The Hidden Drivers of Clinical Trial Success

The Hidden Drivers of Clinical Trial Success

The Hidden Drivers of Clinical Trial Success

Interview with Rivermark CEO Dr. Adam Kadlec

Guest

CEO of Rivermark

Adam is co-founder and CEO of Rivermark Medical, a urology-focused medical device company developing FloStent, a first-line device treatment for benign prostatic hyperplasia (BPH). Under his leadership, Rivermark has raised more than $36 million and is conducting a pivotal clinical trial. Prior to founding Rivermark, Adam was a high-volume urologist in Milwaukee and consultant to multiple medical device companies. 

Key Learnings From Adam's Experience

  • Design for the workflow physicians already have — not the one you wish they had. Adoption barriers aren't just clinical; they're operational. FloStent works with equipment urologists use every day, turning diagnostic visits into therapeutic interventions without new capital, training, or scheduling complexity. Technologies that slide naturally into existing practice patterns face less friction and scale faster.

  • In clinical trials, identify who actually recruits patients — it's usually not the PI. Site performance often hinges on a single individual who talks to patients, follows up, and drives enrollment. Ask upfront: Who is your recruiter? What's their process? What's their track record? These questions predict trial momentum better than investigator reputation.

  • Raise capital in stages, communicate constantly, and protect your mindset through the grind. Rivermark launched with $2.5 million and proved value at each milestone before raising more. The hardest part isn't mechanics; it's the emotional toll. Adam notes the importance of finding a way to stay positive — because investors respond to conviction, and sustaining that energy matters as much as the pitch itself.

Medicine trains physicians to follow structured paths — collect credentials, move through gate after gate, and operate within well-defined rules. Innovation doesn’t work that way. Dr. Adam Kadlec learned that firsthand when he shifted from a high-volume urology practice in Milwaukee toward becoming a medtech founder.

Like many physicians, Adam first engaged with device development as a consultant, offering clinical insights on products that were already nearing market. But the more he dug in, the more he realized that meaningful influence happens much earlier — long before practicing clinicians ever see a device. What appeared “new” in the clinic had often been in development for a decade. If he wanted to shape solutions from day one, he needed to move upstream.

That insight ultimately led to the formation of Rivermark Medical, a urology-focused medical device company developing FloStent, a first-line device treatment for benign prostatic hyperplasia (BPH). Co-founding the company with a non-physician partner required a mindset shift few physicians make. In medicine, badges unlock opportunities; in startups, they don’t. Progress depends less on credentials and more on building a profile — a track record of decisions, judgment, and curiosity.

Adam’s journey reflects what it actually takes to move from clinician to founder — and why success in medtech requires leaving parts of the physician playbook behind.

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Design Devices That Fit Existing Workflow — Not the Other Way Around

When physicians evaluate new technologies, clinical efficacy isn’t the only barrier. Workflow often matters just as much. Adam learned this early in his innovation journey: if a device requires new capital equipment, specialized training, or changes to the daily routine, adoption slows — even when the technology works.

That insight guided the development of FloStent from day one. Instead of creating a device that required new tools or procedural steps, Rivermark aligned it with equipment every urologist already uses: the flexible cystoscope. “It’s like our stethoscope,” Adam says. “You almost have it hanging around the wall.” Urologists use cystoscopy routinely in the clinic to evaluate BPH patients and assess anatomy before recommending treatment.

FloStent was designed to fit directly into that existing visit. The same diagnostic cystoscopy can become a therapeutic intervention. No OR scheduling. No anesthesia. No additional setup. “What the FloStent can be is a therapeutic option… that can be delivered essentially during the diagnostic cystoscopy,” Adam says. “That’s something we really don’t have right now.”

For patients, this approach solves a different challenge: commitment. Most BPH procedures are irreversible. Once the tissue is altered, there’s no going back. FloStent’s reversibility makes it an on-ramp to device therapy — something patients can trial without burning bridges. “If things are going well, you can keep it,” Adam says. “If you decide it’s not for you, you’ve burned no bridges.”

The broader lesson: designing for workflow is as critical as designing for outcomes. Technologies that slide naturally into existing practice patterns grow faster, face less friction, and expand access to procedure-averse patients. Good devices solve clinical problems. Great ones solve operational ones, too.

Build the Right Team and the Right Decision-Making System Early

Adam’s transition from physician to founder required more than insight into BPH. It required the right partner — and a support system capable of guiding decisions in an environment where certainty is scarce and real-world execution determines success.

Start with a complementary co-founder

In Adam’s view, two physicians rarely form an effective founding team. Clinical expertise is essential, but startups demand operational horsepower — fundraising, execution, manufacturing, regulatory strategy — that rarely comes from medical training. “You don’t see a lot of two-doctor teams doing stuff,” he says. “It’s often a physician and a non-physician.”

