Building Relationships, Raising Capital, and Establishing Reimbursement Codes

If you watch football or read the news, you already know that concussions have become an area of increasing concern for many sports associations, particularly the National Football League (NFL).

Rosina Samadani initially watched the emerging discourse around concussions play out from the sidelines of her sister’s medtech company, Oculogica. Rosina’s sister, Dr. Uzma Samadani, is a renowned neurosurgeon at the University of Minnesota At that point in time, she was in the preliminary stages of developing the EyeBOX: a cutting edge medical device designed to diagnose concussions by reading cranial nerve palsies.

Uzma periodically tapped Rosina for advice in the early days. As a serial entrepreneur with a PhD in biomedical engineering, Rosina wasn’t just a trustworthy and supportive sister, she was also a valuable consultant. Rosina eventually moved over to work on the project full time, and is now the CEO of Oculogica.

In this episode of Medsider, Rosina shares her advice for managing various stages of the regulatory journey, the importance of nurturing relationships with key stakeholders, and why entrepreneurs shouldn’t be intimidated by the complex reimbursement process.

Key Learnings from Rosina’s Experiences

• Put people first. It can be easy to lose sight of the fact that there’s a human on the other side of every interaction. Forming authentic and meaningful relationships with your various partners — from investors to regulators — goes a long way.
• Prioritize function over flashy design, especially in the alpha and beta stages of your company. Prototypes should be easy to use and free of glitches if you want to move quickly through clinical trials.
• Don’t be intimidated by complex initiatives. Breaking large objectives down into digestible action steps demystifies the process and makes challenging tasks manageable to achieve.

Product-Market Fit: Know Where To Play (and Where Not To)

With an almost ubiquitous association between football and concussions, it’s not surprising to Rosina that many are quick to ask if the EyeBOX will soon appear on the sidelines of NFL and collegiate games.

But for now, that’s not Oculogica’s focus. First, the medtech company is focused on placing its product in clinics and hospitals, where the device will be used under the supervision of physicians, and other qualified healthcare professionals.

Having a narrow focus is the result of careful planning and preparation, a strategy that Rosina credits to Steve Blank, her former teacher and the mastermind behind the Lean Launchpad, a popular methodology used by entrepreneurs.

The Lean Launchpad approach focuses on finding product-market fit, which requires extensive initial customer research. Only then should entrepreneurs move on to develop an actual product. It’s a strategy endorsed by other Medsider guests, including Holly Rockweiler, who used similar research tactics while enrolled in Standford’s Biodesign program.

As a result of Oculogica’s research, Rosina knows the NLF won’t be its first client. “Everybody says, Oh my gosh, the NFL and the sidelines, this is where you guys are going to kill it,” says Rosina. “But they’ve [already] got their concussion protocol.” As a result of her research, she knows the NFL isn’t going to be first-in-line to adopt brand new technology.

Similarly, Oculogica isn’t targeting other athletics organizations, because current practice is to sit out any player with a suspected concussion for the remainder of the game, rather than try to diagnose it on the spot.

Instead, the company is targeting the medical professionals who are consulted after a game, who operate in medical settings.

By clearly defining product-market fit, Rosina and her team are able to develop an intentional and efficient go-to-market strategy.

The Alpha and Beta Stages: Make Sure It Actually Works

In addition to prioritizing product-market fit, Rosina thinks many entrepreneurs in the early stages of their company should change their focus when developing prototypes. Function should take precedence over form.

Oculogica's first prototype for EyeBOX was lovingly referred to as “the duct tape prototype,” not because it was flimsy, but because it was held together and secured to the table with actual duct tape.

“It was really difficult to put together and set up at clinical trial sites, but it worked,” Rosina recalls.

The prototype got the initial data they needed, but it had its flaws, mainly because the setup was too complex. Rosina advises that entrepreneurs focus on robust but basic devices that are stable and free from glitches. It's essential that those using your device can troubleshoot with ease. If not, they'll get frustrated and are less likely to enroll patients in the trial.

“They're not going to have the instinct that you do. So you need the software to be safe, stable, and you need the thing to be able to fall on the floor and still be OK — most likely that is going to happen,” Rosina says.

