of a device.

In addition, manufacturers must pay attention to both the direct and indirect costs of molding. The goal should be to cut costs without sacrificing quality and productivity, which may involve investing more in one area to realize a greater savings overall. The greatest benefits are obtained with a big-picture team approach that focuses more on cost interactions and overall costs.

Mark Yeager is principal engineer for Bayer MaterialScience. He can be contacted at mark.yeager@bayerbms.com.

Copyright ©2008 Medical Device & Diagnostic Industry

Challenges to International Device Reimbursement

REIMBURSEMENT


Illustration by iSTOCKPHOTO

As the world grows smaller, national politics increasingly affect global healthcare economics. Although the medical device industry has boosted its international harmonization efforts, wide variation still exists with respect to healthcare reimbursement. Therefore, device companies must understand reimbursement schemes in their relevant geographic markets before making any significant investment in product development.

The goal of this article is to provide foundational knowledge for U.S. device companies for selecting markets in which product reimbursement will most likely be secured. It also aims to help OEMs craft a unified approach to international product marketing that addresses differing national requirements, particularly in Canada and within the European Union (EU).

The Government's Role

There are many nuances in the reimbursement schemes of the United States, Canada, and the EU. A thorough understanding begins with examining the government's role in each scheme.

United States. Although the United States does not provide public healthcare to all of its citizens, the federal government does provide qualified healthcare subsidies through Medicare and Medicaid. CMS is the agency responsible for oversight of those subsidies. CMS makes coverage decisions that dictate what will be reimbursed by the government, making it both a regulator and a purchaser of medical devices.

Private insurers responsible for reimbursement to most patients are not bound by CMS coverage decisions, but do not typically deviate from them without cause. Private payers often cover items not yet addressed by CMS, such as orphan drugs or new devices. Private payers also adjust their reimbursement rates more quickly. But because there are myriad private insurers, presenting a device for approval can be costly. Therefore, favorable CMS coverage decisions are critical to device companies regardless of whether government reimbursement applies. FDA and CMS are separate government agencies but each influences the other. For example, CMS is unlikely to reimburse a medical device that has not been approved through FDA.

Table I. (click to enlarge) Reimbursement coding systems.

According to CMS, healthcare insurers process more than 5 billion claims for payment each year. The agency uses standardized coding systems to help process these claims. Coding is used to translate the various care settings for medical device use into the language necessary for payment. The U.S. reimbursement scheme is based on the Healthcare Common Procedure Coding System (HCPCS) that CMS derives from broader systems provided by other organizations (see Table I). Manufacturers should know under which category they want their devices to be coded for greatest return before approaching FDA. If no 510(k) is possible, the manufacturer should make the strongest case possible for having its device fit into an existing code for similar devices. The alternative is creating a new code, which is time-consuming and more expensive.

CMS also considers several variables that FDA does not apply. The greater the patient need, the more likely it is that CMS would cover the device. It's important to note that FDA only validates the safety and efficacy, not the medical necessity, of the device. CMS views that necessity as reduced if other products are similarly effective, or if the magnitude of the potential benefit is otherwise diminished. CMS uses its Level II codes to cover those items not included in ICD-9. CMS has yet to adopt ICD-10, which lists many of the Level II procedures.

Table II. (click to enlarge) Canadian healthcare plans listed by province.

Canada. Canada's healthcare system is based on universal publicly funded health insurance. The country uses a Beveridge system, which usually involves funding through taxation and payment distribution by the taxing government. The system is defined by the Canada Health Act (CHA). CHA provides for allocations of funds to Canada's provinces, each of which uses the money to set up healthcare payment systems for its citizens (see Table II).

Table III. (click to enlarge) Example health service codes and reimbursements.

Provincial insurance systems established under CHA provide service-based reimbursement. Each province sets up a unique classification of services, and each service is given a code that corresponds to a payment amount that healthcare providers and patients can use to make individual decisions. Table III shows some examples. Definitions of each component are provided by the respective provincial system. Medical devices are reimbursed according to how the procedure and indication are coded. The coding is determined by each system based on approval information provided by Health Canada, the agency responsible for market approval. It is then up to the individual physician or hospital to determine whether reimbursement, and the profit margin created for performing a given procedure, justifies performance of that procedure.

Europe. Classification is the first step in determining how primary payers are reimbursed in the EU. But the EU's reimbursement landscape is difficult to navigate, mostly because the community is not fully harmonized. Influence from within the EU comes from the national Health Technology Assessment agencies of its member states, which are charged with promoting cost-effective technologies and eliminating harmful or ineffective interventions from the marketplace. The agencies are further organized into the European Network for Health Technology Assessment to facilitate information sharing and harmonization.

Because the EU treaty proviso stipulates that the community must respect the national rights of members regarding healthcare, there is tension between harmonization and respect for national rights. EU countries continue to offer tax-based public insurance at different rates based on individual government schemes.

The 27 EU member nations have independent control over pricing as well as different health payment systems. Almost all of the member countries have implemented evidence-based medicine, which requires medical device companies to demonstrate the safety and efficacy of each device prior to approval. In theory, all EU member states are equal, so achieving approval in one member state should provide access to other markets. In reality, however, each country's institutional arrangements for pricing, market access, and enforcement are different.

