Sunday, February 21, 2010

New Medical Classifications Suggested for Service Robotic Companies

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices and grouped them into 16 specialties. Each of these is assigned one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

1. Class I   General Controls
2. Class II  General and Special Controls
3. Class III General Controls and Premarket Approval

The FDA approved Intuitive Surgical's da Vinci surgical system not as a robotic system... because at that time they didn't have any such classification.  Instead it fell under the rules and definitions of a tele-manipulated medical device.

In the FDA workshop on Medical Care Robots, held in Washington, DC, February 19, the FDA was attempting to update their definitions for present and emerging medical and personal care robotics.

There were 60+ participants.  Military and VA, hospital administrators, medical device manufacturers, lawyers, engineers, standards experts, surgeons, professors, FDA staff.  Very sharp crowd carefully parsing proposed definitions from the ISO (International Organization for Standards) with the wisdom of their particular experience. There was resistance to the definitions that were proposed and to the implied compliance once those definitions were finalized as if there was money on the table.

One politically savvy scientist said that his father taught him that when attending a meeting such as this one, that all the information wasn't presented, factual, nor even known, and that any consensus involved money.  There is money involved in the approval process.  If the product is a Class III, involving premarket approval, much cost in time and money are likely for trials and discussions leading to approval. Thus the somewhat contentious interplay between the attendees to insure that the products they represent will be categorized in the least costly approval grouping.  Suggestions ranged from special hygiene and safety requirements all the way to the addition of a "black box" which accumulates all the data streams of a medical robot so that the data is available to be reviewed for educational, accident investigation and other statistical purposes.

I attended because I am interested in emerging robotic products and applications in health care.  It's a big industry and a big user of new technologies, many of which are emerging with breakthrough inventions almost every day.

A comparison to new imaging, medical and robotic technologies available to a surgeon would be the technological advances in boating and airplane piloting. First there was radar and paper charts.  Then there was GPS, electronic charts and navigational systems.  Then radar data was overlaid on top of the digital charts and tags were given to planes and ships to identify them.  With the radar points, the chart points, ship/plane identity tags and some clever software, ships and airplane pilots are now able to visualize the direction, speed and size of ships/planes in their sphere.  With adaptive auto-pilots working in concert with all this and additional wind/speed/currents data, the ship/plane can steer it's course adjusting for wind and sea variants and the pilot can visually oversee the progress.  Add 3-D vision and one can easily see the level of capability - and complexity - available to pilots, ship's captains, and surgeons as these systems augment their skill and judgement.

The FDA's role in all this is to provide regulation of those devices that affect humans.  Various classifications were suggested by the participants.  I've presented one set of classifications from the folks at Intuitive Surgical (click here to see the whole PDF file):
  • Surgical assist devices (scope positioners)
  • Surgeon augmentation devices (enhance skills, eg: da Vinci and guided catheter systems)
  • Caregiving augmentation devices (remote presence, physical therapy, play therapy)
  • Hospital augmentation devices (pill dispensers and transport systems)
  • Patient augmentation devices (bionics and exoskeletons) 
  • Decision support devices (remote presence, medical diagnosis)
  • Autonomous action medical devices (smart artificial pancreas)
  • Autonomous care-giving devices (robotic wheel chairs, feeding and bed turning)
From the discussions one could glean emerging robotic technologies in micro surgery, surgery assistance, personal care and therapies, telepresence robots, smart devices such as an artificial pancreas, N.O.T.E.S. and single port surgery which use natural orifices and internal incisions thereby eliminating external incisions, image-guided placement of instruments, etc.

The whole discussion of robotic classifications suggests the quickly changing movement in the industry and has me rethinking the categories that I currently use for The Robot Report's directories. Perhaps additional segmentation of Service Robotics beyond the two present categories...? And a new grouping for embedded systems? Comments? Suggestions?

Tuesday, February 16, 2010

Personal Robots Making News

NASA and General Motors have come together to develop the next generation of dexterous humanoid robots. They just released information about Robonaut2. Although in its present form it's only a torso, arms and head, Robonaut2 will be refitted to be mobile depending on the tasks that it will encounter.
"For GM, this is about safer cars and safer plants," said Alan Taub, GM's vice president for global research and development. "When it comes to future vehicles, the advancements in controls, sensors and vision technology can be used to develop advanced vehicle safety systems. The partnership's vision is to explore advanced robots working together in harmony with people, building better, higher quality vehicles in a safer, more competitive manufacturing environment."
"Our challenge today is to build machines that can help humans work and explore in space," said Mike Coats, NASA's Johnson Space Center director. "Working side by side with humans, or going where the risks are too great for people, machines like Robonaut will expand our capability for construction and discovery."
Two weeks earlier Honda premiered "Living with Robots," it's new 6-minute video about ASIMO at the Sundance Film Festival in Park City, Utah.  The video addresses preconceptions and fears about robots and shows Honda's efforts to make their robot appealing rather than creepy.  Erik Sofke, writing for Popular Mechanics in an article entitled "Can Robots be Trusted?" discussed the psychological phenomena that occurs when a robot behaves and moves in ways that enhance trust and engagement -- humans think it's alive.  But Sofke also discusses the "uncanny valley" effect which occurs when robots too closely resemble humans -- people get creeped out.

