"The future of surgery is not about blood and guts; the future of surgery is about bits and bytes.”
/Dr. Richard Satava/

Monday, December 29, 2008

Medical Device Regulatory Bodies


I read a paper recently from Dr. Taylor and Dr. Kazanzides (developers of the ROBODOC system) that describes well the different regulatory procedures for medical devices. This should be posted to follow up the previous post on the ROBODOC system's approval.

"The medical device industry is a heavily regulated industry. In
the United States, medical devices must be cleared for market
by the Food and Drug Administration (FDA). There are two
paths to market. One is via the 510(K) premarket notiWcation
process and the other is via the premarket approval (PMA)
process. A manufacturer can obtain a 510(K) clearance if the
new device is ‘‘substantially equivalent’’ to an existing device
that is already on the market. Otherwise, the PMA application
is required. Surprisingly, several medical robots obtained
clearance via the 510(K) path, including Aesop (Computer
Motion, Inc.), Neuromate (Innovative Medical Machines
International), and daVinci (Intuitive Surgical). In contrast,
the earlier ROBODOC System (Integrated Surgical Systems)
started down the PMA path and in the first round it has not received
clearance. ROBODOC was tested in multiclinical trials in the
United States under an investigational device exemption,
which is the mechanism by which FDA authorizes limited
clinical trials to gather supporting data. In August 2008 it received a 510(k) approval.
In addition to the need for 510(K) or PMA approval medical
device companies must comply with the quality system regulations
(QSR) and are periodically audited by the FDA to verify
compliance. Initially, the FDA required companies to adhere to
good manufacturing practices, which regulated just the manufacturing
phase. For simple devices, this worked well because
device failures were primarily due to manufacturing Xaws. As
devices became more complex, especially with the integration
of computers and software, the FDA discovered that a large
number of device failures were due to design Xaws rather than
to manufacturing Xaws. The infamous Therac-25 accident,
where six patients received massive overdoses of radiation
from a computer-controlled medical linear accelerator, is
a well-known example. As a result, FDA QSR began to
regulate the design phase as well.
In the European market, all products (medical or otherwise)
require Conformité Européenne (CE) marking. Furthermore,
the design and manufacturing processes must comply with
International Standards Organization (ISO) 9001 and 9002,
respectively (often these are grouped together by the term ISO
9000). The CE marking and ISO 9000 certiWcation are handled
by a number of notiWed bodies, which are independent, nongovernmental
entities.
To comply with ISO 9000 and/or FDA QSR, medical device
companies must deWne their development and manufacturing
processes and then produce documents (quality system records)
that demonstrate adherence to these processes. Although
ISO 9000 and FDA QSR are similar, they are not
identical, which requires most medical device companies to
comply with both of them."

Source: R. H. Taylor, P. Kazanzides, "Medical Robotics and Computer-Integrated Interventional Medicine". Chapter 18 in Biomedical Information Technology by D. D. Feng (Editor), 2007

Wednesday, December 24, 2008

Happy Holidays

Wishing a merry merry Christmas and a happy New Year to all my dear Readers!

Tuesday, December 23, 2008

NJSZT RobotDay

The John von Neumann Computer Society (NJSZT) is "dedicated to preserve values that can be included in today’s knowledge-based society as well as to setting new directions that meet the requirements of the age and to actively forming the ICT Society the future". In 2007 finally a Robotics Society was founded within NJSZT to collect, represent and promote the different robotics related R&D projects and people in Hungary. This semester, they organized the first RobotDay that was a symposium and exhibition combined (in Hungarian).
As it was expectable, I was the only one presenting about surgical robotics (giving a general introduction), however, many other interesting robots were shown. Some Hungarian high-school teams developed pretty impressive skills in building and programming the LEGO Mindstorms NXT sets. They got good result in international championships as well. Another team entered the RoboCup competition with different legged and wheeled robots. They won awards with their dancing RoboNova humanoids. Another interesting project is the privately build Simon robot, that will be a good developing platform one day; and the Sphere robot built by two undergrads.