OEMs that want to sell their medical devices in Europe need to go through the same regulatory processes as non-OEM device companies in the region. The process starts with selecting a notified body of their choice—an organization that certifies devices for the EU based on national compliance assessments. Products in compliance are then identified by CE marking. Most countries have at least one or two fully independent notified bodies.

In addition, if an OEM chooses to outsource and intends to market and sell a medical device in Europe, it must take responsibility for the regulatory requirements and collect all of the appropriate documentation from the contract manufacturer for submittal to the proper agency.

The Role of Nonpublic Sources

The health payment systems of Europe and Canada are often considered national health systems with a single payer: the Ministry of Health. However, most of the countries have supplemental private insurance industries, and how each country operates in such a system varies widely. In the UK, for instance, about 80% of healthcare funding comes from general taxation, with 20% coming from other sources.1 The Italian National Health Service, by contrast, bears the cost of a declining percentage of total healthcare in Italy, with about 40% of payments now coming from nonpublic sources.2 In Canada, a robust private insurance market exists alongside public healthcare, with employers providing supplemental coverage for about 42% of all Canadian employees.1

In Europe, there are a number of payment sources for medical care in addition to public insurance. One major source is private healthcare insurance, but citizens may also establish third-party indemnity insurance with specific payment structures. Independent providers of benefits-in-kind also exist, allowing individuals to tailor policies to suit their needs.

There are other insurance entities in Europe that manage groups of providers, and these organizations offer reimbursement for services falling within the spectrum of provider expertise for the plan. This presents a challenge for a company trying to determine where to market a medical device in Europe, because each type of payer has different reimbursement schedules. For example, Luxembourg, France, and Belgium use the Bismarckian model. Under this model, payments are made by public insurance and third-party indemnity payers. Germany and The Netherlands also follow a Bismarckian approach, with third-party payers providing structured indemnity insurance as well as benefits-in-kind.

Global Strategy Development

It is critical to know whether payers will cover a new product and at what rate, so manufacturers must develop a reimbursement strategy very early. If the product is not covered, there is essentially no accessible market, because patients generally are not willing to absorb the high costs of devices and associated procedures personally. The most efficient way to approach global marketing of medical devices is to identify areas of commonality among international regulations and reimbursement criteria. Firms should bring products into conformity with those regulations and criteria and subsequently prioritize markets of interest and approach the applicable market nuances case by case.

Regulatory Classifications. Regulatory approval does not guarantee reimbursement. However, the classification of devices by the appropriate national agency is typically factored into reimbursement decisions by the applicable payers. In the United States, FDA classifications affect CMS coding and subsequent payments made for devices. Similarly, classification by Health Canada affects how products fit into provincial payment structures. In Europe, the challenge of guiding classification is exacerbated by multiple-agency participation.

Medical devices are classified by the Organization for Economic Cooperation and Development (OECD), an international organization including EU nations as well as countries outside of Europe, including the United States. But devices are also classified by national agencies. The UK utilizes a Medical Device Agency; France has the Health Care Product Safety Agency; and Germany has the Federal Institute of Medicinal Products and Medical Devices. The UK has also launched the National Institute of Clinical Excellence at the University of Birmingham to evaluate new and innovative technologies. In France and Germany, such national agencies not only review the clinical trials, but also set the prices, which affects the percentage of devices and procedures that are covered by the government or other payers.

Primary and Secondary Payer Effects. Negotiations in countries with public insurance are more political in nature than they are in the United States. Tax revenue determines the healthcare appropriations in each country. Residents of each country want the best possible public health insurance, but they also want to keep the highest possible percentage of their earned income. Therefore, tax payments and subsequent healthcare appropriations are ultimately dictated by prevailing view of the polity. In socialized countries, a device firm must determine whether the current trend is driving reimbursement to public or private insurance. It must look to the applicable government or insurance market practices to see how payment structures are determined and how payments can be negotiated.

Government-approved reimbursement often requires lengthy negotiations. For example, in France, if a device company's sales exceed the agreed-upon volume, the negotiation process is reopened and the product prices are further reduced.

In Spain, the government determines product prices, and reimbursement negotiations can take two to four years. Prices in Spain are based on innovativeness, profits, the amount of domestic research and development, volume and value of sales, manufacturing and marketing costs, and international price comparisons.

In Italy, products must first be registered, and then may be priced freely unless reimbursement is sought through the Italian National Health Service. Again, negotiations for reimbursement can be lengthy, and price is based on many factors, including a price comparison with at least four other European nations.

The UK boasts the fastest average time to market for medical devices following regulatory approval. It is probably the best place to begin marketing in Europe for companies located outside the EU. The government occasionally institutes across-the-board price cuts, but reimbursement prices are usually granted quickly.

