How to Build Commercially Viable Devices at Scale
Innovating in medtech takes more than building something new. You need to build something better — viable, scalable, and clinically meaningful.
Balance innovation with industry standards: Investing in in-house capabilities helps you test, learn, iterate, and scale more efficiently when bringing new technology to market. Own what gives you an edge, but know when to follow the playbook to keep things moving.
Minimize risk, maximize traction: For a lower-risk path, focus on building the next-generation device in an existing therapy space with a clear unmet need. Tackle clinical and technical risks one step at a time. At every stage, demonstrate measurable progress.
The best products don’t just work — they evolve: A product launch isn’t the finish line. Real-world use will expose gaps that bench tests can’t predict. Build with flexibility in mind — whether it’s designing for serviceability, efficient scaling, or adaptability across markets.
Build from the problem, not the tech: Design from the problem outward. Start with a real clinical need, not just a clever technology. Test in real-world conditions early, not just idealized lab settings. Unexpected challenges often reveal new data and opportunities.
Don’t rush into investment — or commercialization: Focus first on proving your technology. Validate rigorously, build credibility, and bring in investors only when you're ready to scale — not before.
Shorten the Feedback Loop: Build It Yourself
Connor Cullinane, co-founder and CEO of Pirouette Medical, is an aeronautical engineer with an impressive resume that spans MIT and Harvard, and he even designed spacesuits for NASA.
But his latest mission is far more personal: inspired by his brother’s severe allergies, he set out to reinvent how emergency drugs like epinephrine and naloxone are delivered. The result is QuicPush — a discreet, disc-shaped injector designed for ease and speed.
Instead of outsourcing development, Pirouette built its own in-house manufacturing capabilities. This is a risky path, especially for a startup. But it paid off — it actually saved them time and money.
“Owning core competencies, especially for new product introduction, helped us internalize key learnings,” said Connor.
“We would have an idea on the whiteboard in the morning, and by the afternoon, we had that part physically in our hand, ready to test,” Connor noted. By internalizing production, the company accelerated prototyping, reduced costs, and refined designs without the delays of external vendors.
But not everything can be reinvented. After designing a novel fill-finish process, the team realized it clashed with biopharma standards — risking delays and added cost.
“You can do yourself a favor by aligning with the industry standard on specific points,” said Connor. The lesson: innovate where it counts, but don’t ignore the rules of the road.
What Kind of Risks Are You Tackling?
Nitin Salunke has a PhD in Mechanical Engineering and decades of experience leading R&D at Medtronic Neurovascular, Altura Medical, Cordis (J&J), and W.L. Gore. Today, he’s the CEO of Supira Medical, which is developing a next-generation heart pump to provide critical hemodynamic support for high-risk cardiac procedures. Under his leadership, the company secured FDA Breakthrough Device Designation and raised a $120 million Series E to push clinical development forward.
Nitin brings a risk-aware perspective to medical device innovation. In his view, startups face two major types of risks:
Clinical risk: Entering a new therapy space without established precedent for treatment efficacy.
Technical risk: Developing next-generation technology to improve an existing therapy.
One of the biggest mistakes, he said, is trying to take on both types of risk at once. His recommendation: tackle one at a time. Drawing on his experience in interventional cardiology, Nitin has found that improving existing therapies with better technology often delivers more predictable returns. “Most of the time, I go into the existing therapy spaces where there is a true need for the next generation,” he said. "Find a space where there is already validation but where innovation can lead to clear advantages rather than trying to create an entirely new therapy from scratch."
When the clinical need is already established, startups can focus on refining a proven concept rather than building credibility from the ground up. Plus, physicians are more likely to embrace an improved device that fits into their current workflow. That means faster adoption, fewer regulatory hurdles, and a clearer path to success.
For Nitin, next-generation medtech isn’t about reinventing the wheel—it’s about delivering meaningful improvements that benefit both patients and physicians. "If you can reduce the size or profile of the device while maintaining or enhancing its efficacy, that’s an immediate win," he said. This principle has guided much of his career in interventional therapies, where smaller, more efficient devices often lead to better outcomes.
That’s the approach Nitin brought to Supira. The field was already well established, with Abiomed leading the market and generating strong clinical evidence. But as a first-generation product, their heart pump had a bulkier delivery system and room for performance improvements. The opportunity was to develop a smaller, more effective device that seamlessly integrates into existing workflows — and Nitin took it.
Another way he manages risk is by creating value at every step of development. “As you use capital, you should be creating disproportionately higher value. And that value creation has to coincide with your own objective of value creation versus what investors may think about value creation," he said.
This means showing clear, measurable progress at every stage of device development. By systematically reducing risk and demonstrating traction, fundraising becomes easier. Bottom line: investors want traction — not a science project.
Launched? Great. Now Keep Building
Born into a family of doctors, Dhruv Agrawal was on the path to a career in medicine when a 3D printer changed everything. What started as a birthday gift quickly turned into an obsession with bionics, leading him to co-found Aether Biomedical when he was just 18 years old.
Today, as CEO of Aether, Dhruv is leading the development of ZEUS, a high-durability, multi-articulating bionic hand designed to offer stronger grip strength, faster repairs, and better adaptability than traditional prosthetics.
The company’s first investment round was just $250,000 — a tiny budget for a hardware device, but it was enough to build an early version of ZEUS.
“We got some really strong, passionate people on the team. Our VP of Engineering is the kind of guy who watches CNC machine videos before going to sleep. That’s the type of passion you need," said Dhruv. Due to their high cost, the same VP of Engineering had never even touched or seen a real bionic hand before joining Aether. Without predicate devices to study, the team had to be creative. They visited clinics and pretended to be customers just to see real bionic hands up close. From manuals, videos, and sheer problem-solving drive, they engineered a demo prototype that could be fitted on a patient.
