Her career began in computing, as a communications manager and business development director at Xerox PARC, before becoming Chief Strategy Officer for Norwegian electronics manufacturing company Thin Film Electronics.

But then the field of bioelectronic medicine caught her eye. She knew this was an area where her experience in translational science — taking groundbreaking research and turning it into a commercial product — would make a difference.

“It’s really an exploding area in science. I was incredibly drawn to it in part because of how little is actually known about how the electrical system of the body works,” Jennifer says.

In 2016, she and biomedical engineer and inventor John Claude founded Tivic Health with the goal of developing advanced bioelectronic solutions that treat disease, increase wellness, and improve lives.

Their flagship product is ClearUP, an over-the-counter handheld device that uses gentle pulsed electron waves to relieve symptoms of sinus and nasal inflammation, nasal allergies, sinus infections, chronic sinusitis, cold, and flu.

The device received FDA clearance in early 2019 and entered the market later that same year. Tivic has since sold more than 30,000 units of ClearUP.

“It’s been a pretty fast, rapid and exciting journey from concept through commercialization now to actually providing our investors liquidity and having the opportunity to grow the company in the space of bioelectronic medicine to a multi-product company,” Jennifer says.

In this episode of Medsider, Jennifer shares how consumers can play a key role in boosting support and evidence for over-the-counter medical devices, and why she thinks direct-to-consumer business models will transform the medtech space.

Key Learnings from Jennifer's Experiences

• If you’re making a consumer device, think about the form and function of your product and how that aligns with consumer expectations. Your advertising and instructions for use should be as clear as possible from the outset.
• Focus on building support for your over-the-counter device through user reviews and word-of-mouth. If consumers back your product and use it every day, they’re more likely to share that with physicians who will then recommend it to other patients, resulting in a flywheel effect that could open doors to further channel opportunities.
• Don’t shy away from challenges, but make sure you’re also prepared. Getting financial backing in the direct-to-consumer space isn’t easy. The more you demonstrate the value of your device in the real world, the more comfortable investors will be in funding your vision.

Focus on User-Friendly Design

People tend to come in with preconceived notions of how something works or should work. For example, when they see something that’s supposed to help with sinus pain, they might automatically think it should be inserted inside their nose and operate like a nasal spray.

But that’s not how Tivic Health’s ClearUP works. Users should hold the device against their cheeks, nose, and below their eyebrows.

The Tivic team had to figure out how to communicate that information to people buying the product on Amazon or at their local drugstore.

“We had to really think about: How’s this form factor going to communicate that you don’t want to [put this in your nose]? That’s not how you use it,” Jennifer says. “How are we going to communicate with all the video, with the advertising to make sure that the first time somebody picks up the product that we aren’t feeding into a mental model that’s going to lead them into misuse?”

How much time will it take to train the user on how to use the device? That’s something any company that is making an over-the-counter (OTC) or home-use device should think about, Jennifer says.

Jennifer and her team concluded they had about 2.3 seconds to show consumers how to use ClearUP, and they figured out how to communicate that information succinctly through advertisements, videos, and the user manual.

This user-centric philosophy is something all medtech companies should consider when developing direct-to-consumer devices.

“This is not ‘open up the book and let them really study and read the user manual in detail.’ … As medical companies, we have to be aspiring to the level of design … that the best of consumer product companies have achieved,” Jennifer says.

Jennifer emphasizes that entrepreneurs need to design products that people want to use every day. Developing devices with consumers in mind will have a major impact on the future of OTC devices, she says.

Let Consumers Lead the Way

About 40% of the potential ClearUP user population — those that experience pain and congestion from sinus inflammation — never see a doctor, Jennifer says. That statistic was the driving force behind Tivic’s decision to make the device available over the counter.

Jennifer hasn’t ruled out the possibility of making it available via prescription and eligible for reimbursement later down the road, but the team needs to figure out what reimbursement codes would apply to the device.

In the meantime, Tivic is focused on building up a consumer base and a body of evidence for ClearUP.

“[That evidence] includes your Amazon reviews, it’s your product reviews, it’s people talking about your product, it’s your news coverage. So [it’s] really building up the base of the consumer first, and making sure that we’re creating benefit for the person that has to pay for the product,” Jennifer says.

Jennifer believes this consumer-first strategy is the future of healthcare.

“There are a couple of big trends that suggest this is going to become a more dominant part of the health tech world,” she says.

She points to Roman, a digital health clinic for men, and Nurx, a female-focused telemedicine company, both of which offer prescriptions after allowing patients to consult with a physician online.

There’s also a movement in which treatment for certain conditions is moving from specialty clinics to the primary care setting. For example, patients might go to a specialist for a migraine diagnosis, but most of their care might be managed at their primary care office.

“More and more of the consumer [experience is] realizing that they’re stewarding their own healthcare, and beginning to use doctors more and more as the consultant in the process, but not always as the single-source provider,” Jennifer says.

There was a similar situation in the market with AliveCor, a medical device company that developed AI-enabled electrocardiogram sensors that deliver heart data digitally. AliveCor started with patients as its end users, and those patients introduced the product to their doctors. Doctors then created more demand for the product and asked for the device to be integrated with their health systems.

In that same vein, Tivic Health believes patients are the key to success. Being able to excite end users and making sure your product is well-positioned for them is the critical first step for consumer medical devices. Users will then help bring the medical community on board as part of their care journey, Jennifer says.

“I honestly believe that we’re going to see that as a pattern that starts to emerge the same way we have seen direct-to-consumer emerge in other industries,” Jennifer says.

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Take Risks and Try Something New, but Keep in Mind the Challenges Ahead

If you’re working with a business model that hasn’t been used before, be prepared for more of an uphill battle when it comes to fundraising. It’s an even steeper climb if you’re looking to enter the direct-to-consumer space. It can be difficult to find medtech investors who want to invest in direct-to-consumer healthcare models, according to Jennifer.

“When we think about the medtech funds, people haven’t been out raising capital to tell people, ‘I’m going to invest in a direct-to-consumer new model in healthcare innovation.’ Those investors are on the rare side. They may have raised it to say, ‘We’re going to invest in early-stage medical device companies,’” Jennifer says.

Jennifer likens it to the early days of Warby Parker — a first-of-its-kind direct-to-consumer prescription eyewear company.

“In the early days of Warby Parker, they did not have backing … until the breakthrough moment where they demonstrated that people really would buy glasses online,” Jennifer says. “It was a really strange concept … that’s [now] an iconic case study.”

Now, entrepreneurs will often say they want to be the Warby Parker of whatever industry they’re in.

Jennifer predicts similar things will happen in the medtech sector as companies show they can be successful.

