Building the Beachhead Strategy

On Commercialization: Find Your Beachhead and Create a Repeatable Process

When Erica arrived at Silk Road Medical, one of her first priorities wasn't clinical or technical — it was linguistic. She literally locked executives in a room with pizza until they created a name for their procedure. The result, TCAR (TransCarotid Artery Revascularization), is now written into medical textbooks. This branding move exemplifies her approach to carving out a clear identity in a crowded marketplace.

"Find a beachhead. Really be focused on where you can land first and expand from there," Erica emphasizes. "What I mean by that is a defined market segment where you can go to the clinician and say, 'It's not every single patient in your practice. That's too big for customers to think about. Let me focus you in on this very specific clinical profile.'"

This focused approach mirrors Randy's strategy at Axena Health, where despite urinary incontinence affecting tens of millions of women, the team has identified specific patient profiles for initial targeting.

"There are many shiny objects that come at you, especially as you get into the clinical and commercial stage of a company," Randy notes. "Focus becomes critical."

Both leaders stress the importance of establishing a repeatable process — what Randy calls "the funnel flow" — to acquire customers and track their progress through the funnel. Once that process is well-defined and consistently executed, scaling becomes a mathematical exercise.

For medical devices requiring physician prescriptions, like Leva, establishing this process means prioritizing healthcare provider education before direct patient outreach. Both Erica and Randy caution against direct-to-consumer marketing before securing physician buy-in.

"If you activate patients and you have not brought the clinicians into the partnership already, it's not going anywhere," Randy explains. "A patient that walks into a doctor that has no idea what that patient is asking them about — their first reaction is always no, and usually fairly visceral."

This strategic approach requires patience but builds a more sustainable commercial foundation.

Make Clinical Evidence Your Cornerstone

For Axena Health, FDA clearance marks the beginning of the clinical journey, not its conclusion. With 11 peer-reviewed journal articles already published on their device, the company views evidence generation as a perpetual mission.

"The approval is just the first step," Randy states firmly. "We are engaging with clinicians, and they all have a patient in mind. They want to think about that and be able to link it to what you're doing."

This commitment to evidence extends beyond regulatory requirements to encompass payer relationships, physician education, and continuous product improvement. Remarkably, 98% of Axena patients have consented to having their blinded data used for ongoing research, creating a robust database for answering stakeholder questions with evidence rather than assumptions.

Erica, drawing from her experience across multiple medical device companies, emphasizes the growing importance of real-world evidence: "Payers are often more interested — CMS has become even more interested — in what happens when you launch these things to the masses."

She continues, "You cannot underestimate the power of real-world evidence, and it should start on day one of your commercial launch. Because every day that goes by that you're not collecting real-world evidence, you're losing that opportunity to understand what happens when you put this in the hands of clinicians."

This evidence becomes particularly powerful when used to refine the product itself. Axena recently published a study showing they can predict with 80% accuracy which patients will succeed with Leva therapy after just two weeks of use — potentially allowing physicians to quickly pivot non-responders to other treatments.

"That's the promise of continuing the clinical evidence," Randy explains, "and frankly, continuing to engage with your customers as they're looking for other ways to think about how they care for their patients."

Master the Milestones-to-Money Connection

The medtech fundraising landscape demands more than promising technology — it requires strategic milestone achievement and clear communication.

"Let's talk about why we're raising capital in the first place," Erica begins. "I think folks get distracted on what we're doing with a capital raise, and it's really to achieve a meaningful and timely milestone."

She advocates for defining clear milestones tied to each fundraising round. When approaching investors, be specific about your needs and objectives — explain that you need a certain amount of funding to accomplish specific milestones, and how achieving them will increase your company's valuation. This clarity shows investors exactly how their capital will translate into measurable progress and value creation.

Both leaders stress the importance of consistent communication with current investors, who can become champions for future rounds. Randy has implemented a monthly scorecard system using red-yellow-green indicators to keep his board updated on progress against key metrics.

"What has the most success is a history of success," Randy reflects. "They are investing in a history, whether it's in this company or in the people that are there that have done it elsewhere."

Erica adds a crucial reminder about investor psychology: "Keep in mind that these investors are involved in dozens of companies. We think that we're the star of the show, and they're going to remember every last detail about our company every minute. You'll be surprised how you have an investor who's been around the table for five years, and they literally forget where you are in your journey, what's been accomplished."