Speaking of surgical robots, the surgical robot “Da Vinci” developed by Intuitive Surgical of the United States is famous.
In Japan, more than 200 “Da Vinci” are in operation at each hospital.

Surgical robots perform precision surgery that is impossible with human hands, are minimally invasive, minimize bleeding, and have small incisions that reduce pain in the affected area.
Surgical robots are used for about 80% of all-out surgery in the United States.

The patent is about to expire
Now in 2019, many of the core patents for the surgical robot “Da Vinci” are nearing expiration.
In line with this, it is expected that competitors, including those in Japan, will rebound.

Meanwhile, the Ministry of Economy, Trade and Industry has issued an international standard for surgical robots.

The following is quoted ( https://www.meti.go.jp/press/2019/07/20190716003/20190716003.html )
As the demand for minimally invasive surgery increases, surgical robots are being developed in many countries to solve the problems of minute work and limited field of view.
At the suggestion of Japan, an international standard for the safety of surgical robots has recently been published. This is expected to promote the introduction of Japan’s advanced medical technology into the international market.

    1. background
      Robotic surgery enables fine operations and operations that cannot be performed by human hands. As a technology that enables early removal of cancer and precision orthopedic surgery, development efforts that transcend the boundaries of precision mechanical engineering, information technology (IT), optics, and material engineering have been carried out in Japan as well.
      In order for surgical robots to be used around the world, safety examinations based on the laws and regulations of each country are required, and international safety standards can be a prerequisite for such examination standards.

  1. Background to the issuance of the standard and an overview of this standard
    Experts from both sides have important standards for the safety of surgical robots, both in terms of mechanical safety like industrial robots and in terms of medical device safety from the medical side. A joint working group of ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) has been proposed and established by seven countries including Japan.
    After that, discussions on standards related to the safety of surgical robots began in July 2015. From Japan, members of the National Institute of Advanced Industrial Science and Technology have continuously participated in discussions and coordinated with experts from China, Germany, South Korea, the United Kingdom, the United States, etc., and as a result, internationally on July 9, 2019. Published by Standard.
    The main points of the international standard (IEC 80601-2-77: 2019 Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment) issued this time are as follows. ..

Addition or relaxation of requirements based on the characteristics of surgical robots as individual safety standards for IEC 60601-1 (Japanese standard: JIS T0601-1 Medical electrical equipment – ​​Part 1: General requirements for basic safety and basic performance).
Not limited to endoscopic surgery robots and orthopedic robots, it can be applied to a wide range of “surgery robots”.
Requirements for removable surgical instrument parts, such as strength testing of removable parts.
Adopted “protection stop” introduced in the life support robot safety standard ISO 13482.
The safety factor requirement is relaxed by exemplifying an alternative test method for strength testing of support mechanisms suitable for robots.
An example of a test method for resistance to electromagnetic interference from an electrosurgical instrument (electric knife).
The test methods 5 and 6 were proposed and adopted by Japan based on the methods implemented in Japan and the methods proposed in the medical device development guidelines.

    1. Expected effect
      Many countries and regions, including the United States, have indicated their intention to incorporate this standard as their own standard. As a result, it is expected that Japanese medical devices based on innovative technology will be smoothly evaluated and approved in other countries. In the future, it is expected that Japanese medical devices designed and manufactured in accordance with this standard will spread to medical sites around the world as safe and secure devices, leading to the strengthening of the competitiveness of the medical device industry.

The Ministry of Economy, Trade and Industry will continue to support rule-making activities such as international standards in order to make it easier to deliver advanced medical technology originating in Japan to the world. In addition to surgical robots, the international standard IEC80601-2-78 regarding the safety of functional recovery robots that support post-surgery rehabilitation was also published on the same date.

  • The international standard issued this time is a part of the result of the strategic international standardization acceleration project (international standardization for surgical robots), which is a project commissioned by the Ministry of Economy, Trade and Industry.

Surgical robot to the Warring States period
Since the patent expires, it is possible that the announcement and development of surgical robots will be accelerated in Japan as well, but it is unclear whether the day will come when they will line up with the high-share “Da Vinci”.
I hope that surgical robots using high technology unique to Japan will be developed.

Thumbnail image quote: ( https://www.meti.go.jp/press/2019/07/20190716003/20190716003.html )

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