Sean Fenske, Editor-in-Chief11.13.23
For virtually everyone in the U.S., November marks the beginning of winter, shorter days, decreasing temperatures, and Thanksgiving. For those involved with medical device development and manufacturing, it’s also the month for the Medica and CompaMed trade shows in Dusseldorf, Germany. While last year’s event seemed to bring the crowd’s back following the COVID-induced hiatus, this year may be a more true return to form.
With this in mind, I reached out to a number of companies who will be exhibiting at the show to find out directly from them what they are showing off or focusing on at the event, what challenges customers have brought them, and where they see their role within the industry in aiding medical device manufacturers. Tackling these questions as well as a couple others, Renato Muton, business developer—MedTech at FEMTOprint SA, shared a few insights to help you determine if the firm should be a potential services partner for you in 2024 or beyond.
Sean Fenske: What technology or service are you emphasizing at Medica/CompaMed this year?
Renato Muton: Miniaturization has emerged as a groundbreaking force within the realm of biomedical engineering, propelling innovation in medical devices to unprecedented heights and ushering in a multitude of advantages that dramatically reshape the healthcare landscape. Our micromanufacturing technology serves as a potent catalyst for innovation by enabling the miniaturization of all classes of medical devices.
At FEMTOprint, we are at the forefront of cutting-edge micromanufacturing, specializing in miniaturization and single-micron precision in medical devices’ component fabrication. Our unique expertise in 3D printing of glass microcomponents allows us to create multifunctional components that can be seamlessly integrated into an array of custom-designed medical applications. These encompass diagnostics, ranging from point-of-care devices to benchtop equipment, as well as minimally invasive and robotic surgery tools, packaging for active implants, bio-sensors, wearables, advanced imaging solutions, drug delivery systems, endoscopes, labs on-a-chips, optical equipment and biophotonic devices at large, just to name a few.
What truly sets us apart is our unwavering commitment to achieving elevated, down to single-micron, accuracy in our components. We provide medtech manufacturers across various categories with a diverse set of solutions to effectively infuse micro-scale mechanical, optical, microfluidic, and photonic functionalities into their products. Moreover, our capabilities extend beyond the core fabrication process, as we can also deliver functional coatings, perform treatments to enhance surface quality, and provide specialized services like cutting, dicing, and welding for glass parts. When precision and miniaturization are imperative, FEMTOprint is a trusted partner for pushing the boundaries of what's possible in medical device technology."
Fenske: What’s the most common challenge customers inquire about and how do you address it?
Muton: In the ever-evolving landscape of medical device manufacturing, clients are increasingly drawn to the seamless fusion of miniaturization, precision, and the seamless integration of diverse functionalities and capabilities. They recognize this formidable triumvirate as indispensable for fulfilling their unique requirements. We achieve that with glass micro-components.
However, when it comes to the domain of glass components, it's not uncommon for companies to approach us with limited information or preconceived misconceptions about the potential of our micro-manufacturing technology. These notions often come intertwined with concerns about solidity, manufacturing timing, scalability, sustainability, and costs. Yet, the truth is our technology is exceptionally equipped to meet the exacting demands of the medtech industry.
We specialize in crafting intricate geometries with single-micron tolerances, harnessing the often overlooked and lesser-known attributes of glass, including its elasticity, durability, transparency for inspection, low MRI interference, and efficient light and electromagnetic wave transmission. Moreover, in the realm of implants, glass emerges as the optimal choice for biocompatibility.
While the initial cost of our devices may seem substantial, a more in-depth cost analysis, accounting for factors like precision, planned and unplanned design adjustments with swift implementation (especially for complex geometries), and the eventual cost per unit during industrial production, unveils the cost-effectiveness of our technology. We collaborate closely with our clients to adopt a holistic, reality-grounded perspective.
As our environmental consciousness expands into medical device manufacturing, it's crucial to note glass provides a sustainable solution for disposable products, given its high recyclability.
Fenske: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Muton: When assessing the reliability of a potential partner, one should take a discerning approach, focusing not only on their capacity to meet specifications—a fundamental aspect in itself—but also on their profound mastery of the underlying technology used in component manufacturing. This deep technological understanding enables the partner to offer candid insights into the inherent limitations of the technology while simultaneously highlighting unexplored possibilities that can enhance the value of your medtech end product.
Furthermore, it's crucial to seek flexibility in your partner's ability to accommodate unexpected requests, all while maintaining an extensive knowledge of the raw materials they work with. Given the persistent presence of regulatory challenges, creativity in engineering is a valuable resource that can address the ever-present thirst for innovation.
