As the medical device industry adjusts to a new business paradigm that is all about containing costs and proving not just the clinical but the economic value of new technologies, it needs to question an array of ingrained practices, starting with how it manufactures its products. From that perspective, and depending on the application, industry would do well to take a closer look at laser-based manufacturing processes, says Glenn Ogura, Executive Vice President of Business Development at laser micromachining systems supplier Resonetics (Nashua, NH).
"Lasers and automation can bring tremendous value to medtech companies, which often still rely on manual labor," says Ogura. "In the medtech space, you still see rows of operators punching holes in tubing and peering through microscopes to check coatings. The drive to lower healthcare costs by its nature will force manufacturers to change practices," says Ogura. His mission is to explain why lasers are the change you've been waiting for. They are ideally suited for the repeatable and reliable machining of miniature parts that make devices tick while reducing development costs and accelerating time to market.
|Glenn Ogura will present a paper on Laser Micromachining of Polymer-based Medical Devices during PLASTEC West in Anaheim, CA. He is scheduled to speak at 3 PM at the Medical Device Polymers and Plastics Conference on February 11. The PLASTEC West exhibition runs from February 11 to 13.|
In some cases, lasers enable the fabrication of features that would be extremely difficult, if not impossible, to achieve cost effectively using other techniques. As examples, Ogura cites point-of-care diagnostic devices that require precisely drilled holes in polymer-based microfluidic products and applications with microarrays in challenging geometries. Embolic filters, for example, incorporate thousands of 100-micrometer holes in thin polymer films. In some cases, the nonplanar geometry of the device adds to the complexity of repeatably and precisely fabricating the apertures. Laser technology achieves that in a cost-efficient manner, says Ogura, and typically eliminates the need for secondary processing.
|100-micrometer-diameter holes laser drilled
in EPTFE material.
Bioresorbable plastic stents, which Medical Channel Editor Doug Smock calls the "big story of 2014," also stand to benefit from laser-based machining. Excimer, femtosecond, and picosecond lasers can be used to cut intricate stent patterns in the bioabsorbable materials, notes Ogura, who adds that novel techniques are available to dramatically drive down the cost of manufacture. That's critical, he adds, because payers are determined "to make bioresorbable stents no more expensive than drug-eluting metal stents, and even to make them less expensive." That's a tall order, especially for what is still a fairly new technology, he notes, but it is a reality that device makers must confront.
Resonetics supplies a full array of laser systems, including excimer, CO2, picosecond, and femtosecond models. Given the abundance, sourcing a suitable laser is not an easy proposition—it depends on material type, size and thickness; feature sizes; and other factors. For instance, 193-nm excimer lasers are best suited for bioabsorbable materials, which only absorb light adequately at this wavelength. Lasers in this configuration feature relatively high average power, resulting in fast cycles and low device processing costs. Polyurethanes and polyimides, on the other hand, are best served by 248-nm excimer lasers. If you are interested in diving deeper into this topic, I highly recommend reading "Fundamental Principles of Laser Micromaching Polymers," authored by Ogura and published on mddiononline.com.