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The Device Files: From Concept to Commercialization · Jun 24, 2026

Final Episode of Commercialization Confidential: Best Practices for Hospital Commercialization with Jess Richter

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Blythe Karow · The Device Files: From Concept to Commercialization

If you’ve been reading The Device Files for a while, you know the usual format. One CEO, one product launch, five takeaways.

This episode is different on two counts.

  1. Instead of picking one company to feature, I sat down with Jess Richter for a conversation that pulled from five different commercialization stories spanning her 20-year career in MedTech. We used a different example to ground each takeaway, which I think was a great way to summarize half a year of podcasts, especially given part 2:

  2. This is the last episode of the Commercialization Confidential podcast. Don’t cry just yet - we’re revamping the podcast!! Moving away from the narrow scope of lessons learned during those first years of commercialization and expanding into a variety of areas. Details are still TBD - we’re going to workshop it over the summer and come back with something new because the feedback I’ve consistently heard from you all is that there’s appetite for a broader set of topics across MedTech (and wearables, DTx, TechMed, and AI) commercialization than what this single-launch format covers. But also, if I’m going to keep this up I really need to hire some help because I am really over editing this stuff!

I think Jess was the right person for the send-off. She and I do very similar work in MedTech commercialization consulting, and we end up at the same conferences regularly enough that getting her on the show was overdue. This was a really fun one to record, and closing out the original format with a cross-cutting, best-practices conversation felt like the right note to end on.

As always, three ways to enjoy the episode:

(Side note: the NEW podcast will also DEFINITELY involve me outsourcing the editing - and hopefully that will mean no more goofy mid-sentence pictures here :D)

Jess Richter runs Richter Advisory Collective, which has a lot of similarities with The Karow Advisory Group - not too surprising since we both have a long history in MedTech commercialization.

Where I come at MedTech commercialization from an upstream product strategy background (BME turned product strategist turned startup CEO turned consultant), Jess came at it from the opposite end. Her first decade was spent in the field commercializing devices at Becton Dickinson, Medtronic, Covidian, and Given Imaging. Her second decade pivoted more upstream into regulatory, quality, clinical, and market access strategy. It a cool background and why Jess does such a good job of providing a “Best in Class” version of the podcast - she has such great examples to draw from in her experience!!

Most founders I work with identify a single physician champion at a target hospital, put that person on the advisory board, and assume the champion will drive the purchase. As Jess put it, those days are mostly gone:

"Who can say no and kill the deal, especially with capital equipment, is maybe more important than anything else."

For anything that requires hospital approval, especially capital equipment, you need alignment across multiple stakeholders who each have different motivations and different veto power. The framework Jess kept coming back to is Miller-Heinman strategic selling, which breaks the buying group into four roles:

  1. The economic buyer. Controls the budget and owns the ROI decision.

  2. The user buyer. The person on the front lines who cares about workflow and usability.

  3. The technical buyer. Compliance, IT integration, cybersecurity. Easy to forget if you’re not selling software.

  4. The coach. Your internal advocate. The one who can back-channel about fiscal year timing, earmarked funds, and which decision maker is actually going to be at the next value analysis committee.

Jess walked through an example from her time selling esophageal manometry systems. (For those of you who, like me, had to look it up: manometry assesses the function of the esophagus, things like swallowing and motility, and it’s used to determine which patients are candidates for surgery downstream.) These are expensive capital equipment systems sold into hospital value analysis committees. Her motility champion at one of the UC hospital systems was excellent at articulating clinical value but couldn’t speak the economic language.

The most important question Jess asks is who can say no and kill the deal. With capital equipment, that’s often more important than who’s going to say yes.

The story behind this one is pretty good.

Jess walked through Bravo, a disposable reflux diagnostic implant. It was a new product that offered 48 hours of uninterrupted reflux data, more accurate medication management, a simple outpatient procedure, and good reimbursement. Everything that should drive adoption was there, except for one thing: the device required a 15-step, 15-minute calibration process that the nurses and techs in the office had to perform before each implant.

Fifteen minutes doesn’t sound like much, but for an already overburdened support staff, fifteen minutes was a wall. Jess described what happened:

“They would get annoyed and they would get frustrated and only a couple of people would be trained. And if those people weren’t in the office on the day that the procedure was done, the rep would have to show up. It created a lot of turmoil and it made the clinicians not really want to do this procedure because it was just not worth it to get their staff so frustrated.”

