Outset Medical Brand Guidelines: Home Dialysis Plus, San Jose & the Tablo System

A home-dialysis start-up with a new name.

Outset Medical began under a name that stated its aim. Home Dialysis Plus, often shortened to HD+, was founded in 2003 and renamed itself Outset Medical in 2015, according to StarFish Medical, the Canadian device-engineering firm that worked on its early hardware. StarFish says HD+ engaged it to develop and prototype a new haemodialysis system aimed at the home market, and that it was involved “from concept to the build of the first fully integrated dialysis system prototype.”

The new name arrived with the first clearances. The US Food and Drug Administration’s premarket notification database lists a Tablo Console with Wireless Capability cleared for Outset Medical on 1 May 2015, with the applicant in San Jose, California. A second clearance, for the Tablo Console, followed on 15 November 2016; the FDA summary for that device gives its use as patients with acute or chronic renal failure “in an acute or chronic care facility,” under a physician’s prescription.

The company has had the same chief executive since before the rename. Outset says Leslie Trigg has served as chief executive since November 2014 and was elected chair in 2022, after earlier roles at Warburg Pincus and at several device companies. Its website describes Outset as headquartered in San Jose, says it “operates across the United States and manufactures in North America,” and lists the trademarks Outset, Tablo, TabloCart, MyTablo, TabloHub and Better Begins Now. Outset is a public company that reports to the US Securities and Exchange Commission, as Healio noted in July 2023 when it covered one of those filings.

One console, from hospital to home.

The Tablo Hemodialysis System is the company’s single product line. In the FDA summary for its 2020 clearance, Outset describes the Tablo Console as “a single module consisting of multiple fluidic systems” that do the work of a water purification system and of a conventional dialysis delivery system. StarFish Medical puts the same idea in plainer terms: a portable console that integrates water purification and dialysate production into one unit, needing only an electrical outlet and a tap-water connection.

That design is what the brand is built on, and Outset’s own website advertises “no water room needed” to hospitals. The system uses a single-use Tablo Cartridge, cleared together with an updated system on 12 December 2019 and again on its own in November 2021, according to FDA records.

The decisive clearance came on 31 March 2020. The FDA summary for that submission describes it as “an indication expansion to include home use of the device,” and the cleared wording adds that the Tablo Hemodialysis System “is also indicated for use in the home.” The same filing lists one-way data transmission from the device to the cloud for home users among the changes from the earlier model. StarFish Medical, for its part, calls Tablo the first haemodialysis system cleared by the FDA for use in the home; that is its claim.

Outset has kept refining the system through further clearances, in July 2022, June and December 2023, and January 2026, all listed in the FDA database under its San Jose address. Around the console it has built a set of named services: Outset Connect, which it calls a data and analytics product with electronic medical record integration; MyTablo; and TabloHub. Its website now addresses two audiences side by side: hospitals, invited to “insource” acute dialysis care, and patients considering dialysis at home. The company says nearly 1,000 hospitals and health systems have insourced their acute dialysis with it; that figure is its own.

Design and documentation.

Hospital device makers sell to clinicians, purchasing teams and hospital engineers rather than to shoppers, and their brands are built for that audience. Their catalogues and websites tend to show the equipment where it is used: infusion pumps on poles beside a bed, dialysis machines lined up in a treatment room, monitors and consoles in intensive care.

Much of the product is small and disposable, so the pictures often come close. Gloved hands hold a catheter, a cannula or an infusion set; blood tubing is coiled for a dialysis session; a dialyzer or a single-use endoscope is photographed on plain white so that every connector and label can be read. Product names usually lean on model numbers and technical terms rather than on lifestyle words.

People appear too, usually in uniform: nurses and doctors at the bedside, technicians at a workbench, trainers at a company teaching centre. Several makers in this group run their own training facilities for clinicians, and they present them as part of what they sell alongside the devices.

The trade meets at congresses and fairs. Medica in Düsseldorf gathers hospital suppliers from around the world each autumn; ASN Kidney Week, the American Society of Nephrology’s annual meeting, draws dialysis makers; and Digestive Disease Week brings together gastroenterologists and endoscopy suppliers. Stands, booth graphics and congress brochures are where many of these brands are seen at their largest, and this guide sets out what can be checked about each company: who founded it, who owns it, and where it says its products are made.

Better Begins Now.

Outset’s record also includes a regulatory episode. On 5 July 2023 the FDA issued a warning letter to the company after an inspection of its San Jose site between January and February that year. The letter said the TabloCart with Prefiltration, a cart with filters for incoming water, needed its own premarket clearance, which the company had not obtained. Healio reported on 11 July 2023 that Outset’s filing also described FDA concerns over website material promoting continuous renal replacement therapy, a use outside Tablo’s cleared indications; the company said it was addressing that through labelling and promotional changes, and that the letter did not ask it to halt production or shipment of Tablo machines. The FDA database records a TabloCart with Prefiltration Drawer cleared for Outset on 3 May 2024.

The brand itself is spare. The name Outset replaced a descriptive one, Home Dialysis Plus, with a single word about beginnings, and the company’s trademark list includes the line Better Begins Now, which runs through its website. Product names keep to one root: Tablo, TabloCart, MyTablo and TabloHub all build on the console’s name, so the system and its accessories read as one family. The website itself is divided into two clear paths, one for hospitals and one for people at home, each with its own language, case studies and contact forms; the hospital pages talk about staffing, training and efficiency, while the home pages talk about fitting dialysis into daily life.

That split shapes the identity. Outset presents one machine to two very different users — a hospital administrator weighing an acute dialysis service and a patient setting up treatment at home — and keeps the same product name and the same plain, reassuring tone for both. Its pages lean on short headings and on quotations from nurses, nephrologists and programme managers.

For a design guide, Outset Medical shows how a single product, named once and extended carefully, can carry an entire company brand. Compare Fresenius, the German group whose dialysis business works on a far larger scale, and Nikkiso, the Japanese maker of dialysis machines. For this guide we use a harbour blue and a sea-glass green with a sans, an unofficial interpretation; no product or logo is reproduced.

Keep Outset Medical’s identity on hand — save it to a board in the Made Good inspiration library.