Most medical device companies start with a team of three to five people and a seed round of $2-5 million. VynMed started with one person, me, and is raising an angel round of $250,000 on a SAFE at a $4 million post-money cap.
The obvious question is whether this is ambitious or whether it's naive. I've thought about it a lot, so here's the honest answer.
It's neither ambitious nor naive. It's a deliberate choice that reflects what stage the company is actually at and what the next 12 months need to accomplish.
The accounting is simple. The patent is granted and assigned. The codebase is substantially written. The device is designed and has working prototypes. The regulatory strategy is drafted and the FDA Pre-Sub is scheduled. What's left is not technical invention. What's left is three pilot sites worth of real-world data, an FDA Q-Sub meeting, a formal 510(k) preparation, a second non-founder hire, and an amount of commercial hustle that one person can do if the pilots are physically close together.
$250,000 is the amount that buys those specific next 12 months. About $10,000 of it goes to pilot hardware and test-strip inventory. About $40,000 goes to one non-founder hire, probably part-time regulatory or part-time business development, whichever the first three pilot conversations tell me is the bottleneck. About $50,000 is insurance, legal, accounting, and operating reserve. The rest is working capital for pilot execution and the FDA Pre-Submission package. When I hit the first real milestone, three pilots delivering data and a Q-Sub meeting on the calendar, I raise a seed round at a higher valuation that's justified by that milestone.
What I lose by doing it this way is speed and parallel bandwidth. A three-person team could run three pilots simultaneously, ship a firmware update, and draft the Q-Sub in parallel. I run them in series. If one pilot needs extra hand-holding, the other two slow down. That's the cost.
What I gain is two things. First, capital efficiency. A $250,000 round at a $4M cap means I give up 6.25% of the company to reach a milestone that many founders pay 25% or more to reach. When I do raise seed, I'm doing it from a stronger position with more of the cap table intact. Second, clarity of purpose. A one-person company cannot drift into building things it doesn't need. Every hour I spend is an hour I consciously chose. Scope creep is expensive for a team of five because each member finds their own reason to add features. For a team of one, scope creep is a decision I have to make out loud, to myself, and I usually decide no.
What should make an investor confident in this plan is not my optimism about any of it. It's the specific, concrete, already-done list of what's in place. The patent is granted. The company is incorporated in Delaware. The bank is Mercury. The EIN is issued. The 83(b) is mailed. The codebase is 15,000+ lines. The research bibliography is 40+ primary sources. The regulatory strategy is drafted. The pilot agreement template exists. I'm not asking investors to fund a plan. I'm asking them to fund the execution of a plan that's already standing on its legs.
If you want to see the deck, the data room, or the patent, email me directly.
If you are a SNF in the Las Vegas area interested in being pilot site 1, 2, or 3, email me directly.
If you're someone who has walked a Class II medical device through 510(k) before and wants to share wisdom, email me directly.