M. Stephen Heilman
Encyclopedia
Marlin Stephen "Doc" Heilman (born December 25, 1933) is an American physician, entrepreneur and inventor. Among other things, he is credited with inventions in the fields of flow-controlled angiographic power injection, implantable cardiac defibrillators or ICDs and the patient wearable defibrillator. His first invention, the flow controlled power injector, advanced the fields of radiology
and diagnostic cardiology
by allowing physicians to better diagnose blockages and other abnormalities inside arteries and vein
s. MEDRAD, the company he formed to manufacture and market his invention, has become the leading producer/supplier of power injection devices and disposables in the world. The ICD, which he also helped develop, has revolutionized the treatment of patients at risk of sudden cardiac death. Now, routinely implanted in tens of thousands of patients who are at high risk for sudden death, ICDs are manufactured by major medical-device giants like Medtronic
, Boston Scientific
and St. Jude Medical
. These devices have saved tens of thousands of lives and generate over three billion dollars in annual revenues. Heilman, who holds more than 30 patents related to medical imaging, ICDs and cardiac assist devices, has also founded and run several medical device companies, including Medrad Inc.
, Medrad Intec, Lifecor, and Vascor. He has served on the board of several for-profit and not-for-profit corporations and continues his work with Vascor in developing an implantable heart assist device to treat patients having advanced heart failure.
, a small Pittsburgh suburb. His father Glenn, Glenn's father U.O.,and Glenn's brother and sister were all physicians. Heilman, his brother J. Daniel, and son Carl have all decided to follow the family tradition and pursue a career in medicine. Heilman’s maternal grandfather was a successful business person and plant manager for Pittsburgh Plate Glass, a fact that Heilman feels contributed to his entrepreneurial instincts and interests .
After graduating from the University of Pennsylvania
with a Bachelor of Arts and chemistry major in 1955, he matriculated at the University of Pennsylvania School of Medicine
. There, he developed an interest in medical research. Initially, he considered pursuing a career in academics. However, while taking pharmacology
in his second year he noted that most of the innovative work in new drug development was being done by pharmaceutical companies. Later, this experience motivated him to start his own companies to provide the necessary capital for developing clinically useful medical devices.
After graduating from medical school, he performed a general medical internship in 1960. During this time, a prominent cardiologist showed him an early version of a heart image known as a ventriculogram, an x-ray movie where the moving blood in the ventricle of the heart was made visible through the use of an injected contrast agent. Heilman immediately recognized that angiography, the field of providing internal patient images using contrast agents, would become an important area in medicine. Having already decided that he did not want to establish a practice in a traditional medical specialty, Heilman opted to forgo a residency
. Instead, he joined the US Air Force to satisfy a deferred military service obligation and was stationed in Soesterberg, Holland, where he spent two years as the Medical Officer in Charge of the 654th U.S. Airforce Tactical Hospital.
technology that made it possible to “see” blood vessels inside the body. Injecting a radiographic contrast agent at a servo controlled rate into the vessels, he thought, would improve the image and make it possible to diagnose and treat heart attack and stroke
patients like the ones often seen in the emergency room. In February 1964 he formed a new company to develop, produce and distribute angiographic products for hospitals. He named the new company Medrad, an acronym for medical research and development. During that year, he also started work on his first invention: the automatic flow-controlled angiographic power injector. He had observed that existing injectors injected contrast material into the blood stream at unknown flow rates and produced unreliable results. Working at night in his basement, he developed a hydraulic flow controlled injector that would supply a known preset flow rate of radiographic iodine
-based contrast material into the bloodstream. This, he theorized, would produce much better radiographic images. His initial prototype leaked oil. In order to correct this problem, Heilman and partner Rudy Kranys asked an electrical engineer friend for help in developing the necessary servo system, and together they came up with a solution: the use of velocity feedback to control power transistors. Upon entering the market, however, Heilman was threatened with a patent infringement
suit by a much larger competitor. Fortunately, Heilman was able to find prior art to the competitors patent and the suit was dropped. Medrad started to produce and sell increasing numbers of power injectors and syringes. Nevertheless, the company did not become profitable until 1970, six full years after its inception. During this time, Heilman worked to support his family as an emergency room physician and as a consultant to the Westinghouse Electric Corporation in the development of an intraortic balloon heart assist device. Heilman’s injector invention was the first of many Medrad inventions, and over the past four decades, Medrad has become the world’s largest supplier to hospitals of devices to improve diagnostic imaging through the delivery of contrast agents for x-ray, computed tomographic or CT scans and magnetic resonance imaging or MRIs.
