Minnetronix expands from contract manufacturing to launching its own product

For more than 25 years, Minnetronix Medical has made products for original equipment manufacturers in the medical industry. But with the release of the MindsEye, a neurosurgical expandable brain port, Minnetronix only had one company they needed to listen to...themselves.

When they began the project in 2017, Minnetronix realized neurosurgeons needed a more controlled way to see the effects of hemorrhagic strokes or tumors deep inside the brain. By 2020, MindsEye received U.S. Food and Drug Administration (FDA) approval and Minnetronix found themselves moving from contract manufacturer for OEMs to an OEM as well.

"It started out as, how do we leverage all of the product development and manufacturing expertise we have in house?" says Matt Adams, vice president and general manager at Minnetronix Medical. "And if we were to point those [capabilities] at very specific unmet needs in the market, can we effectively expand our offering, from our traditional engagement where an OEM comes to us with an idea or a product and we do the development and manufacturing? Can we build on that core expertise by going all the way from concept to FDA cleared device and be able to drop a complete product straight into the sales bag of one of our partners?"

© Minnetronix Medical | https://minnetronixmedical.com/

Now on the market, the MindsEye is being used at Tulane University in minimally invasive surgeries for hemorrhagic stroke, cancer, and other brain patients by Dr. Art Wang and Dr. Johnny Delashaw.

“Its benefits to neurosurgeons, such as expandability, easier insertion and removal, and transparency that minimizes glare and allows surgeons to see surrounding tissue, are truly unique,” says Dr. Delashaw, Tulane University neurosurgeon and neurology professor. “The MindsEye expandable port has raised the bar for standard of care in neurosurgery and will improve patient outcomes.”

A manufactured sheath had to stretch but still maintain strength for the MindsEye to be successful, so a combination of machined plastics and metals were used by Minnetronix. By developing a proprietary process to enhance the strengths of the raw material, they made a sheath with 500% elongation while staying clear, transparent, and tough enough to withstand a surgical environment then return to its original shape.

“The team of engineers came up with a hybrid molding, extrusion process built on a deep understanding of material science to come up with a sheath polymer that can get 500% elasticity, stay clear, stay tough, and return to its initial shape,” Adams says. “In a surgical environment, you're trying to coagulate vessels and so on, you've obviously got sharp instruments in the surgical field dealing with that toughness perspective. That process along with the cleanroom manufacturing environment that MindsEye is produced in today, was 100% developed and run by Minnetronix, and you won't find that anywhere on the planet.”

© Minnetronix | https://minnetronixmedical.com/

The expandable sheath may be the secret sauce to the MindsEye device but so far it hasn’t expanded to other products. However, Aaron McCabe, Ph.D., executive/technical lead at Minnetronix Neuro says that could be coming in the future.

“You start seeing surgeons that specialize in other pathophysiology’s saying, ‘I sure could use minimally invasive, expandable access in my specialty,’” McCabe says. “We've gotten a lot of that. And that's one of those moments where you really must stay focused on where you're going. Listen, file it, but keep your focus, and come back to it in the near future.”

The MindsEye won four major industry awards for its unique technology and design, even before it was available to the market. Mizuho America signed on to distribute the MindsEye expandable port in the U.S.

“Mizuho’s mission is to deliver the best devices to neurosurgeons,” says William Delaney, vice president of sales at Mizuho America, a company with 30 years of history in developing the most advanced medical devices for neurosurgeons across the globe. “We now consider Minnetronix a partner for new device ideas and finished products. Since they handled all the steps in creating the MindsEye expandable port, we can concentrate on bringing it to market by leveraging the strength of our distribution channel to accelerate adoption and enhance patient outcomes.”

Minnetronix is one of the few companies on both sides of the fence, an OEM and a contract manufacturer. The experience has helped them in producing products for themselves and customers.

“Our customer is still the OEM, but we now have this whole new vernacular of dealing with the end customer, the user, the device,” McCabe says. “And that's across the whole lifecycle of the device from the beginning and the knowledge of how to engage those users, how to listen, how to determine what's what, and what are real needs, versus ‘this is what was on fire this morning’. All the way to learning through the development process, to the use cases, when the product is commercially used, treating human patients. It takes that engagement level up a notch. Our customers value the fact we also understand and have engaged directly with the user of our devices in the same way they do every day.”

Minnetronix will continue to produce the MindsEye device while supporting OEMs working in radio frequency (RF) energy, fluid and gas management, optical systems, and stimulation and active wearable devices.