A promising technology can get a MedTech startup off the ground. However, it cannot by itself build a successful medical device company.
Axel Strombergsson, VP of QuickVault by Veeva, has spent more than 15 years mentoring hundreds of MedTech startups around the world. At the time of this blog post, he mentors 13 companies across MedTech Innovator, MedTech Actuator, and Plug and Play, ranging from founders spinning technologies out of academia to companies entering early commercial distribution.
Across those hundreds of companies, Axel has seen the same pattern repeatedly. When a startup struggles, the problem is often not the technology itself. It is the team’s approach to building a solid strategy to bring that technology to the market, and creating a successful business around it.
This is especially challenging for first-time founders. They may spend years proving that a device can work while giving far less attention to whether customers will buy it, how it will be commercialized, what investors need to see, how adoption will happen, or what would make the business attractive to a future acquirer.
The five mistakes below all stem from that same underlying problem, focusing on the technology without having enough foresight with planning far enough ahead.
Mistake #1: Building Before Validating the Customer
Customer discovery in MedTech is much broader than asking a physician whether they like your idea.
A device can solve a genuine clinical problem and still fail commercially if it does not create enough value for the people who need to use, purchase, implement, or pay for it.
Meaningful customer discovery requires both breadth and depth. Before investing heavily in development, map every stakeholder who could influence whether the device succeeds. That could include clinicians, patients, nurses, hospital administrators, procurement teams, value analysis committees, payers, distributors, and hospital staff.
Even stakeholders who seem peripheral can create barriers if their needs are overlooked.
One practical approach is to create a stakeholder mind map around the device. Start with the obvious end user, then work outward. Who pays for it? Who approves the purchase? Who stores it? Who trains people to use it? Whose workflow needs to change? Who could prevent adoption even if the clinician or user loves the product?
QuickVault’s guide to customer discovery for MedTech startups explores this process in more detail, including how to translate what you learn into product, regulatory, risk, and commercial decisions.
The next question is harder: does your product provide enough value to justify the purchase and also change what people already do?
Founders naturally compare their technology to the problem they are trying to solve. Customers compare it to their current standard of care, competing products, existing workflows, and the cost and disruption required to switch. A solution that is incrementally better may not be compelling enough to warrant the cost of the product nor change behavior.
Axel saw this firsthand while mentoring a company developing a surgical preparation device. The technology could make orthopedic surgical prep easier for nurses by moving part of the process outside the operating room. The nurses liked the concept.
But the team had focused too narrowly on that user group. When the entire hospital workflow was considered, moving the preparation process created new logistical challenges elsewhere. The benefit to one group did not outweigh the disruption to the larger system. By the time those barriers became clear, significant time and capital had already been invested.
That is exactly what early customer discovery is supposed to uncover. Before building further, do not just ask, “Who will use this?” Ask, “Who has to say yes, spend money, change behavior, or alter a process for this product to succeed?”
Mistake #2: Waiting Too Long to Think About Commercialization
“We just need to get FDA clearance.”
It is an understandable mindset. Regulatory authorization is a major milestone, and getting there requires an enormous amount of work. But treating clearance or approval as the finish line can leave a startup dangerously unprepared for what comes next.
Commercial strategy should influence product development long before launch. Your regulatory pathway, intended use, labeling, evidence strategy, and product design all affect what the company will eventually be positioned to communicate and sell.
For example, FDA’s 510(k) pathway requires a device to demonstrate substantial equivalence to a legally marketed predicate, including the same intended use and same or less indications for use. This means that once 510(k) cleared, you are stuck with the same wording, which will be leveraged in marketing and sales, as the predicate device and your competitor.
That is why product development and regulatory strategy cannot be developed in isolation from commercial strategy.
Imagine a device that could eventually be sold either for prescription use by a trained healthcare professional or directly to consumers over the counter. Those scenarios can create very different product, usability, risk, and development considerations. Understanding the commercial opportunity and what needs to be done to be successful when you are in the prototyping phase gives you options that will de-risk your business and set you up for commercial success.
