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I, Surgical Assist ROBOT

By Daniel R. Matlis

On February 13th, I had the pleasure to participate in a panel at Furness High School in Philadelphia to expose students to careers in science and technology.

One of the topics discussed was automation and robotics. Alicia B., a student at Furness, asked if I thought that we would ever see robots like those in the movie I,ROBOT?

My prediction was that in her lifetime, she will see autonomous robots.  Crazy, you might think, but many of the products you use today, from cars to computers and medical devices, are assembled by industrial robots.

I’m not taking about humanoids robots like Lieutenant Commander Data on StarTrek or the Humanoid Cylons on Battlestar Galactica. I am referring to robots that can duplicate the complexities of human motion and genuinely help people. One such example is Honda’s ASIMO. The robot took more than two decades of persistent study, research, and trial and error before Honda engineers achieved their dream of creating an advanced humanoid robot.

By now you are thinking, this is interesting Dan, but what does it have to do with the Life-Sciences industry?

Have you heard of Robotic Assisted Surgery?

Traditionally, surgeries had been performed in the open manner, in which large incisions were required for the surgeon to plainly observe and manipulate the surgical field. Large incisions translate into increased patient trauma, extended recovery time, prolonged pain management and elevated costs.

In the past two decades we have seen a transition in surgical technique to minimally invasive surgery (MIS). This less-invasive approach to surgical procedures, including endoscopic and laparoscopic techniques, is fast becoming the treatment of choice for patients around the world. Innovative surgical products and medical device technology coupled with life-enhancing procedures have made this revolution in the world of medicine a reality.

In MIS procedures, surgeons insert cameras and instruments in the patient’s body through small ports.

MIS has a couple of drawbacks for the surgeon:

  1. Using 2D monitor instead of looking at his or her hands, flattens natural depth perception (try grabbing an object in front of you while covering one eye)
  2. Using instruments through a scope can limit the surgeon’s dexterity (it can feel like operating with the proverbial 10 foot pole)

Since July 2000, the FDA has cleared Intuitive Surgical’s da Vinci® Robotic-Assisted Surgical System for a wide variety of adult and pediatric procedures.

The da Vinci Surgical System consists of a surgeon’s console, a patient-side cart with four interactive robotic arms, a Vision System and Instruments. Powered by state-of-the-art robotic technology, the system seamlessly translates the surgeon’s hand, wrist and finger movements into precise, real-time movements of the surgical instruments inside the patient.

I,SURGEON it’s not, but can you imagine the offspring of ASIMO and da Vinci?

Let’s hope they don’t forget to program Isaac Asimov’s “Three Laws of Robotics”

  1. A robot may not injure a human being or, through inaction, allow a human being to come to harm.
  2. A robot must obey orders given it by human beings except where such orders would conflict with the First Law.
  3. A robot must protect its own existence as long as such protection does not conflict with the First or Second Law.

Steve Ballmer shares views on “what technology can do to positively revolutionize healthcare”

By Daniel R. Matlis

On February 26, 2007 Microsoft’s CEO, Steve Ballmer, offered his view on the role of technology in healthcare during his remarks at the Healthcare Information and Management Systems Society (HIMSS) in New Orleans, Louisiana.

He commented: “we take a look at the whole area of health and we say this is the largest segment of the world’s economy, it’s one of the fastest growing, it’s one in which information plays and will play an increasingly large role, and really the opportunities for information technology to make an incredible difference is the way and the quality of health that people have a right to pursue is stunning.” 

During his remarks, Mr. Ballmer touched the following of key issues facing the Healthcare industry:

1. The explosion in the amount of clinical data available
2. The growing  interest and opportunity for patients to participate in their own healthcare
3. The need for Healthcare providers to fully leverage automation and information technology
4. The imperative for Healthcare firms to harness technology successes from industries like Airlines, Banking and Finance
5. The need to standardize and embrace XML as the set of standard protocols
6. Information Technology industry must build the tools that will allow healthcare to advance to the next level.
7. The need for an aggregated view of patients, so that practitioners can not only look at an individual patient, but what the experience has been with groups of patients
8. The challenge to let people communicate securely in a clinical context
9. The need to centralize records, and allow the data that’s in them to be mined

“We need to see policy that really talks about cooperation, group access to information, privacy, ownership of information. That needs to continue to evolve. Standardization of healthcare records, CCR, the NHIN initiative is very important, HL7, and, of course, the work that has gone on with XML Web services needs to be continued and extended” said Ballmer.

“Service-oriented architecture is a new technology, and one that I think will be more important in this industry than in any other” Ballmer added.

To meet these challenges, Microsoft announced the release of the Connected Health Framework, a set of tools and technologies that are designed to facilitate interoperable systems and the movement of information across the Healthcare spectrum.

I am pleased to see that many of the issues discussed by Mr. Ballmer have been covered in Life-Science Panorama. It’s good to know we are on the right track.


Are you ready for Virtual Clinical Trials?

By Daniel R. Matlis 

The Kaiser Permanente Northern California Division of Research announced yesterday, February 14 2007,  that it is launching one of the largest research projects in the United States to examine the genetic and environmental factors that influence common diseases such as heart disease, cancer, diabetes, high blood pressure, Alzheimer’s disease, asthma and many others.

The goal of the Kaiser Permanente Research Program on Genes, Environment and Health (RPGEH) is to discover which genes and environmental factors are linked to specific diseases.