Saturday, December 13, 2008

The FDA clearance of the ROBODOC system


Even though the Integrated Surgical Systems Inc. developed the Robodoc and sold app. 50 units in Europe and Asia, due to the continuing liquidity problems it could not live long enough to vitnes the FDA approval of the robot. (See previous post.)
The ROBODOC, a Curexo Tech, Inc. was founded in 2002 to marketize and profit from the Robodoc system. In August 2008 the system finally received a 510(k) clearance from FDA.
This 510(k) FDA clearance is an important milestone because it opens up doors to other manufacturers of similar (automated) robotic surgery systems. The process of applying for FDA clearance is easier for other robotic systems if they can prove that they are sufficiently similar to an existing product (i.e., ROBODOC).
"The newly cleared system delivers a precise, repeatable surgical technique to prepare the joint for hip replacement procedures. The process allows the surgeon to select an ideal implant from multiple implant manufacturers after reviewing a detailed CT scan of the patient’s joint. Utilizing the proprietary system software, surgeons for the first time can now preview the surgical outcome before beginning the actual operation.
This system includes two components; ORTHODOC®, a computer workstation equipped with proprietary software for 3-D preoperative surgical planning, and the ROBODOC® Surgical Assistant, a computer-controlled surgical robot utilized for precise cavity and surface preparation for hip and knee replacement surgeries. The ROBODOC System, previously marketed by Integrated Surgical Systems (ISS), made medical history in 1992 as the first robot assisting in a human Total Hip Arthroplasty (THA).
The robotic assistant has been used in over 24,000 joint replacement procedures worldwide and is shown to be less traumatic for patients and more precise than manual preparation techniques. In Total Hip surgery applications the ROBODOC System executes exact bone cutting and precise implant placement to reduce surgical fractures and complications and minimize human error."

Update: TV coverage of the approval, and the press conference (video) about it.

Update2: ROBODOC starts to sell large in Japan

Source: Robodoc.com

Wednesday, December 10, 2008

Integrated Surgical Systems Inc.


Integrated Surgical Systems Inc. (ISS) was one of the earliest companies in the field of surgical robotics, founded in 1990 in Sacramento, California. It has developed two image-directed, semiautonomous robotic products for neurological and orthopedic surgical applications.
The ROBODOC Surgical Assistant System was developed together with IBM T. J. Watson Center. A 5 degree of freedom (DOF) IBM SCARA robot (manufactured by Sankyo Seiki) was custom designed for total hip arthroplasty - THA (surgical shaping or alteration of the joint). The system consists of a robotic arm assembly and a PC-based 3-D planning station called Orthodoc.
The Orthodoc together with the Robodoc use pre-surgical images and software to first design the surgical procedure. Surgeon can precisely define the cavity in the hip bone, size and position the prosthesis before the real surgery. Robodoc cuts the patient without direct human control of the cutting tool during the procedure. The computer aided design of the surgery results in cleanly cut cavity, accuracy, precise fit of the prosthesis and long lasting hips joints compared to the traditional methods.
The more than 50 units sold had been used in 8000 arthroplasty procedures worldwide (including hip and knee) in the 90s, and almost 20 000 in the last couple of years. In 2000, formal clinical trials for US Food and Drug Administration’s (FDA) clearance began for premarket notification 510(k) . It targeted the approval for THA procedures with the use of VerSys line of cementless hip prostheses made by Zimmer (Warsaw, IN). Unfortunately, ISS did not make it to the end of the procedures (see next post). It ceased operations in mid-2005 because of lawsuits and lack of funding, and sold Robodoc assets to Novatrix Biomedical in 2007. Using those assets, Novatrix has set up Curexo Medical Co. to continue development of Robodoc Robodoc is now sold by ROBODOC, a CUREXO Technology Co.

In 1997 ISS. purchased Innovative Medical Machines Int. (MMI, Lyon, France) to acquire the NeuroMate neurosurgery system developed at the Grenoble University based on an AID industrial manipulator. The 5 DOF NeuroMate’s controller was re-designed, and used for surgical assistance for biopsy and tumor removal. In stereotatic neurosurgery, instead of pre-operative images, the NeuroMate system provided real-time 3D images to give surgeon precise location of a tumor. This was the first neurosurgical robotic device to get CE mark in Europe, and then the FDA approval in 1997 for stereotactic neurosurgical procedures. It also has an approval for neuro-endoscopic applications and for frameless stereotactic surgery in 1999.
In the first couple of years the company has installed around 20 NeuroMate systems in the United States, Europe and Japan, and the system has been used in 8000 stereotactic brain surgeries. The system and the frameless device were sold together for about $400,000.
ISS ceased operations in mid-2005 because of lawsuits and lack of funding, and it sold its Robodoc assets to Novatrix Biomedical in 2007. Using those assets, Novatrix has set up a new company called Curexo Medical to continue development of Robodoc, which is still sold in Europe, Asia, and other regions and finally received FDA approval in 2008. The NeuroMate technology was recently acquired by Schaerer Mayfield NeuroMate AG (Lyon, France), and it is currently not available on the market.
[Source: Old robodoc.com site]