Raising Capital: Know Your Audience and Customize Your Pitch

Rosina’s best advice for raising funds: “Put yourself in the seat of the person you’re talking to,” she says.

Angel investors and venture capitalists (VCs) think differently about the return on their investments. Therefore, your presentation should reflect their specific needs and concerns.

Do your research upfront. Know a VC’s portfolio and investment thesis. If a VC isn’t a good fit for your company, don’t waste your time (or theirs). Instead, only pitch to investors you believe are good fits for your company.

“Narrowing that down will really help you,” says Rosina.

Earlier investors, particularly angel investors, are looking for something exciting. They’re not afraid of risk and are willing to take a chance. But the further you move through the fundraising process, the more mitigating risk will become a vital part of your strategy.

Alternatively, consider building strategic partnerships. TitletownTech Ventures, a Wisconsin-based VC firm backed by the Green Bay Packers, is one of Oculogica’s investors. The partnership makes sense from both a financial standpoint, and also because of the potential connections with the NFL.

The Wisconsin-native sisters didn’t make their pitch by strolling down to Lambeau Field and knocking on doors. Instead, they asked one of their angel investors, Golden Seeds, to make the introduction. Which, when coupled with some cold calls, got their foot in the door.

The “surround sound” strategy is an approach that has worked for Oculogica, and shows the company’s credibility and determination.

Relationships Matter: Authentic Connections Will Take You Far

Strong relationships have consistently been at the crux of Oculogica’s success. Whether turning to a pre-existing connection or forging new ones, EyeBOX’s evolution has benefitted from Rosina and Uzma’s understanding that people are important.

Rosina shares three crucial moments in Oculogica’s journey where relationships mattered:

Making friends at FDA

Rosina believes in taking advantage of every moment of an interaction. At the conference table for their pre-submission meeting with the Food and Drug Administration (FDA), her team made sure they spread out instead of sitting next to one another. It allowed the team to make personal connections with as many of the regulators as possible. They were able to develop more personal connections, which continued to grow as they worked together throughout the regulatory process.

Advice from StartX’s accelerator network

Rosina is a passionate advocate for StartX, an independent non-profit accelerator for Stanford graduates. When she needs feedback from a peer, or sample contracts, she turns to her network of fellow entrepreneurs. Members of the program are eager to support one another, and value community-wide success.

The clinician stamp of approval

When Oculogica went through the reimbursement process, it had 11 medical societies willing to support it. Uzma’s connections in the medical field certainly helped at this juncture, but it was the team’s commitment to cultivating long standing win-win relationships that drove the strategy home.

Rosina is quick to point out that relationship-building only matters if it’s genuine. She recalls an interaction with the lead reviewer at the FDA, whom she’d gotten to know during the regulatory process. After reading news headlines about the government shutdown, she decided to check in on him. She sent an email to let him know she was thinking of him during such a stressful time. “It wasn’t even about our submission. I actually cared about him as a human being,” she explains.

Forming relationships, though, should never be forced. “You’ve got to read the room,” Rosina says.

Reimbursement: Remember, It’s Not Brain Surgery

Many medtech entrepreneurs are quick to describe the reimbursement process as complex and time-consuming, but Rosina believes that shouldn’t deter entrepreneurs from pursuing their medtech dreams.

Oculogica also needed to apply for a Current Procedural Terminology (CPT) code, which further complicated the process, but that didn’t dissuade Rosina’s team.

“Don’t be intimidated when applying for a CPT code,” says Rosina. “A brain surgeon invented our technology, but what I tell people in my company is, We’re not doing brain surgery.”

It may seem overly simple, but Rosina says: “Google it.”

Once a complex process is broken down into small, actionable steps, it becomes much easier to pursue.

“Maybe I’m foolish, but we did it. We’d never [applied for reimbursement] before, but honestly, it was fun. We went in front of the American Medical Association (AMA), we were really prepared, and we did a great job,” Rosina says.

One thing she wishes she knew in hindsight: You don’t have to have FDA clearance before applying for a CPT code. “We waited. You don’t need to do that. Make sure you’re applying as early as possible,” she says.