June 14, 2012, was the best day of Derek Herrera’s life.

He was working his dream job as a Special Operations Team commander for the U.S. Marine Corps., leading an elite group of men into battle in Afghanistan. His military career was approaching its pinnacle, and Herrera’s mind wandered to the future that day as he and his team prepared to ambush the enemy.

The best day.

In an instant, however, Herrera’s best day turned into his worst.

A sniper shot both Herrera and a fellow marine as the pair crouched atop a desert compound; the bullet that felled Herrera entered his shoulder and lodged in his spine, instantly paralyzing him. Another bullet passed through his colleague’s neck, miraculously missing all vertebrae.

The worst day.

A critically injured Herrera worked to keep his comrade alive as his fellow team members summoned a medivac helicopter and carried the pair on stretchers to safety, albeit exposing themselves to enemy fire.

“It was the best and worst day of my life,” Herrera told NBC’s Today Show in late 2019. “As a leader, it was the best day of my life because the team showed the best, the most heroic actions on the battlefield. I’m still alive because of that and so is Ricky. And, obviously, it was the worst day because so much was taken away.”

Indeed, the loss was enormous: a dream job, a steady income, and the ability to walk.

The worst day.

Rather than mourn his former life, though, Herrera worked to build a new one. He returned to school, earning an MBA from the UCLA Anderson School of Management in July 2015.
The best day.

He then founded a business to improve the quality of life for people suffering from spinal cord injury or disease. Its first product is a semi-permanent, internal urinary “smart” catheter that would replace single-use devices for patients lacking bladder control.

UroDev Medical’s IntelliFlow Bladder Management System enables patents to empty their bladder with the touch of a button on a wireless remote control. IntelliFlow reduces the number of consumable catheters from 200 (disposable) to four per month.

Crafted from silicone, the catheter tip features a magnetic valve pump that opens and closes, allowing the bladder to fill naturally.

Catheters like the kind developed by Minneapolis-based UroDev Medical are among the most widely used healthcare products, having been designed to carry fluid to and from the body. These thin, flexible tubes vary by type, size, length, and material composition (latex, silicone, Teflon, rubber, PVC) and are usually extruded. A common manufacturing technique among medical device developers, extrusion creates specially shaped objects by forcing metal or other materials into a pre-set mold.  

Since its birth more than 200 years ago, extrusion has advanced far beyond single, hollow tube-making capabilities to encompass multi-lumen processes that incorporate stops, bumps, and varying thickness in one design.

“Next-generation materials that offer enhanced and unique properties seem to be a dominant market trend,” noted Alex Kakad, Global Product manager at TekniPlex Healthcare, a materials science solutions firm. “Market demand is increasing for microextrusion products that are smaller and more intricate in design. These products require much tighter tolerances—an ongoing challenge for manufacturing facilities.”

AME was one of more than a half-dozen experts who shared their thoughts with MPO about the trends, challenges, and market forces impacting medical extrusion. The group included:

• Lars Gerding, vice president of Corporate Technology at Freudenberg Medical, a global partner for the design, development and manufacture of medical devices, components, and product solutions.
• Alex Kakad, Global Product manager at TekniPlex Healthcare, a Wayne, Pa.-based materials science solutions partner.
• Geary A. Havran, president and board chairman of St. Petersburg, Fla.-headquartered medical device contract manufacturer NDH Medical Inc. 
• Jonathan Jurgaitis, senior extrusion engineer – Interventional and Surgical Technologies at Spectrum Plastics Group, an Alpharetta, Ga.-based medical components and contract manufacturer.
• Steve Maxson, Innovation and Business Development manager at US Extruders, a Westerly, R.I.-based developer of highly engineered, custom single-screw extruder solutions.
• Tim Steele, manager, founder, and owner of MicroSpec Corporation, an advanced custom medical extrusion provider located in Peterborough, N.H.
• Patrick Straub, key account manager at Röchling Medical Waldachtal AG, a German provider of high-quality, customized components and assemblies.
• Tyler Ware, owner/president of GenX Medical LLC, a provider of quick-turn, custom-extruded medical tubing. The Chattanooga, Tenn., firm specializes in microbore tubing, bioresorbable extrusions, and multilumen tubing.