in 1972, Heilman met Dr. Michel Mirowski, a cardiologist from Baltimore
. Mirowski had the patented idea for an implantable cardioverter defibrillator or ICD. Theoretically, an ICD could prevent sudden cardiac death, a frequent fatal outcome for heart disease patients. Mirowski with his fellow cardiologist partner, Dr. Morton Mower, had been working for three years with Medtronic attempting to develop the ICD, but Medtronic was giving up on the project, believing there was an insignificant ICD market. Heilman, however, immediately saw the potential of the ICD concept and offered to help Mirowski and Mower develop the product. He put together a team consisting of himself, consultants Mirowski and Mower, and Dr. Alois Langer, a PhD biomedical engineer. Along with several other Medrad employees, the Medrad spin-off company Intec Systems was created to develop the ICD. From 1973 to 1986 they overcame the multiple technical and regulatory challenges associated with creating this revolutionary new device. Among other things, the device had to be small enough to implant, have a battery that would last for years and that could supply both low and high levels of energy, have small but sufficiently reliable capacitors to store charge quickly, and be enclosed in a hermetically sealed biocompatible encasement. Heilman not only helped to solve these problems and make the device work successfully, but his new company Intec, along with outside venture capital, provided funding for the research. In 1980, the first ICD, provided by Medrad/Intec, was implanted in a patient at Johns Hopkins Hospital
in Baltimore. In 1985, with FDA approval virtually in hand and to satisfy the venture capital investors, Heilman and his coworkers sold Intec to Eli Lilly & Company for approximately 100 million dollars. Lilly, placed the ICD technology with pacemaker subsidiary CPI and subsequently merged CPI into the newly formed Guidant Corporation. To date, there have been well over a million ICD recipients, including former Vice-President of the United States, Dick Cheney
.
. They immediately hired a team of former Medrad/Intec employees who developed the ICD. Heilman and Bowling saw the possibility of creating this product for people at high risk of sudden death but not able or ready for a variety of reasons to receive an ICD. The company’s main product, the LifeVest, has gone through four iterations, each successive one smaller and lighter than its previous version. The present LifeVest product is easily and comfortably worn by persons having risk of sudden cardiac death. The LifeVest wearable defibrillator is currently marketed in the United States and parts of Europe, and will eventually be sold worldwide. The Lifecor business was acquired by ZOLL Medical Corporation in 2006 and is growing rapidly.
Radiology
Radiology is a medical specialty that employs the use of imaging to both diagnose and treat disease visualized within the human body. Radiologists use an array of imaging technologies to diagnose or treat diseases...
and diagnostic cardiology
Cardiology
Cardiology is a medical specialty dealing with disorders of the heart . The field includes diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular heart disease and electrophysiology...
by allowing physicians to better diagnose blockages and other abnormalities inside arteries and vein
Vein
In the circulatory system, veins are blood vessels that carry blood towards the heart. Most veins carry deoxygenated blood from the tissues back to the heart; exceptions are the pulmonary and umbilical veins, both of which carry oxygenated blood to the heart...
s. MEDRAD, the company he formed to manufacture and market his invention, has become the leading producer/supplier of power injection devices and disposables in the world. The ICD, which he also helped develop, has revolutionized the treatment of patients at risk of sudden cardiac death. Now, routinely implanted in tens of thousands of patients who are at high risk for sudden death, ICDs are manufactured by major medical-device giants like Medtronic
Medtronic
Medtronic, Inc. , based in suburban Minneapolis, Minnesota, is the world's largest medical technology company and is a Fortune 500 company.- History :...
