The Hard Truth About Partnerships

What It Takes: From FDA Clearance to Global Market Adoption

Great technology is a good starting point, but it doesn’t guarantee success, especially in medtech. 

Prior to starting Vivos, Kirk discovered a patented technology addressing sleep apnea developed by a professor. “He was not a business guy, and he was never going to scale this up,” he recalls. Kirk reached out, and together, they founded Vivos.

To successfully bring an innovation to market as a CEO, you must understand both the clinical and business aspects of your industry. That includes expertise in your niche, how it fits into the healthcare ecosystem, and what you bring to the table for all stakeholders, including physicians, patients, and providers. Even with solid technology, you still need regulatory approval, reimbursement, and a go-to-market strategy to build distribution channels and drive adoption.

When building distribution channels, partnerships can make a huge difference. However, Kirk cautions against rushing into deals with large companies. Early-stage firms often believe these partnerships will solve their problems, but large corporations move slowly and prioritize differently. “You're a little piece of their great big pie,” Kirk says. 

For example, when Vivos signed a distribution agreement with a big player, the team was initially optimistic. But when the partner company’s CEO left, new leadership shifted priorities, nullifying months of negotiation.

That’s why Vivos is now partnering up with sleep testing centers — even acquiring some — where patients first learn they have sleep apnea and start weighing their options. Kirk’s goal is to establish a presence at the diagnosis stage so that patients immediately consider Vivos as an alternative to CPAP. As Kirk puts it “We want to be there at that juncture to have our hand up to say, ‘Yes, look at us, look at this alternative technology’, and someday we think we're going to be the go-to technology.” 

When starting the company, the first thing Kirk focused on was the research. Once he and the team had enough data, they presented it to FDA, but the process wasn’t straightforward. “When they put a podiatrist in charge of an oral appliance, you know you're in trouble,” Kirk says. They eventually got the approval after investing time and resources. Once that was done, it was time to take the device to market. 

When the team secured FDA approval, their stock — Vivos is publicly traded on the NASDAQ stock exchange under the ticker symbol VVOS — surged up to $48 a share, before dipping to $2 Navigating such volatility while addressing other challenges requires resilience. Despite this, FDA approval attracted serious interest from providers and patients, creating demand and strengthening their position in in reimbursement conversations.

After FDA approval, the next step is getting insurance to pay, which requires securing CPT codes . This process is involves lengthy bureaucratic procedures and payer negotiations — but it’s essential for long-term adoption.

And then there’s international expansion, a dream for many companies but one that adds a whole new layer of complexity since each country maintains its own regulatory requirements. For example, Vivos has entered Dubai and parts of the Middle East, but Saudi Arabia requires separate approvals — a process that takes time and resources. Kirk sums it up: “You've got to be able to fight battles on multiple fronts at the same time. You've got to be winning those battles so that as you get a win over here, you can go and use that as leverage over there.”

Driving Adoption Using a Page From Invisalign’s Playbook

Today, Vivos enjoys persistent demand for its sleep apnea solution that doesn't require nightly device use. However, the company’s path wasn’t always smooth. 

Kirk and his core team come from the dental industry, so it felt natural to market their oral appliance to dentists first. Since their device fits in the mouth, they assumed dentists would readily prescribe it for sleep apnea. But many dentists, focused on teeth and oral health rather than sleep disorders, didn’t feel qualified to treat this condition. This strategy stalled, but Kirk persisted. 

Physicians get pitched new medical devices all the time, so they’re naturally skeptical. They stick with what they know, and when it comes to sleep apnea, CPAP is the safe, established choice. It’s widely used and low-risk, so no one gets sued for prescribing it. Kirk adopted a two-pronged approach: “We're going to the providers to make them aware, and then we're going to the public and making them request this by name.”

He decided to approach the medical community with a solid selling point: An FDA-cleared device that treats severe sleep apnea in adults and children. While 200+ oral appliances existed in the market, most performed similarly, and none had FDA approval. Medical professionals already treating sleep apnea patients who disliked CPAP proved more receptive than the dentists.

The company has treated over 50,000 patients, reports zero lawsuits (almost unheard of in the medical device world), and maintains high patient satisfaction. Despite these metrics, physician adoption remains gradual.

Stanford University’s endorsement adds credibility. “We're going to the very best and brightest in medicine and getting those guys to put their stamp of approval,” Kirk notes. Having Dr. Clete A. Kushida, a leading sleep researcher at Stanford, on their R&D team makes it easier for doctors to trust the solution. 

Vivos also reaches patients directly through social media. Word-of-mouth marketing has fueled expansion, with patient and physician testimonials featured on their website. Healthcare providers talk to each other, sharing insights on new treatments, and patients go online to research what works for others.

Kirk compares Vivos’ approach to how Invisalign disrupted orthodontics. Initially dismissed by dentists, clear aligners gained traction through direct-to-consumer marketing. As patient demand grew, dentists had to offer the service or lose business.

Vivos is taking a page from Invasalign’s playbook. Increasing patient demand for CPAP alternatives forces physician attention, and positive outcomes accelerate adoption.

As a result, eight out of 10 patients choose Vivos over CPAP, even though it’s more expensive. But there’s a silver lining: “Our cost of treatment is higher than a CPAP machine, but it actually gets the job done,” Kirk says.