Germany's Future Model. Germany is one of the leading high-tech countries of the EU. It converted to a diagnosis-related group (DRG) hospital care reimbursement system for medical device procedures fairly recently. Until 2000, Germany had a more traditional per diem reimbursement system; hospitals were reimbursed for long hospital stays to compensate for high-priced, innovative medical devices. Under the DRG system, however, the main push is to reduce the length of hospital stays, and all reimbursements are done via a catalog of diagnoses maintained by the German Health Technology Assessment (HTA) agency. If a device is not listed, the hospital may not be reimbursed if it chooses to use the new technology.

This new system has had an unexpected backlash for innovative medical devices. Unlike pharmaceuticals, which undergo extensive, long-term clinical trials, usually through a double-blind study, medical devices are often marketed after just two to four years of clinical trials. The number of patients involved in device clinical trials is much smaller, and it is often impossible for the patient and physician not to know a new medical device is being used.

In addition, some new medical devices are so superior to previous technologies that denying use of them seems unethical. HTA, which demands large clinical trials, double-blind randomized clinical results, and a number of high-quality published studies, often will not approve high-priced innovative medical devices, and thus the technology is not available within the approved catalog.


Read more articles from Scott Lloyd here.

Over the next five years, Germany hopes to develop a reward system in which it provides incentives for high-risk devices to speed their introduction to the market. One incentive may be supplemental reimbursements. The country may also change the reimbursement rules at research hospitals, where expensive, innovative medical devices are usually first used. Overall, its plan is to further simplify the entire system, making it easier for hospitals to use new technologies. If Germany is successful, similar systems may emerge in other EU nations—a point of consideration for manufacturers of cutting-edge devices.

Conclusion

There is no solitary approach to ensure reimbursement for medical device technology internationally, but best practices should include centralized information management and guidance through the various national government and insurance schemes. OEMs should use this information to identify markets in which reimbursement will be most readily secured, or where it will be most likely to influence other markets, and start the reimbursement process there.

Scott Lloyd, Clarence Mayott III, PhD, Deborah Schenberger, PhD, Perry De Fazio, and Jerry Burke are analysts at Nerac Inc. (Tolland, CT). Contact them at slloyd@nerac.com, cmayott@nerac.com, cmayott@nerac.comdschenberger@nerac.com, pdefazio@nerac.com, and jburke@nerac.com, respectively.

References

1. C Jommi et al., “New Funding Arrangements in the Italian National Health Service,” International Journal of Health Planning Management 16 (2001): 347–368.

2. J Munn et al., “Single-Payer Health Care Systems: Roles and Responsibilities of the Public and Private Sectors,” Benefits Quarterly Q3 (2007): 7–16.

Copyright ©2008 Medical Device & Diagnostic Industry

Automated Testing for Real-Time Embedded Medical Systems

GUIDE TO OUTSOURCING: TESTING

Medical device companies, especially those with real-time embedded-system products, are often burdened with lengthy verification cycles. Even small development efforts can result in months of verification. There are numerous reasons for such extended verification efforts, but chief among these are

  • Complexity due to permutations of input or system configuration.
  • Complexity due to the system environment or system setup required for testing.
  • The number of external system possibilities for connectivity and interoperability.
  • A reliance on manual execution of tests for all aspects of verification (e.g., functional testing and system behavior testing).
  • A lack of support for test automation in the product itself (e.g., the absence of hooks or callable application programming interfaces (APIs) necessary for the scripts or code that drive automation).

Manual testing is time-consuming and error prone, with functional and system testing that starts late in the software development cycle. Relying on manual testing alone can increase the risk of late defect discovery and often leads to delays in product release. A lack of test automation can also cause delays in manufacturing and support.

Although there are proven automated test tools and techniques for unit and integration testing, most medical device companies have yet to embrace an overall automated testing strategy for embedded real-time devices. These firms must understand the challenges of testing embedded real-time medical systems and examine strategies to improve quality and reduce verification cycle time and costs.

Embedded systems come in many variations, but in general they share the following characteristics:

  • Special-purpose control logic, designed to support a few dedicated functions.
  • Part of a complete device including electrical and mechanical parts.
  • Varying complexity, from a single microcontroller to multiple processors, units, and peripherals.
  • An optional user interface and connectivity with external systems.

These characteristics differ from a general-purpose computing platform, like a desktop or enterprise system, which can perform multiple functions depending only on programming. However, many test automation approaches for general computing can be applied to real-time embedded systems. These approaches include determining which testing to automate, demonstrating a return on investment (ROI) to gain management buy-in, formulating the automation strategy, and identifying test tools needed. The approaches also include constructing the test framework and addressing regulatory requirements.

Embedded systems do present some unique testing challenges, such as parallel development of hardware and user-interface availability restrictions. Parallel development of hardware requires the use of emulators and simulators until later-stage system testing, once the actual hardware becomes available. For those systems with a user interface, it is also often developed in parallel, rendering it available only for later-stage system testing.

Because of such challenges, test hooks need to be built into the software to support testability as identified in an overall test automation strategy. This embedded test code simulates actions normally begun through a user interface or other command-control trigger (pressing a button on the device, confirming an action, selecting a value, etc.). A test case can be constructed by invoking a sequence of these actions via the callable test hooks. Furthermore, if target hardware is absent, these test cases can be executed by using a suite of emulators and simulators as part of the automated test environment. This approach enables testing software early in the development cycle, in advance of both user interface and hardware dependencies.

