Getting Your Medical Device to Market: Here’s What Really Works

The medtech market closed 2024 just shy of $400 billion and could exceed $500 billion by 2029.  But growth in the sector hinges on more than novelty alone — adoption is what turns a startup into an actual business.

Even the most advanced technology can fall short if it doesn’t fit into real-world clinical workflows.

As co-founder and CEO of FastWave Medical and founder of Medsider, I’ve gained valuable insights from startup founders and CEOs who have successfully transformed unique concepts into thriving businesses. This article shares key lessons learned on the path to medtech market adoption.

Build Your Market Access Strategy

Reinhard Krickl, former CEO of Phagenesis, is an engineer by training with over 25 years in medtech, spanning multiple startups as well as Medtronic, where he led the commercialization of deep brain stimulation therapies across Europe.

In 2014, Krickl took the helm at Phagenesis, leading the company through FDA approval, a Series D financing, and European market entry. The company’s product, Phagenyx, focuses on swallowing difficulties, or in medical terms, dysphagia. The device uses electrical stimulation to restore swallowing function within just a few days, saving patients from the risk of serious complications like aspiration pneumonia.

A seasoned leader in bringing devices to market, Krickl relies on a medtech market access checklist he developed.

Understand structural barriers:

• Be crystal clear about the problem you’re solving — and who you’re solving it for. “You’d be surprised how often it’s not obvious which patients will benefit most from a therapy,” Krickl points out. Define your patient population precisely so that physicians and hospitals see where the solution fits.
• Make sure there’s strong evidence to support the benefit(s) you’re claiming. A good clinical strategy ticks regulatory boxes and generates solid data to back your claims. Especially if you’re dealing with higher-risk interventions, you’ll need rock-solid proof to reassure clinicians.
• Take a hard look at healthcare economics. Hospitals or clinicians need to be able to afford your device, and it has to make financial sense for them.
• Ensure your product integrates smoothly into existing workflows and doesn’t create bottlenecks.

Evaluate therapy readiness: The easier and safer your therapy is to deliver, the more likely it will be adopted. Complex therapies with high complication rates or steep learning curves create barriers. Consider how straightforward it is to train someone on your solution and integrate it into existing workflows.

Drive physician awareness and adoption: Focus on the people who will prescribe or use your therapy. Are they aware of it? Do they understand how it fits into their workflow? “For Phagenyx, the same clinician handles everything from placement to follow-up, which simplifies adoption,” Krickl shares. If your solution involves referrals or multiple stakeholders, develop a strategy to align them all.

Accommodate the human element

Sumit Nagpal’s career took off after he worked with Steve Jobs at NeXT in the early 1990s. Over the last three decades, he’s built and scaled five companies, addressing some of the toughest challenges in healthcare.

In 2020, Nagpal co-founded Cherish Health to develop Serenity — a discreet, radar-based, in-home monitoring system that tracks falls, rising risks, and key biometrics — without the need for wearables or cameras. The platform serves a range of use cases, ranging from pediatric asthma to dementia care.

Nagpal, who thinks at scale, has watched big tech and retail companies enter healthcare, only to struggle with its high and unpredictable costs. He saw a need to reduce preventable emergencies — many of which begin at home. He realized, ”People wind up in ambulances, in emergency rooms, in hospitalizations, when those are, in fact, avoidable.”

Wearables exist for emergency detection, but they often fail due to inconsistent use and user fatigue. “Home security systems detect fires without you having to do anything. We need healthcare devices to work the same way — passively and reliably,” he says. That insight led to Cherish. In 2024, the company launched Serenity at CES and has since partnered with AT&T and Alarm.com, one of the largest home security firms in the U.S.

Nagpal’s medtech marketiung lesson is clear: If your solution requires people to change their behavior, it’s unlikely to scale. Pinpoint a critical unmet need and work backwards to design a solution that fits seamlessly into users’ everyday lives. Don’t expect them to go out of their way to use your device. Put yourself in their shoes — what might make your product feel intrusive or inconvenient? With passive, ambient sensing, for instance, privacy is non-negotiable. That’s why Cherish opted for radar technology, reassuring users that Serenity doesn’t collect personal information.

Let the medtech market pull you

After starting his career in Boston’s startup scene, Bryan Lord took on roles in corporate finance, technology licensing, and M&A in various tech-related industries. Now, he is President and CEO of Pristine Surgical, which is developing Summit, a 4K, single-use digital arthroscope. Unlike reusable arthroscopes, Summit simplifies processes, minimizes the risk of cross-contamination, lowers maintenance costs, and delivers high-quality imaging support with cloud-connected features.

Lord knows the challenge of identifying disruptive medical technology in its early stages. “With that humility, your job is to look for market responses, pay close attention, and think soberly about them,” he advises. Be objective about whether your solution addresses genuine market demand rather than simply showcasing interesting technology. In his words, focus on “market push” versus “technology pull.”

As a founder, it’s natural to see your invention as your baby and assume everyone will be as excited about it as you are. “That myopia is common, and it’s understandable,” Lord says, “But probably the most important thing is to be as objective as possible with the market.”