“As we build success cases, and as we see companies that successfully build and acquire and exit, then firms will become more comfortable investing in that model,” she says.

Jennifer envisions Tivic as being the “acquirer of choice” for emerging bioelectronic medicine technologies.

The way to do that is to continue listening to consumers and doctors, building trust within the science and investor communities, and always being prepared for the challenges ahead.

Like many medtech company founders, Dan was technical by training. He started out his career in the private sector at Parker Hannifin — “the biggest company nobody’s ever heard of,” he says. Although the company had a small medical device segment, the industry wasn’t on his radar.

But after diving deeper into the medtech space, he learned about the innovation cycle and eventually managed strategic relationships toward the end of his tenure.

He got antsy, though, and was itching to innovate.

“I can't stand the idea of not having a new innovative way to do things or a different perspective,” he explains. As he considered his next steps, he knew that eventually, he wanted to start something himself. The right opportunity — what would become Linear — came about in 2015 when a friend introduced him to a physician with an idea that seemed to be right up Dan’s alley.

The initial concept pitch evolved into the Orchid Safety Release Valve. Co-founded by Dan and Dr. Ryan Dennis, Linear is shifting the standard of care for medical tubing dislodgement. In this episode of Medsider, Dan explains when and how Linear raised capital, how it has navigated complex regulatory pathways, and why you need to be your own worst enemy as an innovator.

Key Learnings from Dan's Experiences

• Don’t skimp on research during early-stage development. Soliciting feedback from a broad range of stakeholders before commercialization will set you up for a smoother process when it’s time to scale.
• Know your skill sets, find the right partner, and divide and conquer. Dan focused on product development, marketing, and regulatory, which freed his co-founder to tackle fundraising full-time.
• For a smoother regulatory pathway, bring the FDA into the conversation as early as possible to foster understanding. Be your own worst enemy, asking the difficult questions to ensure you’ve done all you can to be compliant.

Steps to Take Before Commercialization

Today, Linear is full-scale commercial with the Orchid safety release valve. The device is designed to mitigate unwanted or accidental IV dislodgement by creating a sterile barrier between an IV extension set and administration set.

If the IV is dislodged, an occlusion alarm sounds, and the separated valve halves can be replaced. This allows for a simple return to treatment, bypassing the need for a full replacement of medical equipment.

Linear took strategic steps before and during the early-commercialization stage to ensure success.

1. Conduct Research to Inform Product Development and Ensure Scalability

Before commercialization, Linear gathered feedback from a wide variety of stakeholders while developing the Orchid, one of the most critical aspects to address during product iteration.

In other medtech projects, Dan has seen companies experience success when gathering feedback from not just physicians, but the nurses and technicians who use the product every day. Here’s one prime example: The Orchid is purple, due to feedback from nurses who place IVs daily and need the valve to be visible against a white bedside.

Price point feedback is essential as well: Know where you fit into the market, and understand what it can bear.

Prior to commercializing, clarify that your manufacturing can be scaled exponentially. For Linear, this includes ensuring that the geometry of the valve could be replicated across a platform of products for all medical tubing. Even if there is a market need for your product, a unique design may not be scalable if it’s a nightmare to produce on a daily basis.

2. Educate Providers on the ‘Why’ of Your Product

Before and during commercialization, education has been a central part of Linear’s process. Helping users understand why a device is worth adopting is an essential part of the process that shouldn’t be discounted.

Linear had a lot to be proud of, but also a lot to explain about how its device would improve the standard of care.

Apart from the Orchid, the current process when replacing a dislodged IV is waste-intensive. The IV itself, the tubing, whatever is being infused, and the bag of treatment must all be disposed of.

What’s more, for critical treatments like chemotherapy or total parenteral nutrition (TPN), this waste is incredibly costly, and precise dosages are imperative. Additionally, introducing more needles means more trauma for the patient and redundant clinician activities.

Orchid aims to resolve those issues by replacing a simple valve set. Although the use case for the product may seem clear and feedback thus far has been positive, education is still needed.

The metrics around medical tubing dislodgement are nearly nonexistent, which means getting definitive data is challenging. For basic IVs, reported dislodgements range from 9.5 to 24%. But in reality, it is actually a much larger problem.

For devices like the Orchid — that solve largely unreported issues — founders are tasked with educating audiences not just on how the product solves the problem, but on why there is a need in the first place.

“[Medical tubing dislodgement] has been fundamentally accepted as status quo when it doesn't have to be and, quite honestly, it shouldn't be,” Dan says. “Right now, we’re in the early stages: commercialization and education, the most difficult and most exciting component of this.”

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Raising Capital in the Medtech Space

Linear arrived at the commercialization stage seven years after its genesis. Like many medtech projects, it evolved from a bootstrapped, part-time project to eventually needing capital.

Although Dan and his team didn’t have to raise money for the first two years, he certainly learned valuable lessons at major inflection points of the company’s evolution. At first, the team thought that they could bootstrap Linear, but Dan now says that belief stemmed from a lack of knowledge.

Looking back with the benefit of experience, he knows that to reach a point of “liftoff,” financing is a necessity. But it’s important to start fundraising at the right time, particularly because most investors want to see a proof of concept and to know that you understand the market before they’re willing to invest.

One of Dan’s keys to success for others who are fundraising is to find people in your network that believe in what you’re doing. Linear has raised three rounds of funding for a total of $10 million. Much of the first rounds of capital came from family, friends, and physicians connected to his co-founder.

While Linear’s story of success is encouraging, Dan cautions, “It's no easy path to go raise money because you have to be the biggest proponent of what you're doing.”

He goes on to explain that while you’re focused on developing the product, you might not be as focused on the needed conversations with various investors. For that reason, many people with experience say that fundraising is a full-time job.

Dan’s focus on product development, marketing and regulatory work opened up his partner to concentrate on fundraising, a reminder of the importance of building a team with balanced skills and interests.

Lucky for Linear, the duo found dedicated investors who believed in the work and came back for multiple rounds. But to anyone raising capital, Dan advises that fundraising can feel deeply personal, so it’s critical to get comfortable with being told “no”.

Navigating Regulatory Pathway Roadblocks

While raising capital comes with its own challenges, Linear has faced a particularly uphill battle in moving through the regulatory process.

Over the course of seven years, product development at Linear was relatively straightforward. But the team has spent years locked in a difficult battle with FDA — during which time it received several Not Substantially Equivalent (NSE) Determinations — and often felt like it was going nowhere.

Finally, after a formal appeal and a three-year journey, Linear found success.

On paper, the device’s function exists in other spaces already — which some might take to mean a smooth regulatory process. But the FDA review group associated the device with a risk profile that was at odds with the market and the product’s end users.

