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This podcast episode of "AM Insider" features an interview with Ryan Kircher, a principal additive manufacturing engineer at RMS Company, a medical device contract manufacturer. The discussion centers on the adoption of additive manufacturing (AM), specifically within the medical device industry. Kircher shares his 20 years of experience in the field, detailing the challenges and successes of using AM for medical implants, including the complexities of FDA regulations, process validation, and quality control. The conversation also explores the economic considerations and the integration of AM with traditional manufacturing processes, highlighting how these factors influence the widespread use and future of additive manufacturing in medicine.

1. Significant Investment Required for Medical AM: Establishing additive manufacturing capabilities for medical devices demands substantial upfront investment, often in the realm of millions of dollars, and takes years to develop the necessary qualifications, validations, and a robust quality system. Many companies tend to underestimate this significant financial and time commitment.
2. Evolution of Regulatory Landscape and FDA Guidance: Early pioneers in medical additive manufacturing faced the daunting task of creating new terminology, standards, and process validations from scratch, often having to adapt existing standards for conventional materials. However, the FDA has since published guidance documents, such as "Technical Considerations for Additively Manufactured Medical Devices," which have helped clarify requirements and streamline the clearance process, making it easier today for those who understand the process.
3. Additive Printing is a Small Fraction of the Total Process: While the actual "additive portion" of manufacturing a medical device might only take 2-3 days for a build, the entire process from initiating the print to shipping a finished device can span 6-8 weeks. This highlights the extensive pre- and post-processing, quality control, and other complementary steps that are crucial for medical device production.
4. Integrated Manufacturing Capabilities are Essential for Success: Being a successful medical device manufacturer using additive processes requires much more than just a "print shop." It necessitates comprehensive in-house capabilities, including downstream processes like CNC machining, thorough powder removal, and advanced inspection techniques. Companies that already possess a strong manufacturing infrastructure (like contract manufacturers) are better positioned for success.
5. Strategic Application Drives Value in AM: Additive manufacturing should be leveraged for the unique value it can add, such as creating complex porous lattice structures that promote osseointegration or eliminating secondary manufacturing steps (e.g., coating processes). Simply using AM to replace an existing conventional manufacturing method for a part that could be made cheaper or better otherwise is often a struggle. It's crucial to objectively determine if AM is the right fit for a particular part or feature.
6. Medical AM is a Large-Scale Success Story: Despite common misconceptions, additive manufacturing has achieved significant scale and success in the medical device industry. For example, RMS company alone has sold over 1 million off-the-shelf additively manufactured medical implants, and other major companies like Stryker operate at even larger scales. Spinal fusion cages, in particular, represent a major success story for AM due to their part volume and design requirements.
7. Economic and Incumbency Barriers Can Hinder Adoption: While hip cups were one of the first applications for AM (circa 2008-2009), they serve as a cautionary tale. Only a small percentage of hip cups

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This episode features an interview with Rajeev Kulkarni, a seasoned professional in the additive manufacturing industry, who shares his extensive experience and insights into the history, evolution, and future of 3D printing. Rajeev discusses his early contributions to the field, including the invention of support generation for SLA and the creation of the STL file format, highlighting the collaborative effort required for innovation and the importance of focusing on problem-solving and applications rather than just technology. He also offers advice for newcomers and executives in the industry, emphasizing the need to view 3D printing as a manufacturing technology and to integrate it within a broader digital ecosystem rather than positioning it against traditional methods. The conversation touches upon the impact of AI and the rewarding aspects of 3D printing, particularly in healthcare.

