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...

1. Applications of Robotics in Healthcare and
Medical Devices
By: Govind Yatnalkar
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
commandsfrom theuser. Withtime,thefield of robotics is proving to be moreusefulinthehealth
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
1 Global Data, Medical Device Network, (January 2020). Whatare MainTypesof Robots used in Healthcare? Retrieved on 16th
November2020 from https://www.medicaldevice-network.com/comment/what-are-the-main-types-of-robots-used-in-healthcare/.
2 Jennifer Yang(July 2017). Meet Paro, a furry friend to dementia patients. Retrieved on 17thNovember2020 from
https://www.thestar.com/news/insight/2015/10/05/meet-paro-a-furry-friend-to-dementia-patients.html.

2. 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
hardwareutilizedforbuilding thesystem should be appropriately documentedandtested 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,Roboticshasa hugepotentialin thehealthcaredomainandwith elementssuch
as fine precision and autonomous monitoring, these smart devices are contributing to the overall
quality ofhealthcare.Surely,theserobotic devices may automatehealthcareandmedicalservices,
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.
3 FDA (March2019). Computer-Assisted Surgical System.Retrieved on 16thNovember2020 from https://www.fda.gov/medical-
devices/surgery-devices/computer-assisted-surgical-systems#3