How to Transition from a Consumer Product to a Medical Device: Interview with Rohan Dixit, CEO of Lief Therapeutics

We recently caught up with Rohan Dixit, the Founder and CEO of Lief Therapeutics, which makes consumer- and clinical-grade wearable devices for mental health.

Rohan is a neuroscientist who started his career as a researcher with Stanford and Harvard. Rohan founded BrainBot, his first company, at age 23. He’s been the CEO of Lief since 2015.

Today, Rohan’s going to break down how Lief started, and we’ll get into product development, how he approaches clinical research, why they initially launched their device as an over-the-counter consumer product, and many other topics related to medtech startups.

Listen to the Interview with Rohan Dixit

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Read the Interview with Rohan Dixit

The following interview has been lightly edited for readability.

Thanks for joining Medsider, Rohan. Can you provide us with a high-level overview of your background and how Lief came together?

I struggled with anxiety and depression as a young adult and that led me into the field of neuroscience. I studied mental health at Harvard and Stanford ,as well as mindfulness, and how that kind of interplay occurs in the brain. That was the impetus for Lief Therapeutics. What we ended up finding in the laboratory, through neuroimaging and structural imaging work of the brain during mindfulness meditation, formed the basis for how self-regulation tends to work in ameliorating mental health conditions. That was the inception point for our company.

Can you give us an elevator pitch, if you will, around heart rate volatility? What is it and why it’s so important?

Heart Rate Variability, or HRV, are the little variations from one heartbeat to the next. You actually want variability in your heart rate. It’s a signal of both physical and mental health. It's this amazing biomarker that's at the intersection of the mind-body connection. In our field, we’re trying to understand the mental health statuses that correlate with this biomarker and how we can tease apart the specific aspects of the biosignal that correspond to different conditions.

At Lief, we’re focused on anxiety. Using machine learning and AI, we take this biomarker and find out what’s happening in a person, what their chronic level of anxiety is, and what their HRV is in real-time when they’re having an acute stress response.

Analyzing these things in parallel can allow you to create a digital care plan for a behavioral health patient, where you're really understanding where they're coming from, how they're tracking over time, as well as being able to intervene in real-time at the moment. So, that's the promise of HRV, this ability to understand somebody's wellness, their mental health, and to allow them to improve it over time.

How did the Lief product idea come to life? Can you also help us better understand how your HRV diagnostic technology compares to others?

A lot of our work started in the laboratory looking at mindfulness techniques. As a neuroscientist, I think there is a bias in the field to assume that everything interesting about the mind is happening between your ears. When it comes to HRV, it turns out that there's a lot of emotional information that is represented by the millisecond time scale differences from one heartbeat to the next.

The heart and the brain are actually connected in a feedback loop whereby a lot of your emotional state is actually your brain recognizing the state of your body as well as your heart. So, at Lief, we’re trying to measure this biosignal as accurately as possible in a clinically-meaningful way.

We’ve taken a clinical approach where we have this single lead ambulatory ECG, which is an FDA Class II medical device, for measuring HRV at a super high degree of accuracy. We have such good data coming in that we can provide people real-time biofeedback on their HRV, this key biomarker of mental health.

Take anxiety. You may go into a situation where there's a lot of pressure. Perhaps you're giving a big presentation. What the Lief device is able to do, by tracking HRV, is to detect that very early phase and give you immediate biofeedback through a tactile interface built into the patch that reflects your HRV in real time. It teaches you how to breathe and relax to actually self-regulate that biomarker back into a healthier space so you can go about your day.

Let’s talk product development. With the Lief device, how did you go from an idea on the back-of-a-napkin to a physical prototype?

Initially, the approach we took involved looking at EEG, the electrical activity of the brain. But what we learned through that process was that if you're looking for a biomarker for mental health, you tend to only look at the brain. But there are a lot of disadvantages to only measuring from the brain in terms of practicality.

MRI machines are too big and expensive and you can’t use them in real time. With EEG, a person can’t really move or it corrupts the signal. With mental health, your issues aren't happening when you're sitting still. There are so many interactions that happen in an environment where you would want real-time feedback to be able to guide you at the moment. That's how real learning happens.

