EXECUTIVE SPOTLIGHTThis article was adapted from an interview with Daniel Hawkins by Scott Nelson, cofounder, Joovv and founder, Medsider.
In 2009 it seemed that there were numerous medical devices available to address peripheral vascular disease—from self-expanding stents to plain balloon angioplasty, atherectomy, drug-coated balloons, and others. What, then, inspired Daniel Hawkins and his Shockwave co-founders, John Adams and Todd Brinton, to enter what looked like a crowded marketplace?
Insight. But before we get to that, a little background.
Daniel grew up in what he describes as a “medical entrepreneurial household.” His father is a primary care physician who began his practice out of their Philadelphia home, treating a lot of Department of Public Assistance patients. Daniel and his brother and sisters did the coding on the DPA forms, and Daniel moved on to his own entrepreneurial pursuits, from selling Christmas tree clippings to operating soda machines. That paid for his Wharton undergraduate studies. He was simultaneously fascinated by both science and business. When he discovered what venture capital was, he joined a leveraged buyout house upon graduation from Wharton. He became attracted to the deals they made in medtech. “The prospect of being able to move the clinical needle on millions of patients versus one at a time, like my father, was compelling for me, very compelling,” says Daniel.
He went back to business school at Stanford, and afterward investigated medical technologies, medtech and medical devices.
Around that time, angioplasty balloons were $600 apiece, stents hadn’t been invented yet, and the hottest areas were orthopedics and interventional vascular. Daniel says “I was fortunate enough to get a position in marketing at ACS, Advanced Cardiovascular Systems, a division of Eli Lilly at the time. I joined there pre Palmaz-Schatz Stent, so that was a long time ago. The first indication of that stent was abrupt closure, or threatened abrupt closure, that comes from high-pressure dilation of the vessel due to calcium. The IVUS studies, intravascular ultrasound studies, in the mid-90’s confirmed all of that and really, that laid the groundwork for what I later traded on when I came up with the notion for what is now Lithoplasty, to avoid those dissections and see if we could get better results long term. I’ve stayed in it and have been fortunate enough to be involved in a number of significant startups along the way.”
He held senior roles in general management, marketing, and business development with a number of private and public companies. Daniel started the marketing department at Intuitive Surgical, where he guided product feature development for the da Vinci Surgical Robot and developed key foundational marketing strategies for the company. He has also held senior leadership and/or founder roles with Endologix and Calibra Medical, which is now part of J&J. Today he holds over 100 patents and applications, and is president and CEO of Shockwave Medical, where he continues innovating.
“In 2009, drug-coated balloons were emerging; they were not yet in the forefront as they are today,” Daniel says. “Back then there were varying versions of scoring balloons, like AngioScore balloons and other types of specialty balloons, high-pressure balloons, and atherectomy. Then there were balloon expandables and self-expanding stents. The challenge with all of the non-stent technologies, which we identified in 2009, is that they are not addressing the fundamental issue of calcification embedded in the vessel wall. Balloons put pressure on the calcification, but really overstretch the soft tissue on the other side of the vessel, and then create vessel injury.”
Daniel described other problems, such as restenosis, the inability of existing technologies to reduce blockage under a clinically meaningful 30%, and the high possibility that a stent will ultimately be needed anyway.
“What we realized with Shockwave is that the physics of high-speed pressure waves is completely different than constant high pressure that you get in regular balloons. High-speed pressure waves travel through the soft tissue and do not disrupt it, do not create the injury that is very common with scoring balloons or high-pressure balloons. Instead, it actually creates cracks in the calcification.
Great products are purchased, not sold. If you create a fantastic product, users will come to you.
“You can think of them as expansion joints…we inflate the balloon just a little bit. Frankly, very gently. What we’re doing is expanding those cracks in the calcification and therefore the vessel without the injury that everybody else gets, and we’re in fact, getting stent-like results without stents.”
But even with an innovative product, the path to market is not easy. Where is Shockwave today? They are CE marked in Europe, and FDA cleared in the United States. In November of 2016 they raised a $45 million Series C. They had six-month results in the second peripheral vascular study in 60 patients done in Europe and New Zealand, and at that point had achieved a 30-day outcome in their first coronary study using lithoplasty for the treatment of coronary vascular disease prior to stent placement. They began their early commercial activities in Germany in the peripheral vascular space.
LEARNING FROM THE BEST
Daniel talked about some of the mentors who influenced him, such as Fred Moll, co-founder of Intuitive. A small group of executives would meet every Tuesday for a “Critical Path” meeting to assess progress toward their milestones CEO Lonnie Smith, and current CEO, Gary Guthart, were always there, along with Fred Moll. “We thought we were pretty far along, frankly, centering down to our final design, and Fred came into the meeting — I’ll never forget this day — and said, ‘I think we have a problem. I think our vision system is inadequate.’ That was a very material statement to make at that point, because we were marching along with a set of presumptions.
