David Neale, co-founder and CEO of Argá Medtech, has 30 years of experience bringing medical goods, services, and devices to bear across the healthcare space — from cardiology to neurology and nephrology to orthopedics. He’s also helped lead product development teams around the world, including South America, Europe, and the United States.
David’s international experience came into play when he decided to launch his startup, Argá Medtech, at the beginning of the COVID-19 pandemic.
He always had an interest in electroporation — the use of electrical currents to open up muscle cells, allowing them to absorb medication. And when he met up with an old friend, Randy Werneth, to go over ideas, they realized they had access to technology that could advance the use of electroporation to help patients with atrial fibrillation.
David and Randy pulled together a team and launched Argá Medtech, focusing on developing its Coherent Sine-burst Electroporation (CSE), the next generation of nonthermal cardiac ablation systems. The company hopes it can provide a safer, faster, and more efficient technology to treat atrial fibrillation.
As a startup, Argá is more nimble and can move faster than a lot of larger companies, according to David. That flexibility was key to helping the company score initial investments and quickly develop the product for testing, all in the midst of a global pandemic.
“We’ve been able to deliver in 18 months what some of the big players, because of their structures, take so much longer to do,” David says.
David believes his experience working with international teams across markets played a key role in helping get the business up and running.
In this episode of Medsider, David discusses how his experience working for multinational organizations helped him launch Argá, and why more medtech companies should focus on the healthcare economic impacts of their technologies.
David has three decades of experience bringing medical goods, services, and devices to bear across a range of sectors and in multiple countries. In 2020, he launched Argá Medtech, a multinational company focused on developing new, more efficient ways to treat atrial fibrillation.
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Key Lessons from David’s Experiences
- Understand how clients will use your product across the globe, and get input from a diverse array of stakeholders and experts. It’s important to consider the myriad of ways that healthcare is structured, reimbursed, and regulated worldwide.
- Think about the financial impact of your product, and measure healthcare economic outcomes in your clinical studies. Ask yourself how your product benefits all stakeholders, including patients, providers, hospitals, and payers.
- Don’t just focus on meeting business and development deadlines — make sure that what you’re producing is something that patients, providers and hospitals want and need. It’s important to have a great technical solution to a problem, but also make sure you don’t minimize other stakeholders’ input or consider additional challenges that could arise.
Make Connections Around the Globe
David’s international experience and outlook were critical to getting Argá up and running. Because of his connections and ability to work across borders, David and his team were able to successfully set up facilities in Switzerland and San Diego, establish business partners in Germany, and get input from international experts.
This global approach will also help ensure multiple countries can use Argá’s CSE.
Healthcare is structured, reimbursed, and regulated differently across the globe, David says. To be successful, medtech companies need to understand how countries worldwide and in different markets manage through various dynamics.
The Argá team wanted the company’s product to be used in any market, not just in the United States or Europe, David says.
“We really wanted to get the best and to understand and get the collection of experiences that others could deliver, and I think I could only do that because I had this global experience.” he says.
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Include Economic Outcomes in Your Clinical Trials
Anyone who’s serious about introducing a new medical product should set out to discover how it will affect every single stakeholder, including the patient, surgeon, nursing staff, and technicians, as well as hospitals and payers.
David advises startup teams to start thinking about the healthcare economics now and incorporate those assessments into clinical trials.
Argá has planned a clinical trial strategy that assesses core outcomes — safety and efficacy — along with economic data and milestones that would affect buyer and healthcare system decisions. The goal is to prove that by using Argá’s CSE, surgeons can more effectively treat patients while also saving time and money.
The company’s first-in-human trial is already collecting economic outcomes data that a safety-only study typically would not evaluate.
“Is the hospital going to be able to make money off of it or not? Does the reimbursement system support this or not? Does it make more money [for] the hospital and allow it to treat more patients compared to existing technology? We have to aim for that,” David says.
Stand Out From the Crowd: Answer the Tough Questions
In the early days of Argá, David and his team talked to customers and stakeholders in the field to find out what kind of technology people were looking for in atrial fibrillation. They asked about the shortfalls of devices and what Argá could bring to the table.
“We had to bring something different,” David says.
After receiving input and putting the answers together, they had to challenge themselves to answer other key questions and focus on the bigger picture.
The team had to recognize what it didn’t know. They also wanted to avoid getting tunnel vision — focusing too much on meeting product development deadlines and not enough on creating something that patients need and want.
“I think that’s one of the biggest mistakes I see with some of the early-stage startups — you have a great technical solution and you trust the solution to be perfect, and you minimize a lot of the other input or other challenges that you could have,” David says.
David says he and Randy always challenge themselves and their team to ask two key questions: So what? What if?
“It gets people out of their comfort zone … there’s always something you didn’t think about,” David says.
It’s not easy to stand out in the crowd, but David and his team were able to do it, all while in the middle of a global pandemic. David leveraged his experience working in markets around the world and received input from a diverse group of experts, proving to investors that Argá has what it takes to change the treatment landscape for atrial fibrillation.
Big Sky Biomedical is a medtech incubator co-founded by Scott Nelson and a team of serial entrepreneurs and proven operators with a stellar track record of success.
One of their first companies, FastWave Medical, closed on an investment plus milestone-based acquisition agreement within 6 months of forming the entity. Supposedly, that breaks some type of record within the medical device space.
The incubator model is certainly not a new concept within medtech, but the Big Sky team is doing things a bit differently.
First, their entire team has deep domain expertise in the interventional arena and it's the only sandbox they play in. Second, through their partnership with Switchback Medical, they can often shave 6-12 months off a traditional R&D PDP. Third, their wheelhouse is going from zero to one and their team can leverage capital to kickstart projects quickly and efficiently.
If you're interested in learning more or potentially partnering with the Big Sky team, check out their site right here.