The Orchid went through multiple rounds of enhanced testing that similar medtech companies didn’t face. Dan recalled that at the height of this ordeal, his stress hit a peak. “My exact words were, ‘This type of regulatory environment is what is killing innovation in this space,’” he says. They also called in outside resources, including well-known attorney Mark Duvall to guide the regulatory legal process.

Linear had to work hard to shape the narrative around the device throughout their dialogues with regulators. When others at the table perceived the device as removing patients from treatment, Dan and his team had to shift the perspective, explaining that the concept of IV dislodgement is what actually removes patients from treatment.

Dan’s learned a lot the hard way and encourages others to involve the agency as early as possible. Despite the challenges Linear faced, he still acknowledges that FDA’s goal is to approve safe products that don’t adversely impact the public. So the sooner they are involved, the more thoroughly they can understand your device — and the better your chances are for smooth regulatory sailing.

Dan also advises innovators to be their own worst enemy. In other words, you need to ask yourself the hard questions:

• What have I done wrong?
• What have I not done?
• What should I redo?

The exercise allows you to enter difficult conversations with more confidence in your product and your overall compliance efforts.

Admittedly, Dan says, the Linear team was afraid of the FDA at times, particularly because they didn’t want to be on its bad side. But they had to remind themselves that, as much as was within their power, they had executed the right way and were not at fault. From there, they had to trust their team, their resources, and their product.

“Pulling the right levers at the right time is absolutely critical, and you cannot be afraid to do it,” he says.

So where did Heather’s unique approach to running a company come from? Her interdisciplinary past can shed some light on the subject.

Starting with her Bachelor of Science, cum laude, in computer science and engineering from the University of Washington, Heather’s analytical mind was at work: her undergraduate research focused on developing multiplayer educational game platforms for primary schools in India.

Continuing onward, Heather completed her Ph.D. at the University of Colorado Boulder's ATLAS program where she developed and implemented clinical decision support systems for midwives and nurses in Kenya, receiving the NSF Graduate Research Fellowship Grant and a Gates Grand Challenges Grant to support her research.

Heather then cofounded Inworks—an interdisciplinary initiative offering courses and certificate programs in innovation, prototyping, and design as a professor at the University of Colorado Denver. Her last stint in academia occurred when she was selected for the 2018-2019 Stanford Biodesign Fellowship Class. Upon completion, she entered the medtech space and has been leading EvoEndo ever since.

As Heather’s roles have changed, she’s never left behind her distinct skill sets, but instead honed them to positively influence her role leading EvoEndo.

In this episode of Mediser, Heather elaborates on her unique approach to innovation in the medtech arena, how fundraising isn’t one-size-fits-all, and why regulatory clearance isn’t the end of the road.

Key Learnings from Heather’s Experiences

• You don’t need to come up with something completely new to solve a difficult clinical problem. Starting with a deep understanding of the challenge you’re trying to solve and staying solution-agnostic allowed EvoEndo to use key learnings from other fields of medicine to create something unique that ultimately meets patients’ needs.
• Stay open and be creative when it comes to fundraising. It doesn't have to all come from venture capital. Angel investors can provide more than money: their care and emotional investment means they’re in it for more than financial returns.
• The FDA is definitely a hurdle, and 510(k) clearance is something worth celebrating. But it is not the end of the race. Figuring out reimbursement can make or break a company. The earlier you start to think about it, the better.

Don’t Bother Reinventing the Wheel

It’s easy to get caught up and overwhelmed by the urge to create something brand new that solves all the problems in your given field, but it’s rarely doable. This was the case for EvoEndo early on when they were first trying to nail down prototypes around solving endoscopic challenges.

As Heather puts it, they overshot the initial design and created something that was too different from what physicians were used to. This wasn’t a complete failure though, thanks to early user feedback and consistent input from our co-founders.. Heather explains that “[after] getting people to evaluate the prototypes and just kind of have them in their hand and play with them, [we learned] it was not intuitive to them at all.”

This setback, while difficult, didn’t stop EvoEndo. It simply forced them to reevaluate their approach. One bit of insight Heather shares is simple: “The departure from what they're used to, to what they're going to use now can't be so vast if you want them to adopt it quickly and incorporate it into their day-to-day practice.”

It seems obvious when she says it, but it’s easy to fall into the trap of creating something so new and impressive that you forget that the actual people using your product have to want to use it, and that the jump from one technology to the next can’t be monumental.

Looking at the big picture, Heather explains, “new ideas are not new….oftentimes they're just mashups of other ideas.” This concept was central to what eventually became the “EvoEndo System.”

By using and combining ideas from other fields, and taking to heart valuable feedback from their clinical partners, Heather and the team at EvoEndo were able to come up with a physician-friendly system that allows endoscopic procedures to be performed without the need for general anesthesia or conscious sedation.

While the initial innovation was sparked by a need identified in the pediatric field, the application also has value for adults: a smaller, less intrusive scope is a win for people of any age.

“Stay curious and stay flexible. Things are going to change,” Heather says.

Keep Your Investment Options Open

Fundraising is a crucial part of every company’s path, which is hardly arguable. The journeys raising capital vary wildly from one company to the next, though. Rolling with the punches and adapting your strategy to different investment opportunities is crucial, especially when it comes to innovative medical technology.

Heather and EvoEndo ran into a series of particular situations. Early on, they approached traditional venture capitalists and were met with a surprising response: the investors wanted to put more into EvoEndo; they wanted to write bigger checks for ultimately bigger returns.

However, VCs were skeptical of the possibility for larger returns based on what they viewed as a small market opportunity in pediatrics, and wanted the company to demonstrate commercial traction before considering an investment.

So EvoEndo shifted their approach to something that felt more applicable to their journey: angels. From the beginning, there had been a core group of angel investors, but after getting feedback from traditional venture capitalists, EvoEndo decided to double down.

Heather explains, “[Angels] are some of the most passionate, committed, involved people. They care on multiple levels. They're not in it for just a return. I'll say if you're looking for other angels and you've already got angels interested, just leverage their enthusiasm to put the word out to their networks. And that was kind of how we saw our angel group, our investor group, grow.”

Aside from angel investors and traditional venture capitalists, Heather says there are other routes to funding as well. “I would recommend that [you] don't limit yourself. There are a lot of opportunities for non-dilutive funding through grants or Department of Defense or whatever it is, where your solution or your device really resonates with the population. There might be some funding there.”

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Regulation, Commercial Adoption, and Reimbursement: All Things to Consider

No two aspects of an innovative medical technology journey are the same.

One company’s successful path does not guarantee future wins. Just because you raised millions doesn’t mean your device will pass regulatory standards, and just because you pass regulatory standards doesn’t mean that commercial adoption will be easy. On top of those layers, and often overlooked, is reimbursement.

