Applications of Robotics in Healthcare and

Medical Devices
by Govind Yatnalkar | Nov 19, 2020 | AI, FDA, Medical
Devices, ML, Quality, Regulatory, Requirements, Robotics
The platform of Robotics facilitates automation in any industry. It uses various streams of
Engineering including Computer Science, Electrical, and Mechanical, and is primarily used
to build intelligent machines where human safety is of major concern. Generally, the major
components include a brain or the main controller, sensors that provide the surrounding
data to the brain, and the assembly or the body of the robot which may include motors,
arms, or axles. The controller is coded along with sensors, and together, they facilitate
movements based on the commands from the user. With time, the field of robotics is
proving to be more useful in the health industry, and when implemented in medical devices,
it should be of utmost importance that these robotic medical devices meet the required FDA
quality and safety regulatory guidelines.
Out of the many robotic systems, one of the key robotic types is the robotically-assisted
surgical device (RASD) or surgical robots. They are designed to assist medical
professionals in surgeries for purposes such as minimally invasive surgeries or
enhancement of visuals for reaching confined body locations. With platforms such as
wireless technology and 5G networks, doctors can perform surgeries from a remote location
on patients using RASDs. An example of RASD is TransEnterix Surgical Inc’s Senhance
System which facilitates minimally invasive surgeries. Hospital robots are another key
robotic type where they provide functionalities such as patient monitoring, transportation of
hospital resources such as medicines, and assist in patient communication. An example of
a Hospital Robot is the IRobot’s RP-VITA system which allows doctors to visit patients and
consult them remotely. Both the mentioned robotic systems are approved through the
FDA’s 510(k) notification.1
Additionally, there are Exoskeletons and Care robots. Exoskeletons are robots that are
utilized in recoveries, and sometimes in surgeries. Care Robots provide support to elderly or
disabled patients, assist healthcare personnel in their activities, and can also be used as
therapy robots. An example of an Exoskeleton is the Cyberdyne’s Hybrid Assistive Limb
(HAL) which is the first FDA-approved robot that detects bioelectrical signals from brain-
based sensors attached to muscles and stimulates movements in artificial limbs. AIST’s
Paro, a cute baby harp seal Care robot is an emotionally responsive pet-bot that is built for
therapy and was certified as a neurological therapeutic device by the FDA.2
As observed, these smart robotic devices are increasing the quality of health services, but a
vital factor to consider is that these devices are hosted live in an environment where patient
care is of the highest priority. In such cases, manufacturers should ensure that their robots
have been sufficiently tested and mitigate all potential risks. What this means is that the
software and the hardware utilized for building the system should be appropriately
documented and tested to reach the highest levels of safety, security, efficiency, and
quality. Indeed, based on the class of the device or the risk associated with the system,
FDA may ask to conduct clinical trials that provide real-world insight on the intended use
validation along with the associated hazards. If the FDA finds that the robotic system meets
all required regulatory guidelines, it approves the system for marketing.3
To sum up, Robotics has a huge potential in the healthcare domain and with elements such
as fine precision and autonomous monitoring, these smart devices are contributing to the
overall quality of healthcare. Surely, these robotic devices may automate healthcare and
medical services, but to ensure patient safety, these medical robots should be FDA
compliant before they are released in the market for patient use. Do you have a medical
robotic device that needs FDA approval? Our regulatory and software experts at EMMA
International can help ensure your robotic device is FDA compliant. Contact us at 248-987-
4497 or info@emmainternational.com for additional information.

Jan Marisse P. Licong 10-SSC