Christopher Delporte, Editorial Director04.08.15
Extrusion is just old-school manufacturing technology. A catheter is a catheter is a catheter, right? Not quite. Nor are extrusion providers strictly the third-party producers of only a few years ago. Once only focused (though they still are to a great extent) on large-volume manufacturing, extruders are responding to new and increasing demands from their OEM customers, who are pushing for the use of novel material combinations and the creation of highly specialized products. The clinical need for ever-smaller (a fraction of the thickness of a human hair), minimally invasive, catheter-delivered technologies continues to grow. From the development of next-generation transcatheter aortic valve replacement technology to neuromodulation therapy devices used to treat a variety of conditions, extrusion companies are being included earlier in the product development process and asked to step up with material expertise, design solutions and added services, all to help increase the competitive advantage for the OEM and reduce time to market.
For on-the-ground feedback about current market trends in this sector, Medical Product Outsourcing turned to the following medical extrusion market insiders:
Sonia Schwantes: We’re being asked for more complex extrusions such as para tubes and multi-lumens made from a wider variety of materials that are needed for specific applications. The more commonly used materials like silicone and PVC (polyvinyl chloride) can provide tighter tolerances and smaller outer diameters but do not always have the ideal properties that are needed for specific applications.
Apur Lathiya: We continue to get strong demand for tri-layer extrusions and thin-walled extrusions.
Ronelle Decker: We are working with several companies in the product development phase for micro-catheters and shafts primarily within the neurovascular space utilizing micro-coils and hypotubes. The primary goals are to create minimal wall thicknesses to offer largest inner lumen and smallest outer diameter along with lubricious inner lumens. This includes outer diameters from .012-.013 inches and some at 2-meter lengths.
Rick Ellis: We are seeing more multi-lumen extrusions and a greater number of requests for secondary operations—punching, printing, etc.
Jim McCormack: Healthcare is trending toward minimally invasive surgery techniques. Our customers are asking us to produce multi-functional extrusion in incredibly small spaces. We met the challenge with micro-extrusions—a fraction of the size of human hair—while maintaining outstanding tolerance control, length accuracy, and tubing consistency. We also produce ultra-lite PTFE (polytetrafluoroethylene) liners with walls as thin as 0.0005 inches. Extrusion does not necessarily translate to only tubing. Sutures and fibers are other types of extrusions.
MPO: What are some of the materials challenges (or opportunities) you have faced?
Josh Ridley: We see material opportunities more than challenges. We also view opportunities through two lenses: big, breakthrough changes; and incremental changes. Both have their place in the constantly changing world of minimally invasive devices. In terms of revolutionary change, our bioabsorbable polymers have been shown to behave and perform like traditional metallic components, but ultimately disappear, allowing the body to return to its normal state without anything left in the body. This encourages improved patient outcomes and reduces hospitalization time.
Lathiya: Higher-temperature materials such as PEEK (polyether ether ketone) and polysulfone have become more popular in some of the larger sizes. This becomes a challenge when customers continue to ask for tight tolerances with the larger sizes.
Ellis: We are seeing more requests for “loaded” materials—mostly radio-opaque [which become more visible on X-rays or other imaging technology].
Schwantes: Some opportunities call for specific materials that are not widely available. More customers are requiring specific properties so more development and material knowledge is involved. Plus, FDA (U.S. Food and Drug Administration) scrutiny has created a demand for more chemical and biocompatible testing on materials to make sure there are no issues further down the development chain.
Decker: Our polymer solution casting technology lends itself to a seamless transition with multi-durometers and materials along the length of the medical tubing with limited to no-bond joints. The technology provides for reinforcements—for example, braids, coils, hypotubes—imaging targets, ports and holes and tips all from one-piece construction.
MPO: How are clinical demands shaping medical device companies’ extrusion needs?
Ridley: Minimally invasive surgery will always be a hot topic and area of focus. Clinical demand continues to drive innovation in device technology and polymer extrusions across a number of market segments, but the overarching theme is the same—easier, quicker access with improved outcomes and minimal trauma. In addition, OEMs are feeling the need—and seeing the benefit—of looking to their polymer tubing suppliers to function as an extension of their R&D (research and development) divisions. Prior to this current round of healthcare-related cutbacks, the vast majority of applied innovation may have previously occurred in-house. Now, a well-vetted and trusted extrusion supplier can become a visionary partner, working with OEMs to reduce costs while helping to keep them ahead of the curve with new and improved product designs and applications.