Benefits of Automated Testing

Automated testing can reduce the amount of manual testing, shorten the process schedule, and reduce cost. Testing is often viewed as a bottleneck in the software and system development process. By automating testing, a test team can help ensure that the software development, as well as the overall development, meets its schedule and budget goals.

Automated testing can increase efficiency in the software development process. Because automated tests consistently repeat and document a specific sequence of steps, the development team can reproduce defects found by an automated test case. This leads to quicker defect resolution early in the software development cycle. Furthermore, automated tests can be executed before source code check-in, which prevents defects from making it into the code base.

Test coverage is also increased. Comprehensive automated tests can be executed, unattended, 24 hours a day. This allows the test team to focus on safety-critical or complex parts of the product.

Automated testing can improve consistency and repeatability of testing over manual testing. Manual testing can be time-consuming and monotonous, resulting in mistakes by even the most conscientious testers. Automated tests repeat the same sequence of steps and record results with each execution, thereby ensuring overall accuracy of regression, integration, and system testing.

The process also facilitates performance and stress testing, which can be difficult or impractical to perform manually.

Early-stage test automation helps isolate problems encountered in the software, because hardware is often unavailable in early-development-stage testing. The early identification of software problems can ease integration with hardware. In addition, the embedded test code can also be used to support manufacturing and field-service system test needs.

Limitations of Automated Testing

If the automated test results are to be used for formal verification and validation evidence, the automated tests need to be executed on the actual target hardware against the software that is a candidate for final release. The additional code may increase the complexity of the code base and become a burden for development and maintenance. Also, because it will be included in the software released as part of the embedded real-time system, the test code needs to be validated to ensure that it has no undesired side effects on the intended use of the product.

Another drawback is that emulators and simulators, used as part of the automated test environment, may not accurately represent the behavior of the actual device and can give a false sense of application usability and system performance. In such cases, the emulators and simulators should be evaluated for accuracy relative to the actual device.

Embedded software development is complex. Changes to software interfaces and hardware are common, which makes testing especially challenging. Modular and extensible automated test environments can significantly reduce the influence of these changes. However, such a development effort requires careful design and continual maintenance.

Medical device OEMs often use independent test teams to develop and execute manual tests. Automated testing requires specialized programming skills that often require additional training. Depending on the automated test framework, the test team can use a programming language such as Perl to design and develop test cases.

Strategies for Effective Automated Testing

To articulate the strategies for effective test automation, this article uses a patient monitor as an example of a real-time embedded medical device. A patient monitor is a portable device used for standard physiological parameters such as ECG, heart rate, SpO2, NIBP, and temperature. The monitor is applied outside the body. It automatically analyzes the patient's waveforms and warns clinicians if a parameter is out of range via a visual or audible alarm.

First, designers need to decide what to automate. They must consider the performance implications on the system. A monitor displays waveforms on an LCD. Embedded test code that supports the verification of the integrity of this real-time signal may artificially add to the schedulability and resource load of the system. In this case, the designer would likely decide not to automate the testing of this functionality. Instead, it would be better to focus on automating functionality for which the embedded test code would have no effect on device performance, such as device configuration.

Figure 1. (click to enlarge)
The test automation environment. Application programming interfaces (APIs) define the set of actions to construct the test case.

The next step is to design the test automation environment. The environment consists of APIs, a framework used to invoke the APIs and execute a defined set of actions to construct the test case, and, potentially, emulators and simulators (see Figure 1). Working with the development team, APIs are added to the code to simulate user actions such as button presses on the device. These APIs create a layer between the user interface and the control logic code, effectively creating an alternate externally callable interface that can be invoked by the framework. In addition to adding the callable interface, the APIs add logging capabilities that record input values and results, capture start and stop times, and log other data that may be needed.

The framework, in this case, consists of a set of scripts used to call the APIs and execute the sequence of actions defined in the test cases. These test cases will have been defined by test engineers and were previously executed manually. Once established, the test automation environment can be integrated with a build system to provide regular verification of implemented functionality. The integration facilitates regression testing and continuous feedback during the software development cycle.

Unlike test automation tools for general computing platforms, there are few tools available for system-level and functional testing of embedded real-time systems because these tools often need to be compatible with the technology (i.e., RTOS) for the application under test. Therefore, there is usually a need to create custom automated tools. The cost of development, testing, and qualification of these tools is part of the investment in test automation.

There are some third-party products that can be used as part of a test environment or within an overall test strategy, such as QualiSystems TestShell and National Instruments LabVIEW, among others. Designers still need to develop test scripts, though, and the license cost for such tools should be factored into any investment considerations. Remember that it is likely that these tools still need to be qualified to comply with regulatory guidelines.

Return on Investment

Automation requires an investment with a justifiable, and potentially significant, payback. In the patient monitor example, the costs may include the following:

  • Purchasing or development of automated test tools.
  • Training staff on automated test tools and scripting.
  • Qualifying automated test tools, simulators, and emulators for their intended use, as required by FDA.
  • Developing modular test frameworks to support automated test case creation, execution, and results reporting.
  • Building and maintaining testability in the application (i.e., embedded test code).
  • Developing, debugging, peer reviewing, and maintaining automated test cases.

