Medical Robots: Overcoming Design and Regulation Challenges
The Landscape of Medical Robotics Design
AI is playing an increasingly pivotal role in the development of medical robots, enabling real-time decision-making, precision movements, and adaptive responses. For example, AI-powered machine vision enhances surgical precision, while machine learning (ML) algorithms help optimize robotic control systems. As AI continues to mature, it is poised to address complex challenges, such as ensuring robots can safely interact with patients and healthcare providers.
Navigating Regulations and Standards
Medical robots must adhere to stringent safety and performance standards, including IEC 80601-2-77 for surgical equipment and ISO 14971 for risk management. Engineers are also tasked with meeting regional regulatory requirements, such as Food and Drug Administration (FDA) approval in the U or EU Medical Device Regulation (MDR) compliance in Europe. Integrating these standards early in the design process and collaborating with regulatory experts can streamline compliance and reduce costly redesigns.
In the US, the FDA classifies medical robots as medical devices, depending on their intended use and their risks to patients. Most medical robots fall under Class II or Class III and must undergo a rigorous review process. Class III devices require premarket approval (PMA), which involves extensive clinical testing to ensure they perform reliably and safely while effectively improving patient outcomes in healthcare environments.
Overcoming Technical Barriers
Designing medical robots requires precision components such as sensors, encoders, and motor drivers to ensure reliability and accuracy. AI-enhanced perception systems, like global shutter sensors, support machine vision by capturing precise images for navigation and surgical assistance. Additionally, magnetic encoders are gaining traction for their cost-effectiveness and durability, balancing performance with scalability.
Medical Robot Breakthrough
A prime example of cutting-edge robotics in the medical field is Intuitive’s next-generation da Vinci 5 surgery robot. The FDA cleared this state-of-the-art robotic-assisted system last year, and according to Intuitive, this new robot includes over 150 enhancements. This medical advancement offers surgeons improved accuracy and precision, next-generation 3D display and image processing, force feedback technology to feel subtle forces exerted on tissue during surgery, and more than 10,000 times the computing power of the previous generation da Vinci robot that has been used in over 7 million procedures
Figure 1: Minimally invasive robot-assisted surgery with the da Vinci surgical system has been used in over 7 million procedures. (Source: Georgii/stock.adobe.com)
The Newest Products for Your Newest Designs®
This week’s New Tech Tuesday features cutting-edge electronic devices from Renesas Electronics and Broadcom® that are helping to drive innovation in medical robotics technology.
Renesas Electronics’ RZ/T2H is a high-performance MPU designed for multi-axis robotic applications. Featuring quad Arm® Cortex®-A55 cores for application processing and dual Cortex-R52 cores for real-time control, it ensures precise, high-speed motor control. With Time-Sensitive Networking (TSN) and integrated industrial Ethernet, it simplifies control of up to 9-axis robots while enhancing real-time performance. Ideal for industrial and collaborative robots, PLCs, motion controllers, and AGVs/AMRs, the RZ/T2H delivers the power and precision needed for advanced automation tasks.
The Broadcom AEAT-901B incremental magnetic encoder delivers high-resolution, contact-free angular detection with 256 to 10,000 cycles per revolution (CPR) for accurate positioning and speed measurement. Utilizing magnetic technology, it eliminates mechanical wear, ensuring durability and reliability. Its three-channel output includes an index channel for each full 360° rotation, making it well-suited for robotic applications. Operating within a wide temperature range (-40°C to 125°C) and powered by a 5V supply, the AEAT-901B supports direct cable connectivity and simple assembly, making it well-suited for speed detection, rotary control, and other automation tasks.
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