“The issue was very fundamental. For a physician to be able to trust a robot, they need to be able to see perfectly. Be able to discern tissue edges in the different tissue planes, the resolution needed to be there. The problem is that there was no existing camera system at the time that could solve the problem. We literally had purchased one of every camera system available worldwide and none of them was good enough.
“Fred put out there that we should create our own, as if we didn’t have enough to do, right? What made us think we could do that? It was a hand-wringing moment. Fred said, ‘Wait a minute, isn’t the real reason why none of these cameras work because they need to make them lightweight because the procedures are an hour or two hours long and a human has to hold it? We don’t have that constraint; we can make this thing 30 pounds because we have a robot holding it.’ The second that statement was made, everything changed.
“We removed weight as a constraint, and when that happened, we were able to fast forward to the best laparoscopic vision system available on the market. The second we were able to make that and put it in the system, it became crystal clear what you were looking at and the physician community raved about the vision system and their sense of control and accuracy. Fred was 100% right that that was a need, and he was a 100% right to test the assumption.”
A MAJOR BREAKTHROUGH
Daniel was an entrepreneur in residence at Three Arch when he came up with the concept for applying lithotripsy to arterial plaque. We asked him about the lightbulb moment for that breakthrough.
His colleague John Adams was working on identifying the root cause for a product failure, and as part of that investigation he put the two leads for a pacemaker in a beaker full of water. As it turns out, he created lithotripsy, but he didn’t know what it was at the time. He shattered the beaker and there was water all over a high voltage table.
“So he realized he had a problem, and he figured out ultimately that it was lithotripsy. He shared that anecdote with me and while I found it interesting, there was no particular utility at that time. My job as an entrepreneur and residence was to look at unmet clinical needs and, with John, either invent or license a technology to solve those needs. And then Three Arch and Prospect Ventures would fund a company around that if everybody agreed. Fast forward about six months and I happened to be looking at the angioplasty market and came across some specialty balloons that claimed that they were able to, with differential pressure, crack calcium. I am not a physicist, nor am I a scientist, but again, being scientifically-minded, that didn’t make good sense to me.
“I started wondering what would actually crack the calcium, and then I remembered John broke the beaker with electricity. So I looked at lithotripsy a bit more, and I suggested it to John and I asked him if he thought it would work and he said, ‘Not only will it work, it will work great and the pressure waves will be so fast, they won’t pop the balloon. They’re faster than the speed of sound.’”
John was right. It worked perfectly. They then identified the opportunities in the peripheral vascular space, and created a prototype that leveraged existing technologies. Todd Brinton, an M.D., helped with the clinical view of the performance requirements, designing the protocol for first in-human trial, and developing the relationships with clinicians along the way.
“John kept us pointed straight from a technical perspective and I served, if you will, as program manager and head of marketing and CEO and all of that together to drive the creation of the first prototype, the builds, the testing, the verification, the animal testing the like, etc. Once we finished all of that, we went into the clinic and headed a very successful first inhuman experience.”
Even with success like that behind him, the path to founding Shockwave was rocky. Daniel heard from potential investors that “You shouldn’t start with the periphery. It’s a graveyard of dead technologies.” Between 2008 and 2009, Daniel, John Adams and Todd Brinton acquired the intellectual property out of the incubator because Three Arch and Prospect did not want to move forward with the idea.
What propelled them to pursue it anyway? Science fiction author Robert Heinlein famously said “Always listen to the experts. They’ll tell you what can’t be done and why. Then go ahead and do it.”
As an entrepreneur, you’ve got to listen to advice that other people have, and then very often, you need to deliberately not follow it.
Daniel took a similar attitude. “As an entrepreneur, you’ve got to listen to advice that other people have, and you’ve got to gather all the data you possibly can, and then very often, you need to deliberately not follow it,” says Daniel. “Why? Well, it was going to be difficult to create a device that had lithotripsy in it, make it deliverable, make it small enough to get through the vasculature, through a blockage, and be able to deliver the therapy. Peripheral vessels are bigger. Because of the risk profile, peripheral vasculature had a greater chance of a 510(k) pathway versus a PMA pathway.
“Because there is such an enormous need in the periphery, we had a very wide margin of potential benefit. So if we were able to go halfway to optimal, given how wide that margin was, we would be incredibly successful. In the coronaries, the margin is a lot tighter because devices have gotten better. In the periphery, we had greater opportunity to be able to create a solution that, with a relatively lower bar, could show a benefit. We trusted our gut.”
In Shockwave’s recent rounds of financing, which drew a more enthusiastic response than their first round, we were curious about getting a variety of investors involved.
He told us “The first institutional investor was Sofinnova out of Paris. They were the first money in Core Valve and a great visionary group. When we broadened our footprint in the Series B in 2015, that’s when we first brought in strategics, and we brought in crossovers and the like. We had in fact, strategic offers for the entire round in a non-diluted fashion. We are in a business that is very, very strategically significant. So we had an offer on the table for that. At the 11th hour, terms got inserted into that deal which were not attractive, so we walked away from it. What we tried to do from the very beginning was lay the groundwork for a long-term play in the company. We believe we’ve got a company that has staying power. We believe we have an opportunity to be a very successful standalone organization.