Payment strategy matters just as early.
At one startup, Axel’s team developed a wound-care product expecting reimbursement economics closer to one category of treatment. As they dug deeper after 510(k) clearance, they discovered the applicable payment economics were far less favorable than expected. The technology had reached the market, but a core assumption underpinning the business model had changed.
For venture-backed startups operating against a finite runway, those surprises can be existential.
“As soon as you get clearance, approval, or CE-mark, you should be ready to start running.” |
A strong commercialization plan should therefore be established early and also extend beyond the regulatory submission. It should address how the product will be paid for, what evidence customers will expect, how manufacturing will scale, what the supply chain looks like, how the device will be distributed and sold, what people the company needs to hire, and how much capital will be required to support the transition into commercial operations.
QuickVault’s on-demand session on how regulatory strategy impacts MedTech reimbursement and commercialization goes deeper into these connections.
Mistake #3: Underestimating What Investors Really Want
Founders understandably want investors to be as excited about the technology as they are.
But investors are choosing among far more opportunities than they have capital to fund. Axel knows investors who receive roughly 10 startup investor decks in a single day. If an opportunity does not quickly make the investor excited, closing one deck and opening the next is easy; investors are looking to say no rather than saying yes, which is generally not understood in the startup community.
Another common mistake is treating “investors” as a single audience. In reality, each investor has an investment thesis that may define the technologies, clinical areas, stages, risk profiles, and opportunities they will consider.
A better fundraising strategy begins with startup and investor fit. Research investors whose focus and thesis aligns with your company rather than broadly distributing a pitch deck and hoping something sticks. Then, recognize that the technology is only one part of what they are evaluating.
Investors need confidence that the team can execute. Can you accept difficult feedback? Adapt when assumptions prove wrong? Explain what the next round of capital will accomplish? Show which milestones you have already reached and what the next 18 to 24 months look like?
As we explored in our guide to building an investable MedTech team, investors are ultimately evaluating whether the people behind the technology can turn it into a successful company.
Before approaching an investor, founders should be able to answer three questions clearly:
- Why is this specific investor a strong fit for our company?
- What milestone will this capital allow us to reach?
- What evidence shows that our team can execute the plan?
Mistake #4: Assuming Market Adoption Will Happen Automatically
Regulatory authorization allows you to market and sell a device. It does not make anyone buy it.
For many devices, regulatory authorities are solely focused to ensure the product is safe and effective for its intended use. That determination does not answer whether clinicians will change their behavior, hospitals will allocate budget, payers will pay for the product, or customers will adopt it at scale.
Founders often underestimate how slowly healthcare changes. A physician may have practiced successfully in a particular way for 15 or 20 years. Asking that person to change a familiar clinical workflow requires more than novelty. The benefit of the new approach needs to justify the effort, uncertainty, training, and disruption involved.
That means market adoption work needs to begin years before launch.
Identify key opinion leaders (KOLs) early. Build relationships with respected clinicians and organizations in your field. Understand what clinical evidence future users will expect to see. Develop opportunities to generate and publish relevant data when appropriate.
“When you get regulatory clearance or approval for, you shouldn’t have things to figure out to achieve market adoption and sales. You should have already primed that pump for years.” |
Once you do launch, resist the temptation to scale broadly immediately.
Axel recommends beginning with a controlled pilot launch among trusted early adopters. No matter how thoroughly you have tested the device or assessed risk, real-world use will expose things you did not anticipate.
Starting small gives the team an opportunity to identify unexpected workflow problems, product issues, training needs, or other friction while the scope is manageable. Once those issues have been addressed and confidence grows, the company can scale more aggressively.
Our webinar on how industrial design drives MedTech adoption and commercial success explores another side of this challenge, including how workflow fit, usability, and user friction influences adoption.
Mistake #5: Believing an Acquisition Will Happen Early
Another common assumption is that as soon as the technology reaches the market, one of the large global medical device manufacturers will acquire it. And while that may happen, it should not be the strategy within your business plan.