Lathiya: Antimicrobial continues to attract more requests. Longer term, being able to deliver drugs via the polymer will be a game-changer.
Schwantes: Catheters are bringing forth a demand for tighter tolerances as well as a variety of sizes. More customers seem to be moving away from PVC so other materials are coming into play. Smart technology is pushing medical devices to be smaller and wearable with better accuracy. Where previously engineers would work around the weaknesses in materials, now materials are being tailored for specific applications and R&D is finding ways to overcome those weaknesses or developing new grades that eliminate them all together.
McCormack: Minimally invasive procedures requiring the delivery of a device—such as a stent or transcatheter heart valve—or therapy are on the rise across the world. We have a history of extrusion and catheter-based delivery systems that can help customers with the development and production of interventional catheters required to deploy a stent, heart valve, therapy, and/or medication.
Ellis: We are seeing demands for more lumens in each catheter and tighter tolerances.
MPO: Has the nature of your relationship with customers changed much over the last few years?
Lathiya: Customer demands in quality-system parity have continued to grow. Customers view their suppliers as an extension of their manufacturing. To be successful, a contract manufacturer must have quality-system parity and robust processes in both manufacturing and business systems.
Ellis: We have seen increased focus on quality systems and compliance. We are also being asked more often to manage a broader range of the supply chain.
Ridley: Yes. For many [customers], we have become a virtual extension of their R&D divisions. Healthcare reform has forced many medical device manufacturers to cut or at least scale back R&D budgets, limiting their ability to organically innovate. We can take on challenges for these companies and assist them in moving to the next level of product development.
Schwantes: More OEMs are working with contract manufacturers as they outsource assembly and packaging. Many are even outsourcing their development engineering to design firms. Since other companies are involved in the processing and more relationships are developed in the value chain, projects can become more complex because not all companies have the capability or capacity to handle secondary operations.
McCormack: We’ve watched the medical device world go through a tremendous amount of change and consolidation. There’s been reduction in R&D staff and investment, as well as the elimination of many in-house production environments. As a result, we have transformed from being an outsider used for contract manufacturing into an integral part of our customers’ R&D and engineering teams for device development and production. We know the ins and outs of materials and their best applications, and will provide the integrated capabilities that can save on development time and cost.
MPO: What kind of services (R&D, prototyping, etc.) other than providing the highest-quality extrusion are your customers expecting from you?
Decker: Our customers are looking for regulatory support for new development projects that are global in nature, along with material science and testing services.
Ridley: We perform a great deal of R&D for customers and potential customers as well as prototyping. We also have developed a sampling program to allow customers to evaluate products for their next-generation prototypes. We also have developed a “Technical Z-Team,” which translates to having an innovative partner developing medical solutions at our client’s side. The Technical Z-Team is a multi-disciplined traveling team developed to provide onsite and offsite support for everything from medical device development projects and consultations to presenting at conferences, in-house seminars and medical and industrial trade show events.
Schwantes: Prototypes and samples have always been very important, but more stringent validation requirements have become a bigger priority. Many OEMs are looking for a company that can offer a full list of services like assembly, packaging, and sterilization. They are looking to consolidate to one supplier to provide all of the services for more efficient project management and cost savings.
McCormack: Our customers told us they need a partner with streamlined processes for completing every aspect of an extrusion product from material selection to manufacturing. Our capabilities include product concept development, engineering, design for manufacturability, regulatory affairs, material selection, prototyping, testing and validation, production process development, custom tooling, manufacturing, secondary processing, assembly, packaging, private labeling, and sterilization. Our vertically integrated solution for extrusion greatly facilitates communication and decision-making while improving quality control, scrap reduction, and speed to market.
Lathiya: Customer demands for engineering services, similar to consulting, continue to increase. Also, OEMs want supply chain solutions in order to minimize their on-hand inventory.
MPO: What would you say is the single most important capability you offer your customers, and why?
Ellis: We offer deep technical expertise in material selection, process development and customer tool/fixture design to support the customer’s development efforts.
Ridley: We have the ability to partner with our customers from initial idea to prototype to full production. Our polymer experts don’t just apply their scientific knowledge of resins and extrusions, they work with customers on everything from reducing waste to speeding delivery times to cutting costs. Also, the fact that we have multiple facilities is key, as it means if there ever is a problem in one facility, we can still meet deadlines and delivery dates.
