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From Idea to Impact: Prioritizing and Efficiency in Early Medtech R&D

Nathan Friedman, CEO of HemaSense

Note: This is an edited transcript from the MedTech Summit talk Nathan presented on July 8, 2025.

I'm Nathan Friedman, CEO of HemaSense. Today I'm not going to talk about the entire list of things you should be considering, but rather how you take that list and start to wrangle it and prioritize when you're in what is essentially a resource-starved situation—which many of us are in, especially in the early phases.

My Background

Before I jump into detail on that topic, I want to give you a little background about myself and where I'm coming from with this topic, because I think it provides useful context.

I'm a mechanical materials engineer by training, graduated from Rensselaer Polytechnic Institute, and currently live in Flagstaff, Arizona. I've been here for about 20 years now. The reason I came to Flagstaff was because out of college, I got a job with W.L. Gore & Associates.

Most people in the medtech space have heard of W.L. Gore & Associates—it's a big multinational company with over $4 billion in sales and 12,000 people worldwide. But the medical division has been headquartered here in Flagstaff, Arizona for many years.

I came out here and immediately jumped into product design and development for cardiovascular and structural heart devices. I worked on many of the branch devices in the aortic space, and the device on the right that you see—their septal occluder—was really my first device that I helped through development.

I spent 19 years at W.L. Gore & Associates. Through that experience, I had what I think is similar to many people who have gone through these large companies: you get a great education in hands-on medical device development, especially when it comes to complex devices like implantables that have very long timelines. Our rule of thumb was seven to nine years of development before one of these devices was fully released to the market.

Part of that experience involved going through the gamut of different tools that were the "tool du jour" at these companies. We probably talked to all the major consulting firms you hear about. Over the years, you start to distill down which of these tools you really resonate with and which ones don't seem like a great fit. The company will find the next new tool and bring it to you, and it's really up to you to figure out how to take that forward. That's really the basis of my talk.

The Entrepreneurial Detour

About 12 years ago, I started a microbrewery here in Flagstaff as well. This was just because of my entrepreneurial spirit. At the time, Gore was going through some transitions, and I did this in addition to my job at Gore. Wanderlust Brewing Company grew from me working evenings and weekends in addition to my engineering job to about 10 employees, statewide distribution, and a really nice tap room with a focus on Belgian and German beers. I sold that business about two years ago.

I left Gore about a year and a half ago as they were going through another reorganization because I wanted to get back to my entrepreneurial roots and really play in this entrepreneurial startup space in the medtech world.

I'm also an instructor for I-Corps, which was mentioned in our first talk today. This is a great program to help de-risk a lot of early-phase work, so I'm a huge proponent of that. I'll put in the plug—if people haven't been involved in that, it's a free program as well.

HemaSense

The bulk of my time now is spent on HemaSense. HemaSense is an early-phase device company making a wearable monitoring device. We're specifically focused on detecting subcutaneous bleeding events following surgeries in general, but our first application is around catheter-based surgeries.

When you have a catheter that goes in for a femoral access procedure—whether it's a heart valve, stent graft, or similar procedure—there's a pretty high rate of bleeding at that access site. Right now, the only way of detecting that is visual inspections by a nurse every 15, 30, or 60 minutes, depending on what they have time for. We can do that continuously.

This is really where I've had the opportunity over the past eight to nine months to bring to bear a lot of the prioritization and efficiencies that I learned at Gore and in my other endeavors to try and help move us quickly through this early phase.

The Challenge We All Face

I don't think I have to state this, but I like putting it up here as a reminder: all of us are struggling. It is not an easy thing. We have all made the decision to play in a highly regulated, very complicated, long-timeline space. We've done that because there's a lot of good we can do for everyone involved in this ecosystem—whether it's the payers, the physicians, or especially the patients. That's what draws a lot of us to this.

But we want to make sure we maintain perspective that this is complex, and there are a huge number of different considerations and priorities that may pull you in 100 different directions on a daily basis.

We're all trying to compete with timelines, money, and resources. As a CEO or founder, you have to figure out how to deploy those—especially considering you probably don't have a lot of any of them. I don't think any of us have enough of all three that we feel set and it's not keeping us up at night.

A Framework for Prioritizing Uncertainties

What I like to do is use frameworks that I can apply very quickly and easily to do frequent check-ins on: are we doing the right thing at the right time?