Late last year Waseda University premiered its new Twendy-One, a robo nurse for the elderly.  She is designed to assist in daily household tasks and activities.  Twendy-One is one of many robots being developed in research labs around the world focused on eldercare.

Fraunhofer is Germany's largest applied research association providing advanced technologies of direct utility to private and public enterprises and society and was the lead research facility for the recently completed SME Robot project - an integrated public-private effort to create a new family of small and medium enterprise-suitable robots that exploit robotic potentials for competitive SME manufacturing.  I've referred to this SME Robot public-private project often in The Robot Report - and also in this blog - because it is such a good example of a strategic investment by the EU in an area of industry that can benefit greatly by the innovations developed by the consortium. Although America doesn't have similar public-private partnerships in the commercial sector, in the area of SME manufacturing there is one emerging start-up developing a personal robot: Rodney Brooks' Heartland Robotics.  Heartland is purported to be developing the Obrero robot to be a shop assistant working hand in hand with SME factory workers.

Care-O-Bot is a large scale Fraunhofer IPA experiment towards building a robot built to assist humans in their daily life.  It's an interactive butler and is able to move safely among humans, detect and grasp household objects and safely interact with humans.  In an effort to make the Care-O-Bot more accessible to researchers and potential users, they have redesigned in an open-source repository for different softwares, drivers, simulation and industrial grade hardware components.

Similar in its open resource format, Willow Garage's PR2 is an open and robust robot platform designed from the ground up for developers and researchers. By eliminating the need to first build a hardware system and then re-implement code, the PR2 allows software experts to immediately create new functionality on the robot.

MIT's Media Lab has MDS Nexi; Osaka University has Q2 and CB2; there's the European RobotCub; Vietnam's TOSY Topio; Stanford's PR1; the Intelligent Robotics and Communication Lab in Kyoto has Robovie-IV; Korea's KIST Mahru-Z; and Kokoro and UC San Diego's Diego-san. All are prominent personal robots in development and recently appearing in the news.

These personal robots are well-funded and in development to be commercialized and adapted into worldwide service before 2020, hence their importance. I'm sure I've missed one or more serious player in this market segment and would appreciate your helping me build the list of personal robots to track. Thanks very much.

Thursday, February 11, 2010

Robotics Received Just One Sentence in the President's Stimulus Message

In a recent Washington Post op-ed piece, Google's Eric Schmidt described why America has an innovation deficit and suggested ways that stimulus might change that situation.
We see it reflected in our search trends at Google: Too many people are out of work, and the fear of unemployment is changing the behavior of millions more. 
We have been world leaders in innovation for generations. It has driven our economy, employment growth and our rising prosperity. 
But much of the cutting-edge research and development in key and critical areas now takes place outside the United States. 
We can no longer rely on the top-down approach of the 20th century, when big investments in the military and NASA spun off to the wider economy.
Schmidt is saying is what I have found to be true in robotics funding.  Other than DARPA, DOD and NASA, funding for robotics is not directed or strategic.  In other countries, however, strategic funding is reaping benefits that are placing America farther behind in robotics development, deployment and manufacturing.

Here is Schmidt's five-point prescription to invigorate American technology innovation:
  1. Start-ups and smaller businesses must be able to compete on equal terms with their larger rivals. They don't need favors, just a level playing field. Congress should ensure that every bill it passes promotes competition over protecting the interests of incumbents.
  2. Encouraging risk-taking means tolerating failure -- provided we learn from it. If we want to be a leader in new industries such as green energy [and robotics], we have to accept that some of our investments won't pan out.
  3. We need to invest more in our knowledge base. The decision by Congress to double science funding last year was a big step in the right direction. Now we need to extend the R&D tax credit so businesses can confidently invest in their future.
  4. Information must become even more open and accessible. Government-funded research should be made public through "a Wikipedia of ideas," so entrepreneurs can harness ideas commercially. Broadband is a major driver of new jobs and businesses, yet America ranks only 15th in the world for access. More government support for broadband remains critical.
  5. We need to hang on to talented people. The best and brightest from around the world come to study at U.S. universities. After graduation, they are forced to leave because they can't get visas. It's ridiculous to export such talent to our competition.
Yes, all these points are fine. But there are more important issues going on. There is a perception that robotics takes away jobs which is not being factually countered.

National Robotics Week - an awareness program initiated by a few companies and America's major tech universities - is a good first step. However, the government's consistent omission of robotics in their stimulus proposals is, to me, a sad surrender to the cry from unions and others that robots take away jobs.

Instead of arguing that retraining and innovation and strategic funding create jobs, we are steadily giving in to these ill-founded claims and eroding our possibilities to lead again in technological innovation.