Decker: Improved reliability with Avalon’s polymer solution casting with limited bond joints and the ability to integrate atraumatic tips and flaring, reinforcements within a single-piece construction.
Schwantes: The most important capability we offer is collaborative solutions. By working with customers to develop a solution or material specific to their project not only creates a strong relationship but also focuses on actually coming up with a permanent solution rather than giving them a temporary fix.
McCormack: Our extrusion team is among our most important capabilities. Although device companies don’t necessarily know all about these new technologies and advanced materials, they expect their product development and production partners to be expert advisers on these topics. Our team of highly-qualified engineers, material and polymer experts, Ph.D. scientists, and skilled technicians has the deep expertise, technical ability, and decades of experience to successfully complete customer-specified extrusion for tubing and fiber-based projects.
MPO: What’s the biggest challenge to providing all the services your customers demand?
Ellis: One challenge is the length of development projects. It can take years for new ideas to reach the market.
Lathiya: Experience and competency. While growing by introduction of additional or new capabilities is the right way to grow, it is important to not stray too far too fast from your competency. Customers prefer to have their suppliers do more but if you are not competent in a certain process or you take on more than you can really handle you have done a disservice to your customer and company.
Ridley: The biggest challenge is simply staying ahead of the device innovation curve. We put a great deal of emphasis on educating our staff and recruiting the top polymer science minds in the industry. The payoff is that we have a unique perspective and the newest information that allows us to align more closely with some of the world’s leading multinational OEMs to help foster device innovation through polymer science.
Schwantes: Making sure that everyone involved in the project understands what is required to make the finished product and also making sure that quality and regulatory systems are put into place to meet those expectations. Clarity of those expectations upfront prevents costly changes and delayed project completion. It has also been more challenging to help the customer meet the expectations of the FDA.
MPO: There has been so much consolidation in the medical device industry over the last year. As OEMs merge and consolidate supplier lists, has this impacted your business in any way? Has it changed how you do business? If not yet, are you expecting its impact?
Schwantes: Consolidation tends to bring big changes in both projects and contacts. What one company felt was a very important project, the new company may not. There is always the possibility of people you have worked with for years potentially leaving the company or taking a different position within the company. We have had customers wanting to fast-forward projects so that they can be completed before someone new comes in and makes changes. We have to be ready to respond quickly to projects that were previously delayed.
Lathiya: The consolidation and rationalization of the supply chain has provided us with tremendous opportunities to grow our business. It has changed the way we view or business as not only being a solution to their product needs but by being a better business partner. That would include having a quality system that is in parity with our customers, offering supply chain solutions to meet their needs, having a worldwide sales force to interact with the customers regularly, ensuring we have the appropriate resources internally to support our customers’ needs and having the financial stability and flexibility to grow with our customers.
Ellis: We are seeing consolidation of purchasing and quality functions and movement toward standardization of processes and expectations. This has brought us opportunities that we otherwise might not have accessed.
Ridley: It’s actually changed our business in a positive way. We’re at our best when we’re able to act in the role of partner/advisor versus straight supplier. With consolidations occurring, less R&D is being done in house, driving OEMs to approach us with more partnering opportunities. We thrive on opportunities that afford a consultative approach when solving a problem or addressing challenges.
MPO: How do you stay ahead technologically?
Ridley: Many of the technology advancements come as a result of consultative dialogue and getting to the heart of our customers’ challenges. When our sales team or polymer staff expert talks with a client who says, “I wish I had something that would …” we take that back to our team of experts and start working on a solution. We have participated in numerous medical conferences for physicians over the last decade to hear directly from the doctors as to what they are looking for in the future in an unfiltered environment.
Schwantes: We have focused our R&D resources on improving our process capabilities with projects like our Compass Technology that optimizes speed with precision in a closed-loop extrusion system. We have also started to optimize materials to improve accuracy and function in medical devices. By working closer with our customers we can understand their challenges and create solutions that give us an edge in the marketplace.
Decker: We have a staff of qualified manufacturing, material science, design and development and quality engineers that push the boundaries of tubing technology to provide products that offer clean transitions, no delamination concerns, seamless tapers and tips with limited to no bonds.