Put yourself in the acquirer’s position. They’re not simply asking whether your technology is interesting. They’re asking what it will inherit by acquiring your company.
Does the product fit its portfolio? Can it be manufactured reliably? Has the market demonstrated that customers want it? Are major operational, regulatory, and commercial risks already under control? Do you have broad market adoption and strong increase in revenue?
Strategic medtech startup buyers evaluate companies based on readiness. They want a business they can seamlessly integrate and scale, not a long list of unresolved regulatory, commercial, or operational problems they are forced to fix the moment the deal closes.
There are exceptions. Some higher-risk Class III technologies may become acquisition targets before commercial revenue because substantial clinical evidence can exist before Pre-market Approval (PMA). FDA requires valid scientific evidence to support reasonable assurance of safety and effectiveness for Class III PMA devices, which can materially reduce technical and clinical uncertainty before market entry.
But founders should not build the company around being the exception.
Instead, build a company capable of surviving independently. Develop the technology, operations, commercial engine, and team as if you may be running the business for years. Ironically, that is also what can make the company more attractive to an acquirer.
To truly understand this dynamic from the buyer’s perspective, we highly recommend watching our free on-demand webinar on Raising Capital and Maximizing Your MedTech Exit.
The session features panelist Dan Gilberston from Medtronic, who provides a firsthand look into how large manufacturers evaluate potential targets. During the discussion, Gilberston compares a MedTech startup acquisition to buying a house. If a homebuyer discovers during an inspection that the windows need replacing, they would much rather have the current homeowner address the problem than move in and immediately have to fund a major repair themselves.
The same logic applies to acquiring a medical device company and reinforces why strategic buyers are looking for a structurally sound, de-risked business. The cleaner your “inspection”, with broad market adoption, reliable manufacturing, and regulatory compliance already handled, the more attractive your company becomes.
The Common Thread: Work Backward From Commercial Success
These five mistakes are not independent.
Weak customer discovery can lead to the wrong value proposition or buying assumptions. Those assumptions feed into commercialization planning. An incomplete commercial strategy makes fundraising harder. Late market preparation slows adoption. Weak adoption makes an acquisition less compelling.
The pattern continues because decisions made early in a MedTech startup can affect outcomes years later. That is why founders need to think beyond the milestone directly in front of them.
If commercial success is three to five years away, work backward from it now. What evidence will customers need? Who will pay? What claims will matter? What capabilities must the company build? Which relationships need to exist? What milestones will investors expect? What would a strategic acquirer eventually want to see?
Bringing a medical device from idea to commercial success as a massive project. Like any complex project, it becomes much more manageable when the destination is understood and the major dependencies are planned before they become emergencies.
Run a Gap Analysis on Your MedTech Startup
If you recognize your company in one of these mistakes, the answer is not to keep moving forward and hope the issue resolves itself. Assess where you are today, then identify the gaps.
Have you spoken with every stakeholder who could affect adoption? Do you understand who will pay and why? Does your commercialization plan extend beyond regulatory authorization? Are you pursuing investors that actually fit the company? Have you started building the evidence and relationships required for adoption?
This exercise is useful whether you are still prototyping or already in commercial distribution and struggling to gain traction. The earlier you uncover what is missing, the more options you have to address it.
The technology still has to work. But that is only one part of building a successful MedTech company. The strongest startups plan for the entire journey.
Looking to build a connected foundation that can support your MedTech company from development through commercialization and beyond? See how QuickVault unifies design, regulatory, and quality management in one purpose-built platform for small and growing MedTech teams by booking your demo now.
Article Contributor
Axel Strombergsson
Vice President of QuickVault, Veeva Systems
Axel brings over 20 years of diverse experience in MedTech, 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.
As VP of QuickVault, Axel helps small and growing MedTech companies strengthen quality operations, connect design and risk processes, and build scalable systems for the full product lifecycle.