The savings are determined by the amount of manual test execution time saved in functional, regression, and system testing. The savings also come from early discovery of defects through unattended and repeated execution of automated test cases. Industry data suggest that the cost of finding and fixing a defect during the system-testing phase is seven times the cost of finding and fixing a defect during the coding phase.1 For subsequent releases of the product, there can be additional savings in early stages of development if standardized tests are made part of the development effort.

The initial investment is usually recouped by the second release, after which savings are seen for subsequent releases. Upfront ROI analysis is essential to get management support.

Complying With Regulatory Guidelines

FDA's General Principles of Software Validation: Final Guidance for Industry and FDA Staff, provides guidance for medical device manufacturers related to software verification and validation.2

Automated Test Tool Validation. Section 6.3 (Validation of Off-the-Shelf Software and Automated Equipment) of the guidance recommends that medical device manufacturers are responsible for validation of off-the-shelf software for its intended use. This requirement applies to any software used to automate device testing. Automated test tools purchased from third-party vendors are used to generate automated test cases and test results that may be used for formal verification evidence for the product. In this case, these tools need to function as expected and should be validated for their intended use. Artifacts that should be reviewed, approved, and collected as a record of validation include requirements documentation, qualification procedures, and qualification results for automated test tools.

Note that third-party vendors may be able to supply automated test tool qualification documentation if they have qualified the tool. In this case, the medical device manufacturer may be able to use this qualification documentation to satisfy FDA's validation requirement for off-the-shelf software.

Software Verification and Validation Plan. Section 5.2.1 (Quality Planning) of the guidance suggests that verification and validation activities should be planned and documented. The automated test strategy and related activities must be documented, reviewed and approved as part of the overall software verification and validation plan for the product.

Automated Test Cases and Test Results. Section 5.2.5 (Testing by the Software Developer) of the guidance says “test procedures, test data, and test results should be documented in a manner permitting objective pass-fail decisions to be reached.” The creation of automated test cases using a scripting language is a development effort and, therefore, requires processes and standards similar to the development of application code. Automated test code must be source-controlled, appropriately commented, peer-reviewed (for both quality and adherence to predefined coding standards) and approved. Test results generated by automated test cases as a result of executing automated test cases must be reviewed and approved if they are to be used as formal verification evidence for the product.

Conclusion

Automated software testing is not right for everyone. It requires upfront investment and proper due diligence to ensure that it is right for the organization. Otherwise, adopting automation can be expensive and frustrating. Once the benefits of automation are understood, it is important to establish expectations and present management with sufficient data to support a program so that they may plan accordingly.

Implementing an automated software-testing program requires a structured approach. It requires a test strategy specifically tailored to a product and its regulatory requirements. It also requires that designers build or select the right automated test tools and that the environment use automated test frameworks and appropriate emulators and simulators.


Read more articles from Foliage contributors here.

By following the approach presented here, device firms can realize a significant ROI for automated software testing, gain a competitive advantage in the industry by reducing time to market, and increase the quality level of an embedded real-time medical device product.

Amit Shah is test engineering manager for Foliage, and he can be reached at ashah@foliage.com. Tim Bosch is chief architect in the medical division of Foliage. He is available at tbosch@foliage.com.

 

References

1. Case Study: Finding Defect Earlier Yields Enormous Savings, [online] (Dulles, VA: Cigital [cited 8 July 2008]); available from Internet: www.cigital.com/solutions/roi-cs2.php.

2. “General Principles of Software Validation; Final Guidance for Industry and FDA Staff,” (Rockville MD: FDA) January 11, 2002.

Copyright ©2008 Medical Device & Diagnostic Industry

Animated Videos Guide User Interactions with Complex Medical Devices

DESIGN


Figure 1. (click to enlarge) The first three frames illustrate how to identify and resolve the cause of a flow obstruction on an infusion pump. The fourth frame illustrates how to install a tubing set on a dialysis machine.
See sample animations.

Imagine you're a nurse in the pediatric intensive care unit (PICU) monitoring an infant on hemodialysis. Abruptly, the hemodialysis machine stops circulating the child's blood and emits a piercing alarm. A quick scan of the machine's screen tells you that it has detected and trapped air in the blood return line to prevent an air embolus. You have a brief window of opportunity to eliminate the air and restart the blood pump before clotting occurs and the entire tubing set needs replacement. Your task is to perform a lengthy sequence of actions, including clamping and unclamping lines, opening and closing valves, suctioning syringes, and pressing buttons to clear the air. Perform a step out of sequence or too slowly and you must start over, or worse, lose a portion of the patient's blood due to clotting. Are you feeling the stress?

Every day, caregivers face similarly stressful scenarios involving interactions with complex medical devices. The scenario du jour might involve one of several devices, such as a multichannel infusion pump, a rapid infuser, or an anesthesia workstation, which typically incorporate a software user interface in addition to specialized hardware. Response strategies vary. Caregivers might respond properly to common events by rote. They might collaborate with a more knowledgeable colleague to resolve less-familiar events. But sometimes, they might take a trial-and-error approach because there is no alternative, possibly placing their patients at risk. The latter strategy is largely avoidable through proper training and the availability of helpful learning tools.