McCormack: In today’s medical device environment, technology is changing so fast that keeping up with it requires full-time engagement. We stay closely connected with our customers to be able to get a glimpse into the future. Our customers often grant us access to their future medical device development plans. We remain flexible, keep a keen eye on university–based research and invest in the most promising projects, analyze trends in healthcare across the world, and nurture a company-wide culture that promotes a “what if … ?” approach to projects. In the past three years, we have expanded our global network of extrusion facilities, and invested in the latest equipment and technologies so that we have room to grow and innovate.
Ellis: We have good working relationships with our silicone suppliers and leverage learning from them. We also actively work with product development teams to understand new requirements and opportunities.
MPO: How will extrusion and other highly commoditized medtech areas change in the next five years?
Schwantes: While some things have become commoditized there are some extrusion capabilities that are still more specialized especially with materials that are harder to process. As requirements become more demanding I think some customers will choose to keep focusing on improving extrusion processes and add new materials while others will prefer the commoditized products. I see medical devices becoming more complex with more technology built in, which will push for more specialized engineering and more stringent FDA regulations.
Ridley: With budgetary cutbacks, having a one-stop shop may take on a greater importance when looking for an extrusion supplier. The demand to offer value-added optimization versus straight product is already pronounced in the market and will continue to grow. And, as extrusions become more commoditized, the level of service provided is what will make suppliers stand out and cement their relationships in the medtech space. We’re involved with everything from material selection and component supply all the way down the line to applications, such as our biomaterials product line used in bioabsorbable stenting. We work side by side with customers on every step of the journey, a need that is only continuing to grow.
Decker: There will be consolidation and acquisition activity of medical manufacturing companies mirroring medical device companies to offer more full-service capabilities.
Lathiya: I think you will continue to see industrial-type companies entering the medical device industry, and we will continue to see high M&A (merger and acquisition) activity within the medical device space.
Ellis: As customers consolidate, we would expect suppliers to consolidate as well. Integration of secondary operations and production of completed devices will offer growth opportunity.
For on-the-ground feedback about current market trends in this sector, Medical Product Outsourcing turned to the following medical extrusion market insiders:
- Ronelle Decker is market development manager for Rancho Dominguez, Calif.-based Avalon Laboratories LLC, a division of Nordson Corp. that makes products for surgical and minimally invasive procedures, including valve replacement and repair, bypass surgeries, urology, lung support and ventricular assist device therapies, and other specialized medical tubing applications.
- Rick Ellis is vice president of engineering for the silicone division of Vesta Inc. in Franklin, Wis. Vesta, which recently was acquired by Lubrizol Corp. and integrated into its life-sciences unit, specializes in silicone molding, precision medical extrusion of thermoplastics and silicone, and medical device assembly.
- Apur Lathiya is senior business development manager of Vesta’s thermoplastic division in Corona, Calif.
- Jim McCormack is the manager of global marketing communications-OEM for Teleflex Medical OEM, a division of Wayne, Pa.-based Teleflex Incorporated that makes custom-engineered extrusions, complex catheters, introducers and sutures/fibers.
- Josh Ridley is senior manager, biomaterials division, for Zeus Inc., which is headquartered in Orangeburg, S.C. The company makes polymer components for minimally invasive medical devices. In addition to medical, Zeus serves other industries, including aerospace, automotive, oil and gas, and general industrial.
- Sonia Schwantes is product specialist in the medical components division of Saint-Gobain, which provides silicone molding, thermoplastic and silicone extrusion, and custom fabrication for medical device OEMs.
Sonia Schwantes: We’re being asked for more complex extrusions such as para tubes and multi-lumens made from a wider variety of materials that are needed for specific applications. The more commonly used materials like silicone and PVC (polyvinyl chloride) can provide tighter tolerances and smaller outer diameters but do not always have the ideal properties that are needed for specific applications.
Apur Lathiya: We continue to get strong demand for tri-layer extrusions and thin-walled extrusions.
Ronelle Decker: We are working with several companies in the product development phase for micro-catheters and shafts primarily within the neurovascular space utilizing micro-coils and hypotubes. The primary goals are to create minimal wall thicknesses to offer largest inner lumen and smallest outer diameter along with lubricious inner lumens. This includes outer diameters from .012-.013 inches and some at 2-meter lengths.
Rick Ellis: We are seeing more multi-lumen extrusions and a greater number of requests for secondary operations—punching, printing, etc.
