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LOCATION: Palo Alto, CA, US YEAR: 2007 STATUS: Laureate CATEGORY: Manufacturing NOMINATING COMPANY: Borland |
ORGANIZATION:
Varian Medical Systems
PROJECT NAME:
A Revolution in Cancer Care: Intensity-Modulated Radiation Therapy
Short Summary
Varian Medical Systems is the world's leading manufacturer of medical technology for treating cancer and other medical conditions with radiotherapy, brachytherapy, and radiosurgery. Cancer remains one of the leading causes of death throughout the world, with 1.3 million new cases occurring yearly in the United States alone. More than half of U.S. patients will be treated with some form of radiation therapy. Varian Medical Systems has developed technology for planning and delivering an advanced form of radiation therapy technology called SmartBeam™ Intensity-Modulated Radiation Therapy (IMRT), which has improved the success and safety of radiation oncology and expanded its use to the treatment of tumors that might have been difficult or impossible to treat. The Software Quality Engineering department within Varian Medical Systems has leveraged technology from Borland to ensure that the software that supports IMRT technologies can be delivered to market quickly and is fully compliant with FDA requirements for quality and safety.
Introductory Overview
Cancer remains one of the leading causes of death throughout the world, with 1.3 million new cases occurring each year in the United States alone. More than half of the U.S. patients will be treated with some form of radiation therapy. Varian’s mission is to cure cancer. Varian Medical Systems has been committed to the fight against cancer for more than a half-a-century, pioneering several innovations in radiation therapy which have revolutionized cancer treatment, increased survivor rates and significantly improved the quality of life for survivors. The technologies developed and marketed by Varian Medical Systems are taking the life-threatening element out of many of the most pervasive and deadliest forms of cancers and transforming these diseases into manageable conditions. Among these innovations is a truly groundbreaking technology for planning and delivering an advanced form of radiation therapy called Intensity-Modulated Radiation Therapy (IMRT). IMRT has been hailed as one of the most significant technological breakthroughs in cancer treatment. It is revolutionary because it has the ability to deliver high doses of radiation directly to cancer cells in a very targeted way. This technique delivers highly effective treatment for eradicating cancer cells, while sparing more of the surrounding healthy tissue. This technology has saved the lives of thousands of cancer patients throughout the world and, perhaps even more importantly, improved the quality of their lives after treatment. Varian’s SmartBeam™ Intensity Modulated Radiation Therapy (IMRT) technology makes it possible to paint or conform a dose of radiation very tightly to a small or irregularly shaped tumor while sparing important structures nearby, such as the optic nerve (a nerve in the eye) or the spinal cord. In cases like these, SmartBeam™ IMRT can shape the treatment beam to improve target dose homogeneity and sculpt dose around critical structures more effectively. Today physicians are using IMRT to treat carcinomas of the prostate, head and neck, thyroid, breast and lung, as well as gynecologic, brain, and paraspinal tumors. Varian introduced SmartBeam™ IMRT in 1999. Since these early days, the technology has been adopted widely – from 1 installation in 1999 to 40 in 2000 to over a thousand in place today providing treatment for cancer patients around the world. The advent of SmartBeam™ IMRT depended on earlier advances in digital imaging and data processing, because every computer-controlled treatment requires manipulation of massive amounts of image data that are unique to each patient. Complex algorithms are used to convert image data into a set of computerized instructions that drive the treatment machine and its accessories, based on a doctor’s treatment prescriptions. For a human being to do the relevant calculations by hand would be impossible. To speed acceptance and overcome the barriers to adoption (such as cost and learning curve), Varian developed software to automate the entire process, implement treatment plans, and simplify the IMRT delivery experience. A critical component of any SmartBeam™ IMRT delivery system is an information system backbone. Varian’s ARIA® oncology information system is designed to optimize data management for a clinic delivering SmartBeam IMRT and other advanced treatment modalities. An oncology-specific Electronic Medical Record (EMR), ARIA makes all administrative, clinical and financial information readily available to cancer care professionals when and where it is needed. ARIA optimizes oncology processes, linking medical and radiation oncology data in one system. The application ties the elements of the SmartBeam™ treatment process together and ensures that the proper treatment is delivered to each patient. This helps medical facilities save time and improve efficiency and is largely responsible for making the technology more accessible to doctors and hospitals around the globe.