EvoEndo was fortunate to receive 510(k) clearance relatively quickly. The news came on Valentine’s day, like a nice gift from the FDA. But it wasn’t good luck that carried them through clearance: diligent planning and knowing what to include in their submission is what propelled them over the FDA regulatory hurdle.

This sort of future planning is integral to EvoEndo’s success. By considering the common challenges that face medtech companies, and anticipating future hurdles, Heather and her team have been able to cross the chasm to commercialization.

One of the largest obstacles Heather thinks is deserving of time and effort is reimbursement. She says EvoEndo spent a lot of time on this topic, and that she’s glad they did.

“We did a reimbursement landscape [analysis], and I would highly recommend it. It may not seem worthwhile early on and it may seem like a very expensive endeavor for an early-stage startup, but that was absolutely crucial to our success and why we're commercializing now.”

Staying ahead of the game is always important, and it can’t be stressed enough in the startup world. “Maybe the biggest takeaway is if you're developing a device and you've got a working prototype and hopefully a little bit of funding: it's never too early to address the reimbursement topic.”

That's why Yoav Kimchy, Founder and CTO of Check-Cap, launched the company in 2005 with the goal of creating a technology that could make colorectal screenings easier and less invasive for patients.

The company developed a first-of-its-kind technology — the C-Scan ingestible capsule, or C-Scan Cap. In lieu of a traditional colonoscopy procedure, patients can swallow C-Scan Cap just like a normal pill. The capsule then travels naturally along the gastrointestinal tract while scanning the inner lining of the colon.

“The person is free to do whatever he wants while the capsule is traveling naturally, and then it goes out. All the data is recorded and then reconstructed for the physician to look for potential polyps, which are the precursors of colon cancer,” Yoav says.

The goal is to find polyps before they become cancerous, he adds.

Check-Cap received a CE mark in 2018 and the marketing approval was reauthorized in 2021 for another five years.

The company is now focused primarily on getting clearance from FDA for the U.S. market. In May 2022, Check-Cap launched a pivotal trial that will be conducted across 15 clinical sites in the United States, with a goal of enrolling about 1,000 trial participants between the ages of 50 and 75.

Check-Cap is also working with the Centers for Medicare & Medicaid Services to obtain reimbursement for C-Scan.

Yoav says the company is exploring additional products that can use the C-Scan system, too.

“It looks like we have quite a few potential components or potential products that can come out of what we have, which is very exciting as well,” he says.

In this episode of Medsider, Yoav shares how getting early feedback from regulatory professionals can help streamline your development efforts, why you should shift your team’s focus as your company grows, and the importance of knowing when to lead and when to follow.

Key Learnings from Yoav's Experiences

• Take every opportunity to get feedback from regulatory professionals. Getting their input, especially early on, can help pinpoint what may or may not work and help to streamline your development initiatives.
• Know when to lead and when to follow. Yoav realized soon after launching Check-Cap that he didn’t want to run the company, so he hired someone to take on the CEO role. It was a good decision, he says, as it allowed him to focus on what he’s good at — R&D — while letting other more experienced people lead the business forward.
• Expand and diversify your team as the company grows. Over time, as you get further into the development process, you’ll need to focus more on logistics and regulation, rather than solely focusing on R&D. Hire people accordingly.

Use Feedback From Regulators To ‘Clean Up Your Act’

Looking back on the early days of Check-Cap, Yoav says he would have interacted with regulators earlier on in the process to better understand the regulatory pathway

Getting input from agencies like FDA can help you pinpoint what may or may not work in your development plans, which is especially crucial as you start testing your product in humans.

Regulatory professionals can essentially help you tidy up your efforts and even point out things you may have missed, Yoav says.

As an example, he adds, Check-Cap just recently learned about FDA’s breakthrough device designation process, which allows device makers to interact with the agency throughout the premarket review phase and prioritizes review of medical devices that qualify for the pathway.

That’s one thing Yoav says he wishes Check-Cap would have known about sooner.

Yoav suggests working with regulatory bodies as soon as possible so you can better understand the landscape, get feedback, and refine your initiatives before heading into human clinical trials.

Know When to Lead and When to Follow

About three years after launching Check-Cap, Yoav began to realize that he did not want to be CEO. Running the company, he says, would not allow him to continue his R&D work.

He hired Guy Neev for the CEO position, and Yoav took on the CTO role in 2009. Guy helped take the company public, with backup support from Yoav.

Alex Ovadia is the company’s current CEO, and has been with Check-Cap since 2013. He served as the Israeli site manager, vice president of R&D, and COOr before being named CEO.

“[It works best] for me to have an experienced person. … [Alex is] running the company as a public entity, and I can do my work in the R&D [function],” Yoav says, emphasizing the company is better with him as CTO, rather than CEO.

He advises medtech startup leaders to check their egos at the door.

“We really have an incredible team of people that are working very hard to get the technology to where it needs to go, to where it can go. So, ego is not something that you can leave on the table there. You need to put it aside and do the actual work,” Yoav says.

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Make Sure Your Team Grows and Evolves with the Company

Over time, your company’s focus will start to shift and your hiring needs will change. At the beginning, you’ll want people who are technical experts, but as your work expands, you’ll need people who are more process- and regulation-oriented.

At that point, it’s time to hire more people and focus less on trying to be innovative and more on trying to streamline your processes, Yoav says.

Check-Cap still has a relatively large R&D team that comprises 30 people, but that only accounts for a third of the company’s nearly 90-person staff. The remaining employees are focused on logistics, including manufacturing and quality assurance processes, Yoav says.

“[There’s] a lot of functions that you don’t think of and that you don’t need earlier on, but afterwards, they’re very crucial to the process,” he says.

As your programs evolve, think about your ideal team structure and hire accordingly.

The world of medtech is a complex and interesting space, and there’s room for multiple voices at the table, according to Yoav. The key to success, he adds, is making sure you have the right people in place, and that those people believe in what you do.

Before joining New View, Bryce was the Vice President of Commercial Strategy and Emerging Markets for Covidien. There, he expanded the medical devices conglomerate across Asia, Africa, Latin America, and the Middle East.

Under Bryce’s leadership, New View is pioneering laparoscopic technology. Their VisionPort combines the laparoscope, camera, light, and access port into a single instrument that promises to slash the cost and preoperative time of a laparoscopy.

The device also shows the potential to reduce the number of incisions needed for some surgeries and widen access to the surgery by making laparoscopic technology easier to transport to the patient’s location.