“While we did want to have a strategic involved, what we did not want to do is have just one. That’s really the reason why we ultimately ended up with two different strategics. The reason why you bring in crossovers is to set up for future rounds of financing, not the least of which is a public offering. In our Series B, we brought in quite a number of crossover funds. As it turns out, in our series C, there was a great interest to complete the round from inside investors and the only new investor that we brought in was T. Rowe Price, again for the exact same reason of setting ourselves up for a future public offering.”
A lot of their investors have also been publicly quoted as saying they believe Shockwave can become a company that is able to sustain itself, versus traditional medtech startups that are gobbled up early in their life cycle. What does Daniel think of as the future for Shockwave?
“Our future is going to be defined by how we perform clinically, and of course, how we perform commercially. In the very near term, we’re going to start what turns out to be history’s first randomized-controlled study in peripheral vascular calcified lesions. So really, our specialty is calcium. In the legs, there’s lots of it. Half of the patients have it. Surprisingly, there’s never been a randomized-controlled trial of one technology against another one to treat those patients.
“I didn’t realize that we were going to be the first one until some reporter told us that, frankly. We think it’s the right thing to do. We’re doing the right clinical work going forward, with at least 330 patients kicking off very shortly. With that, we intend to demonstrate the capabilities and usability of the Lithoplasty system versus angioplasty and recognize those differences across a very broad patient set.
We asked Daniel about some of the wisdom he has acquired over a long career in medtech. Here’s a summary:
1 Focus on true needs—not wants, desires or vitamin pills. He calls the true needs “painkillers.” In the case of Shockwave, for example, avoidance of vascular injury.
2 Keep the function of technology as simple as possible. “At Intuitive Surgical, the robot was incredibly complicated. It started off [in 1999] with 2,700 parts on the bill of materials. It had 1.1 million lines of software code. That’s a lot of complexity. But in the end, what it was is something the surgeon looked into, saw the operative field, put their fingertips into the tip of a controller, and moved their hands like they’re operating with their fingers. What we really did is use complexity to make the experience simple. Now, what problem did we actually solve? We allowed the physician to operate in an open surgical environment, but do it through a hole the size of a trocar.” Trocar-based surgery is minimally invasive. What the physician needed to do was advance their capabilities in spite of the restriction of that tiny hole. Daniel explains that Intuitive removed the restriction. “That was a pain killer, and they made it incredibly easy to use, and that’s the reason why it ultimately took off.”
What we really did is use complexity to make the experience simple
3 Check your core assumptions at every point in development, because correcting mistakes early is much easier than doing it further down the line. “One of the things I find more often than anything else is when there’s disagreement among very bright, experienced people about a direction, very often they’re operating under different core assumptions. One of the things I will often do is get back to, ‘What are your assumptions?’ They’ll list them, and I’ll say, ‘Take away that constraint. Take away that other constraint. Now, what would you do?’ That’s exactly how we ended up with the device that we did at Shockwave because my engineers were saying there was a constraint; we couldn’t get more than one emitter in a balloon. I asked them to remove a couple of constraints; now it’s limitless. I didn’t know how to solve it, they did. All I really did was remove that constraint.”
Daniel’s favorite business book? The 22 Immutable Laws of Marketing. His favorite advice from it is if you’re not number one in a category, create a category in which you can be number one
The CEOs he admires? Obviously Fred Moll is one. “He continues to identify the pain-killers and re-move barriers. Omar Ishrak from Medtronic. I’ve been extremely impressed with the culture that he’s been able to create, the quality of people in that organization, the consistency of the messaging, and the capabilities within the organization. Mike Mahoney for what he’s been able to do in terms of the turnaround of Boston Scientific. He launched them into the number one position in stents and pushed the entire franchise forward. And Mike Musallam. His vision for what became TAVR and acquiring Sapient early, and then the management of that has been nothing short of spectacular. He’s created an incredible amount of value for shareholders and incredible therapy categories for patients.”
And the advice he’d give his 30-year-old-self? “Number one, two, three, four and five is trust your gut. Your gut is never truly wrong. When you trust your gut properly at those high-intensity moments, it won’t fail you.”
Another poignant bit of Daniel’s wisdom is that great products are purchased and not sold. “If you create a fantastic product, users will come to you.” That’s what he experienced at Intuitive, and what they’re enjoying at Shockwave.
Cofounder, Joovv Founder, Medsider
Scott is a self-described medtech enthusiast and currently leads all commercialization initiatives for Joovv, a company he cofounded in 2015. Prior to his work with Joovv, Scott held sales and marketing leadership positions with some of the largest medical device companies in the world, including Medtronic, Covidien, Boston Scientific, and C.R. Bard. He is also the founder of Medsider, which helps ambitious doers learn from proven medtech thought leaders. His work with Medsider has been featured in publications like Forbes, MassDevice, MedCity News, and MD+DI. Scott also serves as an advisor to the Medical Devices Group, which includes over 300,000 members worldwide.