What I'm going to give you is this framework that I use. Full acknowledgment—the work I did at Gore is derived from several frameworks we used there. But I think it's in a simplistic form that helps you work through what are the biggest uncertainties we need to be thinking about right now, and how do we prioritize those uncertainties and which ones we're going to de-risk first.

I put them in three categories:

1. Technical Risk

This is what we commonly think of as product-related development uncertainties. Can we build something? Can we prove it works? Can we deliver it reliably? What is the actual product we are delivering—whether it's a physical medical device, software solution, or therapeutic?

These are the things that are actually, in a lot of cases, the easiest ones to think about because they're more than likely directly under our control as a company. This is inside our walls most of the time. I can deploy more people on it, I can deploy more money to it, and try to accelerate it.

2. Market and Adoption

This is from the external perspective. We talk a lot about product-market fit, problem-solution fit, finding that right customer—all those kinds of things. But at the end of the day, it boils down to: does anybody care enough about what we're building, what service we're delivering, and what problem we're solving that they will adopt it and pay us for it?

These are things we don't have control over a lot of times, but we need to understand them because this is the environment we're working in.

3. Business and Execution

This is where you bring it all together—the company, the funding, the business opportunity. Do these things come together from the technical category and the market category to create a viable business? Is this real? Can we execute on it? What are the pieces we have to have in place—the right people, the right financing, the right timelines, the right regulatory pathway—so that we actually have a business?

At the end of the day, we are not building charities; we are building businesses. That is fundamental for these endeavors to actually move forward and be successful. You can't just have a cool widget that doesn't turn into a profitable business at some point, or it's never going to be viable.

Deep Dive: Technical Risk

When we think about technical risk—fundamentally, in the early stages, one of the biggest questions we wrestled with at HemaSense is: does the technology exist to accomplish this solution, or do we need to develop it?

Either one will work, but you need to be very aware of the implications if that technology doesn't exist and you have to develop it. Now we're talking about more of a science project. This is what happens in universities. This is where government grants fund things. It's probably not investment-ready if you're doing early technology development.

Key questions include:

HemaSense Example

At HemaSense, the actual computation, electronics, and materials we're using for our skin-contact electrode patch are all off the shelf. We knew from the start that wireless communication, control systems, and data processing exist. That's not our biggest uncertainty.

But if we don't have the right skin interface and the right electrode configuration to actually get good data off our patient, we have nothing.

The image you see is probably the sixth iteration of our electrode patch that we've done in the last four months, because this was our biggest uncertainty at this stage. I don't care if it's hooked up to four prototype boards and three laptops to gather that data. If I don't have good data coming in, then I have nothing. So we started there.

That took us four months to develop. The electronics that are attached to it took about a month and a half because we pulled that off the shelf. We know what we need at that point. We've de-risked that biggest uncertainty from a technical standpoint.

Deep Dive: Market and Adoption

This is something we hear all the time. How big is this market? Are people willing to pay for it? Are you treating three people at a rural hospital somewhere, or do you have a million patients who all need this problem solved?

We also need to understand: who are we solving this problem for? Who are the stakeholders, decision makers, and those who will drive adoption of your product? You could be selling to doctors who have no say whatsoever in what actually gets brought into a hospital. Or you're talking to hospital value committees when actually the doctor has the final say.

Key considerations:

HemaSense Example

This has been something we've hit really hard with HemaSense because we have an economic value proposition. We need to understand: how much better do we need to be? How much money do we need to save for the hospital? How many costly complications do we need to eliminate that will actually drive meaningful adoption?

For us, this was a very clear problem. We know that hematomas and bleeding complications are a problem, but how many procedures have this problem? Are we talking about just one procedure type or is it across the board?

This is data we spent a lot of time wrapping our heads around. Once we formulated that, we validated it with physicians in multiple ways. We've gotten to the point where we've validated it with so many physicians that I'm getting papers sent to me before I even see them published because they say, "Here's another data set that validates what you're trying to do."

Deep Dive: Business and Execution

This includes things like funding and capital strategy and burn rates, but really making sure you've looked at this business portion from many different angles and understand: is this your biggest uncertainty today?

Key questions:

A Critical Insight About Investors

I went to LSI this year for the first time. There were fireside chats in the evening with panels of investors, founders, and people who were founders turned investors. One statement just resonated with me perfectly.

