Have you considered what it means to have an FDA-approved, life-changing, medical product? It’s nothing short of amazing! However, let me add on to that question, have you considered what it means to have an FDA-approved, life changing, medical product WITHOUT a clear path to predictable revenue? At this point, you don’t have a business. You have an expensive science experiment.
As a MedTech Founder, the scenario you likely dream of goes something like this: “We just heard back from the FDA; we’ve received our regulatory clearance. Bring in the champagne and set up a call with the Board! Let’s go change lives and generate lots of revenue!”
First, let’s absolutely recognize the amazing accomplishment of clearing the regulatory hurdle. In the increasingly complex and competitive global environment, achieving regulatory clearance is a monumental feat of engineering and clinical perseverance. However, the Founder’s Trap is thinking that this is the last and highest hurdle, and now the product will move itself.
“But we’ve heard from our advisors, and even our close physician friends that this will be a game-changer!” And it very well might be, but your product isn’t changing any games or impacting any outcomes if it never reaches the hands of the user. In today’s cost-contained healthcare market, we must understand the difference between the clinical user and the economic buyer. The physician or even the patient is typically not the ones who are paying for the product, many times they are only a small part of the buying process.
Now, back to your dream scenario, fast forward about 6 months later, you have another Board call. No champagne this time; only you, as the Founder explaining why the burn rate is accelerating and the sales aren’t there yet. If you’ve not built an executable plan considering all requirements for all parts of the buying process, you’ve hit a wall and this is a real conversation that has to happen. More of a realistic nightmare than a dream.
Why does this happen? Well, let’s go back in time to when you were pitching for your most recent round of funding. Did you spend the significant majority of your time and energy solving only the clinical problem instead of also solving how the solution (aka your product) will reach the hands of your customer? Did you think about this as a linear process – something along the lines of: “we can deal with how to build a commercial engine after we receive clearance.”? Are Kevin Costner, Ray Liotta, and James Earl Jones your advisors, whispering in your ear, “If you build it, he will come.”? If you answered yes to any of these three questions, then the science has outpaced the strategy, or you probably fell asleep watching Field of Dreams again.
The truth is, I’ve seen far too many amazing medical technologies fail because the commercial engine wasn’t built in parallel with the product. I won’t pretend to know all the keys to success, but I do know that thinking the commercial plan is a task to complete only after the product is “done” is a key to failure. And you don’t have to take my word or experience for it, look at the shifts in funding due diligence. According to the EY 2025 “Pulse of the MedTech Industry” Report, investors are requiring companies to prove they have the right to grow by demonstrating commercial scalability early. PwC’s 2025/2026 MedTech Deals Outlook notes that Commercial Excellence is now a top strategic priority for the industry’s elite performers. Companies with a market-ready engine are likely valued higher than a company with a patent. Investors are looking for repeatable revenue models, not just technical breakthroughs.
If you wait until clearance to define your channel strategy, you are already 12-18 months behind. You haven’t recruited the right distributors, your CRM isn’t built, your team doesn’t have the right marketing collateral. You will burn time and cash trying to solve this when you should be trying to figure out how to keep up with the demand of your product.
So what does this all mean? A small shift in process and timing can bridge that execution gap and ensure that your breakthrough product actually reaches the patient. We must move away from linear thinking and towards overlapping cycles. Your customer-centric commercial strategy – identifying customer segments, defining the revenue model, mapping the distribution channels, identifying clinical claims, creating the reimbursement model, finalizing the cost structure, and building the support models – must be done during the clinical and development phase and with the connectedness and collaboration across the various departments.
Now, let’s go back to envisioning that day when you received your FDA clearance letter. You’ve popped the champagne and are toasting your board. Are you toasting a science experiment or the start of a successful, scalable business?
Author Profile:
Todd Laderach Founder, Laderach Nexus
Todd Laderach is the founder of Laderach Nexus, a strategic consultancy dedicated to helping MedTech and BioTech startups navigate the commercialization gap. With decades of experience in the medical device and life sciences sectors, Todd specializes in de-risking the transition from clinical development to market dominance. He is the creator of the Nexus Conflux Canvas, a proprietary framework designed to accelerate speed-to-revenue for pre-commercial innovators. Todd serves as a fractional commercial leader and advisor to VCs, ensuring that breakthrough science translates into sustainable, scalable business models.