Benefits
Has your project helped those it was designed to help?
Yes
What new advantage or opportunity does your project provide to people? About 1.3 million Americans are diagnosed with cancer annually, resulting in 500,000 deaths. According to the National Cancer Institute, about one in three Americans will be diagnosed with cancer during their lifetime. More than half of these cancer patients will be treated through some form of radiation therapy. IMRT has improved the success and safety of radiation oncology and expanded its use to cancers that would otherwise be untreatable. IMRT’s success is based on the ability of radiation oncology teams to deliver lethal doses of x-rays to tumors while sparing most of the healthy tissue that surrounds them. With SmartBeam™ IMRT, the following advantages are achieved: • Higher doses of radiation can be delivered directly to tumors and cancer cells, while surrounding organs and tissues are protected • Lower doses to healthy normal tissues may mean fewer complications or side effects. • Physicians can treat cancers that were previously untreatable with radiation therapy. • IMRT can be a non-invasive alternative to surgery in some cases. • IMRT targets the tumor and not the entire body, which helps spare healthy tissue and speeds recovery from treatment. • Because of Varian’s innovations, IMRT has become more accessible which means each year more and more patients’ lives are impacted. For example, in prostate cancer studies conducted at Memorial Sloan Kettering Cancer Center in New York, local tumor control rates were significantly improved: o Prostate cancer patients treated with SmartBeam IMRT showed a 92 percent three-year survival rate for early stage prostate patients, as compared with an 81.6 percent survival rate for cancer patients treated at lower doses with an earlier form of radiation therapy. o A decrease in rectal bleeding complications from 17% to 3%. Has your project fundamentally changed how tasks are performed? Yes How do you see your project's innovation benefiting other applications, organizations, or global communities? Varian’s SmartBeam IMRT opened the door to widely-accessible radiation therapy treatment that improved outcomes while reducing the kinds of side effects that were conventionally associated with this type of treatment. As a result, many new technologies are being developed and introduced, that build on the gains created by IMRT. For example, image-guided IMRT is now starting to take hold in the U.S., whereby clinicians use imaging systems in the treatment room to fine-tune patient positioning and do a better job of delivering the highly conformal IMRT treatment beams directly to the tumor, which is not always in exactly the same spot within the patients’ anatomy from day to day. Since tumors in the chest and abdomen move when a patient breathes, new tools that compensate for tumor motion during treatment are also being added to SmartBeam IMRT systems. A sizeable percentage of the peer-reviewed journal articles showing up in radiation oncology medical journals are about IMRT, image-guided IMRT, and tumor motion management. The entire radiation oncology profession is changing its practices—revisiting conventional wisdom about: which tumors are treatable, how many treatment sessions are needed, how much dose should be applied. Since more normal healthy tissues can be protected, clinicians are finding they can escalate the dose, and since treatments are more accurate, they can do so over fewer treatment sessions, making treatments shorter without sacrificing effectiveness. This has huge implications for cancer patients and their loved ones.
