If you’re building a medical device startup, you already know the pain: regulatory hurdles, endless FDA 510(k) paperwork, and trying to secure those first crucial pilots. Trying to “wing it” is more likely to leave you limping than launching. That’s exactly why Memphis’ ZeroTo510 Accelerator exists, quietly building a track record as one of the U.S.’ most targeted programs for early-stage medtech founders. 🦥
But is it all it’s cracked up to be? And more importantly—should your startup apply? In this guide, I’ll break down ZeroTo510’s structure, funding terms, alumni wins, and what it actually takes to get in (hint: it’s about more than a great deck). Whether you’re a founder scoping accelerators, or an investor eyeing medtech, this is your deep-dive—plain language, actionable, and updated for 2024. Let’s dig in! 🚦
ZeroTo510 Accelerator Program Overview
Here’s what you need to know at a glance if you’re just sizing up ZeroTo510:
💼 Program Name: ZeroTo510 Medical Device Accelerator
⏳ Duration: 12–16 weeks intensive (rolling/hybrid cohorts since 2020)
🌍 Location/Format: Memphis, Tennessee; hybrid with 2–6 weeks onsite, remainder remote
🚀 Stage Focus: Pre-seed and seed (must have prototype; not idea-stage)
🧬 Industry Focus: Medical devices, diagnostics, medtech with FDA 510(k) pathway
💸 Investment Model: $25k–$50k cash (SAFE, convertible note, or grant) + $10k–$30k in-kind support
📊 Equity Taken: Typically 5–8%
🗾 Fees: None; founder-friendly structure
🌟 Why It Matters: Unlike “spray and pray” accelerators, ZeroTo510 Accelerator is laser-focused on startups tackling FDA 510(k) challenges. That means tailored help, deep industry mentors, and a playbook that’s actually useful if you’re building in the regulated medtech world. The Memphis base plugs you into a med device cluster—including talent and corporate partners most accelerators can only dream about.
ZeroTo510 Accelerator Investment Terms
ZeroTo510’s investment isn’t just about a wire transfer—it’s about structure and ongoing support.🤝 Founders don’t just receive a check—they get regulatory backing, expert connections, and tools to navigate the FDA maze. It’s a comprehensive support model that targets the exact pain points early medtech startups face:
- 💵 Cash Investment: $25k–$50k per startup, usually via SAFE, convertible note, or non-dilutive grant (terms may vary per cohort).
- 🧾 In-Kind Value: $10k–$30k in regulatory, legal, lab, and clinical services; not just freebies, but actual startup-building resources.
- 📈 Equity Model: Most years, 5–8% equity on entry (6% is average), valuation caps ~$1M–$2.5M.
- 💰 Follow-on Funding: Top grads can access $100k–$250k+ from Memphis VCs, with >50% of alums raising more post-program.
- ❌ No Surprise Fees: No founder-burdening fees, “hidden costs,” or forced relocation.
- 🔁 Long-Term Value: Once in, you’re always part of the alumni network and follow-on funding pool.
Benefits & Why ZeroTo510 Accelerator?
Founders navigating medical devices and the regulatory maze need more than money or “generic startup” playbooks. Here’s how ZeroTo510 delivers:
Regulatory Roadmapping 🧣
Get hands-on FDA 510(k) consulting, PMN prep, and support from ex-FDA advisors—something that’s rare even among big-name accelerators.
Clinical Access & Validation 🏥
Direct intros to Memphis hospitals and health systems mean feedback, pilots, and real-world device trials.
Deep Mentor Pool 🧑⚕️
Mentor-matching with medical device operators, clinicians, and regulatory experts who actually know the grind—not just “startup generalists.”
Lab & Prototyping Resources 🔬
Free access to Memphis Bioworks’ wet/dry labs, prototype gear, and committed engineering support—plus ties to university talent.
Network with Purpose 🌐
Connect directly to corporates (Medtronic, Smith+Nephew), VCs, and key local clinical stakeholders—faster than random cold emails.
Credibility Signaling 📣
Surviving ZeroTo510 means you’re instantly more attractive to healthcare VCs, future partners, and other accelerators.
ZeroTo510 Accelerator Eligibility Requirements
Eligibility isn’t a box-ticking exercise at ZeroTo510; it’s how they keep the program’s impact high and cohorts productive. Here’s the no-BS breakdown:
- 🩺 Device Focus: Your product must be a medical device, ideally planned for the FDA’s 510(k) path.
- 👥 Founder Team: At least one full-time founder (technical/clinical mix is loved); no “solo hustlers with an idea.”
- 🛠️ Product Stage: Working prototype or close to it—bench tests, early clinical data a plus.
- 🏛️ Legal/Entity: Willing to form or already structured as a U.S. C Corp.
- 🌎 Location: Open globally, but expect 2–6 weeks in Memphis; rest can be remote.
- 🔐 Intellectual Property: You control your IP or have a clear path to it.
If you’re pure digital health, consumer tech, or all talk and no prototype—you’re not a fit. If you’re ready to tackle regulatory next steps for a real device, you’re in the sweet spot.
Application Process
Applying to ZeroTo510 Accelerator isn’t a black box, but you do need to prep. Here’s the step-by-step:
1️⃣ Online Application: Complete the main form at zeroto510.com, including pitch deck, founder bios, and technical summary.