, Boston Scientific
Boston Scientific
The Boston Scientific Corporation , is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties, including interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention,...
and St. Jude Medical
St. Jude Medical
St. Jude Medical, Inc. is a $16 billion global medical device company, with headquarters in Little Canada, Minnesota, United States, a suburb of St. Paul. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. Its principal...
. These devices have saved tens of thousands of lives and generate over three billion dollars in annual revenues. Heilman, who holds more than 30 patents related to medical imaging, ICDs and cardiac assist devices, has also founded and run several medical device companies, including Medrad Inc.
Medrad Inc.
Medrad is an American company headquartered in Warrendale, PennsylvaniaIt was founded in 1964 by M. Stephen Heilman, a doctor who created the first flow-controlled, angiographic power injector in the kitchen of his home near Pittsburgh, Pennsylvania....
, Medrad Intec, Lifecor, and Vascor. He has served on the board of several for-profit and not-for-profit corporations and continues his work with Vascor in developing an implantable heart assist device to treat patients having advanced heart failure.
Early life and education
Heilman was born on Christmas Day, 1933 in Tarentum, PennsylvaniaTarentum, Pennsylvania
Tarentum is a borough in Allegheny County in the U.S. state of Pennsylvania. It is northeast of Downtown Pittsburgh, along the Allegheny River. Tarentum was an industrial center where plate glass and bottles were manufactured; bricks, lumber, steel and iron novelties, steel billets and sheets,...
, a small Pittsburgh suburb. His father Glenn, Glenn's father U.O.,and Glenn's brother and sister were all physicians. Heilman, his brother J. Daniel, and son Carl have all decided to follow the family tradition and pursue a career in medicine. Heilman’s maternal grandfather was a successful business person and plant manager for Pittsburgh Plate Glass, a fact that Heilman feels contributed to his entrepreneurial instincts and interests .
After graduating from the University of Pennsylvania
University of Pennsylvania
The University of Pennsylvania is a private, Ivy League university located in Philadelphia, Pennsylvania, United States. Penn is the fourth-oldest institution of higher education in the United States,Penn is the fourth-oldest using the founding dates claimed by each institution...
with a Bachelor of Arts and chemistry major in 1955, he matriculated at the University of Pennsylvania School of Medicine
University of Pennsylvania School of Medicine
The Perelman School of Medicine , formerly the University of Pennsylvania School of Medicine, was founded in 1765, making it the oldest American medical school. As part of the University of Pennsylvania, it is located in the University City section of Philadelphia, Pennsylvania. It is widely...
. There, he developed an interest in medical research. Initially, he considered pursuing a career in academics. However, while taking pharmacology
Pharmacology
Pharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...
in his second year he noted that most of the innovative work in new drug development was being done by pharmaceutical companies. Later, this experience motivated him to start his own companies to provide the necessary capital for developing clinically useful medical devices.
After graduating from medical school, he performed a general medical internship in 1960. During this time, a prominent cardiologist showed him an early version of a heart image known as a ventriculogram, an x-ray movie where the moving blood in the ventricle of the heart was made visible through the use of an injected contrast agent. Heilman immediately recognized that angiography, the field of providing internal patient images using contrast agents, would become an important area in medicine. Having already decided that he did not want to establish a practice in a traditional medical specialty, Heilman opted to forgo a residency
Residency (medicine)
Residency is a stage of graduate medical training. A resident physician or resident is a person who has received a medical degree , Podiatric degree , Dental Degree and who practices...
. Instead, he joined the US Air Force to satisfy a deferred military service obligation and was stationed in Soesterberg, Holland, where he spent two years as the Medical Officer in Charge of the 654th U.S. Airforce Tactical Hospital.
