Originally Published EMDM May/June 2005
15th Year Anniversary
15 Years of Sourcing
Industry suppliers reflect on past technological breakthroughs and changing business practices, and speculate on what lies ahead
Cooperation between Materials Suppliers and Customers Creates Mutual Benefit | Automation Industry at the Height of Sophistication | Some Like It Hot: Competition Keeps Filter Suppliers on Their Toes | Motor Suppliers Find that Less Is More | Getting Connected with Wireless Technology | Knowledge Is Power for Outsourcing Firms | Plastic Tubing Climbs Every Mountain | Demand for Smaller Machined Metal Parts Has Boosted Overall Quality | Automation, Sterilization Help Packaging Suppliers Live Up to Industry Needs
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| “The first 10 years in this industry are really spent building a reputation.” —Stephen Cowen, Sandvik Bioline UK |
Cooperation between Materials Suppliers and Customers Creates Mutual Benefit
“The supply-and-demand relationship is changing fast,” says Stephen Cowen, general manager of Sandvik Bioline UK (Sheffield, UK). Raw- materials suppliers are finding that innovations are increasingly being driven by eventual applications, he notes. The demand for materials with specific properties has made for gradual—but welcome—developments over the last 15 years.
Progress has centred largely on new blends based on existing materials, rather than entirely new ones. This is due in part to the cost-effectiveness of relying on materials already known for their biocompatibility, instead of going out on a limb to test and prove new products. “If you look at basic grades, certainly for medical implants, it’s no secret that they’ve been around for some time. There’s not been a great deal of innovation,” says Cowen. “But I feel [innovation in materials] is coming.”
This isn’t to say, however, that advancements have been lacking. “For the last 15 years, there’s definitely been increased environmental pressure on PVC in different applications,” says Thijs Jaarsma, global market development manager of Eastman Chemical B.V. (Capelle a/d Ijssel, Netherlands). “We introduced new copolyester resins and elastomers ourselves, and saw a few new competitive polymers emerge as well.”
For industry veterans, technical advancements have been coupled with the crucial need to tell potential customers about them. “The biggest source of change has been our marketing function. In the last two years, we’ve greatly increased our technical marketing resources for the medical market,” remarks Jaarsma.
Newcomers, on the other hand, find that in the medical field, you have to crawl before you can walk. Cowen reports that incorporating medical materials into Sandvik’s established areas of expertise had to be done gradually. “The first 10 years in this industry are really spent building a reputation,” he notes.
With the global healthcare market growing at 6–8% annually, companies throughout the field are working to keep up with new demands. “We try to grasp these innovative applications, especially when it comes to positioning our materials as an alternative to PVC,” says Jaarsma. “We’ve developed new materials like Ecdel, a plasticizer-free alternative for IV bags.” Cowen speculates that metal-free materials may be the wave of the future, but also acknowledges the continued importance of metal in some applications. “New demands for orthopaedics will place more demand on manufacturers like ourselves, such as [providing materials for] metal-injection moulding,” he predicts.
Erik Luftig, healthcare marketing manager for GE Advanced Materials (Bergen Op Zoom, Netherlands), and Clare Frissora, marketing director, concur that “solutions to end-of-product-life disposal” will be a theme to take notice of in the coming years. The healthcare industry continues to look at ways to reuse through sterilization, they add.
As application advancements continue to challenge the materials sector, every player benefits from cooperation. After all, says Cowen, “products form innovations. We can learn as much from customers as they get from us, and partnership is the way forward.” Jaarsma looks forward to the coming years as a watershed era for the industry. “We’re only at the beginning of an accelerating evolution. We’re looking for a new generation of materials.”
Automation Industry at the Height of Sophistication
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| Increased process validation is an ongoing goal in the development of automation equipment such as this syringe assembly system from Kahle Engineering. |
Two little words can best describe the changes that have occurred in automation over the last 15 years: “more sophisticated.” As Lawrence Davie, sales and business development manager at AGR Automation (Arbroath, Scotland, UK) puts it, “Parts- handling technology has developed into a sophisticated engineering discipline.” Julie Logothetis, president of Kahle Engineering Corp. (Caravaggio, Italy), adds that the technological growth has been huge. “There’s more sophistication—and controls— in the equipment, inspection methods, and process validations,” she states.
