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This episode of the AM Insider podcast is hosted by Justin Hopkins and Dustin Kloempken. It is part of a miniseries focused on the beginnings of additive manufacturing (AM), aiming to share experiences from industry veterans.

The guest is Darin Everett, who is referred to as an industry "longtimer". He joined Stratasys in 1999 when the company was relatively small, starting at $28.5 million. Darin agreed with the common observation that the industry’s start-up era was "darn fun" and dynamic.

Career and Focus at Stratasys

• Darin studied mechanical engineering but transitioned into sales to better communicate with his typical customers (mechanical engineers). Before joining Stratasys, he worked in demanding traditional manufacturing environments like oil refineries, requiring him to wear fire retardant clothing and steel-toe boots daily.
• His passion and specialty during his 16 years at Stratasys was manufacturing, production, and tooling.
• He began in direct sales of large frame systems ("big boxes"). In January 2009, he moved to the first segment team (starting with aerospace) to develop applications such as composite layout tools, jigs, fixtures, and drill guides. After the Objet merger in late 2012, he helped resellers worldwide sell these manufacturing applications through channel management.
• After a sabbatical (2017 to 2020), he returned to work in St. Louis, motivated to be part of the push to bring manufacturing back to the US. He currently focuses on the metal side of AM, specifically refractory metals using electron beam powder bed fusion.

Selling and Production Challenges

• Selling "Black Magic": In the early 2000s, selling AM felt like selling "black magic" as engineers were highly skeptical.
• Focus on Solutions: Darin stressed that the industry sells solutions, not machines, and the only relevant output is the part. Sales must address the customer's pain or the losses they are preventing.
• High Stakes: Production cannot stop, as a shutdown in high-requirement environments (like a refinery) can cost $1 million to $3 million a day. High-requirement applications must justify the entire system cost (machine, people, floor space) with a one-to-two-year ROI.
• Certification Hurdles: Material qualification and certification are lengthy and expensive. The effort to fly the first 3D-printed part stalled for over five years due to the multi-million dollar cost of obtaining burn data and allowables. Currently, a hurdle for newer processes, such as electron beam powder bed fusion of tungsten, is that there is no US-certified lab that has a standardized process to prepare and test the required specimens.

Future Outlook and Advice

• Future Outlook: Darin believes AM has a great future but anticipates an overdue "squeeze" on the number of OEMs. He expects growth tied to critical items returning to US manufacturing, especially in defense, energy, and nuclear fusion.
• Key Advice: The second sale (the repeat sale) is the true test of a company, the machine, and the relationship, as it requires proving oneself after the initial battle.
• Recommended Resources: Darin advised watching "How Things Are Made" to understand traditional manufacturing (casting, forging, molding), reading the Wohlers Report annually, and attending AMUG for real feedback. He also recommended resources on sales and marketing, including Chris Harris’s book Phase Selling.

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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