One thing has matured in how the AM {industry} thinks about healthcare, and the dialog is sharper for it.
The place the {industry} as soon as debated potential, practitioners are actually deep within the specifics: the way to manufacture customized medical merchandise at scale, the way to fulfill regulators who weren’t constructed with AM in thoughts, and the way to transfer a bioprinting breakthrough from the lab into scientific follow. The Healthcare Convention observe at RAPID + TCT 2026 is the place these questions are being labored by means of this yr, by specialists actively navigating medical machine manufacturing, regulatory technique, bioprinting, and extra.
Three of the observe’s audio system shared what years of RAPID + TCT attendance have meant for his or her work, and what attendees can count on from their classes this yr.
Scaling Customized Orthotic Manufacturing by way of Standardized AM Workflows – Shrenik Jain, Operations Engineer, iOrthotics
“Attending RAPID + TCT has helped me keep carefully aligned with the place the AM {industry} is definitely transferring, particularly because it shifts towards manufacturing,” says Jain. At iOrthotics, the place AM has been central to manufacturing for practically a decade, that sort of present, grounded {industry} data feeds instantly into how the corporate makes choices.
Earlier editions have given him a sharper sense of which course of management approaches are literally holding up at scale, and the place the {industry}’s assumptions are nonetheless outpacing the proof. His session takes on one of many extra persistent challenges in AM operations: how do you run a constant manufacturing line when no two merchandise are the identical?
At iOrthotics, the reply got here from reframing the query. “We clear up this by standardizing the method, not the product,” he explains. “Personalization is constructed into the workflow because the default, whereas all the pieces round it, machine parameters, materials dealing with, post-processing, is tightly managed and repeatable.”
It’s a distinction that sounds easy however takes appreciable self-discipline to execute, and one which pays off instantly for sufferers.
AM permits design options that standard manufacturing can’t get near, “like variable stiffness and optimized buildings,” which suggests sufferers find yourself with orthotics higher matched to their particular person biomechanics.
For Jain, that makes the broader argument for his session self-evident: “Scaling requires a shift towards standardization, course of management, and repeatability, areas the {industry} continues to be maturing in,” he says. “That is precisely the sort of dialogue that should occur now as extra firms transfer into manufacturing AM.”
The OEM Collaboration: Navigating High quality and Regulation in Med Gadget Superior Manufacturing – Laura Gilmour, Founder and Principal Marketing consultant, LG Methods, LLC
Gilmour has been attending RAPID + TCT since round 2009, which has given her “a front-row seat to how superior manufacturing is evolving and what’s doable from a technical standpoint,” she says, although she is equally fast to level to the folks as a supply of worth.
Over time, conversations with engineers, innovators, and clinicians, individuals who strategy the identical issues from fully completely different skilled vantage factors, helped her perceive “the place the gaps are between cutting-edge manufacturing know-how and medical machine wants, and the way to bridge them extra successfully.” That’s, in lots of respects, the work her consultancy was constructed round.
The hole she finds herself returning to most frequently is the one between how AM know-how suppliers perceive compliance and the way the FDA really expects it to work. “One of many greatest misconceptions is that there’s a one-size-fits-all pathway for additive manufacturing in medical gadgets,” she says.
In follow, all the pieces flows from the particular risk-benefit profile of the machine in query, and the documentation burden that comes with that’s one thing AM groups constantly underestimate.
“Design selection, materials choice, course of change, and construct parameters needs to be documented, justified, and absolutely traceable for FDA overview and finally, inspection,” Gilmour explains. “That depth of traceability is normally a giant shock for organizations coming into the medical machine house.”
Her argument is that good OEM collaboration is what makes this manageable, offered each side genuinely deal with it as a partnership and never only a handoff. The trickiest a part of getting there, in her expertise, is cultural: “bringing the construction of FDA expectations into an setting that thrives on pace and iteration” requires actual adjustment on each side.
Her session gives a sensible path by means of that, with methods for safeguarding the tempo and inventive flexibility that makes AM value adopting whereas nonetheless constructing the documentation and threat administration foundations that can maintain up beneath regulatory scrutiny.
Bioprinting of Affected person-Particular A number of Myeloma Fashions for Customized Remedy – Julio Aleman, CTO and Co-Founder, Linton Lifesciences
Aleman’s path to CTO ran by means of tutorial analysis at Wake Forest Institute of Regenerative Medication (WFIRM) and Harvard–Massachusetts Institute of Know-how (MIT), and conferences like RAPID + TCT gave him one thing these settings hardly ever supply. “Educational establishments are typically on the forefront of know-how growth and innovation, nevertheless conferences like [RAPID + TCT] showcase the applied sciences which have matured and are sturdy sufficient to be sustainable available on the market,” he says.
At Linton Lifesciences, that work facilities on A number of Myeloma, a blood most cancers that behaves so in a different way from one affected person to the following that standard cell cultures and animal fashions can’t seize it with the precision personalised remedy requires.
Aleman’s session introduces a bioprinting workflow that addresses this instantly, constructing patient-specific illness fashions utilizing “all humanized and recombinant know-how that enables us to attain exact and reproducible merchandise, stepping away from ambiguous supplies that may be biochemically and mechanically unpredictable.”
Past the organic accuracy, the workflow additionally reproduces bodily tissue properties that solely emerge in spatially distributed, matured environments, one thing no standard mannequin can do, and that issues enormously when predicting a selected affected person’s response to remedy.
On the regulatory aspect, the FDA’s lately revealed NAMs Framework “lays down the preliminary tips to streamline these applied sciences from benchtop into routine scientific practices,” and far of the scientific infrastructure wanted to deal with affected person samples already exists. The remaining problem is getting protocols which have developed largely in parallel to start out working in live performance.
For many who don’t see themselves as bioprinting specialists, Aleman places it merely: “In case you are conscious of the impression 3D bioprinting applied sciences are having on de-risking the customized strategy, you’ll discover your self selecting the superior remedy.”
RAPID + TCT 2026 happen April 14-16 in Boston, Massachusetts. To assert your free Expo Cross, or 20% Convention Cross low cost, as a visitor of 3D Printing Trade, click on right here.
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Discover the total Way forward for 3D Printing and Govt Survey collection from 3D Printing Trade, that includes views from CEOs, engineers, and {industry} leaders on the industrialization of additive manufacturing, 3D printing {industry} developments 2026, qualification, provide chains, and additive manufacturing {industry} evaluation.
Featured picture exhibits in-depth discussions cowl a variety of AM subjects, from the industry-specific to Supplies and Course of Growth. Photograph by way of SME.