Michael Barbella: What technology and advancements are improving medtech extrusion?

Lars Gerding: The most significant changes are being seen within raw material development, providing superior mechanical properties. Together with a special coating as a barrier, for friction reduction or an active layer, the material or product can be specially designed for a customer-specific application.

Geary A. Havran: Some of the key advancements revolve around digital control technology and data acquisition. Those allow for more precise control and statistical process monitoring, which reduce variation in product.

Jonathan Jurgaitis: Leading medical OEMs continue to innovate with advancements in minimally-invasive procedures that lead to improved patient outcomes. As a leading contract manufacturer of medical extrusions that means Spectrum is innovating in our own way by delivering consistency through our machinery, operators, and engineers. Modern extrusion line control systems are connected, powerful, and precise in delivering real-time in-line monitoring, vision systems, laser micrometers and flaw detection, with feedback loops to automate a level of control and consistency that is pushing the extrusion process to new levels.

Alex Kakad: The industry is asking for more functionality from our extruded tubing products. This added functionality may come from higher quality extruded products, more complex formulations, or co-extrusion.  Coextrusion is used to provide multiple materials in a singular tube extrusion and pushes the limits of combining materials that may not be completely compatible when processing. Higher quality devices that can maintain tight tolerances or consistent peel strengths to allow for paratubing constructions to up to seven bonded tubes within one extruded length are pushing processing limits and putting more pressure on manufacturers to up their innovation game.

Steve Maxson: Let’s talk about modern therapies that are really driving the medtech industry—neurovascular for very small tubing and structural heart for very large tubing. It requires a lot of flexibility from an extrusion technology and equipment standpoint. And for that reason, flexible extruders that allow you to quickly change the screw and barrel size within minutes is one of the advancements in extrusion technology.
Some people refer to these extruders as modular or flexible extruders. Basically, if I’m running tiny medical tubing in the range of 1.6Fr – 3Fr (.020” – .039” OD) for neurovascular application I might need to run them on a 3/4-inch micro extruder. On the other hand, sheath tubing for structural heart applications can be very large, up to 40Fr (.530”). So, I would need to go from a very small 3/4-inch barrel and screw, all the way up to 1.25-inch extruder barrel and screw. So, these more modern, flexible extruders allow you to swap out barrels very quickly so that you can participate in a very tiny, minimally invasive tubing as well as the larger-bore catheter shaft tubing for structural heart applications on the same extrusion line. This technology also fits very well with the contract manufacturers, which are really running the bulk of medical tubing.

They frequently change out often—they might run for an hour and a half with certain material and tubing size and they will shut down, clean out, and run for a couple of hours, shut down and clean out—that’s what they constantly do day to day. The flex or modular type of extruder allows them to quickly change out from one barrel screw package to another.

Tim Steele: This is a very interesting question. Most of the extrusion advancements in medtech are not being done by the machine manufacturers, so to speak. The extrusion houses—the Microspecs or the Vestas or Putnam Plastics—they innovate in-house and that happens at Microspec with almost every prototype we make. For instance, we’re making a tube for a company and this tube has about a 5mm outside diameter and 10 lumens. The technology innovations are happening at smaller companies, and these companies are leveraging existing technology to make new products. Microspec innovates with every project that we undertake. When we do innovation we keep the technology in-house and treat it as a trade secret or proprietary knowledge. You don’t hear about the innovation but it’s happening everywhere, I guarantee you. We don’t share our know-how with anybody. That’s where the advancements are being made. You see lots of new parts coming out in the marketplace but you don’t see the technology that goes into producing those parts. There’s a lot of project innovation happening but it’s not being shared with the public.