Someone said: "You know what? I was a founder out there trying to find investors. One of the most important things you can remember as a CEO is you are selling two products. You are selling the actual product you're building—those customers are the hospitals, physicians, or patients. But you are also selling an investment to your investors.

"They don't care if you have the greatest product in the world if it's not a smart investment, because that's why they're in this. Yes, they have their focus areas, thesis, timeframes, and company profiles they look for. But ultimately, you are not selling them your product. You are selling them an investment in your company so they can make a return on it."

That simple statement helped me reformulate how I think about meetings with investors. Yes, they have to have evidence and belief that your product will be successful. But at the end of the day—it sounds kind of crass—in many cases, it's not because it's going to save lives. It's because it's a good investment. They're not a charity.

How to Prioritize: Death Blow Uncertainties

My most simple way of thinking about how to prioritize focuses on "death blow uncertainties." We use this phrase multiple times a week. When we talk about something, we ask: is this a death blow? If we don't have an answer to this, will it kill us? Will this sink the company if we don't understand the answer to this uncertainty or haven't de-risked it?

It could be product, market, or business-related. We all feel the pressure of not having funding and runway we'd like, so that one often bubbles to the top. "I need to go hit the streets and fundraise." But there are other things that, even if you had all the funds in the world, would completely destroy the company because you haven't de-risked that uncertainty.

So we start there. We identify the death blows—if we don't know this, we're done.

Don't Work in a Vacuum

When you're thinking about how to prioritize these things, don't do it locked in a room by yourselves. Do it with input from your customers and the ecosystem you're operating in.

We always think about the three P's—patients, physicians, and payers—but regulatory can sink your product. Hospital purchasing and health economics can sink it as well. Investors are your customers too. You are selling them a product, so you need to understand what their priorities are and why they might not be interested in funding you.

I would say go out there, and even if you know somebody's not going to invest—and a lot of times you don't find that out until halfway through your conversation—make sure you ask them how they prioritize investments. What do you look for in a good investment? You need to understand your customer, even if what you're selling them is that investment, not your product.

A Brewery Lesson

When I was running Wanderlust Brewing Company, my bartenders hated this, but I forced them to put me on the schedule to work behind the bar one day a month. I did it for eight years until COVID.

I did that because I wanted to understand what my customers wanted. I can brew all the beers that I like all day long, but at the end of the day, I'm not the one buying it. My customers are the ones buying it.

They'd schedule me with another bartender because they knew I was just going to sit there and talk to customers—I didn't know how to run the register half the time and was really slow. But it gave me that firsthand interaction, sitting across the bar, serving somebody a beer, asking them why they like it, why they don't like it, which one they ordered, how it compared to other things they've had.

It's a simplistic view of this whole customer interaction process. It's very different when you're trying to find that customer in an imposing-looking hospital and figure out who makes decisions. But fundamentally, it's the same process.

Go out and find that feedback, take it back, and use it as a data point. The scientific method says you shouldn't make a decision off one data point, so get two, three, four, or five. Ask different people and start triangulating. Use that to prioritize your uncertainties and make sure that if you have one that keeps coming up over and over again and looks like it's going to be a roadblock, you better think about how you're going to prioritize that against the others.

Summary

Here are my key takeaways:

Focus on uncertainties, not necessarily tasks. The tasks will come out of those uncertainties once you identify them. This is just one model—you could probably scroll through your LinkedIn feed and find five other ways to categorize and slice these uncertainties. At the end of the day, find one that works for you.

I like simple. Simple is better to me because I can check in on a regular basis. I don't have to sit down and open a spreadsheet. I can have a conversation with my co-founder and say, "I think we need to revisit some of the technical uncertainties. Are we prioritizing this right?" It's a quick conversation that allows you to prioritize what matters so you're not chasing shiny objects or redirecting the whole company based on one comment from one investor.

Tackle those death blows first. If it's going to sink the company, don't sweep it under the rug. Go tackle it head-on and figure out the reality. If you need to pivot because of that, do it. If you need to find more information or figure out how to overcome that, call in other people.

Don't work in a vacuum. Talk to your customers, co-founders, and fellow CEOs in this industry. I've found that because this is such a difficult space for development in the medtech world, people are very collaborative. If you have the courage to pick up the phone, give somebody a call, or drop them a message on LinkedIn, more often than not, they're going to be willing to at least chat with you. You'll find common ground on all these struggles we've all had together.