These innovations garnered New View Surgical widespread recognition. At the Keiretsu Forum Investor Capital Expo in 2020, angel investors selected New View as the “Most Valued Company.” Funding and regulatory successes followed, with the business attracting over $14 million in total capital and securing 510(k) clearance.

In this interview, Bryce Klontz shares insights from his decades of experience in the surgical devices space, from building relationships of trust with regulators and investors to working closely with practitioners to perfect product-market fit.

Key Takeaways from Bryce’s Experience

• Be laser-focused on product-market fit. Building great teams and creating innovative technologies are crucial, but ultimately, meeting the needs of both the patient and practitioner must be the priority.
• Go deep when gathering data. You’ll learn a lot more by forming long-term relationships with a select number of practitioners than by collecting data from far and wide.
• Investing in relationships and effective communication are essential to both fundraising and regulatory approval. It’s crucial to understand the incentives of those sitting across the table so you can help them help you.
• Investors know that the path to profitability is rocky. Being transparent with them about the challenges you face builds your credibility and furthers your goals.

Leverage Your Experience at Large Strategics to Accelerate Start-up Success  

Bryce likes to say that start-ups “bookended” his career. Straight out of college, he joined a cardiovascular startup in his native Boston, PLC Medical Systems, as a marketing manager.

The appeal of guiding early-stage companies is the opportunity to build something new. He agreed to join New View six years ago to “see if I could build something, bring a product to market that excites me, and just learn from that experience.”

In between his time at start-ups, Bryce spent a decade honing his skills at Covidien, one of the world’s largest producers of surgical devices.

He spent time there heading up marketing efforts in emerging economies as the VP of Marketing for Asia and VP of Commercial Strategy for Emerging Markets.  

When he returned to the start-up world, first at Woven Orthopedic Technologies and then as CEO of New View, he brought his hard-earned expertise with him.

In his words, “I think some of that vulnerability and that willingness to open communications with the confidence of a 25-year career and also just the understanding that the journey is not going to be smooth and trusting that people know that already.”

Product-Market Fit Must Come First

For Bryce, building a successful medtech start-up is all about a disciplined focus on product-market fit. “You might have an interesting idea, cool technology, and an alpha prototype. But does it meet the expectations of the end user, the customer, and not only the clinical user but the economic buyer as well?”

That’s not to say that technology needs to have a viable market to be a great innovation. Rather, not every great technology makes a great business.

“You can build a great product with a great team, but if you can’t ultimately sell that product, drive profitable revenue, and scale a business out of it, it’s probably not a good idea to have started that company.”

It’s also not enough to have great product-market fit if that market isn’t large enough to support a scaled business. If only “50 people will buy it. And that’s your market size, Bryce commented, that does not make for a sustainable, scalable business.”

Finding product-market fit is great in theory, but can be very challenging to achieve. The key is to develop as nuanced an understanding of your customer’s needs as possible. At New Vision, they formed long-term relationships with a small number of surgeons to understand how their products were used in practice.

For Bryce, “The real proof of adoption comes if you’re doing 20, 30, 40 cases in a single center with two, three, four surgeons…The deeper you go with single users in hospital, the more you learn.”

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The Power of Relationships

Building relationships is crucial to success in any industry. That’s as true in the medical device space as it is anywhere else.

Bryce credits relationship-building and effective communication for New View’s success with regulators. The company was able to secure 510(k) clearance from the FDA within 2 months of applying.

According to Bryce, working with regulators is all about understanding their goals and incentives. The FDA wants to protect patients, but is also motivated to shepherd new technology to the market where it meets requirements.

Moving innovations through the FDA is about communicating your value and limitations effectively. “The more you can help the FDA in this instance and the regulars understand your technology, the better.”

“A lot of founders that I speak to that are struggling with the FDA, and it's taking a lot of time. Fundamentally it's come down to a misunderstanding with the FDA, a misunderstanding about what the technology is meant to do and how that translates into the indication.”

Building relationships with the FDA as early as possible is also a secret of New View’s success. Bryce recommends taking advantage of Q-sub meetings if you can.

This same concept applies to investors as well.Bryce suggests medtech business leaders should trust that investors appreciate the ups and downs of taking a start-up to market.  

“They know you're going to make some poor decisions that you need to navigate through and get back on track. And the more you have a dialogue and an openness with investors. I think the more credibility you can build.”

Eugene’s IT and medical skills came together when he received a Master of Science in biomedical engineering from Cleveland State University (CSU).

“I was actually able to combine both the things I was good at with my passion, into one path,” he says.

After graduating from CSU, Eugene launched DragonID, an innovative healthcare and engineering company specializing in medical devices for the fields of cardiology and orthopedics.

The idea for Lazurite and its bellwether ArthroFree product came to Eugene when he witnessed a physician's assistant, minutes before surgery was supposed to start, trip over a bunch of surgical camera wires in an operating room. The cords were connected to the surgeon’s handheld camera and light, both of which are needed to perform minimally invasive surgery.

“There’s literally multiple cables running out of the surgeon’s hand, [which is] holding this camera that takes the video from inside the body. There’s a light to that camera that provides light into the body. Multiple cables that are heavy, that are bulky [and] dirty, go into the surgical tower that’s across [the room] on the opposite side of the patient — and that’s been the same way for the last 50 years,” Eugene explains.

Eugene recalls wondering why there were so many wires.

“The year is 2014 [or] 2015. Why are there all of these cables and wires to the surgical tower that shouldn’t be there? Wireless surgery should be possible,” he says.

That incident led him to launch Lazurite and begin developing what would eventually become the company’s flagship product, ArthroFree, a wireless camera system for minimally invasive surgery.

Eugene leveraged his experience with previous startups to make Lazurite a success.

FDA granted market clearance to ArthroFree in March 2022 after only a three-month review — a quick turnaround for any medical device. It’s the first wireless camera for minimally invasive surgery to ever receive FDA clearance.

As of the third quarter of 2022, Lazurite has raised about $25 million across multiple fundraising rounds. After ramping up hiring, the company is working through the manufacturing and supply chain logistics to prepare for a full market launch for ArthroFree.

In this episode of Medsider, Eugene shares how planning out every step of ArthroFree’s regulatory and development process helped streamline the FDA clearance process, the importance of preparing for failure and being ready to solve problems, and why entrepreneurs should seek out investor input at every stage of development.

Key Lessons from Eugene’s Experiences

• Put together a regulatory and development roadmap from the start, and hire a consultant to help you refine the plan. Mapping out your path beforehand will pay off when it’s time to submit your application to FDA.
• Eugene sought input from surgeons throughout every step of the ArthroFree development process. Those surgeons then turned into investors who drew in more investors. Maintain a strong line of communication with your financial partners, and garner feedback from them through every stage of development. Let them be a part of the process.
• Be prepared for things to go south, whether it’s a technology failure or a different issue within your company. Be aware of the problems and be ready to solve them; don’t brush them under a rug and kick the proverbial can down the road.