Patrick Straub: Medical extrusion is influenced by a number of factors that will improve future manufacturing in an advanced way. One important factor is the right material. The ability to use existing material compounds and to adapt and optimize them for specific applications, considering the mechanical characteristics, is a major advance. In addition, manufacturing technology plays a major role. In the meantime, “new” manufacturing technologies (e.g., additive manufacturing “SLM”) make it possible to develop tools that were not possible using conventional manufacturing methods so far. This results in new possibilities for product dimensions. The continuous optimization of manufacturing equipment, lead to more cost-effective production, considering increasing requirements in terms of quality and reproducibility. Not to forget the products themselves—optimized compounds for “smart” product labeling and their traceability bring more and more improvements.

Tyler Ware: There has been some improvements in the ability to make your own things since I have been in this industry. It’s easier and cheaper to make your own tooling, components, and improvements using CNCs and 3D printing. Also, the ability to measure using optical scopes is lowering in price and availability.

Barbella: What are customers requesting in their extruded products?

Havran: We’re seeing more interest in tubing that provides higher performance characteristics and, in many cases, minimizes the amount of material or wall thickness. That is done to get more useful space from the same size tube. I think it’s a continuation of a trend.

Jurgaitis: Even smaller dimensions call for tighter tolerances and pushing the limits of our state-of-the-art process capabilities. This tops the list.

Kakad: Depending on the device in development, customers are asking for different things.  High on the list are tubing extrusions that are smaller and more intricate in design with extremely tight tolerances. Tight tolerance inside diameter (+ 0.005”) with a high level of capability (CPk) has enabled customers requiring volumetric flow to develop innovative products within the IV therapy markets. Other key requests include improved shelf life of the drug being transported through the tubing during application use. If preservatives and active ingredients in the drug maintain their efficacy longer, tubing sets can be used longer—an important enhancement for the patient and the environment, with fewer tubing sets being thrown out in a given year. Depending on the drug requirements, this shelf-life enhancement can either be obtained through the use of multi-layer coextruded tubing or with the use of specialty compound formulations that incorporate additives that offer light blocking properties at various required wavelengths.

Maxson: There’s a big shift going on in the market right now due to supply chain constraints. A lot of the fluoropolymer-based extrusions such as FEP heat shrink tubing, for instance, you can’t get access to these components that are required to build catheter shafts. A lot of contract manufacturers are deciding to vertically integrate fluoropolymer extrusion capability into their existing extrusion operations. Most contract manufacturers don’t run these high-temperature fluoropolymer materials because their extrusion equipment is not suitable for processing high temperature fluoropolymer materials that require special corrosion resistant metals for the screw, barrel and die. This supply chain constraint is forcing contract manufacturers and medical device OEMs to bring fluoropolymer extrusion technology in-house mainly for captive use. Customers are asking us to help them bring this new capability, into their extrusion operations.

Steele: It comes down to Business Basic 101. Our customers are first looking for quick service, high quality, and the lowest price possible. They also are looking for innovation, creativity, and good customer service, but that’s what all OEMs are looking for when they deal with a Microspec or a Putnam Plastics. It’s interesting that the bigger companies are probably more demanding on prices than smaller companies.

Straub: There are high requirements in all aspects for extruded products for medical applications. On the one hand, from a technological point of view, the highest process reliability, lowest tolerances, and reproducibility must be guaranteed. The requirements for individual materials with specially-adjustable properties such as buckling stability, torsional stability, compression strength, tribological properties, or temperature resistance call for a high level of material expertise to develop a compound that meets the desired requirements.

Downstream processing steps, inline and offline, such as cleaning and sterilization processes are also becoming increasingly important. Individual medical fields of applications for extruded products require individual manufacturing environments—with ever increasing demands on the respective manufacturing environments such as clean room, gray room, or a controlled environment. The regulatory requirements for traceability, MDR compliance, UDI, or framework conditions such as biocompatibility and cytotoxicity are as individual as the products’ areas of application.