With increased labour costs in Europe, automation is a viable solution for companies wishing to keep manufacturing and assembly in-house, especially with high-volume production of plastic and metal components. As a result, parts handling has changed dramatically, according to Davie. “Effective and efficient feeding of component parts is critical to the success of the rest of the automated assembly system,” he says. The machines are quieter, require less maintenance, and have much higher feed rates. In addition, assembly machines once designed to be stand-alone units are now being integrated into complete systems, and machine vision systems are more flexible and easy to use.
“Increased volumes of single-use instruments have expanded the market,” says Paul Patterson, director of sales and marketing at ATS Automation (Cambridge, ON, Canada). In order to keep up with the trend, “there’s a greater need for high-speed processes,” he adds, “including vision technology, servo control, flexible programming, and process control.”
Quality controls are also being incorporated into the equipment to facilitate process validation. “There have always been certain standards in place,” says Logothetis. “It’s just being taken to the next level.” With more European companies supplying machinery to the United States in recent years, automation equipment must be designed to meet US regulations. Three years ago, sortimat Technology GmbH (Winnenden, Germany) collaborated with Wilden AG (Regensburg, Germany) to develop an inhaler assembly line that would comply with 21 CFR Part 11. In order to meet the regulatory requirements, the firm defined and programmed the system’s interface to generate an audit trail of all operator activity. The system also included functionality for defining user access privileges.
The last 15 years saw AGR Automation shifting its focus to the automated production of small, rigid plastic parts for disposable medical devices. Increased expertise in control technology helped the company stick to its goal of creating appropriate high-speed systems. “We firmly believe that a good mechanical solution is enhanced by appropriate control technology,” says Davie.
“ATS Automation has seen an increased demand for accuracy and flexibility in high-speed assembly operations,” says Patterson. To respond to this demand, ATS developed a line of servo-based standard products. The company also took advantage of advances in computer processing technology to develop SmartVision, a PC-based product inspection system. In addition, when the firm noticed a need for greater front-end planning of automation projects, it established a consulting group called ATS Compliant Solutions. Consultants in the group provide automation engineering support services and regulatory expertise to healthcare, pharmaceutical, biotechnology, and medical device companies.
Having been in the business of manufacturing assembly automation equipment for more than 80 years, Kahle has seen its share of changes in the industry. Traditionally more invested in internal manufacturing capabilities, European medical OEMs have only recently considered the possibility of outsourcing, says Logothetis, but she doesn’t view this as being detrimental to business. “There’s still a need to implement automated processes in order to maintain process validation and product quality.”
One key change seen by Logothetis is more involvement with product development. “As an automation company, we’ve had to become so much more familiar with the entire process.” This increased involvement has given Kahle an opportunity to provide input on product development. “Our understanding of the moulding process is particularly important when the moulded components are transferred directly from the moulding machines to the assembly equipment,” she says. “With a new product that has never been manufactured before, we will prototype the assembly to decrease the risk associated with the high-volume production machine.”
If current automation processes weren’t already sophisticated enough, the next 15 to 20 years may take them to a whole new level. Machine retooling will need to be addressed by the automation industry, says Davie, in order to keep up with shorter production cycles. In-house automation will have to be replaced by true partnerships between clients and suppliers, he adds.
The need for faster automation equipment, as well as machinery that is capable of making highly intricate products, will also play a key role, suggests Logothetis. A higher demand for items such as drug-eluting stents and prefilled inhalers may require an arranged marriage between medical device manufacturers and pharmaceutical companies. Patterson adds that there will be increased pressure to work in the global arena. “Producing consistent quality while adhering to compliance issues in the industry will also be very important,” he says.
Some Like It Hot: Competition Keeps Filter Suppliers on Their Toes
Competition among suppliers of filters for medical devices has increased dramatically over the last 15 years, and nearly everyone is feeling the heat. A handful of acquisitions and mergers have consolidated market share among fewer big players than in the past. Smaller companies hoping to stay in the game have been offering cheaper, less-specialized filters than those manufactured by large firms. But for companies that rely on reputations for quality and want to keep their labour local, that isn’t an option. Enter necessity, the mother of invention.
Increased pricing sensitivity has led some companies to focus on niche applications and customized solutions to distinguish themselves. “Our angle is really to identify the niche market, where customization is important,” says Russell Jones, business development manager for Whatman Inc. (Florham Park, NJ, USA). “Minimally invasive surgery is a niche application where we’ve been successful in recent years. Equipment protection filtration generally leads to some interesting applications, where the competition isn’t so great and there’s a need for a technically differentiated product.”
