Industry: Bioscience & Medical
Products: Design, engineering, regulatory, and contract manufacturing services
President and CEO Jim Kasic is guiding the new medical device design and manufacturing firm to dynamic growth with a close eye on quality and regulatory issues.
Boulder iQ is a new company that's evolved from Boulder BioMed, founded by Kasic in 2009, which specialized in medical, with an emphasis on quality management and regulatory consulting.
The startup has nearly quadrupled its staff from six employees at the time of the founding in January 2018 to 23 at the end of summer.
"It's been a busy year," says Kasic. "The growth was people finding out . . . our capabilities had increased quite a bit."
That is personified by the addition of an experienced VP of quality and regulatory affairs who Kasic had collaborated for 15 years. "We brought on Dr. Carrie Hetrick, who is an expert in regulatory issues," says Kasic. "She brought a lot of clients and clout with her."
That dovetails into Kasic's experience in design and bringing products to market. "We are ISO 13485 certified to design, develop, and manufacture medical devices," says Kasic. "We don't look at ourselves as a true contract manufacturer. We have the capability to manufacture several thousand to 10,000 parts."
At that point, Boulder iQ helps clients move production to a higher-capacity manufacturer in the U.S. or overseas. "It's about time to market and reducing risk for our clients," says Kasic.
Case in point: One client was developing an in-body sensor for monitoring vital signs via a Bluetooth connection. "Because it was an implanted product, the signal wasn't strong enough to get out to a cell phone," says Kasic. After Boulder iQ's redesign, "It's worked 100 percent as it's supposed to."
The company's 6,000-square-foot facility includes two clean rooms, a fully-equipped machine shop, and rapid prototyping equipment. Kasic says the skill set spans "low tech to high tech."
About 80 percent of Boulder iQ's work is related to medical devices, but the company is not exclusive to the industry. Kasic points to the company's experience with power generation, high-end coffeemakers, and energy efficiency. "Their specialty really comes from industrial design and user interface. They have won countless awards for their designs."
Kasic is forecasting continued growth into 2019. "This is really an exciting time for us," he says. "We've been really fortunate to grow organically and have a good business model."
Before the founding of Boulder iQ, Boulder BioMed "doubled revenue every year for the last three years," Kasic adds. "With this momentum, I expect we may double again and be around 30 to 40 employees at the end of 2019."
Challenges: "Finding people in their mid-career," says Kasic. "I can find lots of young engineers and I can find lots of old engineers, but I need engineers in their mid-30s." He's seeking a balance of "longevity and experience."
Opportunities: Continued growth. Kasic highlights a big selling point: Boulder iQ's prices are about 80 percent of competitors on the coasts.
"As a business owner, I feel the economy is on fire right now," he adds. "We get our work from startups and very large, multinational, multi-billion-dollar companies."
With the tight talent market, "The big companies need look at companies like ourselves as a skunkworks," he adds. "Everybody gets squeezed." Startups have different reasons to work with Boulder iQ. "A lot of people have ideas, but they don't have the skill set to develop them past what we call 'Frankenstein designs,'" Kasic notes.
Hetrick's presence is also driving sales. "Carrie is an internationally-known regulatory and quality speaker," says Kasic. "We're starting to see a lot of quality and regulatory work come in."
Companies that are doing business with medical devices in Europe are navigating the transition from the EU's old MDD (Medical Device Directive) to its new MDR (Medical Device Regulation). "Every company that sells a device in Europe . . . will have to update a considerable amount of their documentation," says Kasic.
Needs: "It's human capital," says Kasic. "Right now, that is one of the biggest difficulties." Boulder iQ competes with big companies for the workers to fill manufacturing and assembly jobs. "The large-scale manufacturers, they're busy, too," he says.
To accommodate the growth, the company built a mezzanine above the production floor. "We can do that again," says Kasic. After that, Boulder iQ may be in the market for more space. The lease on the company's facility on the north side of Boulder is up in 2020, but Kasic likes the proximity to residential neighborhoods and Boulder Beer Company, just down the street. "If you can't ride your bike to work and walk to beer, it's not the right place," he laughs.