Lumohs sheds light on surgical innovation

After nearly 30 years and more than 40,000 dermatology surgeries, Dr. Steven Hacker, founder of Hacker Dermatology, used that experience to launch Nano Surgical LLC to manufacture his inventions to “make surgery safer for patients and surgeons.” Lumohsis Hacker’s first product ready for other surgeons to see what changes he has in store for procedures taking place from bedside to the office. The Lumohs illuminated scalpel, a U.S. Food and Drug Administration (FDA) Class 1 510k exempt device, will be delivered into the hands of surgeons this year.

Hacker had grown tired of walking into different clinics with all sorts of different lighting, wearing loop lights on his head, or bringing in additional lights in hopes of brightening up where he needed to make an incision. Instead of finding a way to illuminate the room, he decided to illuminate the scalpel used to make the incision.

Design, development

Hacker cut his medical practice back to seeing patients two and a half days a week and spent the rest of the time working on Lumohs. He worked with teams of engineers, production and manufacturing personnel, and regulatory experts before he put together the right combination to bring the Lumohs device to market.

“I wanted it to be simple for a doctor, turn it on and use it with very little learning curve or instruction,” says Hacker when it came time to design the Lumohs device. “It needed to offer unobstructed, shadowless illumination millimeters from the surgical site; be ergonomic, lightweight, reusable, affordable, portable; wireless; and a simple design that’s easy to use. It needed to help surgeons see and avoid cutting the tiny nerves and vessels in anatomic danger zones of the body. Additionally, it needed to be financially feasible, economically efficient for practicing doctors, but also be a high-end surgical instrument for those doctors wanting a sophisticated illumination device to add to their repertoire of instruments for certain surgical procedures.”

Hacker followed regulatory guidelines to make sure the Lumohs device was manufactured following FDA ISO13485 and Good Manufacturing Processes guidelines and put the device through IEC 60601-1 compliance testing and achieving SGS NRTL certification, sterilization validation, biocompatibility, lifecycle testing, and safety testing. After nearly 10 different designs, Hacker was able to settle on one consisting of stainless steel, plastic, printed circuit boards, brass plated materials, and LED lighting.

Now the final product, in production at a manufacturing facility overseas, Lumohs is expected to be delivered in late 2023 and Hacker expects a lot of medical fields will find the Lumohs device useful.

“If you hold a scalpel, then Lumohs has a place,” Hacker says. “Doctors holding the scalpel for excisions in the outpatient office, excisions in a surgery center, bedside procedures in hospitals, Lumohs helps you see better during wound care procedures. It applies to dermatology, plastic surgery, and esthetics such as dermaplaning; it applies to veterinarians who work on large animals out on a farm. First responders and military medics doing emergency procedures needing skin access for vascular or tracheotomies they can’t see in a dark home or environment.”

Hacker is also working with Floating Doctors and has agreed to donate Lumohs devices to their physicians treating patients in remote villages, accessible only by boat, and providers delivering surgical care to developing countries without adequate facilities and lighting, and Hacker intends to provide Lumohs to surgeons providing care in war-torn Ukraine. No matter who ends up using the Lumohs device, Hacker knows it will impact their approach to surgery.

“This should be viewed as an incremental innovation, rather than a revolutionary innovation; people already use a scalpel,” Hacker says. “It’s just adding functionality to an existing scalpel and with no learning curve. And if you’re a doctor that needs more procedural light, you’re going to like Lumohs. If you don’t care about illumination, then you won’t use it. But most doctors will find Lumohs provides them with unobstructed onsite surgical illumination they never had before. And I’m confident they’ll find this very, very valuable.”

Hacker hopes his invention can motivate or inspire other doctors to do the same.

“Physicians have a lot of great ideas and ways to solve problems but underestimate what it takes to get to the final point,” Hacker says. “It’s a barrage of battles with engineers, developers, designers, it’s a battle of willpower but you can do it, don’t give up. It’s a long, arduous process. But they can do it while they practice. They need to have adequate resources. The final piece of the puzzle is distribution and Lumohs has onboarded with the largest and leading distributors of devices in the world. You can be an inventor, you can be an engineer, and you can develop a device, but it takes an enduring, unshakeable commitment to see it to the finish line.”

About the author: Jake Kauffman is associate editor with Today’s Medical Developments and can be reached at 216.393.0217 or jkauffman@gie.net.

Lumohs: https://lumohs.com