Create a Development and Regulatory Roadmap Early On

Eugene recommends startups flesh out their regulatory and development plan upfront.

One of the first things Eugene did when he launched Lazurite was call in help from regulatory consulting firm Musculoskeletal Clinical Regulatory Advisers (MCRA). “[Days after] after I formed the company, I called [MCRA],” Eugene says.

He then mapped out the company’s development and regulatory pathway and modified it based on feedback from MCRA.

Once the plan was finalized, Eugene made sure to follow it for the entirety of ArthroFree’s development lifecycle. When it was time to go to FDA, the company already had a full submission package put together and ready to submit to the agency.

Eugene also quickly hired a Director of Regulatory Compliance, Patrick Polito, who is with the company to this day. It was an expensive but critical hire, Eugene says.

“Without Patrick being in the mix the entire time, there’s no guarantee that we would have stayed on course, on track to go through all the paperwork and all the processes that we would need to in order to be successful,” Eugene says.

Eugene believes taking those two key actions at the outset — mapping out a development path and hiring a regulatory compliance lead — helped the company’s product get through FDA review in three months.

“We had a plan. We followed the plan. We had a person who was in charge of leading the plan, and then when we did put a package together for the FDA, it was very comprehensive,” Eugene says.

Seek Out Input From Investors and End Users Every Step of the Way

Much of Lazurite’s initial seed money came from physician-investors who wanted to use ArthroFree.

Eugene made sure to connect with surgeons early on in the ideation process when ArthroFree was just a prototype. He began gathering input and connecting with surgeons across the country to talk about what they needed and how they wanted the device to work.

He received positive feedback from surgeons who said they’ve needed a wireless camera option for a long time. After a month or so, and after developing a couple more prototypes, Eugene went back to that same group of surgeons, laid out his plans, and asked if they would invest in his startup. The answer was a resounding “yes.”

Eugene made sure to stay in touch with those same surgeons throughout the development process and get advice on the design of ArthroFree, which allowed those surgeon-investors to be a part of the development and planning process.

“As I developed the product over the years, I kept going back to that well, talking to those surgeons: What’s your market? How much would you pay for it? Who’s on your team? How are the decisions being made? For you as a surgeon, if I got rid of these cables, do these matter? And they provided me with a lot of input, which I then incorporated. I was able to use those surgeon-investors to help build … and create a very nice product,” Eugene says.

Those surgeons also came back to invest in Lazurite when the company entered its Series B financing stage. And because Lazurite had backing from physician users, the company was able to attract “more sophisticated” investors, Eugene says.

Eugene’s advice to medtech entrepreneurs: Keep in touch with investors. Enlist someone on your team — preferably the CEO or founder — who can be the conduit of information and let the investors know how valuable their input is.

“When it’s time to have them come back for an additional round, they will happily do so,” Eugene says.

Eugene offers up some additional quick-hit fundraising advice for medtech entrepreneurs:

1) Double down on your fundraising goals.

Expect everything to take twice as much time and twice as much money, and then double that again. That’s how much money you’ll likely need.

2) Build out your IP portfolio.

The sooner you can get your intellectual property filings in, the sooner you can get them granted and the stronger your portfolio will be, Eugene says.

“Good money management [is] always important,” he adds.

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Prepare for Failure

Eugene combined several different kinds of technology to create ArthroFree, but getting those components to “play nicely together” and not in isolation proved to be difficult, he recalls.

It’s a common mistake among medtech startups to think that separate platforms or modules — once put together — will work flawlessly in a single device, but that’s not usually how it goes, Eugene says. For example, Eugene knew he needed to ensure a strong wireless connection for ArthroFree so he decided to use ultra-wideband technology: a fast, encrypted transmission technology that’s often used for military applications. A few years later, he entered into the alpha and beta testing stages for ArthroFree and started putting all the components together with the ultra-wideband technology.

Things didn’t go as planned. Eugene found that even though ultra-wideband worked great on its own and in other capacities, it actually caused an “incredible amount of lag” between the camera and the screen. That obviously wasn’t going to work for surgeons.

“If you're a surgeon doing surgery, you really cannot have any lag between what you perceive as your hand movement and what you see on the screen,” Eugene says.

The Lazurite team knew it had a module that worked well (the ultra-wideband technology), but had limitations when it was combined with other system modules. They had to clear out those limitations, Eugene says.

Those kinds of situations happened repeatedly during the ArthroFree development process, Eugene says.

The team had to work quickly and efficiently to identify and solve those problems. The trick is to be aware of the problems and don’t brush them off, Eugene says.

“Don’t put your blinders on and ignore that this is a problem because if you try to pretend it’s not [there], it’s just going to come back and bite you,” he says.

And if something isn’t working — whether it’s a technology, communication, or a different company issue — don’t be afraid to move on and try something new. That’s one key piece of advice Eugene would give to his younger self.

“Knowing what I know now, I definitely beat a dead horse longer than I should have more than once, whether it was a people issue, a company issue, a communication issue,” Eugene says. “We’re all prone to just trying to keep something going, even though it’s obvious to everybody that you need to move on, you need to change. I fall into that trap, just like everybody else.”

Don’t forget to rely on the people around you for help. A good, reliable team will help you solve any problems that arise, Eugene says. It’s all about having the right people in place to bring the technology to bear.

But at the age of 22, he wasn’t quite ready for a full-time startup role and decided to join the corporate world and spent four years at Genentech — two years in the company’s leadership development program and two years in the U.S. pricing contracting strategy group for oncology drugs. While at Genentech, Cody learned about business analytics; strategy and commercialization; and how high-functioning, high-performing organizations operate.

In 2016, he met entrepreneur and DermaSensor Co-Founder and Chair Maurice Ferré, who asked Cody to join the company and help bring its namesake product — a handheld skin cancer detection tool — to bear.

With Cody at the helm, DermaSensor has raised $27 million to launch the world’s first point-and-click skin cancer detection tool for primary care providers.

DermaSensor carries the European Union CE mark, and is also registered and available for sale in Australia and New Zealand.

Pursuing FDA marketing approval, the company received breakthrough device designation for the DermaSensor product and in 2021 completed the first-ever FDA pivotal study for a primary care-focused skin cancer detection tool.

In this episode of Medsider, Cody talks about the importance of discovering whether there’s alignment between regulatory requirements and payer needs, as well as finding opportunities to streamline your clinical testing plan to meet both sets of criteria; why you should seek out ally investors; and how you can de-risk your technology for potential investment partners.