Sidebar:

Among the training options, the venerable in-service training session is most beloved by caregivers who prefer to see how to perform a task rather than read about it. Concise, illustrated, and well written quick reference cards are also appreciated and strongly preferred to verbose user manuals written more for clinical engineers and regulators than for end-users. Increasingly, manufacturers are also producing animated videos, a promising medium that can provide a rich training experience similar to in-services but at a lower expense (see the sidebar “Overcoming Operational Difficulties”). The balance of this article focuses on these animated videos, made possible by the increased computing and display capabilities of high-tech medical devices.

The Medium

The term animated video might conjure Disney's cartoon characters, or perhaps Microsoft's much-maligned dancing paperclip that offered assistance to software users. In the world of medical devices, these images can be replaced with more utilitarian visions, such as an animated hemostat clamping on to a blood-filled tube just below an air bubble. The hemostat starring in this video does not have a smiley face. Rather, it looks fairly realistic, and more importantly, provides clear instructions on how to perform one step in a complex procedure.

Animation has significant advantages and a few disadvantages compared with live-action video. Perhaps the most significant advantage is that animations can accentuate important details and actions, avoiding the visual clutter that can diminish a live action video's effectiveness. Animations may include annotative elements, such as arrows to point out special features and indicate direction of motion. Animations can also depict information that is not observable in the real world, such as the cleansing of blood in an artificial kidney, to help users develop accurate mental models of complex concepts.

Animations typically include a voiceover and subtitles to enhance comprehension. While producers might need a voice talent to perform the voiceovers, there is no need for actors—amateur or professional. Using a voiceover makes it convenient to iteratively fine-tune an animation without the need to set up multiple filming sessions. It also makes it easier to update animations many months or years later, even if the original narrator is unavailable and must be replaced. The major disadvantage is that animation can be more expensive than live-action video and arguably requires more-specialized talent.

Animation in Action


Web Exclusive!
View Sample Animations

Figure 1 shows an example of an animation with user instructions.Each frame is intended to teach users how to prevent or overcome an operational problem. Sample animations may be viewed at http://www.devicelink.com/mddi/animations.html.

The Development Process

There's no mystery to the animation development process but it can be a significant amount of work. The five steps are outlined below.

Study User Interactions. Observe end-users performing pertinent tasks and determine where they struggle. Then, ask them to explain sources of confusion and error and how they might be overcome. This kind of work should be done by people accustomed to assessing user interaction quality in an objective manner, such as human factors specialists, but may also be performed by other professionals prepared to set aside their biases.

Talk to Trainers. Ask trainers who deliver in-services or conduct workshops to describe where end-users tend to struggle with a given task, such as clearing air from blood tubes. Also ask them to describe how they help users overcome hurdles, which parts of an interactive sequence require more explanation, and what they tell new users to keep in mind.

Establish Communication Goals. List the lessons you want to teach the animation's viewers, such as where to apply a scissor clamp on a blood tube, or how much pressure to draw using an attached syringe. In the process, consider alternative ways to present potentially complex concepts and procedures in a simple manner. In addition, assess your target audience's understanding of the subject matter and their likely viewing habits. Consider how much time users will have to watch the animation and whether they are likely to watch the animation while they have access to the associated medical device. This information will help you target an appropriate level of content detail and duration for the animation.

Identify an Appropriate Distribution Format. You can distribute your animated videos to users in several ways. The appropriate medium will depend on the target audience's characteristics and their viewing context. Are the users likely to view the animated tutorials at work or at home? Will they view the video while using the product or at another time? The various options include VHS tapes or DVDs, Web-based videos, and device-embedded videos. The trade-offs between these options will be discussed later in this article.

Prepare a Script. Write the passages that will be spoken over the animated scenes. Iteratively review a draft script with key stakeholders and revise it according to their input. For the sake of financial and emotional economy, limit the review process to 1–2 rounds so that the draft script does not become a literary piñata, subject to endless editorial nit-picking. Here are some script-writing tips:

  • Employ a conversational tone matching that used by a friendly trainer when delivering an in-service to the intended users.
  • Keep sentences short to make the content easier to follow and potentially more memorable.
  • Avoid excessively detailed verbal descriptions of information that can be depicted more clearly in the animation.
  • Include transitional sentences that will give the animation better flow, such as “Now, let's turn our attention to restarting blood flow.” Such transitions will also help draw viewers' attention to critical information.
  • Presume that 1000 words will translate into approximately 3–5 minutes of animation, depending on the pacing and accompanying visual detail.

