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The Device Files: From Concept to Commercialization · Apr 29, 2026

Jamie Grooms on the Week Axogen Almost Went Under - and the Commercialization Lessons That Came Out of It

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Blythe Karow · The Device Files: From Concept to Commercialization

A Quick note before we start: I have to say a MAJOR Thank You to Jamie Grooms for this podcast for two reasons:

1. We taped an entire podcast, and then at the end realized that I had forgotten to hit record. He very graciously offered to retape it.

2. Jamie has so much amazing experience and advice that I’ve cut down the podcast a bit and will be turning his experience and mentorship into a short series on advice for founders around how you build and use your board, sales and distribution partnerships, and navigating investor mentality.

If you have spent any time in the Florida MedTech ecosystem, you know or have heard of Jamie Grooms. He’s a founder of RTI Surgical and Axogen, two of the biggest medical device companies to come out of my hometown, Gainesville. He’s also one of the most active mentors, advisors, and investors in the Florida startup ecosystem. I told him in the podcast that he’s the Godfather of Florida MedTech, and I don’t think that’s hyperbole – he definitely earned that title. (I think its a better title than Queen of Wearables too!)

What makes this conversation different from the others on the Commercialization Confidential podcast series is that Jamie’s commercialization lessons don’t come from one launch or one company. They come from his time at multiple startups including RTI and Axogen and from decades of advising other founders. He’s seen the full rainbow of MedTech success, failures, and in between and is a fount of good advice and knowledge.

Jamie tells one story in this episode that I cannot do justice to in writing, and honestly you should hear it from him!

It’s about a single week in Axogen’s history when three separate things went wrong, any one of which could have killed the company, and the year that followed where the company had to figure out how to survive. The way he tells it, the team task division, the calls he was making – it’s quite the rollercoaster ride. Also, just a great case study to learn from.

Jamie has spent most of his career commercializing without the kind of financing that lets you execute a fully planned, year-long, multi-KOL launch. And honestly, what startup has had all the funding they wanted for a launch?

So what do you do when you have limited resources? Go deep.

The discipline is to identify the four or five accounts you can credibly serve. Within each one, find the earliest adopter physician. Build loyalty with that one doctor through real data and real case studies. You know that doctor’s volume. You know they have five other partners. You use the case studies to convert the partners. You stay deep in those four or five accounts until you’ve validated the sales cycle. Then investors will fund you to duplicate it nationally.

The objective Jamie kept coming back to is loyalty, not volume. As he put it:

“Selling has a bad connotation. It’s education and it’s facts. It’s real data. A data-driven story is how you ultimately win anywhere.”

A commercial relationship, done right, is a two-way loyalty program where both sides treat each other well with facts and truth.

This is the lesson Jamie didn’t see coming, and it cost Axogen $20 million. Not exaggeration - and I quote:

“So, that cost us $20 million to dig out of.” - Jamie Grooms

Once Axogen’s product was on the market and the data was showing real results, the competition saw what was happening. They knew the new Axogen product was better. So they quickly thought through their competitive positioning and decided to paint Axogen into a corner. With their corporate marketing machine, they pushed a simple message to surgeons: if nothing else is working, try Axogen. The 'last resort' slogan stuck and left Axogen as an afterthought for years.

His advice for any founder launching today: you have tools that didn’t exist when Axogen launched. Lean in to your ability to get in front of KOLs through guerilla marketing and social media and present them with good data. Get competitive with all of it from the start. When a doctor pushes back, have something specific to send them. You won’t beat corporate loyalty entirely, but the only way you chip at it is with facts.

People always talk about the importance of a sales force, but you also need a solid sales plan; and if you think just telling them to call on doctors is enough, you’re probably planning the wrong way.

Karen Zaderej, who joined Axogen with deep experience from Johnson & Johnson and Stryker (and helped turn around the image of the Axogen brand after the lesson learned in takeaway #2) taught Jamie what he says was the biggest marketing lesson of his career:

Karen taught Jamie that the way out of being defined by your competitor, and frankly the way to build a clinical adoption strategy from scratch, is to drive the conversation yourself through three places: the podium, your training programs, and the rooms where your most skeptical physicians are sitting with their peers.

  1. The podium is the most obvious one. KOL presentations at the right meetings, with the right speakers, doing the right kind of clinical positioning. You’re not trying to “sell” anything from a stage. You’re educating peers on what the data shows and where your product fits in the clinical decision tree.

  2. The training program is the one most companies underestimate. This isn’t just sales training. It’s the framework you build that maps your product against the clinical decision-making process and shows surgeons exactly when your product should be considered the primary option versus a secondary one. When you build that matrix correctly and train your team on it, your reps stop pitching features and start having clinical conversations with surgeons about which patients are right for your product. That’s what changes adoption.

  3. The third piece is the one many people avoid because it's uncomfortable. You put the unsupportive physicians in rooms with their colleagues. If your data is solid, the data and the peer pressure will do the work that direct argument can’t. You don’t try to convince the loudest critics one at a time. You let them see what their respected peers think when the evidence is on the table.