Filter suppliers have felt the strain of having to diversify their product range and increase quality without the relief of eased pricing pressure. “We’ve been a key player since 1996, but since that time, the need for performance in a filter has continually escalated,” comments Jill Rauszer of Whatman. For instance, she says, “verification of bacterial removal performance is becoming more important, and customers are becoming more specific about what [contaminants] companies claim their filters can remove. But at the same time, the pricing has gone lower and lower. With such pricing pressure, maintaining quality and performance can be challenging.”
Invention, necessity’s offspring, came in the form of advancements in filter media. Nonwoven membranes, such as polyester sulphone, possess unique filtration properties and have proven valuable to OEMs looking to be at the forefront of technology. Industry leaders attribute the membranes’ popularity to their ability to be engineered to specific pore sizes, as opposed to natural fibres, and thus to filter certain contaminants more effectively.
Another area of persistent change has been the trend toward outsourcing, particularly in research and development. As always, it’s important to know your audience. “As a supplier, we have to try to identify which companies are doing this [providing contract services], so we can target them along with OEMs,” says Rauszer.
With ISO standards coming into their own in the early 1990s, documentation and validation requirements have also become more stringent. “In the European market, just in terms of your overall design, your documentation, recordkeeping, communication, everything now is much more regulated, and more defined,” remarks Rauszer. “Traceability of processes and materials that are used to make the devices is part of doing business nowadays….Customers are under such a regulatory environment that every change has to be communicated, reviewed, and documented.”
Current trends toward prevention- and self-care-oriented medical products may continue over the next 15 years. “There will be a lot more point-of-care applications, things like home-care devices, self-testing, and administration-type kits,” predicts Jones. “Anything that will help speed up diagnosis and treatment for patients.”
Pharmaceutical delivery mechanisms and diagnostics may also create areas where filters begin taking on a central role. Several companies are looking at integrating membranes into patch drug systems, which may be used to administer drugs as everyday as over-the-counter pain relievers.
With technology moving rapidly, few can gauge how applications for filters, and thus demand on filter suppliers, will multiply in coming years.
Motor Suppliers Find that Less Is More
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| “Backlash-free motion in the nanometre range is no longer reserved just for instruments in the scientific community...[It has] a much broader market.” —Peo Sollerud, PiezoMotor AB |
How can an industry be getting bigger and smaller at the same time? The market for motors for medical devices has grown enormously in the last 15 years, causing some suppliers to double their business. Simultaneously, the area has become more focused on high-precision work and small components than ever before. Increasing numbers of customers want to see compact motor solutions that encompass recent technological advances.
Peo Sollerud, vice president of marketing for PiezoMotor AB (Uppsala, Sweden), speculates that one reason for this trend is outpatient treatment needs. “As the emphasis on outpatient treatment is growing, [with a greater use of] patient-administered drugs and minimally invasive surgery, there is a [corresponding] need for smaller and more cost-effective motors. We see no end to this.” The shift toward smaller technology has been coupled with the need to know exactly what that technology is doing. “We’ve seen a trend toward more distributed control,” says Ron Rekowski, director of product marketing for Aerotech Ltd. (Aldermaston, Berks, UK). “Intelligence at the drive level allows you to peer deeper into the process. It affords a greater level of control and diagnostics.”
Direct-drive technology has also been a hot spot for progress, reflecting industry demand for more- effective complete motion solutions. “Using stent manufacturing as a benchmark, the original systems were all screw- and belt-driven, and that severely limited the quality and throughput of the manufacturing process,” comments Rekowski. Direct-drive technology has transformed that area of focus dramatically, he adds.
In terms of business, especially for alternative technologies like piezo motors, progress is always something to celebrate. “Advances in motor control—making the controls more intelligent and at the same time more affordable—have helped us to take full advantage of the potential in piezo motor technology. As an example, backlash-free motion in the nanometre range is no longer reserved just for instruments in the scientific community, but can be incorporated in products that have a much broader market,” enthuses Sollerud. “The willingness to try out new motor technologies—like piezoelectric motors—has increased.”
Innovation is a must in this business, according to Minimotor S.A. (Croglio, Switzerland). New magnetic materials in combination with the Faulhaber System coil (from Minimotor’s parent company) make it possible for the firm to design powerful motors in a relatively reduced frame size. New motor construction materials, as well, have resulted in reliable, long-life motors, says the firm.