Key Lessons from Cody’s Experiences

• DermaSensor learned early on in the development process that it needed to conduct multiple studies to get regulatory approval and qualify for reimbursement. Medtech companies should pinpoint the criteria necessary to satisfy both regulators and payers and whether there’s any alignment between the two.
• Show investors that you have the capability and competency to establish a manufacturing process and that you’re prepared to ramp up supply when getting to market. Having commercial product ready to go shows the ability to execute your plans.
• Spend some time each month proactively reaching out to potential investors. Focus on building strong relationships with people in your network who can become trusted allies and provide help during challenging times.

Understand Where Regulation and Reimbursement Align

Early on in the DermaSensor development process, the company set out to better understand both the regulatory criteria to get marketing approval and what payers were looking for so the product could qualify for reimbursement. Through that process, the company learned it could not rely on just one study to satisfy both FDA and payers.

“That was a helpful North Star in a sense [for us],” Cody says.

DermaSensor decided to take a two-step approach to development that involved a large clinical validation study for the FDA regulatory pathway and several clinical utility studies to show payers how the device would benefit patients in the real world.

“[Get] a sense of your regulatory path and [whether there] is some way to align that with reimbursement so you can maybe do one or two studies in parallel versus sequentially. For us, unfortunately, that wasn’t the case, but knowing that in advance was really important,” Cody says.

Cody also suggests bringing in an expert or multiple experts who truly understand and can guide you through the regulatory process, which is filled with nuance. It’s worth investing the time and money to hire someone with domain expertise, he says.

“If somebody only does pharma, and you're a medtech or diagnostic startup, keep looking. There's plenty of folks that you can speak to,” Cody says.

De-risk Your Product to Build Investor Confidence

Getting to market is great and can provide key insights, but investors also want to know that you can successfully set up a manufacturing process that complies with regulations and allows for scalability, Cody says.

“Having that commercial product, even if it’s not the cleared medical device you ultimately want, shows that you just have the … capability and competency as an executive and as a company to execute on that,” Cody says.

Getting all your manufacturing and supply ducks in a row can help de-risk the company for investors. That’s one less thing investors will have to worry about, and it shows you’re prepared for commercialization.

And don’t be afraid to pivot when things don’t go as planned.

DermaSensor had two year-long setbacks. The first was due to a technical issue that led the company to completely change the design and strategy. The second setback was due to production work that led the company to switch manufacturing groups.

Don’t stay wedded to your original plans. Work the setbacks to your advantage, tear up your playbooks, and work within the new timeline, Cody says.

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Build Strong Relationships and Find Allies

Cody admits that he underestimated the importance of fundraising and networking when he first got started with DermaSensor. He learned that you need to build strong relationships with potential investors to be successful.

“[You think] if you do a good job building the business and the product, then you don't really need to worry about money … that’s just not true. You’ve got to have people that know you and trust you and who you've been keeping updated on your work, especially in the earlier days,” Cody says.

Cody suggests finding an ally investor — someone who believes in you, your company and technology, and who will go to bat for and open up their networks to you. Don’t be afraid to take an equity cut or give the backer a discount in the first investing round to get them on board, so they can help you raise more money.

In the end, it’s worth the effort because those allies will be able to help during hard times.

“It's people like that, that aren't just strictly financial investors, but who really believe in you and the product and company [so much] that when there are dark days — which there most undoubtedly will be — [they] will still be there by your side and can help,” Cody says.

Spend some time each month going to lunch or getting drinks with people in your network, Cody advises. Allow potential partners and investors to get comfortable with you as a person and as an entrepreneur.

Successful entrepreneurs do a good job of building and nurturing relationships, and they make better salespeople, Cody says.

“A lot of success in this [startup] world comes down to finding people that believe in the company and that will put money behind it,” he says.

Sina and Seyed-Mahdi bonded when realizing both had loved ones diagnosed with dementia in the later stages of the disease, when it was too late to reduce its effects. Sina, an engineer, and Seyed-Mahdi, a neuroscientist, set out to fix the process for diagnosing dementia, resulting in the launch of Cognetivity in 2013.

Cognetivity is on the cutting edge of neuroscience and uses artificial intelligence (AI) for early detection of cognitive impairment, dementia, and Alzheimer’s disease.

When it first launched, the company was on the front lines of the digital health space, which required blazing new trails with regulators. The Cognetivity team had to learn the ins and outs of digital health product development and regulation on their own.

“There was not much that we could look at in terms of peers or examples that had gone down the pathway, both from a regulatory point of view [and in] product development. So we had to do a lot of the work ourselves,” Sina says.

Since then, the company has launched two products: Cognetivity’s Integrated Cognitive Assessment (CognICA) and OptiMind.

CognICA is a five-minute, computerized test that measures cognitive function. Considered a medical product, it has marketing authorization in the European Union and the United States. OptiMind is a wellness app that measures users’ everyday cognitive performance.

In this episode of Medsider, Sina discusses the importance of getting input from both end users and regulators throughout the development process, why companies should focus on how their product can generate revenue versus reducing costs, and the importance of teaming up with an expert fundraiser.

Key Lessons from Sina’s Experiences

• Get input from experts at every step of the development process, starting with regulators and working back to your end users. Regulators let you know what’s needed to get your device or technology to the finish line, while end users will help you drive toward a compelling product offering.
• Think about the value and benefits of your products first; cost savings should come second. Cognetivity, for example, is focused on showing clinicians that CognICA can generate revenue for their practice. Making sure users get a return on their investment is key to seeing early adoption of your technology.
• Team up with fundraisers who have experience raising money in your field. Worry less about dilution and focus more on raising smart capital. A small piece of a large cake is worth more than a big piece of a smaller pie.

Reverse Engineer Your Development Process

When Cognetivity was just starting out, Sina and his team made sure to regularly interact with regulators to help them understand the nuances of the technology. Regulators at that point were used to reviewing and approving medical products shown to be safe and effective for a specific function and with clear parameters around how to use the device.

CognICA is not a traditional medical device; it’s a computer program developed for an iPad, featuring AI that changes and gets better the more the program is used.

The Cognetivity team had to educate regulators about the product and the nuance behind the technology. Regulators are now using Cognetivity’s platform as an example for other companies developing similar technology, according to Sina.

Sina encourages other medtech developers to speak with regulators throughout the product development process.

“[Regulators] never tell you ‘do this or do that,’ but they will make you aware of the risks and things that you might have overlooked,” Sina says.

Once you have input from regulators, focus on getting feedback from your intended end users, whether clinicians or patients. Those conversations can help ensure your product vision aligns with what users truly need and want. In Cognetivity’s case, the company talked to clinicians who would eventually be administering the CognICA test to patients.