Early career: MEDRAD and the invention of the power injector
After finishing his tour of duty with the Air Force in Holland, Heilman returned to Pittsburgh, Pennsylvania. He took part-time jobs working as an emergency room physician at Passavant Hospital and St. John’s Health and Emergency Center. There, again, he saw the potential of angiography, the new X-rayX-ray
X-radiation is a form of electromagnetic radiation. X-rays have a wavelength in the range of 0.01 to 10 nanometers, corresponding to frequencies in the range 30 petahertz to 30 exahertz and energies in the range 120 eV to 120 keV. They are shorter in wavelength than UV rays and longer than gamma...
technology that made it possible to “see” blood vessels inside the body. Injecting a radiographic contrast agent at a servo controlled rate into the vessels, he thought, would improve the image and make it possible to diagnose and treat heart attack and stroke
Stroke
A stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage...
patients like the ones often seen in the emergency room. In February 1964 he formed a new company to develop, produce and distribute angiographic products for hospitals. He named the new company Medrad, an acronym for medical research and development. During that year, he also started work on his first invention: the automatic flow-controlled angiographic power injector. He had observed that existing injectors injected contrast material into the blood stream at unknown flow rates and produced unreliable results. Working at night in his basement, he developed a hydraulic flow controlled injector that would supply a known preset flow rate of radiographic iodine
Iodine
Iodine is a chemical element with the symbol I and atomic number 53. The name is pronounced , , or . The name is from the , meaning violet or purple, due to the color of elemental iodine vapor....
-based contrast material into the bloodstream. This, he theorized, would produce much better radiographic images. His initial prototype leaked oil. In order to correct this problem, Heilman and partner Rudy Kranys asked an electrical engineer friend for help in developing the necessary servo system, and together they came up with a solution: the use of velocity feedback to control power transistors. Upon entering the market, however, Heilman was threatened with a patent infringement
Patent infringement
Patent infringement is the commission of a prohibited act with respect to a patented invention without permission from the patent holder. Permission may typically be granted in the form of a license. The definition of patent infringement may vary by jurisdiction, but it typically includes using or...
suit by a much larger competitor. Fortunately, Heilman was able to find prior art to the competitors patent and the suit was dropped. Medrad started to produce and sell increasing numbers of power injectors and syringes. Nevertheless, the company did not become profitable until 1970, six full years after its inception. During this time, Heilman worked to support his family as an emergency room physician and as a consultant to the Westinghouse Electric Corporation in the development of an intraortic balloon heart assist device. Heilman’s injector invention was the first of many Medrad inventions, and over the past four decades, Medrad has become the world’s largest supplier to hospitals of devices to improve diagnostic imaging through the delivery of contrast agents for x-ray, computed tomographic or CT scans and magnetic resonance imaging or MRIs.
The Implantable Cardioverter Defibrillator (ICD)
During a business trip to SingaporeSingapore
Singapore , officially the Republic of Singapore, is a Southeast Asian city-state off the southern tip of the Malay Peninsula, north of the equator. An island country made up of 63 islands, it is separated from Malaysia by the Straits of Johor to its north and from Indonesia's Riau Islands by the...
in 1972, Heilman met Dr. Michel Mirowski, a cardiologist from Baltimore
Baltimore
Baltimore is the largest independent city in the United States and the largest city and cultural center of the US state of Maryland. The city is located in central Maryland along the tidal portion of the Patapsco River, an arm of the Chesapeake Bay. Baltimore is sometimes referred to as Baltimore...
