New York move leads medical device developer to develop cutting-edge endoscope in Sioux Falls

Sharma watched the scene out a window of a hospital clinic in London as he was training to become a surgeon. What felt like a lifetime drive toward cardiothoracic surgery had given way to a strong interest in the colorectal field. Time he had spent in the United States doing research at the Centers for Disease Control and Prevention had left a mark on him. It all added up to feeling like he wasn’t headed in the right direction.

“I wasn’t where I was supposed to be,” he said. “Out loud, I said, ‘I wish I knew a surgeon in New York.’”

Behind him, a voice answered.

“I know someone,” the person said.

Sharma turned around – and so did his career path.

His colleague was talking about Dr. Jeffrey Milsom, then chief of colorectal surgery at Cornell University, “and they just happened to be meeting that weekend,” Sharma said. “He connected me.”

That was in 2009. Sharma was about to pursue his Ph.D. at Oxford University, where he would meet Milson at a speaking event that led him to an across-the-ocean career shift.

“It was fascinating because he showed me devices he was evaluating at the time, and I didn’t know doctors could do that,” Sharma said. “At that point, the light went off. I need to be doing that.”

Fast-forward 15 years and Sharma and Milsom are co-founders of Grumpy Innovation Inc., a biotech company that just received clearance from the FDA for its first medical device.

Thanks to a Fulbright scholarship for surgeons, he was able to come to the United States, where he spent seven years helping bring a double balloon stabilization device for use in colon surgery from a sketch on paper to use in a patient.

“I did some back-of-the-napkin math,” he said. “If I was a surgeon, I could help maybe 10,000 people in my career. With the right technology, that number could be orders of magnitude greater. And that cemented it for me. I have to do this.”

Now, thanks to an equally fortuitous series of events, he’s growing his medical device business from Sioux Falls.

“It’s just an incredible story, and we’re thrilled it’s wound through South Dakota,” said Joni Ekstrum, executive director of South Dakota Biotech.

“What Sam and his team have created is a device that truly exemplifies innovation. And I think they’re just getting started.”

‘Getting grumpy’
Sharma and Milsom sat at Cafe Grumpy in New York City’s Grand Central Terminal as the seeds of innovation were planted — inspired by a listing on Amazon.com.

It was a wireless borescope – the kind you use to look down drains – but two colorectal surgeons saw something else.

A typical endoscope is “hundreds of thousands of dollars,” Sharma explained. “It’s large. It requires washers and infrastructure and office space. At the time, there was an issue with cleaning some of them, and some patients were becoming very sick and even dying. We were horrified. We said, ‘Look, if we can get this from Amazon, why can’t we make this?’”

In retrospect, there were plenty of challenging reasons why it hadn’t been done.

But at the time, the two just “started getting grumpy,” Sharma said. “Real grumpy about the lack of innovation in our field. So we sat down and formulated all of this at Cafe Grumpy and said, ‘Why is there no progress in our medical world like we see in the commercial world?'”

Thus began Grumpy Innovation, striving toward one big, bold goal: creating a wireless endoscope.

By 2019, they had raised money “from friends, family and grateful patients,” and Sharma went all-in.

“I left Cornell, left academia and made the decision to do this full time as CEO,” he said.

Finding Sioux Falls
Sharma didn’t set out to move to Sioux Falls – but he was getting close.

“The center of the medical device business is Minneapolis,” he said. “The ecosystem, the manufacturing, to a large extent is there.”

He had a lab there and was starting on prototypes when life took some big twists.

“I was all set to move to St. Paul, had essentially shut down everything in New York, and then I met my future wife in late 2019. So it was like, what am I doing now?”

Months later, he and his future wife, Anne Huntington, spent the pandemic lockdown in New Jersey together as he shifted his approach to developing the endoscope.

“We brought everything in-house rather than outsourcing most of our process,” he said.

“Through an investor’s connection with the University of Minnesota, we essentially hired engineering interns, and for whatever reason, the door started opening from suppliers overseas. We began doing all research, design and development in-house, and it helped focus all our efforts.”

A move to the Twin Cities still called, but after trying various communities for six months, they decided to try Sioux Falls.

Huntington, the president of Huntington Learning Center, had been to Sioux Falls for a conference as had Sharma before they had known each other.

“Everything was closed, and there was a palpable tension in the air in the Twin Cities in late 2020, and we came here, and it was the exact opposite,” he said. “I began looking around for a community.”

That led him to Ekstrum and South Dakota Biotech.

“I met Joni in 2020, and she was incredibly kind and gracious and wanted to help,” Sharma said. “That was key. She started introducing me to people.”