Beyond capability, it's essential to evaluate the supplier's ability to scale up to industrial-sized operations effectively. Equally vital, especially when working within single-micron tolerances, is assessing their capacity for repeatability—an aspect often underestimated but critical for success.
Lastly, one should consider the long-term perspective: Will your chosen partner remain a reliable presence on the horizon in the coming three to five years? An ideal partner should not only meet current needs but also adapt to the evolving demands of the medtech industry, particularly in the realms of reliability, the approval process, documentation management, and forward-thinking miniaturization, not only for mainstream products but for innovative solutions that drive the industry forward.
Fenske: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Muton: Our exceptional expertise in constantly meeting precision requirements stands out as one of our core strengths. This expertise enables us to swiftly develop and modify prototypes, progress to pilot stages, and seamlessly transition to industrial, wafer-level manufacturing. Achieving single-micron precision with glass demands specialized knowledge and significant upfront investments, emphasizing the importance of our capabilities.
Our ISO 13485 and ISO 9001 certifications further underscores our commitment to excellence, offering medtech companies a substantial advantage in managing regulatory requirements, especially regarding components' traceability and quality control.
Our proficiency in welding microcomponents together is highly valued by medtech manufacturers, particularly those engaged in the production of implantable devices. What makes us even more versatile is our ability to not only weld elements of the same vitreous material but also bond different materials, such as fused silica to silicon, making our technology adaptable for engineering and creating medical devices that incorporate various material components.
The key benefit for our clients is a streamlined process that eliminates the need for multiple providers and assemblers. We offer vertical integration that extends beyond micromanufacturing, encompassing a variety of surface treatments that can modify the texture of our components, rendering them either hydrophilic or hydrophobic. Furthermore, we can deposit various types of metals onto our chips, addressing our clients' requirements for conductivity, thereby enhancing the functionality of our components.
We're proud to engineer and construct the equipment used for 3D printing our components, a testament to our self-reliance. This self-sufficiency has been instrumental in minimizing our reliance on third parties for core repairs. It has also enabled us to fully harness the potential of our technology, ensuring operational continuity even during challenging times, such as the recent pandemic.
We also offer an added layer of flexibility. If a client prefers not to manufacture components in glass, we can produce the master that serves as a mold for manufacturing using other microprinting technologies.
Our extensive experience in micromanufacturing, combined with a diverse portfolio of capabilities and robust supply chain agreements, empowers medtech manufacturers to capitalize on the transformative changes currently underway in the medtech industry. This industry is witnessing a significant shift toward miniaturization of devices and components, and the convergence of biotech, pharma, medtech, and digital healthcare presents unique opportunities for success. Medtech companies outsource to us with the goal of insourcing success, recognizing the distinct advantages we bring to their endeavors.
Fenske: In what ways is your company able to aid in getting a product (project) to market faster?
Muton: Let's delve into several key factors that expedite a swift market entry. We'll start with prototyping, where our collaboration ensures rapid realization, typically taking just a few weeks, with an average lead time of four or five weeks to place the prototype in your hands. At this stage, we can provide a substantial number of initial samples during the first delivery, empowering medtech manufacturers to conduct comprehensive testing from the outset and saving valuable weeks. Furthermore, any design optimizations following testing are seamlessly integrated into new prototyping runs. It's important to note this transition doesn't require any capital investments, budget allocations, or internal deliberations, thereby eliminating downtime and further accelerating the time to market.
Effective risk mitigation is paramount during the prototyping phase. Our expertise in managing complex free-form shapes within a single monolithic piece enhances structural integrity and eliminates costly and time-consuming alignment errors. Our comprehensive expertise, including the successful integration of micro-mechanical, micro-optical, microphotonic, and microfluidic components, streamlines the process by consolidating these capabilities under one roof, saving numerous days to market through centralized coordination. For example, a simple misalignment of an optical fiber with its micro-optical components can cause significant delays in the development process, particularly when multiple suppliers are part of the equation.
Moving to industrial-scale production, our wafer-scale capability aligns with industry standards in fabrication and can accommodate thousands of pieces on a single wafer, depending on the size of the device or component. This scalability allows us to meet our clients' demands for serial production without the need for additional capital investments. The transition from prototype to the final product is a smooth process, resulting in further time savings.
