Business & Investment
Go-to-Market Strategy
OralVision’s initial market strategy will prioritize outreach towards administration at local dental clinics and Federally Qualified Health Centers (FQHCs) to establish strategic pilot partnerships. Clinics that participate in this pilot program will receive our device at a discounted rate and provide insightful, HIPAA-compliant training data for OralVision’s federated-learning-based diagnostic model, allowing us to attract a large preliminary customer base through penetrative pricing while also improving OralVision’s software for future global commercialization.
Sales Approach
Most major medical diagnostic corporations employ market strategies like Hardware as a Service (HaaS), where participating clinics are required to pay an extortionate monthly fee in continue using a medical device. However, due to OralVision’s cost-effective design, our company is able to practice an outright sales approach, providing clinics with a cheap, high quality diagnostic device free of additional fees. This competitive pricing strategy incentivizes clinics to switch over from HaaS-based competitors, effectively increasing our market share.
Cost Structure
OralVision’s most significant costs come from the purchase of its primary hardware components:
| Component | Cost per Unit |
|---|---|
| Raspberry Pi 5 SBC (8 GB) | $105.00 |
| Industrial HMI Touch Display | $81.95 |
| Arducam 5MP Plus OV5642 Camera Shield | $72.95 |
| Other Imaging Device Costs | $240.10 |
| Total Manufacturing Cost | $500.00 |
| Domestic Shipping (FedEx 2Day) | $20.00 |
This total manufacturing cost is well below the average production cost for prominent MedTech competitors. Our company plans to utilize FedEx’s standard 2Day shipping program for domestic logistics, since our medical device is below the 150 pound weight floor for specialized shipping and doesn’t incorporate any thermosensitive components that require a climate-controlled shipping environment.
Once OralVision has penetrated the domestic market, our company plans for global commercialization, with international logistics being handled by CENCORA World Courier. The 2 most significant costs associated with global distribution include import tariffs and 3PL fees, which can vary substantially based on the country and shipping volume.
Pricing
OralVision will generate the majority of its revenue through direct sale of our prototype to clinical partners at a highly competitive price. On average, large corporations in the medical device market have consistent profit margins of 20-30%, so OralVision will be priced at about $750 per unit to attain a similar margin, assuming that the approximate cost of goods sold (COGS) is $520.
This price is over 3 times cheaper than existing market alternatives like the VELScope Vx and the ViziLite PRO Oral Lesion Screening System, incentivizing clinics to adopt OralVision instead and ultimately increasing our gross revenue.
Seed Funding Requirements
OralVision will require approximately $28,000 in seed funding to ensure regulatory compliance, support preliminary manufacturing efforts, and facilitate distribution to pilot clinics:
| Allocation | Amount |
|---|---|
| FDA 510(k) Premarket Clearance Fee | $6,517 |
| Manufacturing Investment (3D printers, components) | $20,000 |
| Initial Distribution (FedEx 2Day) | $1,800 |
| Total Seed Funding | $28,317 |
The FDA 510(k) premarket clearance is required for Class II medical devices like OralVision to be commercialized in the US.
Funding Sources
To acquire these funds, we plan to apply to entrepreneurship programs like:
- NSF SBIR/STTR Grant - Federal funding for small business innovation research
- Google Startup Accelerator - Provides mentorship and Cloud TPU access
These programs are equity free and provide access to expert mentorship and Cloud TPUs, allowing us to maximize our profits while also improving OralVision’s software and design.