Create the Artwork. Choose an appropriate visual style and illustrate a few key scenes. Like the script, iteratively review the illustrations with key stakeholders and revise the visual style according to their input. Then, produce the basic artwork needed to create the full animation, such as illustrations of the entire device from different angles, close-ups of specific components (e.g., tubes, syringes, air bubbles), and perhaps the user's hand-operated controls. Pay close attention to scale so that the artwork fits the intended frame (e.g., a pop-up window displayed on a desktop-size monitor versus an image filling a comparatively small, 320 × 240-pixel display) and has an appearance well suited to the display's resolution. Here are some artistic tips:

  • To keep things simple looking, limit the total number of illustrated elements (i.e., the visual vocabulary), using compound elements whenever possible rather than developing entirely new ones.
  • Eliminate extraneous details whenever possible to focus the viewer's attention on salient details.
  • Accentuate salient visual details by using bold colors and outlines.
  • Utilize perspectives that provide sufficient visual context, such as an isometric or three-quarter view that can provide a more complete sense of user-product interactions.
  • Use a limited number of harmonious colors, reserving certain colors for coded purposes (e.g., red for blood, orange for warning messages, green for arrows indicating movement).

Create a Storyboard. To prepare for the creation of the complete animation, produce a series of sketches depicting key scenes. Storyboard sketches can be drawn by hand or by using illustration software such as Adobe Illustrator or even Microsoft PowerPoint. The storyboard shouldn't have the refined visual style of the final animation, but a rough depiction of key steps and animation elements such as movements, transitions, and fades.

Animate. Traditionally, animation production has been a manual and laborious task. Until recently, animators had to spend many hours drawing thousands of individual frames by hand to produce a brief animation. However, computer-based animation tools greatly simplify the animation process, automating the creation of the many frames that produce motion.

Choose an animation software program that can export the finished product in a suitable file format and that is most compatible with your graphics tools. One option is Adobe Flash, a popular animation tool commonly used for creating Web-based animations. Flash is particularly well suited to creating two-dimensional animations, which it can export in many formats. Additional options include 3D Studio for producing three-dimensional animations and Adobe After Effects for producing high-end video that can incorporate advanced special effects. Regardless of the software used, follow these guidelines to ensure effective animation:

  • Utilize a moderate and consistent pace for the animation that is synchronized with the animation's soundtrack.
  • Avoid animating more than two or three on-screen elements at once.
  • Avoid excessively quick (e.g., less than 1 second) motions or transitions, which users might overlook.
  • Use fades or transitions to create visual breaks between key sections of the animation.

Add Sound. With preliminary animated sequences created, sound can be added to bring the animation to life. While sounds might include a bit of introductory music and various machine-produced clicks and beeps, the primary sound will be the narrator's voice. Here are some tips for voiceovers:

  • Ask representative users whether they would prefer to listen to a male or female and choose a narrator accordingly.
  • Choose a narrator whose voice will be pleasing and intelligible to most listeners. Avoid heavily accented voices and voices that are particularly high or low pitched.
  • Direct the narrator to speak in a conversational rather than formal tone, matching the tone you intended when you wrote the script. Specifically, ensure that narrators include lots of prosody (i.e., inflection) and to avoid speaking in a monotone.
  • Direct the narrator to speak with a variable pace, speaking faster through basic material and slowing down to present more-complicated material.

Evaluate the Draft Animation. Invite representative users to watch the animation. Then, observe them perform the associated task—perhaps in the context of a usability test—to identify any continuing difficulties that might be resolved by animation revisions. Also, ask the users to critique the animation, citing its strengths and opportunities for improvement. Focusing on the positive, users might identify segments that provide key insights. Focusing on the negative, they might point out segments that are confusing, boring, annoying, or even insulting. Although users' inputs should take precedence in deciding how to revise the animation, also ask the key stakeholders for their feedback on it.

Refine the Animation. Finally, draw upon the users' and stakeholders' inputs to refine the animation, taking care not to drain it of its cinematic power, if you will, or of its overarching style in a misguided effort to accommodate every last criticism of the draft. Remember that the animation will necessarily reflect design trade-offs, just like the medical device it depicts.

Pitfalls to Avoid

Although well made animated tutorials can help clarify complex user interactions, they are not a panacea. A well produced animation cannot compensate for fundamental design flaws in a medical device's user interface. Importantly, like an unclear user manual or an incoherent trainer, a poorly produced animation can mislead users or complicate their interactions with a medical device. Consider the following risks when producing an animation.

Creating Detailed Animations for Overly Simple Tasks. Animations are particularly useful for complex or involved tasks that might be difficult to depict using text alone. Avoid producing detailed animations for tasks that should be self-evident or better explained with a simple textual instruction or graphic.

Excessive Use of Motion. Animations do not need a lot of motion or visual excitement to be effective. Avoid the impulse to include excessive motion graphics and decorations, which can create an overwhelming impression and distract viewers from critical information.

Excessive Visual Detail. As mentioned earlier, one of animations' strongest advantages over live-action video is the ability to utilize simplified illustrations that highlight the most significant interaction elements to viewers. Avoid the use of technical illustrations that depict vitually all of a medical device's details, especially when producing animations for a relatively small display.
Prolonged Duration. Most users generally want medical device instructional materials to provide just enough information for them to perform their job correctly. Provide too much information in an animated video and viewers become distracted and ignore the video's central messages. When possible, avoid producing videos that run longer than five minutes.