Working with single-micron tolerances leaves no room for improvisation. The time we invest in continually enhancing our process is directly reflected in the time gains that medtech companies enjoy when entering the market swiftly and confidently.
FEMTOprint SA is located at Medica/Compamed in Hall 8A, Booth/Stand M26.
With this in mind, I reached out to a number of companies who will be exhibiting at the show to find out directly from them what they are showing off or focusing on at the event, what challenges customers have brought them, and where they see their role within the industry in aiding medical device manufacturers. Tackling these questions as well as a couple others, Renato Muton, business developer—MedTech at FEMTOprint SA, shared a few insights to help you determine if the firm should be a potential services partner for you in 2024 or beyond.
Sean Fenske: What technology or service are you emphasizing at Medica/CompaMed this year?
Renato Muton: Miniaturization has emerged as a groundbreaking force within the realm of biomedical engineering, propelling innovation in medical devices to unprecedented heights and ushering in a multitude of advantages that dramatically reshape the healthcare landscape. Our micromanufacturing technology serves as a potent catalyst for innovation by enabling the miniaturization of all classes of medical devices.
At FEMTOprint, we are at the forefront of cutting-edge micromanufacturing, specializing in miniaturization and single-micron precision in medical devices’ component fabrication. Our unique expertise in 3D printing of glass microcomponents allows us to create multifunctional components that can be seamlessly integrated into an array of custom-designed medical applications. These encompass diagnostics, ranging from point-of-care devices to benchtop equipment, as well as minimally invasive and robotic surgery tools, packaging for active implants, bio-sensors, wearables, advanced imaging solutions, drug delivery systems, endoscopes, labs on-a-chips, optical equipment and biophotonic devices at large, just to name a few.
What truly sets us apart is our unwavering commitment to achieving elevated, down to single-micron, accuracy in our components. We provide medtech manufacturers across various categories with a diverse set of solutions to effectively infuse micro-scale mechanical, optical, microfluidic, and photonic functionalities into their products. Moreover, our capabilities extend beyond the core fabrication process, as we can also deliver functional coatings, perform treatments to enhance surface quality, and provide specialized services like cutting, dicing, and welding for glass parts. When precision and miniaturization are imperative, FEMTOprint is a trusted partner for pushing the boundaries of what's possible in medical device technology."
Fenske: What’s the most common challenge customers inquire about and how do you address it?
Muton: In the ever-evolving landscape of medical device manufacturing, clients are increasingly drawn to the seamless fusion of miniaturization, precision, and the seamless integration of diverse functionalities and capabilities. They recognize this formidable triumvirate as indispensable for fulfilling their unique requirements. We achieve that with glass micro-components.
However, when it comes to the domain of glass components, it's not uncommon for companies to approach us with limited information or preconceived misconceptions about the potential of our micro-manufacturing technology. These notions often come intertwined with concerns about solidity, manufacturing timing, scalability, sustainability, and costs. Yet, the truth is our technology is exceptionally equipped to meet the exacting demands of the medtech industry.
We specialize in crafting intricate geometries with single-micron tolerances, harnessing the often overlooked and lesser-known attributes of glass, including its elasticity, durability, transparency for inspection, low MRI interference, and efficient light and electromagnetic wave transmission. Moreover, in the realm of implants, glass emerges as the optimal choice for biocompatibility.
While the initial cost of our devices may seem substantial, a more in-depth cost analysis, accounting for factors like precision, planned and unplanned design adjustments with swift implementation (especially for complex geometries), and the eventual cost per unit during industrial production, unveils the cost-effectiveness of our technology. We collaborate closely with our clients to adopt a holistic, reality-grounded perspective.
As our environmental consciousness expands into medical device manufacturing, it's crucial to note glass provides a sustainable solution for disposable products, given its high recyclability.
Fenske: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Muton: When assessing the reliability of a potential partner, one should take a discerning approach, focusing not only on their capacity to meet specifications—a fundamental aspect in itself—but also on their profound mastery of the underlying technology used in component manufacturing. This deep technological understanding enables the partner to offer candid insights into the inherent limitations of the technology while simultaneously highlighting unexplored possibilities that can enhance the value of your medtech end product.
Furthermore, it's crucial to seek flexibility in your partner's ability to accommodate unexpected requests, all while maintaining an extensive knowledge of the raw materials they work with. Given the persistent presence of regulatory challenges, creativity in engineering is a valuable resource that can address the ever-present thirst for innovation.