The Importance of Technology
How did the technology you used contribute to this project and why was it important?The ability to continually advance the capabilities and automation of IMRT has been integral to Varian’s success in making IMRT a mainstream radiation therapy. Oncology systems are complex products, and IMRT involves an intricate system of instruments, accessories, software and networking capabilities that must all work together seamlessly, intuitively for the user, and flawlessly, to ensure quality patient care. An IMRT treatment process involves a number of complex steps. After initial diagnostic imaging, there is imaging for treatment planning, preparation of the treatment plan (which is done by a medical physicist using special software), simulation to verify that the plan is deliverable and will produce the desired dose distribution, patient set up (including creation of immobilization devices), treatment delivery (which takes place daily over several weeks), and treatment verification/QA (to make sure treatments are being delivered as planned). Every one of these steps utilizes and generates data that must be captured and used at workstations throughout the clinic. To speed acceptance and overcome the barriers to adoption faced by new medical technologies, Varian developed software that would automate the major steps, create and implement treatment plans, and simplify this complex process. Much of the success of Varian’s SmartBeam IMRT is attributable to the company’s development of a very comprehensive and user-friendly information system to manage all data and serve as an “engine” for planning and delivering these sophisticated treatments. Once the news of what IMRT could accomplish began to be widely disseminated, thanks mostly to some seminal journal articles published by Memorial Sloan-Kettering Cancer Center, one of the earliest adopters, the demand for IMRT technology escalated rapidly. Varian was working with early adopters to hone the relevant software products, seeking ways to make them easier to implement and use, so that SmartBeam IMRT could be deployed, not only in the large university-based research hospitals, but also in smaller, less resourced community hospitals and clinics. As the development cycle for software and networking products accelerated, the company needed to find a way to maximize its software development resources and boost efficiency, while maintaining the highest quality standards. Today, over half of Varian's R&D budget is spent on software development with a dedicated team of software marketers, engineers and service providers. As Varian staffed up its software development organization to continue to innovate and expand functionality in its software, it also sought ways to leverage technology to gain efficiencies and ensure the quality of its output. As part of this effort, Varian turned to Borland Software to help automate the functional and regression testing of its ARIA software. Using Borland SilkTest as part of its enterprise quality framework, Varian is able to conduct regression tests on ARIA four times faster than with manual testing. Varian now relies on Borland’s products to automate a third of its regression tests so that valuable resources can be focused on ensuring the quality of more sophisticated functionality that can only be tested manually. Borland has helped Varian ensure that each new version of its ARIA system meets the highest quality standards. Varian recently achieved top ratings in the ServiceTrak™ 2006 survey report on radiation oncology technology published by IMV, Ltd., a research company that analyzes service trends in various medical technology sectors and rates manufacturers’ performance on the basis of telephone interviews with customers. Varian beat competitors on all of the parameters related to software performance, with top rankings in the following categories: "System Performance Meets Expectations”, "Reliability of Software," "System Integration for Therapy Planning," and "System Ease of Use."
Originality
What are the exceptional aspects of your project?Varian pioneered the first high-resolution, dynamic form of IMRT, which is the most advanced of all radiation treatments in use today. Varian’s SmartBeam IMRT offering is the only one capable of dynamic IMRT, which means that the radiation beam is continually modulated and shaped (per image data) as the treatment machine rotates around the patient to deliver the radiation dose from different angles. Competing technologies are slower and less precise, because they stop and start as the beam aperture is changed for each different beam angle. Achieving dynamic IMRT made it possible to offer hospitals a machine that would enable clinics to treat as many patients per day as before with a better treatment. No other technology can do this. In that sense, it is the most effective application of its kind. While patient outcomes are important, for Varian, effectiveness means more than that. Varian is committed to maintaining a hospital’s “throughput” levels, which is a term for the number of patients who can be served in a given day. To do this, Varian had to develop a machine that could accomplish a complex IMRT treatment within a normal treatment time slot. Also, Varian’s beam-shaping accessory, called a multileaf collimator, is the gold standard in the industry. This attachment to the treatment machine has 120 thin tungsten “leaves” or fingers—each one separately controlled—that move to create apertures of different shapes and sizes. This computer-controlled attachment is at the heart of Varian’s dynamic SmartBeam IMRT technology, and it is unique to Varian. Varian has taken this life-saving technology quickly to a mass market, taking just seven years to scale from one installation to placement in virtually every leading cancer treatment facility nationwide, as well as globally. How is it original? The answer to this question is included in the response to: "What are the exceptional aspects of your project? (In 300 words or less)" Is it the first, the only, the best or the most effective application of its kind? Most effective
Success
Has your project achieved or exceeded its goals?
