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Founder Track

From device idea to documented FDA strategy

For founders raising or starting their first program. Six steps from "is this even a medical device" to "you have a defensible regulatory plan."

Audience. First-time medical device founders, hardware/SaMD startup CEOs, technical co-founders learning FDA for the first time.6 chapters · ~72 min · 9 articles
  1. 1

    Is your product even a medical device?

    Apply the FDA's definition. Decide whether you need clearance, approval, exemption, or none of the above.

    Do I Need FDA Approval, Clearance, or Exemption? Medical Device GuideAug 14, 2025 · ~8 min readDoes My Mobile Health App Need FDA Approval or Clearance? When Your iOS/Android App Is a Medical Device ExplainedMay 5, 2026 · ~8 min read
  2. 2

    What class is it — I, II, or III?

    Class determines pathway, cost, and timeline. Get the classification right before anything else.

    Understanding FDA Device Classifications: Class I, II, and III ExplainedAug 29, 2024 · ~8 min readWhat Is My Medical Device Classification? FDA Medical Device Classification Class I, II, III ExplainedApr 25, 2026 · ~8 min read
  3. 3

    Which pathway: 510(k), De Novo, or PMA?

    The single decision that controls the next 12-36 months of work. Three pathways, three different bars.

    510(k) vs De Novo vs PMA: How to Choose the Right Pathway Complete GuideJun 12, 2025 · ~8 min read
  4. 4

    What it costs and how long it takes

    Realistic ranges for total spend and timeline. Build a line item that survives diligence.

    How Much Does It Cost to Bring a Medical Device to Market? Complete Budget GuideAug 3, 2025 · ~8 min readHow Long Does It Take to Bring a Medical Device to Market?Dec 22, 2025 · ~8 min read
  5. 5

    How to fund the program

    Grants, non-dilutive, angels, VC. What's available at what stage and what it costs you.

    How to Fund a Medical Device Startup: Complete Guide (Grants, Angels, VC & Non-Dilutive Options)Aug 8, 2025 · ~8 min read
  6. 6

    Build your regulatory strategy

    Pull everything into a strategy document you can show a board, an investor, or a hire.

    How to Build a Medical Device Regulatory Strategy: Complete GuideNov 10, 2025 · ~8 min read
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