This all led to initially stumbling upon heart rate variability. I basically invited a bunch of our hacker friends over to my garage in San Francisco and we started putting together a bunch of different prototypes. We tried to measure heart rate from the bottom of your sole, inside of your ear, clipped to your wrist, all kinds of different places.

I was dating a nurse at the time who left her stethoscope on the desk before she went into the hospital. I looked at the stethoscope and thought, wow, ok, real-time feedback, how could we give that to a user? So, I took the stethoscope, put it on, held it to my heart and started listening, and I was like, I need to go test this in the real world. But, I couldn't figure out how to attach the stethoscope to my body. And my girlfriend’s bra was lying on the ground. So, I just grabbed this pink, frilly bra and strapped the stethoscope on, and started walking around the streets of San Francisco. That was the first Lief device!

Such a great story! Are there any other lessons you’ve learned along the way around the topic of rapid prototyping?

The keyword is rapid. It's not about making a perfect prototype. We used duct tape. You need to think about speed and profit cycles. But it helps to have a good team with deep expertise so you can quickly make adjustments in real time.

A consumer can buy a Lief product from your site, but you also have a clinical device, the Lief Rx. Can you tell us how you've navigated those two sides of the table?

We launched our initial product as a consumer device and we actually crowdfunded it on Kickstarter. I think the trap that a lot of people get into when thinking about clinical products, is that because there's such a high regulatory burden right off the bat, you often need to raise a ton of capital and give up a lot of equity.

So, we were able to bootstrap into a medical device by releasing and selling a consumer product initially. Later down the road, we released our medical device called Lief Rx, and that's focused on clinical populations. The indications for use are different. But again, we were able to use a lot of learnings from our consumer product to bootstrap our way into the clinical arena.

I love the fact that you started with more of a consumer-grade wellness product, learned a ton, which allowed you to raise additional funds and pivot into a more capital-intensive medtech play.

I think that it's worked out well for us so far. I do recommend this approach if it works for your technology.

It’s so valuable to get something in the hands of consumers as early as possible.

Absolutely. The truth is 90% of startups are going to fail. So, the faster you can go through that process, the better.

You’ve got some clinical data on your device. Can you walk us through how you've approached gathering clinical evidence?

If you're able to leverage existing clinical research, even if it's just to build confidence, that's very helpful. In terms of our approach to clinical trials, we have been fairly nimble.

We chose to do distributed clinical testing. We were able to leverage some of our consumer learnings in terms of opening up the funnel of potential patients that might be interested in enrolling in a clinical trial.

Because we offer a totally remote device, we were able to do this very quickly. I think we were able to recruit all the patients within 48 hours. You don't have to necessarily have an in-person location to run a trial. So, that was basically our approach. We had consultants, but we did a lot of it internally as well. We were able to run these studies on a shoestring budget.

Let’s talk about your approach to insurance coverage and reimbursement with the Lief Rx device.

We've designed the product as a biomarker and diagnostic tool to fit into the remote patient monitoring codes that have been released by CMS, which are followed by a lot of private insurers as well. We also have ancillary services like coaching. We have a partnership with a large telepsychiatry provider where we're able to bring in a higher level of care involving coaches, psychiatrists, etc. and those are all additional service bundles.

What lessons have you learned raising capital for Lief?

One of the things that I've learned is that having an extremely high degree of integrity, honesty, and transparency when talking with investors is really important. Oftentimes, you're meeting someone, or meeting a group of people, who need to rapidly develop trust with you as an entrepreneur. Being upfront about what you don't know, as well as your failings, is maybe counterintuitive, but an extremely helpful thing to bring to the table.

Let’s transition to some quick, rapid-fire questions. If you could teach a class on one thing, is there a topic that stands out?

Yeah, I would love to teach folks about deep learning, and artificial intelligence in general, as it applies to predicting patient outcomes from biomarkers and data.

Last, for someone who is starting their medtech entrepreneurial journey, what's the single most important thing they should know?

I think understanding both the patient pain and the provider pain is a really helpful question to assess before you get started. Look at both audiences and really try to understand if you’re really solving a critical need for them.

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