Beyond the 'Print' Button: 20 Years of Hacking, Hip Cups, and FDA Hurdles

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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