In terms of how regulations have affected the industry, changing standards can be costly and involve long bureaucratic procedures, but also engender improvements. Changes in regulations, such as ISO 9001, EMC, RoHS, and WEEE, are challenging but also act as an incentive to innovate and improve designs, according to Minimotor.
As in other segments of the medical device supply market, Europe remains a nucleus for many aspects of motor technology. “Oncology, medical imaging, and stent manufacturing have been big sources of our business in Europe,” says Rekowski. “We’ve also seen significant growth in laser manufacturing in Germany and Ireland.”
Where is this future-oriented technology headed in the next 20 years? Those in the know say faster, cheaper, and smaller. Miniature actuators will be applied to a myriad of functions in and around the human body, predicts Minimotor. Rekowski echoes the “small talk.” “Higher-density magnetic materials and bearing technology could be something big that allows us to shrink footprints and increase performance,” adds Rekowski. He also speculates that industry may see more robotic automation for surgical procedures.
Getting Connected with Wireless Technology
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| “It’s often easier to do new technology in Europe because of US regulations, even though more than 50% of the market is in the United States.” —Bill Saltzstein, Code Blue Communications |
Fifteen years ago, the Institute of Electrical and Electronics Engineers (IEEE) began work on establishing standards for wireless connectivity in the industrial, scientific, and medical (ISM) spectrum. Ten years later, the consumer electronics industry brought the phrase wireless access into everyday use. Although the wireless boom can’t really be considered an overnight success, it would be logical to assume that other industries, including medical manufacturing, would quickly adopt the now popular technology.
Yet that hasn’t been the case. According to Robert Thatcher, senior vice president of sales and marketing at Trivirix (Durham, NC, USA), it’s only been in the last few years that US medical device manufacturers have started talking about wireless or RFID systems. “Clients are learning about the technology and then come to us to find out if wireless is a good idea for their products,” he states.
Telemedicine projects in Europe are much further along than similar projects in the US, says Bill Saltzstein of Code Blue Communications (Woodinville, WA, USA). “It’s often easier to do new technology in Europe because of US regulations, even though more than 50% of the market is in the US,” he adds. This forward-thinking approach in Europe could be based largely on the fact that mobile wireless is the standard method of connectivity. According to 2003 figures, more than 300 million Europeans have cell phone subscriptions. Bluetooth, a wireless personal area network used for transmitting data between mobile and desktop devices, is widely used.
The Internet also has a role to play in wireless connectivity for medical devices. While electronic privacy is a hot topic in mainstream business, there are few concerns over data security within the medical field. “There are good, accepted standards for data encryption and they work quite well,” says Pierre Landau, CEO of Polymap Wireless (Tucson, AZ, USA). Thatcher points out that most medical products using wireless communication are closed-loop devices, meaning information is transmitted to another data source, rather than downloaded from the Internet or another resource. As electronic medical records become the norm, there may be a need to reevaluate privacy issues, suggests Landau.
As more medical OEMs leap into the 21st century and explore the benefits of wireless connectivity, companies that offer wireless solutions are inspired to come up with new ways of incorporating the technology into medical products. Thatcher anticipates that hospitals will use wireless systems to communicate between patients and nursing staff, as well as in operating rooms where space is at a premium. Landau hopes to see fewer proprietary systems and more use of connectivity standards, such as Bluetooth. Creating well-integrated wireless systems that allow products from different manufacturers to communicate with each other is also highly desirable. “Good equipment design is going to allow for better communication between product lines,” says Saltzstein.
Knowledge Is Power for
Outsourcing Firms
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| Roche Diagnostics collaborated with outsourcing firm Wilden AG to develop and manufacture the Accu-Chek device for diabetics. According to Wilden, there will be growing demand for outsourcing partnerships in lieu of traditional customer-supplier relationships. |
From design to engineering, from assembly to testing, medical device outsourcing encompasses multiple facets of the manufacturing process. Once hesitant to embrace the idea of having another company create its products, medical device OEMs have begun to see the value in outsourcing. Recent data from Frost and Sullivan suggest that in 2005, outsourcing will account for 42% of the cost of goods sold for value-added products. While outsourcing has gained popularity in Europe, the trend is still in its early stages with many companies. “This business has constantly grown over the last five years, as the need for outsourcing and custom developments has gotten stronger and stronger,” say Harald Ziebarth and Thilo Brinkman of B. Braun OEM/Industrial Europe (Spangenberg, Germany).
