Build an Optical Coherence Tomography (OCT) Device Manufacturer

1. 1

   Choose the technical and market position

   OCT is significantly harder to build than fundus imaging because it uses low-coherence interferometry to image retinal layers in cross-section. A new entrant can compete on resolution, speed, cost, portability, or an integrated AI analysis layer. Incumbents are established, so a clear technical differentiator or a lower-cost point of entry is essential. Decide whether you are building the hardware, the AI software layer, or both.

2. 2

   Build photonics and imaging engineering

   OCT depends on specialized light sources, interferometry, and signal processing, which is deep engineering. The core team has to include photonics and imaging expertise, and the R&D cycle is long and capital-intensive. This technical barrier is exactly why the field is defensible once you clear it. Budget the science accordingly.

3. 3

   Layer AI segmentation and progression prediction

   Modern OCT increasingly pairs the hardware with deep-learning that automatically segments retinal layers, quantifies biomarkers, and predicts disease progression, adding clinical value and recurring software revenue. Building or partnering on this AI layer can differentiate an otherwise commoditized device. The cloud AI OCT analysis platform (carded separately in this file) is the pure-software version of this opportunity. Decide how much of the AI stack you own.

4. 4

   Secure FDA clearance and quality systems

   An OCT device is a regulated medical device requiring FDA clearance and a compliant quality system (ISO 13485). If you add AI-driven analysis or diagnosis, that software carries its own regulatory requirements. Regulatory strategy across both hardware and software defines the timeline. Plan it before finalizing the design.

5. 5

   Sell into practices, hospitals, and screening

   OCT is near-standard equipment in ophthalmology and increasingly in optometry, plus hospitals and specialty clinics, sold through direct sales and distributors with strong clinical evidence. Recurring revenue comes from software subscriptions, service contracts, and upgrades, which matter more here than the one-time hardware margin. The installed base is the annuity. Build the commercial model around the full lifecycle, not just the sale.

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