How MedTech Startups Can Use Customer Discovery to Build Better Devices
In the high-stakes world of MedTech, failure isn’t just expensive, it’s often irreversible. Teams spend months, even years, developing a device they believe in, only to watch it fall flat when it hits the market.
Sometimes the product works flawlessly, but for a problem no one’s desperate to solve. Other times, it’s aimed at the right use case but misses the true buyer, derailing adoption.
These aren’t engineering problems. They’re customer discovery problems.
Customer discovery (CD) is the structured process of identifying and validating the problem, the market, and the viability of a solution before investing heavily in development. And in an industry as complex and regulated as MedTech, CD is not just helpful, it’s essential.
To explore how startups can do this right, we sat down with two experienced innovators: Ryan Ramkhelawan, a MedTech serial entrepreneur with a successful exit in the past, and Axel Strombergsson, a product development expert and startup growth strategist.
Their insights reveal a powerful, practical approach to customer discovery that helps MedTech startups de-risk their ideas, build smarter products, and go to market with confidence.
Customer Discovery in MedTech: More Than User Interviews
Customer discovery isn’t just about talking to users; it’s about understanding every person and process involved in making a device successful.
“Customer discovery is the process of confirming that there’s a problem people actually care about solving,” Ryan explains. “Then it’s about understanding how they’re solving it today, what they’re frustrated with, and whether your idea is worth pursuing.”
In MedTech, that means validating:
- The problem: Is it painful and urgent enough? Will people be willing to pay for a solution to the problem?
- The stakeholders: Who experiences the problem? Who pays to fix it?
- The context: How does the problem fit into clinical workflows, budgets, and current solutions?
- The risks: What workarounds or unsafe behavior does the status quo create?
Without that understanding, even a technically perfect medical device can fail.
When is the Right Time to Start Customer Discovery?
One of the most common (and costly) mistakes startups make is waiting too long to begin discovery.
“Ideally, this happens before you’ve built a prototype,” Ryan notes. “You want to be exploring: What’s the clinical context? What are the current pain points? Who are the stakeholders?”
Teams often fall in love with an idea or early prototype before they’ve confirmed whether anyone truly needs (or would pay for) it. By that point, it’s harder to pivot.
Starting early also creates space to inform your regulatory strategy. The insights gathered during discovery, especially around intended use, clinical claims, and real-world risks, can shape how you define your indications for use, align with FDA expectations, and plan for payment / reimbursement.
“If you don’t do this early,” Ryan says, “you might design a device that solves the wrong problem and doesn’t support the claims you’ll need to make later.”
It also gives you a clearer sense of when to initiate your QMS implementation, allowing you to embed traceability and compliance into your product development process from the very beginning.
This can prevent costly rework down the line and ensures that your design inputs, user needs, and risk controls are all connected in a way that satisfies both engineering and regulatory expectations.
QuickVault helps early-stage MedTech teams connect discovery insights directly to regulatory and quality documentation, from intended use definitions to early risk logs, within a unified platform.
Talk to Everyone during Customer Discovery, Not Just Users
Patient care is a team sport. Designing a device only for the end user is a common misstep.
“You need to identify all the people involved,” Axel advises. “That includes users, clinical staff, purchasing departments, regulatory authorities, investors, and potential acquirers.”
A typical CD map should include:
- End users (clinicians, nurses, patients)
- Adjacent influencers (caregivers, hospital techs, IT)
- Economic buyers (hospital purchasing teams, payors)
- Distributors and strategics (who might scale or acquire your solution)
- Legal and IP advisors (to assess novelty and protectability)
- Regulators (who may influence what’s possible)
Ryan adds, “Don’t just think about the surgeon. Ask yourself: Who would pay for this? Who benefits? Who might block adoption?”
Understanding the full stakeholder ecosystem helps you spot adoption risks, refine your go-to-market approach, and build a product that fits into, not fights against, the system it’s entering.
Asking the Right Customer Discovery Questions
Customer discovery is not a sales pitch. It’s an exploration.
“You’re not asking, ‘Would you use this?’” Ryan emphasizes. “You’re asking: ‘What’s the last time you did this procedure? What went wrong? What did you wish you had?’”
