OM · CIK 1484612
What Outset Medical, Inc. told the SEC could break it.
Outset's register centers on a single, geographically concentrated supply chain for its Tablo dialysis system: it builds the consoles and a substantial majority of cartridges at one facility in Tijuana, Mexico, leaving it dependent on cross-border movement and exposed to the new 25% Mexico and 10–20% China tariffs that hit its inputs and finished goods. Layered on top is component fragility — among roughly 100 worldwide suppliers, a critical set is single-sourced for parts like pumps, motors, valves and circuit boards — plus customer concentration, with its largest customer at 15% of 2025 revenue and growing leverage from hospital buying groups.
4 self-disclosed vulnerabilities, pulled from its own filings, each in the company’s words, with the source. This is the risk register almost nobody reads.
In its own words
What could break it.
Geographic concentration
- Tablo manufacturing concentrated in Tijuana, Mexico (US-Mexico border dependence)high
Outset manufactures Tablo consoles and a substantial majority of Tablo cartridges at a single facility in Tijuana, Mexico, making it dependent on cross-border movement of inventory/equipment and exposed to disruption of its Mexico operations.
“The Company manufactures Tablo consoles, and a substantial majority of Tablo cartridges, at its manufacturing facility in Tijuana, Mexico which it operates in collaboration with its outsourced business administration ser”
Regulatory & policy
- Mexico (25%) and China (10–20%) tariffs on supply chain; FDA medical-device regulationhigh
New 25% Mexico and 10–20% China tariffs could affect Outset's supply chain (raw materials into Mexico, China-sourced inputs to US suppliers, finished goods imported from Mexico), and Tablo is FDA-regulated as a medical device — both material policy exposures.
“In February 2025, the current administration issued executive orders imposing additional 25% tariffs on products imported from Mexico and additional 10% tariffs on products imported from China.”
SEC filing →As of 2026
Sole-source dependency
- single-source suppliers for critical Tablo components (pumps, motors, valves, PCBA)high
Tablo console production uses ~100 suppliers worldwide, with a discrete set of single-source suppliers (US/Mexico/Europe/Asia) deemed critical for components like pumps, motors, valves and PCBA boards (and 13 single/dual-source cartridge suppliers) — a sharp supply-disruption vulnerability while second-sourcing is incomplete.
“We rely on third-party suppliers, including in some instances single source suppliers, to provide us with certain components of Tablo. The number of suppliers required for Tablo console production is approximately 100 worldwide.”
SEC filing →As of 2026
Customer concentration
- largest customer 15% of revenue; GPO/IDN buying-group leveragemedium
Outset has significant customer concentration — its largest customer was 15% of 2025 revenue (two customers were 11%/10% of receivables) — and increasing GPO/IDN buying-group leverage could further pressure Tablo pricing and margins.
“For the year ended December 31, 2025, our largest customer accounted for 15% of revenues. There are risks whenever a large percentage of total revenues are concentrated with a limited number of customers.”
SEC filing →As of 2026
The hidden graph
Who it depends on, and who depends on it.
Relationships surfaced from filings, including ones disclosed by the other side, which is how the non-obvious ones come to light.
Its suppliers
TACNA Services
“Additional services that TACNA is obligated to provide under the TACNA Agreement include interfacing with both Mexican and U.S. governmental agencies, preparing import-export documentation, coordinating shipment of equipment, raw materials and finished products, and 7 obtaining necessary permits and licenses required in Mexico.”
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