For Rivermark, that partner was Andy Doraiswamy. Adam brought deep clinical knowledge and firsthand understanding of workflow. Andy brought medtech experience, operational rigor, and the ability to translate an idea into a company.

“Once we decided to move forward, it took about a year to get everything together,” Adam says. “Get the company formed, get the money raised.” Neither founder could have covered both sides alone.

Perfectionism won’t serve you

Moving from medicine into innovation also meant unlearning perfectionism. Physicians are trained to eliminate uncertainty before acting. Startups don’t offer that luxury. “You need to be comfortable with 60 to 70% certainty,” Adam says. “The time and resources it takes to get from 70% to 100% start to become a problem.”

This mindset became essential during Rivermark’s clinical development. No matter how much planning went into the pivotal trial, risks remained. “We could do almost everything right, and we could still have a problem,” he says. Accepting this reality — and acting decisively despite incomplete information — became part of his role as CEO.

Source multiple opinions and challenge the idea of a ‘standard way’

In medicine, clinicians rely on textbooks, guidelines, and established standards. Medtech is different. Adam quickly realized experts often contradict one another. “I’ve been surprised how often I hear, ‘This is how you do A, B, or C,’” he says. “Then someone else will say, ‘You never do it that way.’”

Rather than searching for a canonical answer, Adam built a system: gather perspectives, interrogate assumptions, and make the best decision possible with the data available. It’s a shift from “knower mentality” to “learner mentality” — a theme he believes every founder must embrace. “You have to out-learn your peers to win.”

In clinical research, find the person who actually recruits patients

One of Adam’s most important discoveries came not from consultants, but from clinical sites. Trial performance often hinged on a single individual — and it usually wasn’t the principal investigator. “Who recruits patients for you?” he says. “Who is your recruiter? And what’s their process?”

He learned this firsthand. In Rivermark’s first-in-human work, a highly engaged physician personally drove enrollment. But in later phases, that wasn’t always the case. Many PIs were supportive and interested — but recruiting wasn’t their job. And it wasn’t the study coordinator either. Key operators can be a nurse, a clinic administrator, or someone entirely unexpected — the person who actually talks to patients and drives enrollment day-to-day.

Adam realized he needed to ask a different set of questions during site selection. For example:

  • Who talks to patients about studies?

  • Who follows up?

  • Who is accountable for enrollment?

  • What is their track record?

These individuals — not the PI’s reputation — often determined whether a site enrolled at pace or stalled out entirely. It’s a practical insight most first-time founders overlook, and one Adam wishes he had acted on earlier. Identifying the true driver of enrollment became one of the clearest predictors of trial momentum.

Work With the People Who Reflect Real-World Use — Not Just KOLs

Adam applies a similar philosophy to how sales teams should think about physicians. Great device reps, he notes, operate like consultants — not just explaining product specs, but understanding the day-to-day life of their customers. “What do I worry about? What cases do I like to do? What does my workday actually look like?” he says. That level of empathy forms the foundation of strong commercial adoption.

But Adam cautions that while KOLs are essential for shaping early clinical and design insights, they’re not the ones using the device every day. It’s important to get input from high-volume, rank-and-file physicians — the “Joe the plumber” types who understand workflow realities and can offer unfiltered feedback. The challenge is finding them — Adam’s advice: ask the KOLs themselves. “They know who the busy, thoughtful docs are, the ones who like to talk shop,” he says.

These behind-the-scenes clinicians often become the most valuable partners for shaping, testing, and ultimately scaling new technologies.

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Raise Capital in Stages — and Stay Resilient Through the Process

Rivermark’s early fundraising approach was intentionally lean. The company launched with a $2.5 million seed round — a number that felt small even at the time, but one that forced the team to focus on turning every dollar into measurable progress. “We were able to do a lot with it,” Adam says. “You’ve got to turn the dollars into value. That’s what the game is.”

That discipline shaped the company’s trajectory. By staying lean and focused on turning every dollar into real value, Rivermark built the trust and confidence of its early backers. “We stayed focused on our existing investors and making sure they were happy,” Adam says. “Those relationships helped us raise money later on.”

Rivermark’s transparency paid dividends when it came time to scale, ultimately raising roughly $40 million to support its pivotal trial.

But the hardest part wasn’t the mechanics of fundraising. It was the emotional toll. “There are so many negative messages that you get as a founder trying to raise capital,” Adam says. Rejections accumulate. Process delays compound. Even strong companies can struggle to maintain momentum.

Adam learned that managing his own mindset was just as important as managing the round. “However you can be positive — exercise, meditation, prayer — whatever you’ve got to do, stay positive,” he says. “And that is very, very hard.”

Having a co-founder helped distribute the weight, but Adam is quick to point out the importance of early believers — the people willing to back a concept long before it has data. “God bless those investors who come in early,” he says. “They call them angels for a reason.”

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