Exceeded
Is it fully operational? Yes How many people benefit from it? 210,000 If possible, include an example of how the project has benefited a specific individual, enterprise or organization. Please include personal quotes from individuals who have directly benefited from your work. One Pennsylvania youth was 18 years old when he was treated with SmartBeam IMRT for a brain tumor at the Dale and Frances Hughes Cancer Center in East Stroudsburg, Pennsylvania. Early in 2000, a large brain tumor was discovered. A round of chemotherapy did not control the tumor growth, and the tumor began to press on nerves and affect John’s breathing, as well as his balance and coordination. Doctors at Children’s Hospital of Pennsylvania suggested that radiation treatments begin immediately. “Staying in Philadelphia for six and a half weeks of treatment was going to be difficult for us,” his mother recalled. “Around that time, I found out about IMRT, and researched other places where I could get this specialized treatment.” The Dale and Frances Hughes Cancer Center was close to their home. According to the mother, this young cancer patient had no other options. The first week of treatment was difficult. He was on steroids to deal with brain swelling caused by the tumor, and was having trouble breathing. He could not walk unassisted, and required a wheelchair. Each day, he would travel by ambulance to the cancer center for his daily SmartBeam IMRT treatment. After a week, the swelling went down and his breathing eased. There were few side effects. “He did not have headaches. He had some difficulty swallowing at first, but that’s gone now,” his mother said. Several months after treatment, he was swallowing and breathing normally, and no longer required a special diet to prevent aspiration. He could walk unassisted. While there are no guarantees for the future, this young man and his mother are grateful for having had access to SmartBeam IMRT. “If you have to have radiation, you obviously want to spare as much healthy tissue as possible," said the mother. “I would strongly recommend IMRT.” How quickly has your targeted audience of users embraced your innovation? Or, how rapidly do you predict they will? In 1999 there was just one SmartBeam IMRT site in the world, at Memorial Sloan-Kettering Cancer Center in New York City. By 2000, there were 40. By 2003 there were almost 500, and today, virtually all of the radiation treatment machines sold by Varian are outfitted for SmartBeam IMRT. The company ships between 600 and 800 units each year. Orders for software products at Varian, including ARIA, have increased at an annual rate of over 20% between 1998 and 2006, growing over 350 percent over the eight-year period.
Difficulty
What were the most important obstacles that had to be overcome in order for your
work to be successful? Technical problems? Resources? Expertise? Organizational
problems?In the medical industry, the evolution of a product from inception to mainstream adoption does not happen overnight. Hospitals and physicians cannot afford to take on too great a risk when evaluating new technologies and budgeting for these major capital equipment purchases, which includes accommodating the learning curve that is involved when adopting a complex new technology. In order to attract early adopters, a new medical advance must have some external validation. The problem is that technology won’t sell without good outcome data, and you can’t get good outcome data without the technology being in use somewhere. One way to address this is to partner with clinicians at key research institutions, and work with them to develop, test and study new technology. Varian’s first IMRT unit was custom-built for clinicians at Memorial Sloan-Kettering Cancer Center in 1995. These clinicians were instrumental in helping Varian engineers work out the needed capabilities and protocols for how the machine might be used. By 1998, they published a seminal paper that showed how IMRT had increased survival rates while reducing complications in a cohort of prostate cancer patients. Other papers followed, about how IMRT prevented the destruction of salivary glands in patients with cancers of the head and neck, and how breast cancer treatment outcomes could be improved. As other early adopters began to publish, the adoption trajectory took off. When that happened, the problem of keeping up with accelerated demand arose. Varian had to shift resources to accommodate the increased demand for the product, adding people, manufacturing capacity, and automation to make it happen. Due to the increase in emphasis on software-driven technologies, Varian has had to shift its technical expertise, adding software specialists. Today there are 25 software marketing personnel, 200 software engineers, and 150 software service engineers working at Varian worldwide. Often the most innovative projects encounter the greatest resistance when they are originally proposed. If you had to fight for approval or funding, please provide a summary of the objections you faced and how you overcame them. The answer to this question is included in the answer to: "What were the most important obstacles that had to be overcome in order for your work to be successful? Technical problems? Resources? Expertise? Organizational problems? (In 300 words or less)"
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