I’ll also add a piece I picked up during my time at Johnson & Johnson. With the doctors who are going to be the loudest critics - or anyone who is going to throw off a group meeting - try to get to them offline first. Address their objections one-on-one before they’re in front of twenty other people. Some people just have a knee-jerk ‘NO’ to anything new. Let them get the no out of their system in private. By the time they’re in the group setting with their peers, you’ve already laid the groundwork. Karen’s J&J background is probably a major part of where her “start the conversation” instinct comes from.

It worked for Axogen, it was expensive, but it worked. Today Axogen is the standard of care for peripheral nerve repair.

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Axogen initially went after urology. The pain point was unmistakable: after certain prostate and pelvic surgeries, nerve damage can lead to erectile dysfunction and urinary incontinence. Urologists felt that pain acutely because their patients were the ones living with it. Axogen had data showing the product could restore both motor and sensory function, which meant there was a real chance to fix something patients cared deeply about, in a market where patients have historically been willing to pay out of pocket for quality-of-life solutions.

Within six months, the market had told them otherwise. Urologists felt the pain, but they didn’t perform nerve repair. To deliver the procedure, urologists had to learn a new surgery themselves or bring in a plastic surgeon to do the nerve repair. The cost of educating urologists on a procedure outside their normal workflow didn’t match what Axogen could afford. Karen adjusted course and the company pivoted to trauma. Hand surgeons and plastic surgeons already performed nerve repairs, so the Axogen product could easily integrate into their workflow.

So the key piece here: You can’t just identify a good pain point, you have to make sure the clinical workflow also accommodates your commercial strategy.

Urologists felt the pain but they didn’t perform the repair. Trauma surgeons felt the pain and performed the repair. The lift to commercialize into trauma was a fraction of what it would have been to commercialize into urology, even with a smaller theoretical market.

Most founders launch with the assumption that the market is waiting for a better product. Jamie’s lived experience says the opposite. As he put it in the conversation,

“Innovation is not welcome.”

The market is built around incumbents who have spent years cultivating relationships, building corporate loyalty, training surgeons on their products, and locking in purchasing pathways. When you arrive with something better, you aren’t entering an open field. You’re trying to dislodge people from positions they’ve worked hard to establish, and they’ll defend them. Sometimes through legitimate competitive response, like better data and faster iteration. Sometimes through positioning attacks, like the emergency-only label that cost Axogen $20 million. Sometimes through the slower drag of clinical inertia, where surgeons would rather keep doing what they know than learn something new, even when the data says they should.

The takeaway isn’t that the world is unfair. It’s that founders need to plan for resistance from day one. Build your KOL strategy assuming you’ll need to fight for clinical attention. Build your commercial budget assuming a competitor will try to define you. Build your launch plan assuming the workflow disruption will cost you adoption time even when the science is on your side. The companies that succeed are the ones that walk in expecting the headwinds rather than getting blindsided by them.

One thing you’d always do: Build sticky loyalty customers. One customer who’s loyal beats ten who are transactional. The strategy spearheads it. The tactics support it.

One thing you’d never do again: Go out with a sales-only plan. Always start with a marketing-and-sales plan, vetted and approved before you launch.

As Jamie put it, “slow down to speed up.”

When the money lands and you’re anxious to deploy it, that’s exactly the moment to slow down.

This one I see all the time. A company gets a fresh raise plus FDA clearance, decides it’s time to commercialize, and goes looking for a Chief Commercialization Officer. They default to a sales executive because the resume reads well. “I grew sales from X to Y at Big Company” is an impressive number, and the CEO (or their VCs) say “ooh, that’s great.” Sales is a tactic, though. Commercialization needs a marketing-led plan first. Sales gets layered on top.

Favorite KPI: Account predictability. Knowing what an account will deliver month in and month out, with confidence. That’s the best business you can have.

Most unexpected growth lever: Axogen’s transition from a 361 product to BLA approval. Jamie credits the team that delivered it. The exclusivity that comes with BLA approval changes the commercialization moat in a way no startup is going to replicate easily. The team earned it, and now they get to reap the reward.

Thanks again to Jamie for joining me, and especially for filming this twice. He’s a rockstar.

If you’re a MedTech founder, an investor, or anyone trying to figure out how commercialization actually plays out in the real world, I cannot recommend listening to this one strongly enough. The takeaways above are useful. The full conversation is better.

Blythe Karow is a strategic management consultant and founder of The Karow Advisory Group. She writes The Device Files, a Substack publication on MedTech strategy, market access, and commercialization.

We’re aiming to release one episode per month and I’m actively looking for people who might be good podcast contributors.

If you or someone you know has commercialized:

  • As a startup, OR

  • In a completely new market area where your company did not have relationships in the past

And that commercialization isn’t so out of date as to not be relevant, please reach out. I’d love to highlight more leaders on the podcast.

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