Beyond capability, it's essential to evaluate the supplier's ability to scale up to industrial-sized operations effectively. Equally vital, especially when working within single-micron tolerances, is assessing their capacity for repeatability—an aspect often underestimated but critical for success.
Lastly, one should consider the long-term perspective: Will your chosen partner remain a reliable presence on the horizon in the coming three to five years? An ideal partner should not only meet current needs but also adapt to the evolving demands of the medtech industry, particularly in the realms of reliability, the approval process, documentation management, and forward-thinking miniaturization, not only for mainstream products but for innovative solutions that drive the industry forward.
Fenske: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Muton: Our exceptional expertise in constantly meeting precision requirements stands out as one of our core strengths. This expertise enables us to swiftly develop and modify prototypes, progress to pilot stages, and seamlessly transition to industrial, wafer-level manufacturing. Achieving single-micron precision with glass demands specialized knowledge and significant upfront investments, emphasizing the importance of our capabilities.
Our ISO 13485 and ISO 9001 certifications further underscores our commitment to excellence, offering medtech companies a substantial advantage in managing regulatory requirements, especially regarding components' traceability and quality control.
Our proficiency in welding microcomponents together is highly valued by medtech manufacturers, particularly those engaged in the production of implantable devices. What makes us even more versatile is our ability to not only weld elements of the same vitreous material but also bond different materials, such as fused silica to silicon, making our technology adaptable for engineering and creating medical devices that incorporate various material components.
The key benefit for our clients is a streamlined process that eliminates the need for multiple providers and assemblers. We offer vertical integration that extends beyond micromanufacturing, encompassing a variety of surface treatments that can modify the texture of our components, rendering them either hydrophilic or hydrophobic. Furthermore, we can deposit various types of metals onto our chips, addressing our clients' requirements for conductivity, thereby enhancing the functionality of our components.
We're proud to engineer and construct the equipment used for 3D printing our components, a testament to our self-reliance. This self-sufficiency has been instrumental in minimizing our reliance on third parties for core repairs. It has also enabled us to fully harness the potential of our technology, ensuring operational continuity even during challenging times, such as the recent pandemic.
We also offer an added layer of flexibility. If a client prefers not to manufacture components in glass, we can produce the master that serves as a mold for manufacturing using other microprinting technologies.
Our extensive experience in micromanufacturing, combined with a diverse portfolio of capabilities and robust supply chain agreements, empowers medtech manufacturers to capitalize on the transformative changes currently underway in the medtech industry. This industry is witnessing a significant shift toward miniaturization of devices and components, and the convergence of biotech, pharma, medtech, and digital healthcare presents unique opportunities for success. Medtech companies outsource to us with the goal of insourcing success, recognizing the distinct advantages we bring to their endeavors.
Fenske: In what ways is your company able to aid in getting a product (project) to market faster?
Muton: Let's delve into several key factors that expedite a swift market entry. We'll start with prototyping, where our collaboration ensures rapid realization, typically taking just a few weeks, with an average lead time of four or five weeks to place the prototype in your hands. At this stage, we can provide a substantial number of initial samples during the first delivery, empowering medtech manufacturers to conduct comprehensive testing from the outset and saving valuable weeks. Furthermore, any design optimizations following testing are seamlessly integrated into new prototyping runs. It's important to note this transition doesn't require any capital investments, budget allocations, or internal deliberations, thereby eliminating downtime and further accelerating the time to market.
Effective risk mitigation is paramount during the prototyping phase. Our expertise in managing complex free-form shapes within a single monolithic piece enhances structural integrity and eliminates costly and time-consuming alignment errors. Our comprehensive expertise, including the successful integration of micro-mechanical, micro-optical, microphotonic, and microfluidic components, streamlines the process by consolidating these capabilities under one roof, saving numerous days to market through centralized coordination. For example, a simple misalignment of an optical fiber with its micro-optical components can cause significant delays in the development process, particularly when multiple suppliers are part of the equation.
Moving to industrial-scale production, our wafer-scale capability aligns with industry standards in fabrication and can accommodate thousands of pieces on a single wafer, depending on the size of the device or component. This scalability allows us to meet our clients' demands for serial production without the need for additional capital investments. The transition from prototype to the final product is a smooth process, resulting in further time savings.
Working with single-micron tolerances leaves no room for improvisation. The time we invest in continually enhancing our process is directly reflected in the time gains that medtech companies enjoy when entering the market swiftly and confidently.
FEMTOprint SA is located at Medica/Compamed in Hall 8A, Booth/Stand M26.