J. Randall Keene, CEO of Avail Medical Products (Fort Worth, TX, USA), has particularly noticed the growth in the area of finished disposable medical devices. To keep up with its OEM clientele, Avail opened a facility in Luxembourg in February 2003 to offer product design, development, and manufacturing capabilities to its existing customers with European operations. “As the competition becomes more extreme, and the products mature, OEMs will start thinking more about outsourcing,” Keene theorizes. Michael Magerstädt, CEO of Wilden AG (Regensburg, Germany) mentions that large international medical manufacturers are relying more on outsourcing partners than on contract suppliers. “The share of medical sales at Wilden has increased to two-thirds of our total business,” he states.
Working closely with medical OEMs and needing to comply with their standards led to the implementation of quality control systems within the contract manufacturing firms. Similarly, the need for compliance with US FDA and European medical device directives has encouraged contract manufacturers to establish process validation and documentation procedures.
What lies ahead for medical OEMs and the outsourcing firms depends on relationships forged now between the two groups. Magerstädt foresees more outsourcing of entire productions, “which will increase the need for outsourcing partners rather than customer-supplier relationships.” As Keene says, “It’s going to be important for contractors to be able to manage the device life cycle from concept to finished product.” Magerstädt also suggests that contractors will need to become more knowledgeable about complex technologies, such as surface treatment, embedded systems, and materials modification.
Plastic Tubing Climbs Every Mountain
The harder the challenge, the greater the accomplishment in surmounting it. That has been the attitude taken by Europe’s plastic tubing suppliers to the medical device industry over the last 15 years. Temperature tolerances, production capabilities, and small diameters are just some of the factors that device OEMs have been pushing to the limit and beyond. “We even joke that one day we’ll be asked for a tube that has a larger ID than OD,” says Padraic Lunn, technical sales manager for Ansamed Ltd. (Boyle, Co. Roscommon, Ireland).
Though materials themselves haven’t altered tremendously, material diversification has been a source of change for everything from tools to training. “Fifteen years ago, the main material was PVC,” remarks Erik Bjørn Rasmussen, managing director of Totax Plastic a/s (Vedbaek, Denmark). “The challenge over the years has been to adapt the tooling and equipment to process a lot of different materials, and also to educate people in production [about handling the various materials].”
Large companies have subsumed many small plastic tubing suppliers over the last 15 years, making competition tougher than ever. “Today, you have to be very focused on optimization,” comments Bjørn Rasmussen. Lunn suggests that remaining open to new avenues has allowed his company to hold its own. “Because of the new requirements, we’ve had to invest more. We’ve opened ourselves up to a whole new range of customers. . . . It’s still extrusion, but at a much higher level,” he says.
The need for detailed documentation has also affected innovation and production processes. Notified bodies, custom audits, batch reports, and compliance issues have made suppliers more careful about the products they offer. “It’s a much more controlled world today than it was 15 years ago. Back then, we would put the material in an extruder, see if we could use it,” recalls Bjørn Rasmussen. But today, he says, that kind of experimentation isn’t viable.
Alternative, more environmentally friendly materials may prove to be the “next big thing,” both in terms of relief for the environment and their usefulness to device OEMs. “Practically all medical devices have polymers in them,” Lunn acknowledges. “If we could get biodegradable materials in medical devices, or single-use devices that biodegrade, that would be interesting,” he says.
“It’s been a quantum leap in terms of the requirements of 10–15 years ago to now,” reflects Lunn. One can only wonder if the industry is preparing to take a leap of similar proportions over the next 15.
Demand for Smaller Machined Metal Parts Has Boosted Overall Quality
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| Having spent the past 15 years refining processes, Johnson-Matthey is currently focusing on manipulating alloys to meet industry demand for new materials. |
Norbert Sparrow & Caitlin Cook
When suppliers of metal fabrication services recount the reasons they entered the med-tech field, the stories they tell often describe capability meeting opportunity. As the demand for precision-machined metal parts among medical product OEMs soared in the 1980s and 1990s, so did the number of firms that recognized a niche to fill.
Sometimes the encounter came as a result of a supplier to nonmedical OEMs finding it could manufacture products at the level of precision and quality required by the medical industry. This was the case for Johnson-Matthey (Royston, Herts, UK). “We got to the stage where our capabilities were such that it made sense to make machined metal parts for medical applications,” explains Peter Duncan.
