After more than a decade at Johnson & Johnson, launching billion-dollar products and leading businesses across medical devices and pharmaceuticals, Randy Hubbell made a deliberate decision to step back into the uncertainty of startups. Not to experiment, but to execute.
Today, as CEO of Solaris Endovascular, Hubbell is building a rare kind of medical device company: revenue-generating from day one, anchored in a real clinical need, and designed from inception for acquisition.
In this Beyond The Pitch conversation, he reflects on leaving big pharma, the thinking behind Solaris, and the lessons entrepreneurs must internalize when building with investors and keeping exits in mind.
Randy, you spent many years at Johnson & Johnson. What led you to leave the corporate world and return to startups?
Johnson & Johnson is an incredible company. I spent 13 years there across three primary roles. One of the highlights was serving as the launch leader for Cypher, the first-ever drug-eluting stent. We reached a billion dollars in sales in just eight months, the fastest product launch in J&J history.
Those experiences gave me exposure to strategic decision-making at scale - what to build, what to acquire, how to justify investments, and how regulatory paths shape outcomes. But over time, the organization began consolidating business units. The biosurgery group I was part of was losing autonomy, and that wasn’t where I wanted to be.
Earlier in my career, I worked at startups, and I knew that at this stage, I wanted to be closer to building, fundraising, and shaping strategy. I left J&J, joined a startup as Chief Commercial Officer, and eventually became a first-time CEO. That journey ultimately prepared me to build Solaris.
What sparked the idea behind Solaris Endovascular?
Solaris is very close to my heart. I began my medical career at Boston Scientific in the peripheral disease space, working on technologies for peripheral artery and vein disease - precisely the problems Solaris is designed to address.
What made it even more compelling was the technology. Solaris is the only covered stent drug-device combination product. The drug is sirolimus, the same drug used in Cypher, which I helped launch earlier in my career.
Peripheral disease, a proven drug, a combination product where I had deep experience, and it was clear to me that this could be a game-changing technology that genuinely improves patient outcomes.
Solaris is often described as a rare startup that generates revenue from day one. What made the early journey different?
Most startups begin with an idea and raise capital to build something new. Solaris was different. The base mechanical device was already approved in 45 countries, sold in 10, and generating revenue. The drug-device version was already in Phase 2 clinical studies.
I structured Solaris as a Delaware C-Corp and used equity to acquire these assets from SciTech Medical. That allowed us to start with technologies already well into the U.S. PMA process, without carrying years of development costs on Solaris’ balance sheet.
It was a creative way to start a company with mature technology, aligned incentives, and a clear path forward.
What does your go-to-market strategy look like?
My goal is not to commercialize Solaris in the long term. At this stage of my career, all I do is exits.
In medical devices, once you complete most of the clinical spend and approach regulatory approval, the acquisition window opens. Solaris was built for that moment. There are large strategics with established commercial infrastructure in our space, but they lack a self-expanding covered stent, and none have one with a drug on it.
They need new products to feed that infrastructure. We’re leaning into that ecosystem rather than trying to compete against it.
That said, I do have a complete commercial model if needed, focused on the U.S. first, selective European entry, and Japan as a secondary market. But the most efficient use of capital is advancing U.S. approval.
When things get difficult, what guiding belief keeps you grounded?
It always comes back to the problem. Is there a real clinical problem that needs to be solved? And are you uniquely positioned to solve it?
If there’s a significant unmet clinical need, physicians care. Strategics care. Reimbursement follows. But if the space is crowded, even a big problem may not be attractive.
With Solaris, both conditions are true: a significant unmet need and no competing biological solution. That clarity keeps me focused.
You presented at Keiretsu Forum, one of the largest angel networks globally. What was that experience like?
This is my sixth startup, and I’ve raised capital through angel networks before. Solaris is attractive to VCs and strategics, but angels play a particular role here.
We’re using angel capital as a bridge to properly stand up the company, hire full-time employees, and reduce perceived risk. Strategics want to invest in companies that look sustainable, not purely fractional or virtual.
Angels get in at a discount, with much of the development risk already behind us, and a clear exit profile. That capital bridges us to larger institutional or strategic rounds.
How do you approach transparency and communication with investors?
High transparency and high communication, always. Quarterly updates are non-negotiable. I’m surprised when I hear about founders who don’t communicate with their investors at all.
We also host occasional calls and maintain open communication. Investors should feel comfortable reaching out with questions. Trust compounds when communication is consistent.
What key lessons would you share with early-stage entrepreneurs?
First, make sure you’re solving a real problem, and that you’re uniquely positioned to solve it.
Second, start with the exit and work backward. Investors invest for exits, not ideas.
Third, stay standard and customary. Use NVCA documents and avoid one-off terms that can become distractions later.
I’ve been on the buy side at large strategics, and everything I build today is informed by what acquirers actually look for.
