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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Popular Podcasts
Stuff You Should Know
If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.
Dateline NBC
Current and classic episodes, featuring compelling true-crime mysteries, powerful documentaries and in-depth investigations. Follow now to get the latest episodes of Dateline NBC completely free, or subscribe to Dateline Premium for ad-free listening and exclusive bonus content: DatelinePremium.com
The Burden
The Burden is a documentary series that takes listeners into the hidden places where justice is done (and undone). It dives deep into the lives of heroes and villains. And it focuses a spotlight on those who triumph even when the odds are against them. Season 5 - The Burden: Death & Deceit in Alliance On April Fools Day 1999, 26-year-old Yvonne Layne was found murdered in her Alliance, Ohio home. David Thorne, her ex-boyfriend and father of one of her children, was instantly a suspect. Another young man admitted to the murder, and David breathed a sigh of relief, until the confessed murderer fingered David; “He paid me to do it.” David was sentenced to life without parole. Two decades later, Pulitzer winner and podcast host, Maggie Freleng (Bone Valley Season 3: Graves County, Wrongful Conviction, Suave) launched a “live” investigation into David's conviction alongside Jason Baldwin (himself wrongfully convicted as a member of the West Memphis Three). Maggie had come to believe that the entire investigation of David was botched by the tiny local police department, or worse, covered up the real killer. Was Maggie correct? Was David’s claim of innocence credible? In Death and Deceit in Alliance, Maggie recounts the case that launched her career, and ultimately, “broke” her.” The results will shock the listener and reduce Maggie to tears and self-doubt. This is not your typical wrongful conviction story. In fact, it turns the genre on its head. It asks the question: What if our champions are foolish? Season 4 - The Burden: Get the Money and Run “Trying to murder my father, this was the thing that put me on the path.” That’s Joe Loya and that path was bank robbery. Bank, bank, bank, bank, bank. In season 4 of The Burden: Get the Money and Run, we hear from Joe who was once the most prolific bank robber in Southern California, and beyond. He used disguises, body doubles, proxies. He leaped over counters, grabbed the money and ran. Even as the FBI was closing in. It was a showdown between a daring bank robber, and a patient FBI agent. Joe was no ordinary bank robber. He was bright, articulate, charismatic, and driven by a dark rage that he summoned up at will. In seven episodes, Joe tells all: the what, the how… and the why. Including why he tried to murder his father. Season 3 - The Burden: Avenger Miriam Lewin is one of Argentina’s leading journalists today. At 19 years old, she was kidnapped off the streets of Buenos Aires for her political activism and thrown into a concentration camp. Thousands of her fellow inmates were executed, tossed alive from a cargo plane into the ocean. Miriam, along with a handful of others, will survive the camp. Then as a journalist, she will wage a decades long campaign to bring her tormentors to justice. Avenger is about one woman’s triumphant battle against unbelievable odds to survive torture, claim justice for the crimes done against her and others like her, and change the future of her country. Season 2 - The Burden: Empire on Blood Empire on Blood is set in the Bronx, NY, in the early 90s, when two young drug dealers ruled an intersection known as “The Corner on Blood.” The boss, Calvin Buari, lived large. He and a protege swore they would build an empire on blood. Then the relationship frayed and the protege accused Calvin of a double homicide which he claimed he didn’t do. But did he? Award-winning journalist Steve Fishman spent seven years to answer that question. This is the story of one man’s last chance to overturn his life sentence. He may prevail, but someone’s gotta pay. The Burden: Empire on Blood is the director’s cut of the true crime classic which reached #1 on the charts when it was first released half a dozen years ago. Season 1 - The Burden In the 1990s, Detective Louis N. Scarcella was legendary. In a city overrun by violent crime, he cracked the toughest cases and put away the worst criminals. “The Hulk” was his nickname. Then the story changed. Scarcella ran into a group of convicted murderers who all say they are innocent. They turned themselves into jailhouse-lawyers and in prison founded a lway firm. When they realized Scarcella helped put many of them away, they set their sights on taking him down. And with the help of a NY Times reporter they have a chance. For years, Scarcella insisted he did nothing wrong. But that’s all he’d say. Until we tracked Scarcella to a sauna in a Russian bathhouse, where he started to talk..and talk and talk. “The guilty have gone free,” he whispered. And then agreed to take us into the belly of the beast. Welcome to The Burden.