For Creganna (Galway, Ireland), which started out in the electronics field, a one-off medical project and changing circumstances inspired the shift into the medical industry. “Electronics was moving out of Galway,” notes Jack Clarke, project manager. “Two of the biggest medical device manufacturers are in Galway. It made logistic sense to move into medical on a permanent basis, he adds.
Michael Wied of Pinol a/s (Gørløse, Denmark), another former nonmedical electronics supplier, emphasizes the importance of distinction amid competition. “[A few years ago], a lot of other companies were getting into electronics. We had to differentiate ourselves from our competitors,” says Wied, “and there was strong demand from the medical device industry.” Not to mention that more and more electronics manufacturing was being outsourced to China, adds Wied.
Metal fabrication service providers, and the medical device industry they serve, have benefited from significant advances in automation, materials, and the miniaturization of machining. “Stainless steel has been major,” comments Clarke. Wied adds that laser welding has had a noticeable impact. “Simple parts become advanced constructions with laser processes. As a designer, you have fewer limitations.”
As the demand has evolved for smaller components and tighter tolerances, suppliers have been forced to keep pace, says Dave Vincent, director of global sales and marketing at the US headquarters of Johnson-Matthey in West Chester, PA. They have had to do so while accelerating production speeds and improving the materials’ surface quality, he adds. “As you make smaller and smaller parts,” explains Johnson-Matthey technical manager Joe Kain, “the surfaces must be higher in quality. The slightest defect [at those dimensions] could cause a failure.” Consequently, the quality of products has gone up dramatically across the board, says Kain.
Johnson-Matthey’s Paul Williams comments that precious-metal alloys in the industry have changed little in 100 years. “Their history of biocompatibility is well established,” he comments. While regulatory hurdles should not be underestimated, Johnson-Matthey believes that new alloy development is one of the best ways to achieve marked improvement. “Over the past 15 years, Johnson-Matthey has focused on improving its processes,” says Vincent. “Now the emphasis has shifted to manipulating the alloys. Of course, new alloy combinations are going to raise some regulatory issues . . . and they bring into play a trade-off in terms of speed-to-market versus improvement,” Vincent adds. “But changes in diagnostic tools, MRI compliance, radiopacity, and [the emergence of] different marking systems and different products needing marking are pushing us to develop new materials for the marketplace.”
A trend toward outsourcing certain aspects of the manufacturing process has changed things for many companies since the early 1990s. “A lot of companies that we deal with outsource more and more…the advantage we have is that we do design, production, and assembly,” says Wied. Creganna has also benefited from this shift: “A lot of the big companies outsource to us,” says Clarke, because Creganna is in tune with recent innovations.
The movement of manufacturing operations to Asia and other low-wage regions is an inescapable reality in the global economy. However, design and development expertise remains a hallmark of the European medical device industry. Uwe Stoll of EPflex (Dettingen, Germany) echoes many of his colleagues in pointing out that “some of Europe’s greatest strengths are in innovation and improvement on existing technologies. One of the objectives at EPflex is to maintain reasonable prices, but not to make the cheapest products.” Wied adds that consistent interaction between designers and end-users in Europe allows his company to optimize design. The face-to-face interaction and familiarity with local markets are still integral to success.
Among the trends likely to keep medical device suppliers busy throughout the next 20 years are miniaturization and documentation, validation, and certification demands. “There is a trend toward smaller catheters, and associated devices, to allow access to ever-smaller vessels,” says Duncan. “Customers wanting development companies to participate with end-users” will be another major theme, Wied asserts, noting that “it is important for companies to have a feeling of what the strengths and weaknesses of the products are.” Williams remarks that custom alloy innovations may also prove a source of energetic activity in coming years. “We’ll probably be developing alloys,” he says, describing smart alloys with customizable physical properties.
It may be the time-honoured tradition of innovation that carries suppliers to the med-tech industry into the future. “Innovation needs to occur at a constant rate in order to be competitive with Asia,” notes Stoll. “Our advantages are knowledge and capabilities.” Adds Clarke, “What was our specialty three to four years ago has become a commodity. We just need to keep offering value-added services.”