Pristine’s original pitch focused heavily on reducing cross-contamination risk. However, through conversations with ambulatory surgery centers, Lord realized it wasn’t the most compelling selling point. These facilities prioritize cost efficiency, patient safety, and procedural effectiveness while managing diverse equipment with complex protocols. For example, preparing a traditional arthroscope takes 35 steps. That process is expensive and relies heavily on staff — who are increasingly difficult to recruit and train.

After realizing that procedural complexity, not infection risks, created the greatest burden for endoscopy teams, Lord refocused the pitch on how Summit reduces the procedure from 35 steps to just three.

Talking directly to your end users and stakeholders is a good way to uncover real pain points to get your medtech to market. Taking this further, consider implementing a limited market release. Letting users experience your product firsthand is the most effective way to gather feedback, refine your offering, and sharpen your pitch. Just remember that a limited release differs from full commercialization — so setting the right expectations with stakeholders, especially investors, is incredibly important.

Meet patients where they are

Aakash Shah was always interested in leveraging his technical background to start a business. Partly motivated by his passion for entrepreneurship and partly by his own struggle with severe allergies, he teamed up with his cousin and ENT specialist Dr. Manan Shah, to build Wyndly. The service allows patients to buy an at-home allergy test online, connect remotely with a specialist to discuss the results, and receive personalized allergy drops. Wyndly now operates in all 50 states.

This model didn’t just pop up in Aakash’s mind. Their first stint was digitizing Dr. Shah’s ENT practice, as they found aspects that were suitable for a telehealth model. When that was a success, they leaned into customer demand.

Traditional treatments for allergies can take five years or longer, requiring weekly clinic visits for shots. This schedule creates significant barriers — bringing children to an office on a regular basis is challenging, patients relocating results in disrupted treatment, and insurance complications add further stress.

Wyndly’s medtech market model caters to modern consumer behaviors. Patients prefer taking charge of their health rather than fighting for doctor time. They typically start by Googling their symptoms or looking for advice online before seeking professional help. Wyndly meets them where they start — whether through Google searches or social media — not in clinics. Patients can purchase their diagnostic kit online and follow a virtual treatment path.

“I think it’s a tragedy that our current healthcare system is so impersonal,” Aakash explains. Wyndly differentiates itself by setting clear expectations: advising when to consult specialists, maintaining consistency with the same specialist throughout treatment, and enabling patients to receive care without waiting or leaving home.

“It’s constantly experimenting until you realize, ‘OK, this is how the buyer wants to interact with what we’re doing,’” Aakash says. The key is following customer demand while simplifying processes to meet people where they are.

Become the end user

Tim Rosa knows what it takes to turn an idea into a recognizable brand on the medtech market. As the former CMO of Fitbit, he helped build the wearables category, selling over 140 million devices in more than 100 countries. Now he’s at Somnee, which has developed a smart headband to improve sleep quality and make it easier to fall asleep faster.

Rosa discovered at Fitbit and Somnee that complexity kills adoption, especially in healthcare. “When I joined Somnee, the science was amazing, but everything else was overcomplicated. Even I didn’t fully understand it,” he admits. His goal was to simplify the technology for everyday users. “My benchmark is: can my mom in Michigan understand this?” he explains. Fitbit succeeded by establishing simple goals, such as 10,000 steps. At Somnee, Rosa focuses on reducing friction and creating a delightful user experience.

Clear communication is paramount, especially when working with complex technologies as you’re targeting both experts and consumers. “You have to win hearts and minds,” Rosa says. For consumers, simplify the message without diluting the science. For scientists and institutions, provide data in an accessible and actionable format. At Somnee, this balance is critical to gaining trust while validating the product’s effectiveness.

Design isn’t just about aesthetics; it’s about how users feel when they interact with your product at each touch point through the customer journey. Rosa’s approach is to embody the end customer: “No matter what industry you’re in — whether it’s consumer, enterprise, or healthcare — you need to understand who your end-customer is and what their experience is like,” he says. He notes that many neurotech products appear as if from science fiction, alienating potential users. Rosa aims to transform perceptions of neuroscience by making Somnee’s products approachable, modern, and emotionally engaging.

Rosa advises identifying your product’s friction points while investing in product design that combines functionality, beauty, and emotional engagement. Aim for an experience that is intuitive and delightful for your target audience.

In conclusion: Design for reality, not ideals to get your medtech on the market

Successful medtech commercialization demands more than revolutionary technology — it requires deep understanding of how your solution integrates into real-world healthcare environments. The most promising innovations falter when they create friction rather than removing it.

Seasoned leaders recognize that adoption flows from addressing genuine needs with minimal disruption to established workflows. They design around current behaviors, not idealized ones, and let market demand guide their development and messaging. By prioritizing user experience, streamlining integration, building compelling clinical evidence, and communicating benefits clearly, you create the conditions for commercial success.

Scott Nelson is the co-founder and CEO of FastWave Medical, a medical device startup developing intravascular lithotripsy systems for cardiovascular disease. Additionally, he’s the founder of Medsider, where he interviews founders and CEOs of promising, early-stage medical device and health technology companies. As a medtech growth architect, he founded and scaled Joovv from $0 to over $20M in profitable revenue in less than 3 years entirely online without a sales force. Prior to that, Scott held various leadership roles at fast-growing startups and multinational strategics, including Touch Surgery, Medtronic, Covidien, Boston Scientific, and C.R. Bard