Run the Patient-Contact Test
"Medical robot" is used for two very different classes of machine. Intuitive Surgical builds systems that act on a patient during a procedure; Diligent Robotics builds a robot that carries supplies through a hospital. Both appear in the same articles and belong in different procurement processes.
The Bot Scout patient-contact test draws the line precisely: does the system act on, treat, diagnose, or physically support a patient. If yes, it is a regulated medical device with an intended-use statement and a credentialed operator. If no, it is hospital equipment that happens to move by itself.
In the United States, systems in the first category are regulated by the FDA as medical devices, and each clearance covers specific procedures and conditions. The International Federation of Robotics counts many of the second category as service robots instead.
| System | Acts on a patient | Classification | Who buys and owns it |
|---|---|---|---|
| Surgical platform | Yes | Regulated medical device | Clinical service line |
| Rehabilitation and therapy system | Yes | Regulated medical device | Therapy department |
| Patient-transfer or mobility support | Yes | Regulated device in most cases | Clinical and facilities jointly |
| Supply and linen logistics robot | No | Facility equipment | Operations |
| Disinfection or cleaning robot | No, acts on the room | Facility equipment, with efficacy claims to verify | Environmental services |
Why the Line Changes the Purchase
A regulated device brings a clearance to read, an intended-use statement to respect, a credentialing programme to run, and a clinician who remains accountable for the outcome. None of that applies to a robot moving linens, and applying it anyway wastes months.
The reverse error is more dangerous. Buying a patient-contacting system through a facilities process skips exactly the checks that protect the patient and the institution.
The category chooser and the regulated-boundary framework sit in the medical robots hub, with detail in the surgical robots guide and the hospital robots guide.
- Ask whether the system acts on a patient before anything else.
- For regulated devices, read the clearance and its intended-use statement.
- For facility equipment, verify routes, access control, and service instead.
- Name the accountable clinician or operations owner in writing.
- Check efficacy claims separately for disinfection and cleaning systems.
Reading Claims Across the Boundary
Vendors and press coverage move freely between the two categories, and a company that builds one does not automatically understand the other. A capability demonstrated in a laboratory is not evidence for a clinical procedure, and a hallway deployment is not evidence for a surgical suite.
Research and humanoid platforms sit outside both categories for patient use until they carry a clearance. Treat them as what they are, and compare the broader landscape in the robotics in healthcare guide.
Recent regulatory decisions across surgical, hospital, and lab robotics are tracked in medical robotics news.
Bottom Line
A medical robot is defined by patient contact. That line determines the regulatory path, the buying process, and the accountable person, and getting it wrong is costly in both directions.
Ask whether the system acts on a patient, then route the purchase through the matching process.
FAQs
What counts as a medical robot?
Practically, a system that acts on, treats, diagnoses, or physically supports a patient. Robots that only move supplies through a hospital are usually classified and purchased as facility equipment.
Are hospital delivery robots medical devices?
Generally no. A robot that transports supplies, linens, or meals does not act on a patient and is treated as facility equipment rather than a regulated medical device.
Who regulates medical robots in the United States?
The FDA regulates systems that act on a patient as medical devices, with each clearance tied to a specific intended-use statement covering defined procedures and conditions.
Why does the classification matter to a hospital?
It determines the approval path, the buying process, and who is accountable. Routing a patient-contacting system through a facilities process skips the checks that protect the patient and the institution.