To get meaningful answers, frame your questions around real behavior, not opinions or hypotheticals. Topics might include:
- Daily workflow and common bottlenecks
- Workarounds they’ve developed (a major clue for unmet needs)
- How the standard of care and current solutions fall short
- Who gets involved in decisions to try or buy new tools
- Whether a budget exists for solving the problem
- Daily workflow and common bottlenecks
Axel stresses the importance of open-ended curiosity: “It’s about learning where things break down in real life, not validating a solution you’ve already decided on.”
And don’t bring your prototype into the first discovery session. That shifts the conversation to feedback on your idea, not their problem.
The Two Stages of Customer Discovery
Customer discovery isn’t a one-and-done effort. It typically unfolds in two key stages.
In phase one, you’re asking broad, open-ended questions to uncover pain points, workflows, and unmet needs. These exploratory conversations are meant to surface problems without introducing bias from a proposed solution.
Once patterns start to emerge, it’s time for phase two: circling back to the key stakeholders to validate your solution. These follow-up interviews still rely on structured, non-leading questions, but now focus on how well your concept addresses the problems uncovered in phase one. This step helps refine your design and gauge adoption potential before moving forward.
To run these interviews effectively, it’s recommended to bring two people into each session: one to lead the conversation and one to focus solely on logging responses and taking notes. This allows the primary interviewer to stay engaged and present, while ensuring nothing is missed.
Using a simple tool like Google Forms to capture responses in a structured way makes it easier to spot trends and keep everything organized as the number of interviews, and the data therein, grows.
Capture Discovery Insights in a Way That Drives Decisions
Having the conversation is only half the job. What you do with the information is what counts.
Ryan recommends using structured tools like the Business Model Canvas or a Value Proposition Canvas to organize learnings. For teams looking to go deeper, he also points to resources like the Y Combinator Startup Library and Steve Blank’s customer discovery framework.
“Founders often take great notes, but they don’t do anything with them,” he says. “You need to synthesize that into assumptions, risks, and decisions.”
Discovery insights should inform your:
- Design inputs (including user needs, environmental conditions, and clinical tasks)
- Risk assessments (e.g., foreseeable misuse or common workarounds)
- Commercial model (who pays, how, and why)
- Regulatory pathway (what claims are supportable)
- Design inputs (including user needs, environmental conditions, and clinical tasks)
If your discovery notes aren’t showing up in your roadmap, your risk file, or your investor deck, then you’re not using them fully.
With QuickVault, you can centralize and version-control stakeholder insights, tie them directly to design inputs and risk files, and maintain clear traceability across your product development journey.
Let Customer Discovery Guide Your Risk & Regulatory Strategy
Customer discovery doesn’t just make your business plan better, it makes your device safer.
“It’s incredibly helpful to understand where users make mistakes or how they workaround existing solutions,” Axel notes. “That gives you clues about potential risks, usability issues, and design inputs.”
In fact, FDA 21 CFR Part 820 and ISO 13485:2016 require that user needs be traceable to design decisions. IEC 62366-1 emphasizes the need to identify known and foreseeable use errors. And the upcoming QMSR rule expects full lifecycle risk and usability planning.
That process starts in the early conversations.
Real example: A nurse explains they speed through a critical step because they’re pressed for time. That insight reveals a potential risk, which you can mitigate through user interface changes, automation, or training before it shows up in your clinical trial data or post-market complaints.
QuickVault’s Risk Management workflow lets you incorporate real-world feedback from discovery interviews into a living risk file, so you can track, mitigate, and link hazards directly to controls and verification activities.
Customer Discovery Mistakes to Avoid
Even well-intentioned teams often fall into traps that limit the value of their discovery efforts. Watch for:
- Confirmation bias: Seeking validation instead of truth
- Narrow sampling: Only interviewing people like you (or who like you)
- Leading questions: Shaping answers to fit your idea
- Skipping the economics: Ignoring who pays and how
- Overprotectiveness: Avoiding criticism of “your baby”
- Confirmation bias: Seeking validation instead of truth
Ryan offers a practical reminder: “Talk to people who would not use your solution. That’s where the gold is. If you understand why they wouldn’t buy, you’re learning what your market really looks like.”
