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The ability to 3D print micro components in glass provides significant benefits for medical device firms requiring such parts.
November 14, 2022
By: Sean Fenske
It’s been quite the hiatus since attending the Medica and CompaMed trade shows in Dusseldorf, Germany. My last visit to the event was 2019, prior to all the disruption created by the COVID-19 pandemic. With renewed enthusiasm, I was anxious to get back onto the show floor to meet with those companies attending the 2022 event. In anticipation of my visit, I reached out to a number of companies to get the scoop directly from them on what they are showcasing at the event, what challenges customers have brought them, and where they see their role within the industry in aiding medical device manufacturers. With that in mind, Alexander Steimle, chief commercial officer of FEMTOprint, shared the following insights to help you determine if the firm should be a potential services partner for you in 2023 or beyond. Sean Fenske: What technology or service are you emphasizing at Medica/CompaMed this year? Alexander Steimle: 3D printing of miniaturized and multifunctional microdevices in glass to be embedded in all sorts of custom-designed medical components spanning among diagnostics (point of care or benchtop), minimally invasive and/or robotic surgery, active implantables, wearables, imaging, drug delivery systems, and optical equipment. For every category of medical devices, we offer to medtech manufacturers various options for effectively adding or integrating micromechanical, optical, microfluidic, and photonic functionalities at single-micron accuracy. In addition, we are capable of realizing functional coatings, surface treatments, cutting, dicing, and welding of glass parts. Fenske: What’s the most common challenge customers inquire about and how do you address it? Steimle: Components or pieces feasibility in glass. Companies often come to us with limited information, or even misconceptions, about what can or cannot be done with glass through our micro-manufacturing technology, and frequently, those preconceptions are accompanied by concerns related to timing, scalability, sustainability, and costs. The reality is our technology can effectively respond to the medtech industry’s needs for the realization of highly complex geometries with single-micron tolerances while taking advantage of the lesser known, or even unfamiliar, inherent properties of glass such as elasticity, durability, and the ability to convey faithfully and efficiently light and/or electromagnetic waves. Moreover, glass is virtually a no-brainer for biocompatibility in the case of implants. The cost of our devices might seem important upfront, but if one conducts a more careful cost analysis that factors in elements such as actual piece feasibility, accuracy, planned and unplanned design changes with rapid implementation (especially when dealing with complex geometries), and actual cost per single piece when industrial production kicks in, then our technology surely comes out as cost effective, and we support our customers in approaching our technology in a more holistic, yet firmly grounded into reality, view. Without forgetting that, at a time when we shall all increasingly pay more attention to the environment, yes, you can make disposables in glass and those would be easily recyclable. Fenske: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be? Steimle: I’d try to figure out if you can really trust your partner to deliver, but with a spin. I would look for a supplier that can not only deliver on specs, which are critical, but also has a deep command of the technology with which the components are made. By having this in-depth knowledge, the partner can honestly advise you on the eventual inherent limitations of the technology, and also alert you on the yet unexplored potential that would add value to the end product. In addition, I would look for the necessary flexibility to respond to impromptu requests, paralleled by a profound knowledge of the raw materials treated. Regulatory bumps in the roads are perennially presents, and engineering creativity is a well you must always go to in order to quell your thirst for innovation. Besides being capable, I would also check if the supplier can effectively scale up to industrial size capabilities and, equally important when you are dealing with single-micron tolerances, repeatability. This is a frequently overlooked aspect, and erroneously taken for granted. The last question I would ask is: Are you going to be around three to five years down the road? Fenske: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house? Steimle: The highly specialized know-how in glass micromanufacturing is undoubtedly one of the most prominent reasons. From that expertise stems our ability to rapidly generate and modify prototypes and reach piloting stage, from there to move to industrial, wafer-level manufacturing. Working at single-micron precision with glass requires a specialized know-how and significant upfront investments that cannot be improvised. In addition, the fact we are 13485 certified is unquestionably a plus for any medtech company that seeks optimization on the regulatory workload on several requirements such as component traceability and quality control. Other medical device manufacturers strongly value our proficiency in welding the microcomponents we create and our assembly of them into a final impermeable piece, an absolute must for implantable devices makers. Of equal relevance for medtech manufacturers is the fact that, in addition to being able to weld two elements of the same vitreous material, we can also bond, for instance, a fused silica component to another made of silicon, thus making our technology extremely versatile for the engineering and realization of medical devices where different components might require an heterogenous choice of materials. In the end, the client benefits from the agility of the process; gone is the logic of having a provider of one piece whose work needs to be checked and complemented by another party and finally assembled by a third. The vertical integration of our capabilities does not stop at micromanufacturing, but we have in our services portfolio various surface treatments that modify the rugosity of our pieces or make them either hydrophilic or hydrophobic. We can deposit on our chips various types of metals to respond to a client’s need for conductivity or superconductivity, adding functionality to our components. We also engineer and build the equipment that 3D-prints our pieces, and this is no small feat. In fact, the specific know-how generated by the process proves itself to be valuable because it significantly downgrades to negligible our reliance on third parties for core repairs. Those same engineering insights allow the fullest exploitation of our technology’s potential along with a better operational understanding of our suppliers, so much so that even during the pandemic, we were able to supply our clients with little or no delay with the agreed upon lead times. As a further testimony of our flexibility, should the client be unwilling to manufacture the required components in glass, we can produce the master to be used as a mold for the manufacturing with other microprinting technologies. By leveraging both our vast know-how in micromanufacturing and our assorted capabilities portfolio, strengthened with robust agreements mitigating supply chain risks, medical device manufacturers can take advantage of the seismic shifts currently under way in the medtech industry characterized by an elevated degree of miniaturization of both devices and components. Concurrent convergence among biotech, pharma, medtech, and digital healthcare offer secular opportunities to medtech manufactures where quality outsourcing of non-core, yet critical manufacturing processes will discriminate success from failure. We believe this is why medtech firms outsource to us, so they can insource success. Fenske: In what ways is your company able to aid in getting a product (project) to market faster? Steimle: Let’s quickly review a few factors positively impacting a rapid market entry. Let’s start with prototyping. In that respect, the realization of a prototype with us requires a few weeks (on average, 3.5) to have the pieces at your disposal. At that stage, we can provide an already significant number of samples with the first delivery, so testing of the part by the medtech manufacturer can be exhaustive from the start; weeks are gained from that. After testing, optimized designs are also implemented rapidly into new prototyping runs. In addition, moving from one design to the next does not require any capital investment, and/or budget allocation and approval, which generally requires internal discussions and down times. Additional time to market is also gained from that. In prototyping, a design’s risk needs mitigation. For instance, our capability to manage complex free forms in single monolithic pieces increases solidity and avoids costly, time-consuming alignment errors. The wide breadth of expertise mentioned previously, with the ability to include and successfully combine micro mechanic, micro-optical, microphotonic, and microfluidic components makes our process extremely agile. All under one roof, one vertically integrated partner, centrally coordinated interactions: numerous days to market gained. From there we move on to industrial scale production. Our wafer-scale capability is compatible with industry standards of glass fabs and can accommodate, depending on the size of the device or the component, thousands of pieces on one single wafer, giving us the ability to respond to serial production demands. Once again, no capital investments, and the prototype that is easily converted into the final piece—additional time to be pocketed. Working with single-micron tolerances leaves no space for improvisation. The time we spend to constantly improve our process is mirrored in time gains to market access for medtech manufacturers. FEMTOprint is located at Medica/Compamed in Hall 8B, Booth/Stand D36.
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