1. Humble and Challenging Beginnings: 3D printing began in the early 1990s from a state of "nothing," facing significant challenges such as a lack of 3D CAD design, expensive software, and the absence of standard formats, which led to the creation of the STL format. Computers were also slow, sometimes taking overnight to slice a file.
2. Evolving Industry Vision: Initial visions for 3D printing centered on accelerated product development, toolless manufacturing, and customization/one-off production. The concept of on-demand and distributed manufacturing emerged later as the technology evolved and customers presented these possibilities.
3. Innovation Through Collaboration and Iteration: The industry's rapid progress from creating the first 3D printers to establishing business models in industries like hearing aids and jewelry within 8-10 years was a multidisciplinary, cross-functional, and collaborative effort. Success hinged on being nimble and iterative, as customers often did not know what to ask for in a disruptive technology. Rajeev Kulkarni himself invented support generation for Stereolithography (SLA), drawing inspiration from electric pole designs.
4. Focus on Applications and Solutions, Not Just Technology: The core principle for success is that "technology is the cost and the application is the revenue". Focusing on specific applications and customer solutions that address real-world problems is paramount, as demonstrated by the long-term success in sectors like dental and hearing aids.
5. No Single "Killer App" or "Inflection Point": The industry has not experienced a singular "inflection point" or "killer app." Instead, successful applications like aligners, hearing aids, dental, and jewelry have achieved significant penetration through a "grind" that takes years or decades to replace complex workflows and achieve perfection.
6. "Manufacturing," Not "Printing": A significant disservice to the industry is referring to it as "printing" instead of "manufacturing." Executives and professionals must understand that replacing or enhancing manufacturing workflows is a complex undertaking, not a simple printing task, and requires a manufacturing-oriented mindset to succeed.
7. Complementary, Not Replacement, Approach: Positioning 3D printing against traditional manufacturing is often the "wrong approach." The real value of 3D printing lies in enhancing and complementing traditional methods, such as accelerating design cycles, producing complex internal features, or consolidating multiple part assemblies.
8. The Importance of the Entire Ecosystem: The success of 3D printing extends far beyond the printer itself, encompassing a vast ecosystem including design software, reverse engineering, pre-processing, materials, post-processi

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This episode of AM Insider features a special discussion on the history and evolution of the additive manufacturing (AM) industry. Hosts Justin Hopkins and Dustin Kloempken welcome Kevin Mortzfield, an industry veteran who began his career in late 1994, to share his extensive experience.

Kevin Mortzfield's background includes working at 3D Systems as an associate applications engineer, where he started with stereolithography (SLA) on machines like the SLA 250. He then moved to Masco Corporation, running various 3D printing technologies (SLA, SLS, Objet) and managing their R&D facility as a shared service for business units like Delta Faucet and Liberty Hardware. Later, he transitioned to the software side, working for Live Software and currently serving as a solutions engineer at Autodesk, with a focus on Fusion Additive and NetFabb Additive products. This diverse experience allowed him to witness the industry's progression from sales to customer, and then to software development and education.

The discussion covers several key aspects of AM's journey:

• Terminology Evolution: Kevin notes that when he started, it was primarily called rapid prototyping, which was a broader term. The term 3D printing emerged about ten years later, emphasizing the layer-by-layer build process, followed by additive manufacturing, which now encompasses a wider range of applications, including end-use parts.
• Early Applications and Challenges: In the early days, AM was used for form-fit parts and visualization, such as an eight-cylinder engine block that helped identify an interference in a water jacket. Significant challenges included Unix-based software that required manual input and high-end Silicon Graphics workstations. CAD files were often problematic, with issues like bad formats, holes in models, and incorrect parameters leading to distorted shapes or excessively large files. Support removal was also difficult, as solid plastic supports could easily crack parts.
• Technological Breakthroughs: Kevin highlights metal additive manufacturing (direct metal 3D printing) as a major game-changer, allowing for the creation of metal components directly from a 3D printer. The entry of big-name companies like HP into the 3D printing space also brought significant public attention and legitimacy to the industry. The evolution of software from OEM-specific to independent solutions (like Materialise and NetFabb) and eventually integration into CAD packages (like Autodesk Fusion Additive) has greatly enhanced usability and efficiency.
• Successful "Boring" Applications: The episode touches on applications that, while not always glamorous, have proven highly successful and valuable. These include investment casting patterns for complex metal parts (like those used by SpaceX for rocket bodies) and injection molding with conformal cooling lines, which significantly improve manufacturing processes and reduce costs.
• Staying Current and Industry Impact: With the rapid proliferation of different 3D printers—from hobbyist machines to high-end production systems—Kevin emphasizes the importance of staying informed through newsletters (e.g., Additive Manufacturing Media, TCT Magazine, 3D Printing Industry) and attending trade shows like Rapid and AMUG. He stresses that AM has profoundly impacted various industries, including healthcare, manufacturing, and design, becoming an indispensable tool.
• Future Outlook: Looking ahead, Kevin predicts exciting developments in bioprinting (organs, skin) within 5-10 years, as well as large-scale 3D printing in construction for houses and bridges. The conversation also delves into the grow