Jim McCormack: Healthcare is trending toward minimally invasive surgery techniques. Our customers are asking us to produce multi-functional extrusion in incredibly small spaces. We met the challenge with micro-extrusions—a fraction of the size of human hair—while maintaining outstanding tolerance control, length accuracy, and tubing consistency. We also produce ultra-lite PTFE (polytetrafluoroethylene) liners with walls as thin as 0.0005 inches. Extrusion does not necessarily translate to only tubing. Sutures and fibers are other types of extrusions.
MPO: What are some of the materials challenges (or opportunities) you have faced?
Josh Ridley: We see material opportunities more than challenges. We also view opportunities through two lenses: big, breakthrough changes; and incremental changes. Both have their place in the constantly changing world of minimally invasive devices. In terms of revolutionary change, our bioabsorbable polymers have been shown to behave and perform like traditional metallic components, but ultimately disappear, allowing the body to return to its normal state without anything left in the body. This encourages improved patient outcomes and reduces hospitalization time.
Lathiya: Higher-temperature materials such as PEEK (polyether ether ketone) and polysulfone have become more popular in some of the larger sizes. This becomes a challenge when customers continue to ask for tight tolerances with the larger sizes.
Ellis: We are seeing more requests for “loaded” materials—mostly radio-opaque [which become more visible on X-rays or other imaging technology].
Schwantes: Some opportunities call for specific materials that are not widely available. More customers are requiring specific properties so more development and material knowledge is involved. Plus, FDA (U.S. Food and Drug Administration) scrutiny has created a demand for more chemical and biocompatible testing on materials to make sure there are no issues further down the development chain.
Decker: Our polymer solution casting technology lends itself to a seamless transition with multi-durometers and materials along the length of the medical tubing with limited to no-bond joints. The technology provides for reinforcements—for example, braids, coils, hypotubes—imaging targets, ports and holes and tips all from one-piece construction.
MPO: How are clinical demands shaping medical device companies’ extrusion needs?
Ridley: Minimally invasive surgery will always be a hot topic and area of focus. Clinical demand continues to drive innovation in device technology and polymer extrusions across a number of market segments, but the overarching theme is the same—easier, quicker access with improved outcomes and minimal trauma. In addition, OEMs are feeling the need—and seeing the benefit—of looking to their polymer tubing suppliers to function as an extension of their R&D (research and development) divisions. Prior to this current round of healthcare-related cutbacks, the vast majority of applied innovation may have previously occurred in-house. Now, a well-vetted and trusted extrusion supplier can become a visionary partner, working with OEMs to reduce costs while helping to keep them ahead of the curve with new and improved product designs and applications.
Lathiya: Antimicrobial continues to attract more requests. Longer term, being able to deliver drugs via the polymer will be a game-changer.
Schwantes: Catheters are bringing forth a demand for tighter tolerances as well as a variety of sizes. More customers seem to be moving away from PVC so other materials are coming into play. Smart technology is pushing medical devices to be smaller and wearable with better accuracy. Where previously engineers would work around the weaknesses in materials, now materials are being tailored for specific applications and R&D is finding ways to overcome those weaknesses or developing new grades that eliminate them all together.
McCormack: Minimally invasive procedures requiring the delivery of a device—such as a stent or transcatheter heart valve—or therapy are on the rise across the world. We have a history of extrusion and catheter-based delivery systems that can help customers with the development and production of interventional catheters required to deploy a stent, heart valve, therapy, and/or medication.
Ellis: We are seeing demands for more lumens in each catheter and tighter tolerances.
MPO: Has the nature of your relationship with customers changed much over the last few years?
Lathiya: Customer demands in quality-system parity have continued to grow. Customers view their suppliers as an extension of their manufacturing. To be successful, a contract manufacturer must have quality-system parity and robust processes in both manufacturing and business systems.
Ellis: We have seen increased focus on quality systems and compliance. We are also being asked more often to manage a broader range of the supply chain.
Ridley: Yes. For many [customers], we have become a virtual extension of their R&D divisions. Healthcare reform has forced many medical device manufacturers to cut or at least scale back R&D budgets, limiting their ability to organically innovate. We can take on challenges for these companies and assist them in moving to the next level of product development.
Schwantes: More OEMs are working with contract manufacturers as they outsource assembly and packaging. Many are even outsourcing their development engineering to design firms. Since other companies are involved in the processing and more relationships are developed in the value chain, projects can become more complex because not all companies have the capability or capacity to handle secondary operations.