Ware: Customers are asking for thinner products—on ODs as well as small ODs. Lubricious additives are definitely picking up steam fast, more requests are coming in for lubricious additives, and a lot of stabilizers as well. Obviously, multi-lumens are still a very big request, along with balloon tubing and coextrusions. The biggest trend we are seeing across all our customers is that everyone wants it yesterday.

Barbella: Please discuss the challenges in medtech extrusion and how they can be overcome.

Gerding: The understanding of a customer’s requirements and the application is key to be able to provide the best solution for the customer. The best solution varies by application and customer and ranges from very cost efficient to including multiple value-added steps. Being involved in the early phase of product development and interacting with the customer is the key to offering a value added, sustainable solution.
Havran: Sourcing issues. One of the keys is to have a close relationship with material suppliers to minimize disruptions and to continue to develop and incorporate materials specifically tailored to product-specific requirements.

Jurgaitis: Two challenges—not unique to our industry—are supply chain constraints and finding skilled, experienced workers. Employing accurate tracking of current inventory and forecasting demand can mitigate long lead times and shortages. As extrusion is widely considered an art, the secret sauce lies in the ability to attract, train, and retain skilled individuals who find job satisfaction in saving lives through mastering such concepts as extrusion process variables.

Kakad: Market demand is increasing for microextrusion products that are smaller and more intricate in design. These products require much tighter tolerances—an ongoing challenge for manufacturing facilities. Product consistency and batch-to-batch repeatability are the main drivers in the extrusion process. In a continuous extrusion process maintaining factors like OD/ID dimensions, tube concentricity and cut quality—all while factoring in shrink rates for both before and after sterilization—are key elements. State-of-the-art ancillary equipment such as measuring instruments, vision systems, and process controls all can help overcome these challenges but, crucially, cannot replace experience. More than anything, years of hands-on extrusion experience is the differentiating element to success.

Regulatory challenges are also key. Companies must keep the MDR (EU Med Device Regulation) top of mind, and be able to adapt to various changing regulations. They must anticipate and plan for how their business will be affected, and how they must adapt to the different geographies they serve.

Maxson: Some of the really challenging medical extrusion applications are extruding very soft, thin-walled materials that don’t have a lot of melt strength as they’re coming out of the die head. Because they’re very soft like low durometer polyurethanes, they tend to stick and hang-up to guide rollers and other items as they’re progressing down the extrusion line, which creates an unstable process. Tacky tubes can also be difficult to handle post extrusion because they tend to stick together during packaging. A lot of contract manufacturers have developed proprietary technologies and techniques that are used to allow for the extrusion of these very soft materials. A lot of these low durometer materials are used in neurovascular applications and for the atraumatic distal tip on a catheter shaft.

Steele: One of the biggest challenges we’ve run into routinely—and it tends to happen with foreign customers where there might be a language barrier or a communication disconnect—is overspecification of an extruded part, either making the tolerances too tight or not considering all aspects of the tube while engineering it. The engineering and design of the tube being done prior to talking to the extrusion house is probably the biggest challenge. Here domestically it seems that American companies are coming to us sooner, oftentimes at the concept and design stage of a part. They give us the concept and tell us what they want to do and ask for our advice on how we might help them meet their challenge of making a part that will work. The challenge is being connected with the OEM manufacturer at an opportune time to actually help the OEM design and produce a better product. That’s the biggest challenge. Another challenge is tolerances not adding up so you end up with a tube that exceeds the maximum OD of the design. Generally, they are engineering challenges.

Straub: We face a dynamic environment in the field of medical technology extrusion in terms of technology and regulation. Especially in the past two years, the requirements for medical products have increased in terms of MDR and regulatory applications, but, in addition, the supply and procurement issue is still increasing. Moreover, the technology environment and the resulting challenges are evolving very fast, as an innovative company, it is very important to balance the various opportunities here.

