Innovations in micro molding for medical device miniaturization - Medical Design and Outsourcing

October 10, 2024 By Sponsored Content

Partner content with Isometric Micro Molding.

Miniaturization is on the rise in the medical device industry. The global surgical robots market alone is expected to reach $19.4 billion by 2032, driven largely by the ability to perform complex procedures through tiny incisions. There is a shift toward smaller devices for remote monitoring and treatment—from pacemakers and defibrillators to glucose sensors and insulin pumps. In one instance, researchers even implanted a device the size of a rice grain to deliver tiny doses of up to 20 drugs to targeted areas of a brain tumor.

Isometric Micro Molding, a leader in ultra-precision toolmaking and micro molding, plays a key role in supporting this miniaturization trend.

“We mold the smallest parts in the world,” said Brent Hahn, Senior Vice President at Isometric. “A human hair is about 100 microns in diameter, and we speak to one micron.”

When it comes to medical devices for surgery or implanted within the body, reducing their size is crucial. Smaller devices can diminish patient discomfort, reduce surgical risk, shorten hospital stays, and improve healing times. Micro molding these miniaturized components comes with its own set of challenges. Standard injection molding processes usually don’t work when parts are smaller than a pellet of resin or have micro features, thin walls, micro holes, complex geometries and/or tight tolerances. Other factors come into play. “You have to account for mold design and precision mold fabrication, as well as the materials being used,” said Hahn. “You have to understand how the resin works with extremely thin walls and small gates.”

Handling micro molded parts also presents significant challenges, such as controlling static to prevent parts from floating, attracting debris, or even popping like popcorn. It is critical to ensure that parts are successfully removed from the mold to avoid causing damage during subsequent press cycles. Scaling to high-volume production through higher cavitation molds amplifies the difficulty of dealing with micro-sized components.

“We’re molding three-micron sharps with the most difficult resins—PEEK and bioresorbables — and we’re still accomplishing amazing scale of high-volume manufacturing. We’ve molded one part that weighs 0.00004 grams, we’ve accomplished 400:1 aspect ratio thin wall molding, and we continue to push the boundaries,” said Hahn.

In one project, Isometric replaced a metal component with a PEEK part just 0.007” (175 microns) thick, over an inch long. Though PEEK is a rigid material, molding it at this thickness enables flexibility. This opens up new possibilities for part design in applications where metal cannot be used.

Automation is another major differentiator. Isometric’s automation can assess and hold positional accuracy of parts in the mold within one micron, allowing parts to be efficiently picked and assembled into sub-assemblies in line.

“Ultimately, it leads to less cost in the system to create sub-assemblies right there at the press,” said Hahn. “Micro automated assembly is far more accurate and cost effective than shipping parts to low-cost labor areas where a large number of high-dexterity workers try to assemble them under a microscope.”

Isometric’s acquisition by Nissha Medical Technologies, a global CDMO, further extends Isometric’s capabilities, enabling the company to offer a complete solution— from product design & development to manufacturing, final labeling, packaging, and distribution in Nissha Medical Technologies’ FDA registered facilities.

Isometric has been a trusted partner for over thirty years and their advanced micro molding capabilities are enabling the miniaturization of drug delivery and medical devices. Applications include minimally invasive and robotic surgeries, as well as wearables, sensors, ophthalmic devices and diabetes management technology. Other areas include diagnostics and life sciences through the production of microfluidic channels and lab-on-a-chip devices.

Visit Isometric Micro Molding to learn more.