This is what workflow burden actually looks like in a real office. Its one of those things where everyone knew the 15 minute calibration was an effort, but they didn’t weigh it enough during product development conversations. So, instead of incorporating it into the first product design, they started to scramble six months in to launch when adoption started stalling.

The good news is that the company eventually figured it out and redesigned the product to be calibration-free and adoption took off. There was a related point Jess made about the same product: the handle on the original Bravo was so large that clinicians with smaller hands, often female clinicians, couldn’t actually twist and deploy it. So they had a compounding human factors miss on top of a workflow miss. Both pointed to the same root cause, which is product teams that haven’t spent enough time watching the device get used in the actual hands of actual users or not hearing feedback.

If you’re working on a product that hasn’t yet launched, do yourself a favor and put it in front of the people who use it and really listen to their feedback.

This one is interesting because many people want to land Mayo Clinic or Cleveland Clinic as their first big customer. The brand validation is seductive. But here’s what Jess laid out, and I agree: a limited market release (LMR) is not about prestige. It’s about feedback loops.

The job of an LMR is to put your product in the hands of friendly, motivated users in environments you can study closely, so that you can refine messages, training, workflow integration, and reliability before you scale into larger systems. Mayo Clinic is not always friendly in this sense. Mayo Clinic is high-stakes. So, if your product hiccups at Mayo, you might not get a second chance, and the brand validation you were chasing turns into the opposite.

Jess shared a de-identified example of a client running a bladder function diagnostic that combines disposable sensors with software for interpretation. The company smartly chose a limited market release approach and selected 10 friendly sites. The product worked and they were getting some real learnings from it, but it went sideways:

“One of the things that we reflected on in our work together that they could have done better or differently is had a more direct conversation with the sales team that the intention behind this limited market release… We are expecting to learn.”

The sales team wasn’t briefed that the LMR was a learning exercise. So when normal LMR snafus happened (the kind that happen in every LMR, because users always do funky things you didn’t anticipate), the sales team interpreted them as the product failing and their confidence wobbled - impacting sales. The company recovered and is now in expansion mode at 25-plus sites, but they paid for that internal communication gap in months that didn’t need to be hard.

If you’re about to launch an LMR, brief your sales team explicitly on what learning looks like and what kinds of “issues” are actually data, not failures. Frame it like a clinical investigation. The sales team should feel like co-discoverers, not soldiers being sent to defend a product they don’t trust yet.

Jess called this one a tremendous surprise of her career, and I think it’s the takeaway most likely to be new to early-stage founders. The FDA has been incorporating patient voice more aggressively into regulatory decisions for years now (a handful of gastric balloon products were approved primarily on patient desire, even though they missed clinical endpoints). That same patient voice can also drive commercial outcomes if you build the relationship correctly.

The example Jess gave was a pancreatic cancer diagnostic that helped determine which medications would be appropriate for individual patients. The partnership was with PanCan, the Pancreatic Cancer Action Network. Pancreatic cancer can be a death sentence, and the patient population is intensely motivated to find any treatment that extends quality of life. PanCan helped advocate for the criticality of getting tissue samples, connected the company with appropriate clinicians who were already deploying the diagnostic, and drove patients to ask their own doctors about the test.

Tactically, here’s how Jess deployed the advocacy partnership:

  1. Show up at advocacy events. Most are walks or runs. Get a table, bring fun merch. Cheap, high grassroots visibility.

  2. Participate in roundtables, webinars, and patient support groups. Lead with patient impact, not product features. Bring a clinician to discuss case studies, not a sales rep to demo.

  3. Identify the advocacy group’s local champions in each geography. Arm them with information and resources.

  4. Sponsor the organization at the national level so your name lives alongside their educational content on their website.

In case you’re wondering where this shows up in the P&L, advocacy widens the top of your funnel by activating referrals. Jess gave a related example, courtesy of Kristi Nakayama on one of her market development teams. Kristi noticed that patients arriving at the ER with chest pain that turned out not to be a heart attack were almost always actually experiencing reflux. Those patients were going home with a proton pump inhibitor and a vague instruction to follow up. Kristi built a referral channel from the ER directly to the gastroenterologists who would use Bravo to diagnose the underlying condition. That’s not strictly advocacy work, but it’s the same mental move: go upstream and find the moment patients enter the system, then intercept them.