Ware: There are challenges to making large, thin-wall tubing that wants to collapse under the pressure of water used to cool it, and there are challenges to making small, tacky, stretchy tubing. The ways to overcome these are different, but for most of our challenges we try to not reinvent the wheel. There are processes already in place from the commodity tubing industry, so we start by trying to apply these principles to our processes, and sometimes it works and sometimes we must tweak it for our application. The largest challenges in medical tubing extrusion is the range of knowledge needed to extrude all different types of resins to all different sizes, which leads to the need to hire the right person for the job. It’s very hands on, very demanding from a mental standpoint and is not cut out for everyone, so I have some serious discussions and find out about people’s ability to solve problems before I give them a shot. I am also still very hands-on in the room when it comes to teaching and helping, as every day we seem to learn something new.

Barbella: What kinds of value-added features are OEMs expecting their extrusion partners to provide (and why)?

Havran: For some customers, the drive to reduce the number of suppliers involved in manufacturing a device, are leading them to seek out extrusion providers who can also provide additional steps of the manufacturing process, including assembly, packaging and sterilization. I think the trend is accelerating as we’re seeing new companies develop around a new device technology without the manufacturing infrastructure.

Jurgaitis: OEMs are looking to reduce their supply chain suppliers to a trusted few. The motivation of this consolidation is to lower management and audit costs and improve collaboration. This provides an opportunity for extrusion suppliers to add additional process and assembly capabilities to provide added value beyond a simple extrusion. Such processes can include bonding, braiding, reflow, printing, laser processing, over molding, packaging, and others. As a global full-service medical device manufacturer, Spectrum Plastics Group simplifies the supply chain, delivers this value of consolidation, and minimizes lead time risk for the OEM.

Kakad: Proper validation services are now an expected attribute of an extrusion partner. They are now a “must have” rather than a “nice to have.” The ability to vertically integrate by offering value-added features such as assembly, slitting, tipping, or other downstream activities also is expected in a truly turnkey partner. Along with validation documentation, the addition of vertically integrated services helps increase speed to market, even while helping an MDM reduce the number of suppliers they must manage to successfully get a device to market.

Maxson: In general, the medical device OEMs are asking their contract manufacturing partners to provide more value than extrusions, they are looking for integrated capabilities such as tipping, flaring, laser marking, RF welding, and over-molding. Certainly, the ability to integrate metals into the catheter tubing wall such as braid reinforcement and laser-cut hypo tubes.

Steele: We are strictly considered an extrusion house. We don’t do grinding or tipping, which many of our customers do. Some of the things we do that our competitors don’t, include very precise cut lengths of +/- five thousands of an inch and/or cut lengths that require a very specific angle. Another thing we do is we validate parts and processes performing OQ, PQ, and PPAP to support our customer’s FDA submissions. The higher degree of documentation we can give to a customer for a part, the more value it is to our customer in their commercialization process. Also, in some cases we ship directly to stock. That’s a big plus for our customers. Those are the type of things that we put into products that are not necessary tangible but certainly valuable.

Straub: In addition to classic manufacturing, extended services from a single source are becoming increasingly important. As a solution provider, we offer our customers great added value by accompanying the entire value chain from the initial idea to the final product. We provide support in the development and design of the product and tool, which is then manufactured in our in-house tool shop. We advise on materials, automation and manufacturing concepts and also offer downstream machining and assembly steps directly in the clean room. At the request of the customer and according to the requirements of the product, we develop suitable packaging, coordinate sterilization, as well as validation and qualification of processes and machines. In addition, we provide support in regulatory matters and thus cover the entire development process of a finished product from a single source.

Ware: We get requests for all kinds of secondary operations, but we focus on extrusion here.  We do provide very tight cut lengths on many extrusions that some of our customers didn’t know we could do inline.  This really helps them save money in not having to go and cut them again.  We also do very specific parts per bag so that when it goes to other operations at our customers facilities its much easier to divide between operators.  I think providing out final inspection data is also useful to some of our customers, as it lowers the amount of checks they need to do at incoming inspection, and time saved is money saved.