2️⃣ Screening: The acceleration team and regulatory/industry pros review for regulatory/market fit.
3️⃣ Video Call (Deep Dive): If you pass the screen, expect a live pitch/Q&A focusing on your regulatory roadmap and technical readiness.
4️⃣ Final Interview: Meet with the selection panel—VCs, FDA/regulatory folks, clinicians—for a final grilling on fit and vision.
5️⃣ Decisions: You’ll hear back ~4–6 weeks before start. If you’re in, onboarding and milestone setting begins fast.
Pro tip: Acceptance is tough (5–10% rate). Honest, well-prepared answers trump “spray and pray” bragging every time.
How to Get Into ZeroTo510 Accelerator and Stand Out: Insider Tips for a Strong Application
Even great tech gets lost if you don’t nail your application. ZeroTo510 is selective because FDA-stage medtech startups are hard—and not every founder is ready for this level of rigor.🌟
Getting in is about more than what’s on the page. The committee wants teams who’ve thought deeply about regulatory steps, know why Memphis and these mentors help, and show real commitment (not just “idea tourism”). The right approach can dramatically increase your odds. Here’s what that looks like:
Maximize Your Chances
- 🧠 Master the Regulatory Narrative: Clearly lay out device classification, your predicate(s), conversations with FDA or consultants, even basic regulatory mapping.
- 🔍 Show Real (Even Modest) Momentum: Include prototype pics, bench data, clinical feedback, or signed LOIs.
- 👤 Spotlight Your A-Team: Highlight technical, regulatory, and commercial expertise across the team.
- 📍 Tell Them “Why Memphis, Why Now?” Mention how local resources, labs, or clinicians support your roadmap.
- 📋 Be Sought-After, Not Just Grateful: Be clear about how you’ll use the program’s support.
Big Mistakes to Avoid
- 🚫 Applying without a working prototype or device DNA (no software-only, app-only “wishful thinking”).
- 🚫 Generic, copy-pasted decks with no reference to medical device regulatory or 510(k) processes.
- 🚫 Obvious founder-market mismatch.
- 🚫 Over-selling or “hustle-bluffing” with inflated projections and no clinical angle.
- 🚫 Failing to explain IP status clearly.
Take this seriously, but don’t freeze up. In a field this complex, founders who communicate clearly, understand the program, and show real intent are already ahead of the pack. ✅
ZeroTo510 Accelerator VC Partners & Ecosystem Support
Ecosystem isn’t just a buzzword here—it’s part of the value prop. In medical devices, capital and clinical access are joined at the hip.
When you join ZeroTo510, you get plugged into:
- 💼 MB Venture Partners: Memphis-headquartered, healthcare-focused VC
- 🌱 Innova Memphis: Local life science/AgTech investor with follow-on capacity
- 🚀 Epicenter: Strategic co-investor in cohort grads
- 🧠 Medtronic Ventures, Jumpstart Foundry, Morris Innovative: Larger U.S. medtech networks through Demo Day and mentor matches
- 🏫 University Partnerships: Ties to UofMemphis research, labs, and student talent
- 🏥 Hospitals & Corporates: Pilots and clinical access with Medtronic, Smith+Nephew, Baptist Memorial, and more
And because ZeroTo510 is built for Memphis’ legacy as a medical device hub, you get the density of resources and connections needed to survive in regulated healthcare.
Frequently Asked Questions
❓ Is relocation required?
Not full-time. Expect to spend 2–6 weeks in Memphis, especially for key sessions and Demo Day. The rest is hybrid/remote.
❓ Does my product need to be 510(k)-eligible?
Absolutely—unless you can make an incredibly strong case for another FDA path. 510(k) focus is the sweet spot.
❓ Will I get guaranteed follow-on funding?
No guarantees, but historically, >50% of grads raise follow-on money from local and national VCs.
❓ Can international founders join?
Yes! But you’ll need to commit to time in Memphis and accept that a U.S. entity will likely be required.
❓ Are solo founders eligible?
Single founders can apply, but preference goes to multidisciplinary teams with deep technical/clinical grounding.
❓ Are there fees or equity surprises?
Transparent terms: 5–8% equity for ~$25k–$50k cash, plus vital in-kind support; no hidden founder fees.
Final Thoughts
If you’re building a medtech startup anywhere near regulatory or FDA 510(k) “go time,” ZeroTo510 Accelerator deserves a top slot on your radar. Unlike broad accelerators, it’s designed for your pain points: device risk, regulatory strategy, clinical connections, and honest feedback.🌟💹
It’s not the right fit for software-only health startups or founders without a prototype—but for ambitious, regulator-savvy teams, the ROI (network, resources, alumni validation) can be outsized relative to the modest equity ask.🎯
Takeaways & Pro Tips:
💥 ZeroTo510 isn’t just an accelerator—it’s a “force multiplier” for 510(k)-bound medtech founders ready to build, not just pitch.
🧪 Prep your application with clinical, technical, and regulatory depth.
📍 Make the Memphis ecosystem part of your story—show intent, don’t just request resources.
Bottom line:
If you’re serious about crossing the FDA chasm and want best-in-class support, ZeroTo510 Accelerator is your platform. If you’re not device