During the Press Conference David Kessler, former commissioner of the U.S. Food and Drug Administration and current dean of the University of California at San Francisco School of Medicine (UCSF), commented: “Increasingly we are moving into a world of personalized medicine. What does that mean? Right person, right disease, right drug and right dose”

Researchers hope to explain how genes and environmental factors work together to influence the risk of getting a disease or affect its severity or outcome. The Research Program will also include studies of genetic and non-genetic factors that affect how people respond to specific medications, including the occurrence of side effects.

Cathy Schaefer, PhD, director of the RPGEH and a research scientist at the Kaiser Permanente Division of Research in Oakland, added “Our research could help us identify not only what diseases a person may be at risk for, but also identify how to reduce that risk, or how best to treat the disease. This research program provides an exciting opportunity to make significant progress toward improvements in health and medical care.”

The RPGEH initiative represents a major step towards virtual, life-long clinical trails and personalized medicine.


Imagine the level of knowledge researchers and healthcare practitioners will gain from running clinical trials in-silico based on the data gathered by projects like RPGEH.

We would all benefit from safety and efficacy profiles that are orders of magnitude more precise than those available today. Product testing would shift from clinical trials run on 5-10 thousand volunteers to trials run on millions of virtual volunteers based on real people and the environmental condition surrounding them.

This level of knowledge does not come without its problems. To address security and disclosure issues, Kaiser Permanente said that participation in the RPGEH is completely voluntary. Individual’s genetic information will not be used in genetic studies without their written consent. Furthermore, no research data is stored with identifying information.


FDA Moves Closer To Becoming An Information Broker

By Daniel R. Matlis

FDA Commissioner Dr. Andrew C. von Eschenbach recently announced the creation of the Office of the Chief Medical Officer. The position will be held by Dr. Janet Woodcock, a strong advocate for modernization and transformation at the FDA.

“FDA is a science-based agency and science-led Agency; science provides the foundation for our regulatory decisions and the work we do on a daily basis to promote and protect the nations’ health,” said Dr. von Eschenbach. “Creation of this office, and position, will better ensure we achieve this mission with the highest scientific quality and effectiveness needed.”

As the Deputy Commissioner and the Chief Medical Officer, Dr. Woodcock will oversee scientific and planning-related operations for FDA. In this capacity, Dr. Woodcock shares responsibility and collaboration with the Commissioner of FDA in planning, organizing, directing, staffing, coordinating, controlling, and evaluating the agency’s scientific and medical regulatory activities in order to achieve the mission of FDA.

John R. Dyer, MPH, will take Dr. Woodcock position as the agency’s Deputy Commissioner for Operations and the Chief Operating Officer (COO). Mr. Dyer will concentrate on strengthening the management, business processes, and information technology of the agency. In addition, Mr. Dyer will work with the other Deputy Commissioners and the Chief of Staff to provide management leadership and oversight to FDA.

“With almost 24 percent of the products in the marketplace regulated by FDA it is imperative we apply and incorporate modern management tools and techniques to our regulatory decisions. Mr. Dyer’s deep experience in management is ideally suited to meet the emerging challenges and opportunities involved in protecting and promoting the health of the American public in the 21st century” said Dr. von Eschenbach.

Mr. Drier brings significant experience in Information Technology to this position. From 2001-2003, Mr. Dyer worked in the private sector for information technology and executive leadership companies. In his federal career from 1972 to 2000, Mr. Dyer held increasingly responsible executive positions with the Social Security Administration (SSA), including the Chief Information Officer and Principal Deputy Commissioner where he assisted the agency by leading the effort to automate and modernize systems and improve the level of customer service.

These appointments represent an important step by the agency in implementing Dr. Woodcock stated goal to transform the FDA into an information provider as well as a regulator.


Here Is A Tip That Can Make You 2.6 Billion Dollars

By Daniel R. Matlis

No, it’s not insider trading. This is perfectly legal.

Today, Siemens announced that it will acquire UGS Corporation.  UGS’ software portfolio covers the entire array of collaborative Product Data Management (cPDM), computer-aided design/computer-aided manufacturing/computer-aided engineering (CAD/CAM/CAE) and digital manufacturing simulation (‘digital factory’).

During this morning’s analyst conference call, Siemens CEO Dr. Klaus Kleinfeld communicated his company’s vision to connect UGS’ Digital factory know-how with Siemens’ long standing tradition in industrial automation.

“We are going to see in the future that the combination of the digital factory as well as the real factory will shorten the time from early idea of a product to production of the product by 30%” said Dr. Kleinfeld. He continued “not only will we shorten the time, but we will also be able, due to simulation over the process, to clearly have a more reliable process and a more reliable product.”

If you have been reading Life-Science Panorama for some time, this might remind you of the article I wrote on “Total Business Integration”. That article was prompted by the announcement by UGS’s rival PTC of the integration of Windchill and Arbortext.

According to Helmut Gierse, Group President for Siemens A&D, “we will be the first fully integrate solution provider for an integrated software and hardware across the complete lifecycle of products”.

How does this impact Life-Sciences?

According to The Pharmaceutical Research and Manufacturers of America (PhRMA), it takes 10 to 15 years to get a new drug to market. As our industry moves from discovering new therapies to designing them, we have the unique opportunity to benefit from this fully integrated process.

So here is how you make your 12.5 Billion:

I’m sure you heard that every day you shorten a new drug’s time to market it represents a couple Million Dollars.

Cutting 30% off the typical 12 year cycle represents savings of 1314 days, which in turn mean over 2.6 Billion Dollars.

OK, you probable won’t get to keep all $2.6 Billion, but perhaps you’ll get a nice clock engraved with your company’s logo?