McCormack: We’ve watched the medical device world go through a tremendous amount of change and consolidation. There’s been reduction in R&D staff and investment, as well as the elimination of many in-house production environments. As a result, we have transformed from being an outsider used for contract manufacturing into an integral part of our customers’ R&D and engineering teams for device development and production. We know the ins and outs of materials and their best applications, and will provide the integrated capabilities that can save on development time and cost.
MPO: What kind of services (R&D, prototyping, etc.) other than providing the highest-quality extrusion are your customers expecting from you?
Decker: Our customers are looking for regulatory support for new development projects that are global in nature, along with material science and testing services.
Ridley: We perform a great deal of R&D for customers and potential customers as well as prototyping. We also have developed a sampling program to allow customers to evaluate products for their next-generation prototypes. We also have developed a “Technical Z-Team,” which translates to having an innovative partner developing medical solutions at our client’s side. The Technical Z-Team is a multi-disciplined traveling team developed to provide onsite and offsite support for everything from medical device development projects and consultations to presenting at conferences, in-house seminars and medical and industrial trade show events.
Schwantes: Prototypes and samples have always been very important, but more stringent validation requirements have become a bigger priority. Many OEMs are looking for a company that can offer a full list of services like assembly, packaging, and sterilization. They are looking to consolidate to one supplier to provide all of the services for more efficient project management and cost savings.
McCormack: Our customers told us they need a partner with streamlined processes for completing every aspect of an extrusion product from material selection to manufacturing. Our capabilities include product concept development, engineering, design for manufacturability, regulatory affairs, material selection, prototyping, testing and validation, production process development, custom tooling, manufacturing, secondary processing, assembly, packaging, private labeling, and sterilization. Our vertically integrated solution for extrusion greatly facilitates communication and decision-making while improving quality control, scrap reduction, and speed to market.
Lathiya: Customer demands for engineering services, similar to consulting, continue to increase. Also, OEMs want supply chain solutions in order to minimize their on-hand inventory.
MPO: What would you say is the single most important capability you offer your customers, and why?
Ellis: We offer deep technical expertise in material selection, process development and customer tool/fixture design to support the customer’s development efforts.
Ridley: We have the ability to partner with our customers from initial idea to prototype to full production. Our polymer experts don’t just apply their scientific knowledge of resins and extrusions, they work with customers on everything from reducing waste to speeding delivery times to cutting costs. Also, the fact that we have multiple facilities is key, as it means if there ever is a problem in one facility, we can still meet deadlines and delivery dates.
Decker: Improved reliability with Avalon’s polymer solution casting with limited bond joints and the ability to integrate atraumatic tips and flaring, reinforcements within a single-piece construction.
Schwantes: The most important capability we offer is collaborative solutions. By working with customers to develop a solution or material specific to their project not only creates a strong relationship but also focuses on actually coming up with a permanent solution rather than giving them a temporary fix.
McCormack: Our extrusion team is among our most important capabilities. Although device companies don’t necessarily know all about these new technologies and advanced materials, they expect their product development and production partners to be expert advisers on these topics. Our team of highly-qualified engineers, material and polymer experts, Ph.D. scientists, and skilled technicians has the deep expertise, technical ability, and decades of experience to successfully complete customer-specified extrusion for tubing and fiber-based projects.
MPO: What’s the biggest challenge to providing all the services your customers demand?
Ellis: One challenge is the length of development projects. It can take years for new ideas to reach the market.
Lathiya: Experience and competency. While growing by introduction of additional or new capabilities is the right way to grow, it is important to not stray too far too fast from your competency. Customers prefer to have their suppliers do more but if you are not competent in a certain process or you take on more than you can really handle you have done a disservice to your customer and company.
Ridley: The biggest challenge is simply staying ahead of the device innovation curve. We put a great deal of emphasis on educating our staff and recruiting the top polymer science minds in the industry. The payoff is that we have a unique perspective and the newest information that allows us to align more closely with some of the world’s leading multinational OEMs to help foster device innovation through polymer science.
Schwantes: Making sure that everyone involved in the project understands what is required to make the finished product and also making sure that quality and regulatory systems are put into place to meet those expectations. Clarity of those expectations upfront prevents costly changes and delayed project completion. It has also been more challenging to help the customer meet the expectations of the FDA.