One of them was Mark Larson, a professor in the biology department at Augustana University, who suddenly made Sharma feel like maybe he wasn’t all that far from home after all.

“Amazingly, he had been doing post-doctoral research at the University of Birmingham the same time I was there,” Sharma said. “We didn’t know each other, but we’d walk the same halls. I’m still floored when I see him wearing an Aston Villa Birmingham soccer shirt.”

When they met, Sharma had been commuting back and forth to the Twin Cities for a few years and needed workplace in Sioux Falls. Larson solved the need right away.

“He was great. He said: ‘Look, we’ll find you a space. We need people like you, and this is great. Let’s go,’” Sharma said. “He got me a bench, and I had somewhere I could work, which was great.”

Augustana’s Froiland Science Complex had been built with lab space to accommodate growth, which proved an ideal fit for Sharma.

“Joni introduced us, and Sam and I made this connection having been contemporaries in the same place,” Larson said.

“We had capacity for him to lease space from us, and it’s a great way to augment what’s happening in our building. It’s good for the students to see full-time researchers, and it’s great for me to be able to introduce students to someone who can talk to them about the corporate world and biotech.”

That’s the beauty of South Dakota Biotech, Ekstrum said.

“We’re here to be that connector, to help people who are like-minded and have the resources to help one another connect,” she said. “In this case, the impact became huge.”

From his space at Froiland, Sharma continued to ideate on 3D printers with assistance from a team based all across the world.

“He can do the mental gymnastics needed for a device to be functional before he put it to the test in patients, which saves a ton of time and money and becomes a really creative endeavor,” Larson said. “Print it, check it, see what it does. If it doesn’t work, make an adjustment and test that. He’s basically set up a fabrication shop in our lab.”

Device approval
On June 5, Sharma got news years in the making: The FDA had cleared Grumpy Innovation’s wireless endoscope for use in endoscopies of the nose and throat.

“To our knowledge, it’s the world’s first wireless, high-definition, sterile, single-use endoscope,” Sharma said.

The most important advantage is the high-quality view the scope provides, he said.

“Disposable scopes typically are very low-resolution, poor image quality,” he said. “You can’t see fine structures, and this enables you to see very fine detail very clearly, which helps the doctor.”

Gone are the wires and other clutter associated with the traditional procedure – replaced by portability, Sharma added. A wireless transmitter uses a rechargeable battery pack with single-use sterile devices used in patients.

“You can take this anywhere,” he said. “And wireless is the future.”

What’s next
With FDA clearance, Grumpy Innovation can begin marketing the wireless endoscope to clinicians for use in patients while planning to scale manufacturing.

Devices still are being manufactured in Minneapolis with a short-term goal of doing a limited run there while exploring options for manufacturing in South Dakota.

“Our challenge now is we need to raise money to build another batch of units,” he said. “We’ll follow a lean-type approach, which is what we’ve done so far, really utilizing interns with help from senior individuals in a consultant role.”

Larson said he hopes that the relationship with Augustana will continue.

“I’m happy to give up one of my benches so he can take root here,” Larson said. “Having these external connections keeps our department as current and fresh as it can be, and that benefits everyone.”

The hope is to work more closely with Augustana students, Sharma said.

“When we first tried, it was during a critical period with the FDA, so the timing didn’t work out, but I had a number of students who were interested, and they were great and very qualified,” he said. “The timing hasn’t aligned yet, but hopefully it will.”

The FDA clearance is “incredibly significant,” Ekstrum said. “This is rare for a South Dakota biotech company. We see medical device development and manufacturing as a natural growth opportunity for us, but to have an entrepreneur like Sam based here and achieving this level of success already shows what’s possible going forward.”

Looking at the path to market ahead, “I still can’t believe it,” Sharma said.

“I had no idea how hard it was going to be. Every step is such a complex system. You fix one problem, and something else comes up, and decisions you make early in design become critical to what’s approved at the end of the process. I’m just very grateful to an amazing team and for great support from investors.”

Whether it’s building on his current device or pursuing others, Sharma likely has a long career ahead, Larson said.

“It will be interesting to see where he can take it,” Larson said. “It’s not just about one device. Sam’s real talent is identification of what’s needed, what holes are in the medical device field that he can brainstorm what we might do and try it.”

For Sharma, the year has been significant in one more way too.

He recently became a U.S. citizen.

“I’m very patriotic,” he said. “Early on, I felt the support for research and the mentorship I received. It really left a mark on me. That spirit of individuals wanting you to succeed and supporting you every step of the way and doing what they can do help you. I felt it meeting Joni and the individuals at Augustana, and that reminds me of when I first came to America. I came first in 2000, and 25 years later, to me, it’s still there. And you can’t ask for more.”