“It’s easy to sit down and imagine a product that is ideal for your customers. You can do all the hard work, and then face a brutal reality that that’s not the case. One of the good things that we’ve done …from the very early days is [being] in direct communication with end users, which are clinicians, and have taken a lot of input,” Sina says.

Make it a priority to obtain input from multiple experts along the way, including the planning for your clinical trials. Product area experts can help identify overlooked issues that might affect the design, length, and cost of your clinical trial.

“[Spending] tens of thousands of dollars at the very beginning can save you literally millions of dollars down the line,” Sina says.

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Team Up With Fundraising Superstars

Team up with a “fundraising superstar” in your sector — someone who knows how the system works, has a good track record of raising capital, and is hands-on with companies, Sina says.

“I’m not talking about placement agencies and brokers. Even investment bankers have that ‘throw the spaghetti at the wall and see what sticks’ approach … [look for] someone who gets involved, has strategic value-add, and has done this with other companies before.”

There are plenty of people with those qualifications, especially at universities.

Sina recalls that as he was building Cognetivity, he had the opportunity to raise seed capital with a superstar fundraiser. He decided, however, to take another offer with a different group that had more favorable dilution — that is, when the company offers new shares by decreasing equity ownership for existing shareholders.

If he could go back in time, Sina says he would be less concerned with dilution and work with the investor that was more familiar with the space and had a better track record of raising capital.

“The more you raise, the more you’re known in the space, the more you are connected,” Sina says.

He also reminds developers that fundraising is a complicated science in and of itself. That’s why you need to work with people who have experience, starting at the earliest stages of development.

“Bring in someone who has done it before. That will help you a lot down the line. Don’t worry about the dilution. A small piece of a huge cake is a lot more valuable than a big piece of a smaller one,” he says.

Final Thoughts: Listen and Learn

Sina and his team have made a point of listening to experts at every step of the development process, from the regulators to the end users. Being humble and ready to learn are key to success, he says.

“Always be open to different ideas,” he says. “Encourage questions from your team, encourage pushback from your team, and give everyone a voice because it's important that collectively you get to the right answer as a team, before it goes out.”

PiCSO is intended for use during percutaneous coronary intervention (PCI), a first-in-line procedure to treat heart attacks as a way to reduce infarct size, which Olivier says should lower mortality rates and lead to fewer hospitalizations due to heart failure.

Under Olivier’s guidance, Miracor is focused on building a strong evidence base for PiCSO and is pursuing an expansive randomized clinical trial program to demonstrate value for doctors, patients, and payers — by showing that PiCSO can reduce heart failure that can often occur after a heart attack.

“The standard of care [for heart attacks] today is still stenting. Stenting has helped these patients, but at the cost of heart failure hospitalization,” Olivier says.

The company is conducting clinical studies in Europe and plans to initiate a randomized controlled trial for FDA clearance in 2023.

In this episode of Medsider, Olivier talks about the importance of gathering robust clinical evidence in randomized clinical trials, how the company uses remote video monitoring to guide procedures, and why startups should raise the bar on their financial goals.

Key Lessons from Olivier’s Experiences

• Keep collecting data even after you get regulatory approval. Generating strong clinical evidence through randomized trials substantiates the value of your technology to patients, doctors, and payers, even after you’ve hit the market.
• Miracor Medical takes advantage of remote monitoring tools to make its clinical trials more efficient and cost-effective. Consider going virtual using high-end surgical monitoring platforms, like Avail and ExplORer  Surgical. You can also use more common video conferencing platforms for less complicated procedures.
• Focus on long-term fundraising goals and aim to raise more money than you think you need. You want to be prepared should you encounter development delays or challenges.

Generate Strong Evidence in Randomized Trials

Randomized trials have always been the gold standard, and the need for strong clinical evidence has only increased over the years

Without this type of data, you won’t have adequate evidence for health care providers and you likely won’t get reimbursement, Olivier asserts.

“As a company, you want to know the true efficacy and the true value of your product. In the end, randomized trials … will help you understand,” Olivier says.

Miracor is conducting randomized trials with a focus on patients who experience ST-elevation myocardial infarction (STEMI), a more serious heart attack.

The company launched its first randomized study in Europe in July 2019, and the trial demonstrated positive results. The European Union has already granted marketing authorization to PiCSO, but Miracor isn’t resting on its laurels. The company continues to focus on generating strong clinical evidence in its other European clinical studies, too.

Miracor is currently enrolling patients in its second randomized trial in Europe. The company also is conducting an observational study to gather data from the real world and bolster its evidence base.

Miracor is also pursuing regulatory approval with FDA and plans to launch additional clinical trials in the United States and Canada to support its submission.

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Take Advantage of Remote Monitoring Technologies

Clinical trials are expensive and time-consuming, especially when, like Miracor, you’re collecting data across multiple sites.

To boost efficiency, Miracor is using remote proctoring — where clinical specialists use a laptop to virtually monitor and guide cardiologists through the PiCSO procedure.

Miracor’s clinical specialists have proctored procedures from their cars and even the airport, Olivier says.

Virtual surgical consultation platforms like Avail and ExplORer Surgical provide higher-quality video and communication options than platforms available to the general public. But Miracor also uses FaceTime- and WhatsApp-based video. PiCSO is a fairly simple technology, Olivier says, so the learning curve is smaller.

“I think this is only one of the areas where technology is revolutionizing healthcare and will continue to,” Olivier says.

Up the Ante on Your Fundraising Goals

Olivier says more traditional investors — what he calls the “old-money” shareholders — often will direct companies to be more conservative when raising money. But Olivier believes companies should raise more money than they think they will need.

Building a startup is going to require twice the money and twice more time than you think it will, he says. Companies need to make sure they have a financial cushion, especially in case of major disasters or other unforeseen events, like a global pandemic.

Startups should avoid “managing toward a wall” — that is, when leaders focus on raising money to reach a single milestone in the hopes that hitting it will open up opportunities to raise more money.

Think about the long-term goals when setting fundraising targets, Olivier says. Your plan should be to create value for your company and translate that into financial returns for investors.

“I've become very pragmatic. We need to create value for the company. And in the end, a company needs to be able to be independent in some way,” Olivier says.

Miracor is currently focused on raising money for its clinical trial program. Olivier believes PiCSO is a transformational therapy, and he wants to make sure Miracor demonstrates that to investors and payers through robust clinical evidence.

“The focus is really on clinical studies and getting access to the U.S. market with the right data and with the right reimbursements,” Olivier says.

In the medical device world, data is king. Strong clinical results can help medical device companies better understand the efficacy, safety, and true economic value of their products and ultimately boost their chances of success.