MPO: There has been so much consolidation in the medical device industry over the last year. As OEMs merge and consolidate supplier lists, has this impacted your business in any way? Has it changed how you do business? If not yet, are you expecting its impact?
Schwantes: Consolidation tends to bring big changes in both projects and contacts. What one company felt was a very important project, the new company may not. There is always the possibility of people you have worked with for years potentially leaving the company or taking a different position within the company. We have had customers wanting to fast-forward projects so that they can be completed before someone new comes in and makes changes. We have to be ready to respond quickly to projects that were previously delayed.
Lathiya: The consolidation and rationalization of the supply chain has provided us with tremendous opportunities to grow our business. It has changed the way we view or business as not only being a solution to their product needs but by being a better business partner. That would include having a quality system that is in parity with our customers, offering supply chain solutions to meet their needs, having a worldwide sales force to interact with the customers regularly, ensuring we have the appropriate resources internally to support our customers’ needs and having the financial stability and flexibility to grow with our customers.
Ellis: We are seeing consolidation of purchasing and quality functions and movement toward standardization of processes and expectations. This has brought us opportunities that we otherwise might not have accessed.
Ridley: It’s actually changed our business in a positive way. We’re at our best when we’re able to act in the role of partner/advisor versus straight supplier. With consolidations occurring, less R&D is being done in house, driving OEMs to approach us with more partnering opportunities. We thrive on opportunities that afford a consultative approach when solving a problem or addressing challenges.
MPO: How do you stay ahead technologically?
Ridley: Many of the technology advancements come as a result of consultative dialogue and getting to the heart of our customers’ challenges. When our sales team or polymer staff expert talks with a client who says, “I wish I had something that would …” we take that back to our team of experts and start working on a solution. We have participated in numerous medical conferences for physicians over the last decade to hear directly from the doctors as to what they are looking for in the future in an unfiltered environment.
Schwantes: We have focused our R&D resources on improving our process capabilities with projects like our Compass Technology that optimizes speed with precision in a closed-loop extrusion system. We have also started to optimize materials to improve accuracy and function in medical devices. By working closer with our customers we can understand their challenges and create solutions that give us an edge in the marketplace.
Decker: We have a staff of qualified manufacturing, material science, design and development and quality engineers that push the boundaries of tubing technology to provide products that offer clean transitions, no delamination concerns, seamless tapers and tips with limited to no bonds.
McCormack: In today’s medical device environment, technology is changing so fast that keeping up with it requires full-time engagement. We stay closely connected with our customers to be able to get a glimpse into the future. Our customers often grant us access to their future medical device development plans. We remain flexible, keep a keen eye on university–based research and invest in the most promising projects, analyze trends in healthcare across the world, and nurture a company-wide culture that promotes a “what if … ?” approach to projects. In the past three years, we have expanded our global network of extrusion facilities, and invested in the latest equipment and technologies so that we have room to grow and innovate.
Ellis: We have good working relationships with our silicone suppliers and leverage learning from them. We also actively work with product development teams to understand new requirements and opportunities.
MPO: How will extrusion and other highly commoditized medtech areas change in the next five years?
Schwantes: While some things have become commoditized there are some extrusion capabilities that are still more specialized especially with materials that are harder to process. As requirements become more demanding I think some customers will choose to keep focusing on improving extrusion processes and add new materials while others will prefer the commoditized products. I see medical devices becoming more complex with more technology built in, which will push for more specialized engineering and more stringent FDA regulations.
Ridley: With budgetary cutbacks, having a one-stop shop may take on a greater importance when looking for an extrusion supplier. The demand to offer value-added optimization versus straight product is already pronounced in the market and will continue to grow. And, as extrusions become more commoditized, the level of service provided is what will make suppliers stand out and cement their relationships in the medtech space. We’re involved with everything from material selection and component supply all the way down the line to applications, such as our biomaterials product line used in bioabsorbable stenting. We work side by side with customers on every step of the journey, a need that is only continuing to grow.
Decker: There will be consolidation and acquisition activity of medical manufacturing companies mirroring medical device companies to offer more full-service capabilities.
Lathiya: I think you will continue to see industrial-type companies entering the medical device industry, and we will continue to see high M&A (merger and acquisition) activity within the medical device space.
Ellis: As customers consolidate, we would expect suppliers to consolidate as well. Integration of secondary operations and production of completed devices will offer growth opportunity.