Distribution Formats

So far, this article has discussed animations similar to short films, lasting a few minutes. Such animations may be viewed in a medical device's online help system. This approach promises to provide guidance at the place and time when it is needed and is particularly useful for caregivers learning to use a device. However, watching a 3-minute instructional video while treating a patient might not be practical. First, there might not be sufficient time to watch the video while responding to a critical event. Second, a clinician might find it embarrassing to watch a video in front of his or her colleagues because it could suggest lack of preparation. Third, seeking online instruction during treatment might reduce a patient's or visitor's confidence in the clinician. Therefore, users might choose to watch such videos when the associated device is not being used on a patient. Alternatively, the videos might be provided on VHS or DVD so that clinicians can watch them on monitors located in lounges. Streaming video over the Web is another solution.

The problem with streaming video solutions is that clinicians are typically overworked and do not have the free time to watch videos away from the point of care. This reality favors keeping videos fairly short and constructing them so that they operate more like prompts. For example, a dialysis machine could incorporate a series of 15-second animations with discreet, text-based captions rather than audio. Users would have the option to play a series of six, 15-second animations in series instead of watching a continuous three-minute tutorial.

Whether an animation is continuous or segmented, it should give users some control over it. Accordingly, animations should include play, pause, stop, and repeat controls, presuming that the host hardware provides a means to control volume. Segmented animations should give users the ability to navigate among chapters.

Implementation

Perhaps you're convinced at this point that animations are a real asset—worth considering for implementation on an upcoming medical device—and have a better sense for the development process. But, which department should lead the development effort? Design (user interface or industrial), engineering, marketing, documentation, or training? There's no simple answer to this question, noting that departmental capabilities and their interrelationships vary so much among companies. However, for many companies, a multidepartmental, team approach might be most fitting.

The development team will need to address many topics, including:

  • The animation's file format. Make sure it will be compatible with the computing platform, which might be a version of Windows, Linux/Unix, or another operating system.
  • The required computing power. Ensure that running the video will not interfere with critical machine functions.
  • Compatibility between the animation and other training and learning tools.
  • Potential updates to animation content to reflect software or hardware upgrades.
  • Translation of the animations' soundtrack and text content to various languages.

Importantly, an embedded animation becomes part of a medical device's user interface. Therefore, it will be subject to the same design validation requirements applied to the device's primary user interface elements (e.g., menu and parameters display screens).1

Conclusion

We've come this far, but no further, before using the expression, “a picture is worth a thousand words.” It's a truism that applies to teaching people to use medical devices, and it applies doubly to moving pictures (i.e., animations). As discussed earlier, clinicians prefer to be shown how to perform tasks, rather than to find and then study a user manual. Animations can be almost as effective as a live teaching session, assuming they are well designed and executed. So, they are becoming more common, at least as DVD-based aids, in the medical domain. Now, the advent of medical devices with powerful computing capabilities has thrown open the door to embedding them in forms appropriate to viewing at the point of care.

Michael Wiklund is founder and president of Wiklund Research & Design Inc. (Concord, MA). Jonathan Kendler is a cofounder and partner at the firm. He can be contacted at jonathan@wiklundrd.com.

References

1. Michael Wiklund, “Usability Testing: Validating User Interface Design,” Medical Device & Diagnostic Industry 29, no. 10 (2007): 78–89.

Copyright ©2008 Medical Device & Diagnostic Industry

Norman Noble Expands Implant Manufacturing Services

OUTSOURCING NEWS


Medical device contract manufacturer Norman Noble Inc. (Highland Heights, OH) has announced a significant expansion of its orthopedic implant manufacturing operations. The expansion includes the addition of eight Willemin-Macodel 5-axis contour milling machines, positioning the company as one of the largest providers of single-operation machining to the orthopedic implant OEM market. The company also increased capacity in its Swiss turning and milling department and made capital investments in equipment to support its quality inspections department.

The company believes that its new machining technology will complement its core competencies. The expansion is also meant to help support the growth of the company and position it as a leader for implant manufacturing in terms of capacity and capability.

“Orthopedic implants are one of the fastest-growing segments of our business,” says Dan Stefano, vice president of manufacturing. “This additional technology and capacity fits our experience in manufacturing for this market, which requires tight tolerances, complex geometries, and unique finishing requirements,” he says.

The Willemin-Macodel machining centers that the company added are high-precision units that machine parts such as spinal and extremity implants. The implants are machined by milling and turning them in one cycle, from bar-fed stock to a complete six-sided part. Other methods for manufacturing orthopedic implants often require additional machining steps and multiple machining processes. The Willemin center can be programmed to automate the manufacturing process into a single-operation, resulting in higher output with greater precision and quality.

The orthopedic implant manufacturing expansion is part of Norman Noble's ongoing strategy to maintain double-digit growth. In addition to expanding its orthopedic implant manufacturing operation, the company has recently doubled the size of its facilities and made substantial investments in its Swiss turning capabilities and its proprietary laser machining and finishing technologies for stent manufacturing.

Norman Noble is also in the midst of a $1.7 million expansion of its mass finishing operations, which support research and development and automated production. The company believes the mass finishing project complements its expansion of orthopedic implant operations.

Copyright ©2008 Medical Device & Diagnostic Industry