One thing I added to the convo here: This kind of work is valuable even before you have FDA clearance. When I was CEO of a startup developing a PTSD treatment, we spent a lot of time at veteran events, first responder gatherings, and PTSD advocacy meetings well before we had a product to sell. Not to market anything. To learn, and to build the relationships that turned into clinician and patient advisory boards during development. Most startups skip this because they think it’s a commercial activity to be done later. I think it’s also a development activity to be done early, and the founders who do it well end up with champions who feel like they helped build the product, not customers who feel like they’re being sold to.

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Jess called this last takeaway Captain Obvious, but I think for tons of people this is not obvious at all. Unfortunately Jess and I have seen this exact thing play out many times.

The mistake: promoting someone who is great at sales into a sales leadership role. They’ve been crushing their quota so clearly they know how to get it done, right? (Plus - they’re salesmen, so they convinced you that they’re the obvious choice!) You give them management of the team and within six months they’re miserable - and the team is completely disorganized and not executing to plan. As Jess puts it,

“They can wreak havoc within the sales organization.”

The fix is to recognize that selling, coaching, and strategic leadership are three different jobs that occasionally show up in the same person, but usually don’t. Your sales leader needs the respect of the sales team (typically that means previous sales chops), the perspective to see the whole portfolio and pull the right levers, and the execution focus to deliver results. If your best rep is great at the first part but doesn’t have the second two, leave them selling.

There’s a related point Jess made about “what’s in the bag”.

In Jess’s experience, the teams that do the best keep a smaller, focused bag of products. When reps have one or three or five products to focus on, they execute with more precision than when they’re carrying twelve products and trying to remember which one to lead with this quarter. If your company ended up with more - consider specialized reps. If your distributor has more - consider whether you’re getting the support you need to hit your sales goals.

Toward the end of the recording, I asked Jess a question that isn’t officially one of the five takeaways but felt like a natural addition to the conversation.

If you’re ready to build out your initial commercial team, whats that first commercial team look like? Jess’s answer, summarized:

  1. Five is usually the magic number to start with.

  2. Located near your LMR sites. Geographic proximity matters. You want them onsite often.

  3. Seasoned, not green. Five to ten years of experience. Startups don’t have the time or the budget to train someone from scratch.

  4. Background in pharma, big medical device, or another structured B2B environment. They need to know how to work a plan.

  5. Scrappy and hungry. The luxuries of a 50,000-person company don’t exist in a 50-person company, and they need to be okay with that.

  6. Strong EQ. They are the ambassadors of your company. You don’t want someone who steamrolls.

On the org structure question, Jess’s preference is to have a head of sales setting strategy plus reps who can execute. She’s a strong advocate for re-appropriating existing team members into commercial support roles. Your clinical team can become clinical support for the sales team. Your marketer can play product manager. Your technical lead can deploy into the field when complex software issues come up. And the CEO should be out there selling too, especially in the first 18 months.

One thing you’d always do again: Engage clinicians and frontline staff early. Develop those relationships well before you need them.

One thing you’d never do again: Assume a physician can single-handedly drive a hospital purchase. They can’t anymore. Also: don’t white-knuckle one plan. Stay nimble. Lean into what’s working and lean out of what isn’t, even when the original plan was your favorite.

Favorite KPI: Adoption velocity within qualified target accounts. Not just new doctors. Volume of procedures. One physician doing 20 procedures is good. Five physicians at the same account doing 20 procedures each compounds into something powerful.

Most unexpected growth lever: Peer-to-peer physician advocacy driven by early clinical success. The KOL piece is expected, but what surprised Jess is how much faster adoption moves when the KOLs talk to their respected colleagues, not to your sales team. The example she gave was a lunch she organized at a well-respected surgeon’s community office. About 10 surgeons attended. The well-respected surgeon walked them through a specific case where her outcome with the product had been impressive. The other clinicians asked her the questions they wouldn’t have asked a sales rep. That single lunch unlocked more adoption than weeks of direct outreach would have.

Thanks to Jess for joining me on this final episode of The Device Files: Commercialization Confidential. It was a great conversation that really gave best practices across a lot of territory!

Blythe Karow is a strategic management consultant and founder of The Karow Advisory Group. The insights shared here reflect Blythe’s strategic expertise navigating the complex world of MedTech and wearables. Imagine what that same thinking could uncover when applied to your business.

How Blythe can help:

  • Commercialization & Market Readiness Reviews

  • Product & Business Strategy

  • U.S. Market Entry Planning & Education

  • Strategic Advisory for MedTech, Wearables, and HealthTech

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