Customer Discovery Doesn’t End at Product Launch
Customer discovery isn’t just a pre-product step. It’s a continuous loop.
Post-launch feedback helps you:
- Track real-world usage vs. expected behavior
- Identify new use cases or adjacent needs
- Spot gaps that could lead to adverse events or regulatory issues
- Inform your roadmap, marketing, and future filings
- Track real-world usage vs. expected behavior
“Staying close to users after launch is just as important,” Axel says. “You’ll learn things in the field that no prototype or interview could ever reveal.”
That also supports post-market surveillance efforts, complaint tracking, and product line extensions, aligning with ISO 13485’s expectations for continuous improvement.
Don’t Guess. Discover.
In MedTech, the difference between a great idea and a great product is discovery. Startups that commit to structured, honest, early customer discovery are far more likely to build something the market wants, the regulator allows, and the user actually adopts.
Talk to everyone. Start early. Ask better questions. Capture what you learn and let it guide everything that comes next.
Because in MedTech, guessing is expensive. And discovery is how you make sure you’re building the right product for the right reason.
Looking to operationalize your customer discovery process and maintain traceability across design, risk, and commercialization? Book a personalized demo of QuickVault to see how our MedTech-specific platform can support your journey from first interview to product launch.
Meet the Experts
Ryan Ramkhelawan
Co-Founder and Managing Partner, Innovation Exchange Coalition
Ryan Ramkhelawan is a seasoned entrepreneur and venture development professional with a proven track record in the medical device industry. He has successfully guided two startups through FDA clearance, market launch, and growth, with one leading to acquisition. In 2018, he joined Start Co. as Director of Acceleration and was later promoted to Vice President of Venture Development in 2020. In this role, he specialized in identifying investment opportunities for accelerators, building innovation ecosystems for universities, city governments, and associations.
During the Biden-Harris administration, Ryan was appointed by the U.S. Secretary of Commerce to serve a 2.5-year term on the National Advisory Council on Innovation and Entrepreneurship (NACIE). In this capacity, he played a key role in advising on the strategic framework of the EDA Tech Hubs program, which successfully secured over $700 million in federal funding for 18 regional innovation hubs across the U.S. His contributions also helped shape national innovation strategy through policy recommendations, including input into the Competitiveness Through Entrepreneurship: A Strategy for U.S. Innovation.
Beyond his policy advisory work, Ryan co-founded Lasting Machine Ventures, a venture firm focused on medical innovation, and the Innovation Exchange Coalition (IEC), a federally funded cross-border innovation exchange initiative that serves as an innovation diplomacy strategy between the U.S. and allied nations.
His contributions to the business and clinical sectors have earned him widespread recognition. He is a founding member of the Forbes Technology Council, a member of the Young Entrepreneur Council, and a graduate of the world’s top VC emerging manager program. Additionally, he was selected by Harvard Business School for the 2022 Young American Leaders Program, honored in the Memphis Business Journal’s Top 40 Under 40, and received the National Vascular Recognition Award for exceptional surgical dissection technique. He has also represented the U.S. as a Delegate to Ecuador, Panama, and Armenia through the Americas Competitiveness Exchange (ACE).
Axel Strombergsson
VP of QuickVault, Veeva Systems, Inc.
Axel brings over 20 years of diverse experience in the MedTech industry, spanning R&D leadership, operations, regulatory strategy, and medical device commercialization. Before joining Veeva, Axel led R&D efforts for a surgical device company and later transitioned to roles focused on scaling operations and bringing medical devices to market. He also worked at Vanderbilt University’s Tech Transfer Office, where he collaborated with research teams on cutting-edge medical device innovation.
As an integral part of multiple MedTech startups, Axel has gained firsthand experience in navigating the challenges and opportunities of the entire device lifecycle. Beyond his professional roles, Axel is a passionate mentor and thought leader within the MedTech ecosystems in both the US and EU. He frequently delivers lectures and provides mentorship to startups and smaller companies, helping them navigate regulatory landscapes and accelerate business growth.
With his extensive expertise and practical insights, Axel is uniquely positioned to guide companies in achieving success across R&D, regulatory compliance, commercialization, and long-term business development.
