SITH consists of two distinct hubs—the extrusion and additive manufacturing hubs. The extrusion hub serves the industry through its timely supply of complex extrusion profiles and processes to its customers’ demanding tolerances, while the additive manufacturing hub uses 3D printing to create high-precision components out of thermoplastic medical-grade materials. Both hubs collaborate to provide quick iterations and are available to customers at any development stage—from early product development to iterations on an existing design. To help provide some insight into how OEMs can benefit from these exciting capabilities at Spectrum, Tyler Stark, senior director of Additive Manufacturing and Innovation, and Matt Bills, senior vice president of Extrusion Innovation & Technology, responded to several questions around this topic from Sean Fenske, MPO's editor-in-chief in the following Q&A.
Sean Fenske: Spectrum now offers the first two of its Innovation & Technology Hubs. Can you explain what these are and what their purpose is?
Tyler Stark: Yes, the first hub is the extrusion hub, which focuses on developing complex extrusion profiles or new, innovative extrusion processes to create next-generation tubing and devices, furthering the medical industry. The second hub is our additive manufacturing (AM) hub, which involves innovation around 3D printing medical-grade thermoplastics. The AM hub is a “continually innovative” hub that creates high-precision components from any thermoplastic, medical-grade material; that involves micro, large, and infinitely long parts. Both hubs lead Spectrum in innovation and next-generation devices.
Matt Bills: It is also important to note our extrusion hub offers our customers a way to work with our engineering team in-person and on-site while making their tubing and, more importantly, the ability to iterate "on the fly." Thanks to the addition of the two hubs, our customers can get their products to market quicker than previously possible. Through these efforts, we are creating a true partnership with our customers.
Fenske: What types of challenges are you addressing in the extrusion hub? What are some of the more common or challenging issues being addressed?
Bills: Our customers often ask us to push the envelope with the aim of ever smaller, thinner, and tighter tolerances. For instance, we have successfully made a 1/8" diameter tube with a 0.0006" of a wall (yes, only six ten thousandths of an inch). We accomplished this in a free-air extrusion process, holding a CPK of 3.8 on the diameter and even a tighter tolerance on the wall thickness. Spectrum is well-equipped to take on such challenges, as the company is passionate about pushing the boundaries of what is possible. Another challenge we’re in the process of solving is extruding multi-lumen tubing that is also braid-reinforced continuously. When customers present a high-volume single-use device, cost is a major consideration. Producing this level of extrusion complexity in a more economical process is what will help drive innovation while reducing healthcare costs.
Fenske: What about the additive manufacturing hub? What's happening there? Are customers coming to you with more design challenges or full production questions?
Stark: The additive manufacturing hub is full of exciting developments. First, we are in the final stages of installing a cleanroom in the AM area, which allows components to be processed inside a cleanroom environment. Additionally, we have expanded our SLA processes, adding to our already impressive lineup. As a result, Spectrum will be able to print production quantities out of SLA biocompatible materials. We have also achieved stability in producing quick-turn thermoplastic parts. With multiple printers ready to go, we can turn out parts in as little as three to five days.
There has been a noticeable shift in the industry. More and more customers are utilizing 3D printing to create complex designs and multi-material parts that cannot be produced using traditional manufacturing methods. This change has led to more innovative and personalized products and a more customer-centric approach to manufacturing. As a result, Spectrum is now in a prime spot to assist customers in getting them exactly what they need from the same medical-grade thermoplastics as a molded or extruded component.
Fenske: Do these hubs exist in silos, or is there a protocol for them to be collaborative? For example, do the hubs work together if a customer is best served through extrusion and additive manufacturing?
Stark: These two hubs operate independently but constantly collaborate on innovation, developing new ideas to better suit our customers' end needs. Sometimes, the extrusion hub and the additive manufacturing hub collaborate to create a device for a customer. This collaboration can involve developing a component for the device using both extrusion and 3D-printing technologies.
Bills: Another example of collaboration between the hubs would be if a customer's timeline to market is so tight, they can't wait for extrusion tooling. For instance, we can work concurrently together to get the customer tubing through our AM hub in short order while we wait a couple of weeks to get their extrusion tooling.
Fenske: At what stage are customers working with these hubs? Is it from "napkin-sketch," or is it further along the development process?
Stark: Regarding the AM hub, we receive a wide variety of requests, ranging from "napkin-sketch" to highly detailed and specific designs and everything in between. We even had a customer design their part around 3D printing exclusively through us. The AM hub is currently focused on a major goal of producing parts suitable for human use within the next year. There is a lot of involvement and validation to make this happen, but it would also be a game changer.
Bills: Quite frequently, we work with our customers’ Advanced Development teams responsible for their five-year programs. Generally, that means what they are looking for doesn’t currently exist. That’s where we partner together to come up with solutions that are both feasible and long-term manufacturable. Other times, the customer just wants to develop their next-generation device immediately, for which we will modify the current process to their new specifications and enhancements.
Fenske: Is there an ideal timeframe for customers to approach a Spectrum hub with their challenge?
Stark: Any time is ideal for reaching out to the AM hub. Usually, customers benefit more early on as they can decide the materials, design, dimensions, etc., with quick iterations instead of going with a specific design right into larger-scale testing. However, the customer can contact the AM hub and find us beneficial at any point.
Bills: Interestingly, almost all customers who work with our extrusion hub are in the early concept stages of their catheter design, still working out durometers, wall thickness, etc. That's where our extrusion hub really comes through for them. We can go through a matrix of durometers and wall thicknesses within a single day, getting them the answer promptly and enabling them to move on to the next phase of their project.
Fenske: Without giving away proprietary or customer information, can you share insights on some of the future products these hubs are involved in developing?
Stark: One of the big things the AM hub is involved in is a proprietary technology that would create fully fused, smooth, injection-like molded parts from any thermoplastic material. This technology can achieve the same bond strength, fit, feel, and surface finish as an injection molded part, but using a fully 3D-printed part. We are excited about this and will hopefully roll it out in 2023.
Bills: We recently developed a new process for producing soft, tacky, and flexible polyurethanes that achieves tighter tolerances and more consistent results from lot to lot. What we accomplished was a higher level of predictability.
Fenske: Do you have any additional comments you'd like to share based on the topics we discussed or something you'd like to tell medical device manufacturers?
Stark: If you have a design to test out, whether it involves a tube or a 3D-printed component, feel free to contact us! We welcome challenges and constantly evolve and grow our hubs to create the next breakthrough product that better serves our customers.
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