That hands-on mindset became Aether’s edge — not just in development but long after launch. A product launch isn’t a finish line. Real-world testing exposes challenges that lab trials can’t always predict. When ZEUS first hit the market, it lacked the very features that make it stand out today. Stronger grip, better durability, faster repairs, and seamless software integration all came later — shaped by real user feedback.
Designing a high-performing prosthetic is one challenge. Making it scalable, repairable, and globally accessible is another. Aether had to ensure ZEUS could be manufactured reliably, repaired quickly, and distributed across multiple regions.
One of the biggest pain points in prosthetics is long repair times — some take six to eight weeks to fix. Aether tackled this by designing ZEUS with a modular, Lego-like structure that streamlined both repairs and manufacturing, resulting in:
Faster repairs: Clinics can swap out parts on the spot, reducing downtime for users.
More efficient production: Instead of shipping entire units, Aether only sends specific modules.
Lower costs: Clinics avoid sending devices back to the factory
Unlike many medtech startups that begin in one dominant market first, Aether had to go global from day one. Prosthetics is a niche field, and relying on a single country wasn’t viable. But expanding early came with trade-offs: juggling regulatory hurdles, supply chain complexity, and market-specific challenges stretched the team thin.
Looking back, Dhruv says the company would have benefited from a tighter focus. “Europe gave us early feedback, which was helpful in improving the product before launching in the U.S., but in hindsight, the U.S. market is much stronger for us in terms of commercialization success,” he said.
Today, Aether has dedicated teams managing different regions — maintaining global reach without overextending resources.
Design with the Patient Journey in Mind
Ajay Shah is a mechanical engineer with a PhD from Harvard Medical School who has spent his career at the intersection of healthcare and technology. Before founding Cytovale, he co-founded two life sciences startups, one of which was successfully acquired. Now, he’s tackling one of healthcare’s deadliest and costliest problems: sepsis.
Sepsis causes more inpatient deaths than heart attacks, strokes, and opioid overdoses combined. It progresses fast — every hour of delayed treatment increases mortality risk by 8% — yet emergency rooms still lack a rapid, objective tool to identify high-risk patients. Cytovale aims to change that with IntelliSep, a sepsis test that delivers results in under 10 minutes. Under Ajay’s leadership, Cytovale has secured FDA approval, raised over $100 million in its Series D, and launched IntelliSep in hospitals across the U.S.
A common mistake in medtech development is designing a solution first and then trying to force it into clinical workflows. Ajay takes the opposite approach: start with the problem. "Dig in and appreciate where the physician is coming from, what matters to the patients, and ultimately, how does your technology change their care journey?” he said.
To ensure IntelliSep aligned with real-world needs, Ajay and his team built the product using actual ER patient samples — not contrived specimens or theoretical models. Even though much of sepsis research comes from critical care and infectious disease specialists, 90% of sepsis cases first present in emergency departments. That’s why Cytovale focused on meeting the needs of ER clinicians, where speed and clarity are essential.
Bringing a medtech device to market requires more than a great idea — it has to work in the real world. The learning from Cytovale is clear: start with the problem, design around it and test your solution in the environment where it matters most.
More Testing, More Traction: The Power of Over-Validation
Juan C. Jimenez didn’t start his career in healthcare — he came from finance, specializing in M&A at Credit Suisse. When the financial crisis hit, he moved to healthcare, eventually leading TransCita, Puerto Rico’s largest non-emergency medical transport company. That experience exposed him to the inefficiencies in the system and sparked a realization: healthcare was ripe for innovation.
Now, as co-founder and CEO of AccurKardia, Juan is tackling ECG interpretation. His team has built an AI-powered, cloud-based platform that speeds up ECG analysis, helping physicians diagnose heart conditions faster. The software is device-agnostic, compatible with any FDA-cleared ECG monitoring hardware. It also eliminates the need for on-premise servers, integrates with electronic medical records (EMRs), and automates ECG interpretation.
Despite its elegance, Juan quickly learned that even the most efficient technology doesn’t guarantee speed in medtech. "I got wrong the speed at which things get done," he said. "I was naive to believe that I was going to move faster than I have. In medtech, even software-based devices, fast is never an option. The reality is, it's slow, slower, or stop."
So how did AccurKardia make progress despite the industry’s slow-moving nature?
One of the most common mistakes in medtech is rushing into commercialization before real-world product validation. Instead of chasing large funding rounds early, Juan focused on proving the technology first. Operating with less than $6 million, AccurKardia secured both FDA clearance and breakthrough device designation — building credibility without unnecessary dilution. “We compensated for not coming from a traditional medtech background by over-validating,” Juan said. The team’s clinical study had four times the sample size of their predicate.
But validation went beyond regulatory approvals. AccurKardia also built credibility through industry programs like MedTech Innovator and Mayo Clinic Platform Accelerate, gaining access to clinical data, mentorship, and visibility in a competitive space.
“Sometimes it’s good to let the innovators think on their own without too many outside opinions,” Juan said. That mindset guided their decision to delay outside investment. Instead, the team focused on refining their product, understanding the market, and shaping their own narrative — free from external pressure.
By prioritizing product development, forming strategic industry partnerships, and validating extensively, AccurKardia laid a solid foundation. With those pieces in place, the company is now positioned to scale with confidence.
Building devices that actually get adopted
As the examples illustrate, successful medtech innovation is about more than novel technology — it’s about building something better, viable, and scalable.
The most effective founders balance bold ideas with real-world constraints: they de-risk thoughtfully, validate early, and design for continuous improvement. By starting with the clinical need, showing measurable progress, and pacing growth strategically, they position their technology — and their company — for lasting impact.