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Micromolders are developing novel technologies and leveraging creative methods for mass-producing micro parts to meet the growing demand for miniaturized devices and components.
September 25, 2023
By: Michael Barbella
Managing Editor
A pacemaker was not an option. For that he was certain, even as dozens of doubts and questions swirled inside his head. The queries replayed endlessly in Robert’s mind as he lay in his hospital bed, connected to tubes for both hydration and oxygenation: Would his life be the same? Could he work again? Would he want to work again? Would he recover quickly? Was this medical emergency somehow his fault? And, would he have to give up running? The answer to that last question was irrelevant, actually. Robert had no intention of abandoning his passion. He was a state and national championship runner, after all, who averaged 40-45 miles a week. Running had become more than a hobby to Robert—it was his stress reliever, his full-body rejuvenator, his source of contentment. It was part of his identity. Robert was not about to give up such an important piece of himself. “He needs to run, it’s in his blood,” Robert’s wife Maryse said in an online video. “You can’t change that.” Can’t? More like won’t: When stricken with complete heart block a half-dozen years ago, Robert rebuffed any treatment that would compromise his ability to run. Third-degree heart block (a.k.a., third-degree atrioventricular block) is a potentially life-threatening condition stemming from the blockage/interruption of the heart’s electrical signals. The disruption can cause the heart to slow down or stop entirely, and requires immediate intervention to restore proper function. The condition typically is treated with a pacemaker (temporary or permanent). Robert, however, refused to consider such a remedy. “When the doctor told me, ‘I suggest you put a pacemaker in your heart,’ I said, ‘no, no, I don’t need that, it’s not me. I’m in good condition, there’s no reason why I should put that thing in my heart,’” Robert recalled. Turns out, Robert was partly correct. Since his heart’s electrical signals malfunctioned intermittently, there was no medically valid reason to fix the problem with a conventional pacemaker. So Robert’s cardiologist suggested he consider a leadless pacemaker. “The doctor explained to me it was a little device, nobody would see it, that it would go inside my heart, and it’s not a long operation,” Robert said. “When he said I’ll be able to run, my heart rate went up and I said, ‘oh!’” Upon learning he could continue running, Robert—not surprisingly—consented to undergoing an implantation procedure with Medtronic’s Micra, the world’s smallest pacemaker. It is one-tenth the size of typical pacemakers, measuring just 24 millimeters in length and less than one cubic centimeter in volume. Unlike its more traditional cohorts, the leadless device can be implanted directly into the heart and runs on a battery that lasts between 16 and 17 years, according to Medtronic. Approved by the U.S. Food and Drug Administration (FDA) in April 2016, Micra was a byproduct of Medtronic’s “deep miniaturization” program—a decade-long effort to shrink medical devices by up to 90%. The program and its results are indicative of the growing demand for minimally invasive curative and diagnostic procedures as well as smaller medical devices with thinner walls and tighter tolerances. Producing such miniature devices and components would be impossible without micromolding, a technology that efficiently and cost-effectively produces tiny, complex, feature-rich components. Micromolding can create parts that weigh a fraction of a gram or as small as a single pellet. Or, in Micra’s case, the size of a vitamin capsule. “We are looking at the beginning of the future,” cardiologist John Hummel, M.D., said upon the Micra’s FDA approval. Medical Product Outsourcing consulted various experts over the last several weeks to peek into that future and better understand the market forces shaping the micromolding sector. Insight came from:
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