. Mirowski had the patented idea for an implantable cardioverter defibrillator or ICD. Theoretically, an ICD could prevent sudden cardiac death, a frequent fatal outcome for heart disease patients. Mirowski with his fellow cardiologist partner, Dr. Morton Mower, had been working for three years with Medtronic attempting to develop the ICD, but Medtronic was giving up on the project, believing there was an insignificant ICD market. Heilman, however, immediately saw the potential of the ICD concept and offered to help Mirowski and Mower develop the product. He put together a team consisting of himself, consultants Mirowski and Mower, and Dr. Alois Langer, a PhD biomedical engineer. Along with several other Medrad employees, the Medrad spin-off company Intec Systems was created to develop the ICD. From 1973 to 1986 they overcame the multiple technical and regulatory challenges associated with creating this revolutionary new device. Among other things, the device had to be small enough to implant, have a battery that would last for years and that could supply both low and high levels of energy, have small but sufficiently reliable capacitors to store charge quickly, and be enclosed in a hermetically sealed biocompatible encasement. Heilman not only helped to solve these problems and make the device work successfully, but his new company Intec, along with outside venture capital, provided funding for the research. In 1980, the first ICD, provided by Medrad/Intec, was implanted in a patient at Johns Hopkins Hospital
Johns Hopkins Hospital
The Johns Hopkins Hospital is the teaching hospital and biomedical research facility of Johns Hopkins University School of Medicine, located in Baltimore, Maryland . It was founded using money from a bequest by philanthropist Johns Hopkins...
in Baltimore. In 1985, with FDA approval virtually in hand and to satisfy the venture capital investors, Heilman and his coworkers sold Intec to Eli Lilly & Company for approximately 100 million dollars. Lilly, placed the ICD technology with pacemaker subsidiary CPI and subsequently merged CPI into the newly formed Guidant Corporation. To date, there have been well over a million ICD recipients, including former Vice-President of the United States, Dick Cheney
Dick Cheney
Richard Bruce "Dick" Cheney served as the 46th Vice President of the United States , under George W. Bush....
.
LIFECOR
In November 1986, Heilman, and Larry Bowling founded Lifecor, a company that has developed and now provides the world's first patient wearable cardioverter defibrillatorWearable cardioverter defibrillator
The wearable cardioverter defibrillator is worn by patients at risk for sudden cardiac arrest , allowing their physician time to assess their long-term arrhythmic risk and make appropriate plans....
. They immediately hired a team of former Medrad/Intec employees who developed the ICD. Heilman and Bowling saw the possibility of creating this product for people at high risk of sudden death but not able or ready for a variety of reasons to receive an ICD. The company’s main product, the LifeVest, has gone through four iterations, each successive one smaller and lighter than its previous version. The present LifeVest product is easily and comfortably worn by persons having risk of sudden cardiac death. The LifeVest wearable defibrillator is currently marketed in the United States and parts of Europe, and will eventually be sold worldwide. The Lifecor business was acquired by ZOLL Medical Corporation in 2006 and is growing rapidly.
VASCOR
In 1986, Heilman also founded the Pittsburgh based company Vascor. Vascor has been engaged in the development of an implantable heart assist device but as yet has not produced a device for clinical use.Awards
- 1987, Entrepreneur of the Year Award from Arthur Young and Venture MagazineVenture MagazineVenture magazine is a business management magazine. It focuses on business best practices. It is used by business leaders to learn from their colleagues'successes and challenges....
- 1992, Outstanding Venture Capital Achievement Award, Pittsburgh Venture Capital Association
- 1995, Michel Mirowski Award for Excellence in Clinical Cardiology and Electrophysiology
- 2001, Entrepreneurial Excellence Award from the Carnegie Science Center and Pittsburgh Technology Council
- 2002, US Department of Commerce Award for Contributions to American Innovation.
- 2002, Induction into National Inventors Hall of FameNational Inventors Hall of FameThe National Inventors Hall of Fame is a not-for-profit organization dedicated to recognizing, honoring and encouraging invention and creativity through the administration of its programs. The Hall of Fame honors the men and women responsible for the great technological advances that make human,...
- 2003, Tri-State Inventor of the Year Award from the Pittsburgh Intellectual Law Association
- 2003, Pittsburgh Innovators Award from Pittsburgh Magazine
- 2004, Visionary Award from the Pittsburgh Life Sciences Greenhouse.