Automation, Sterilization Help Packaging Suppliers Live Up to Industry Needs
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| “The converting machine, the packaging machine. . . the whole process has to come together. That was unheard of 15 years ago.” —Alan Isaacs, Doyen Medipharm Ltd. |
Over the past 15 years, industry has come to recognize the central role packaging plays in the success of a medical device. More than merely a shell, packaging must be as sterile and reliable as the valuable product it houses. Industry veterans who have been instrumental in bringing packaging into the spotlight have different perspectives on what accounts for that shift.
“A big trend is the increase in automation,” says Alan Isaacs, CEO Europe of Doyen Medipharm Ltd. (Cambridge, UK). “When you reach the speeds we’re operating at, you’ve got to link processes. For the last seven or eight years, maybe more, we’ve had a major focus on linking processes. The converting machine, the packaging machine . . . the whole process has to come together. That was unheard of 15 years ago,” says Isaacs.
Michael Scholla, senior consultant for DuPont (Wilmington, DE, USA) has witnessed significant progress in terms of unified global standards for medical device packaging. “It’s pretty clear that 15 years ago, there was a great discrepancy in various parts of the world over what was a good way to determine whether a package was appropriate or not. It’s become more unified since then,” he says. “That activity has been led by the CEN and ISO groups on medical packaging, working together over the last 15 years.” Scholla chairs the ISO group.
Conor Ward, product leader for Perfecseal Ltd. (Londonderry, UK), remarks that packaging suppliers for medical devices have long striven to establish microbial barriers that ensure product sterility. “That is still vital,” he adds, “but some customers now demand packages with high barrier properties to gas and light.” For example, he suggests, many drug-coated devices require packages that resist oxygen and light infiltration.
Many packaging manufacturers indicate globalization as a trend significant enough to influence both innovations and the speed at which they are developed. “Fifteen years ago, many of the converters were family-owned and -operated businesses. Today, many leading converters are part of multinational corporations,” comments Scholla. “Bringing corporate resources into many of these companies has enabled them to develop [innovative] technology.”
The European market for medical device packaging has gone through changes, many of which have had positive effects for suppliers. A high level of technological expertise in Europe facilitates efficient business practices and eliminates the need for suppliers to explain basic and even complex principles, points out Isaacs. “It’s a good environment in which to sell high-end machines,” he says. “In some of the less-mature markets that don’t have the experience, it [often is] a bit more difficult. We’ve found that [customers in] the new EU countries, Hungary and the Czech Republic in particular, are also extremely knowledgeable.”
The solidification of the European Union also has had consolidating effects for packaging suppliers. “[Fifteen years ago], a lot of the multinational medical device companies had manufacturing sites all over Europe, multiple sites in multiple countries, the goal of which was to establish a country presence,” Scholla recollects. “As the European Community turned into the European Union . . . lots of companies closed their plants and consolidated their operations in one or two locations in Europe. The clear winner there was Ireland due to the tax benefits.”
At the same time, competition from Asia and a decline in customer validation requirements are two of the factors reminding European suppliers to capitalize on their strengths. Martin Jeurissen, director of Oliver Products International (Merelbeke, Belgium), cautions that companies hoping to remain competitive in the new millennium have a clear choice: “To become a highly specialized, service-oriented company, or not to exist any more.”
On a similarly cautionary note, Isaacs suggests that decreased customer emphasis on validation may have unfortunate consequences for the industry as a whole. “If I go back six or seven years, every customer would have thought of validation as absolutely vital, not optional,” he comments. “I’m starting to see the pricing pressure on our customers overriding the imperative of validation, and that worries me. If that’s what they want, we’ll have to react to that in the market, but I’m not sure where that leads. It may meet short-term commercial needs, but I think it’s an extremely dangerous road, and one that, in my view, may be disastrous for customers.”
Peering ahead, two areas that may see some of the most significant progress in the next generation of medical packaging are anticounterfeiting technology and combination devices. Scholla notes that combination products, such as drug-coated surgical tools, require packages that meet device and pharmaceutical standards.
Some suppliers look forward to packaging being identified as part of the device itself. “It is now recognized that the package forms an integral part of the product, that the package becomes an extension of the device,” says Ward. “This realization is driving integrated design and collaboration. Now and in the future, suppliers will need to respond quickly to ever-changing packaging needs that are being driven by advances in technology and healthcare, and the need to conserve materials and reduce cost.”
One thing’s certain: after 15 years of edging toward the limelight, packaging for medical devices is ready for its close-up.
Copyright ©2005 European Medical Device Manufacturer
