M. Stephen Heilman

Marlin Stephen "Doc" Heilman (born December 25, 1933) is an American physician, entrepreneur and inventor. Among other things, he is credited with inventions (U.S. Patents and Applications) in the fields of contrast enhanced medical imaging, the first implantable cardioverter defibrillator or ICD, the first wearable defibrillator or LifeVest defibrillator, and heart assist devices. His first inventions, a flow controlled angiographic injector and pressure tolerant disposable angiographic syringes, advanced the fields of radiology and cardiology by improving the diagnostic image quality and eliminating the imaging risk of blood borne disease transmission from patient to patient. He founded Medrad Inc, now part of Bayer Healthcare, to manufacture and supply these imaging devices on a worldwide basis. In 2013, an estimated 65 million medical imaging procedures were performed usning Medrad products.

Medrad and its subsidiary Intec Systems, in collaboration with Drs. Michel Mirowski and Morton Mower developed the world's first implantable cardioverter defibrillator or ICD.^[1] ICDs prevent the most common form of heart disease death, namely sudden cardiac death or SCD. According to Hauser,^[2] in 2009, 140,000 patients received their initial ICD device and another 30,000 to 40,000 patients received ICD replacements. According to Whiting, 2012 ICD revenues exceeded $6 billion.

In 2014, Heilman and his Vascor coworkers expect to complete the development of a failsafe non-rotary implantable counterpulsation heart assist device that will be powered by a transcutaneous electrical transmission system or TETS. Heilman lives with his wife, Drusie, in the western Pennsylvania countryside near Pittsburgh. They have 5 children and 13 grandchildren.

Early life and education

Heilman was born on Christmas Day, 1933 in Tarentum, Pennsylvania, a small Pittsburgh suburb. His father Glenn, Glenn's father U.O., and Glenn's brother and sister were all physicians.^[3] Heilman's brother, Dan, and son, Carl, are also physicians. After graduating from the University of Pennsylvania with a Bachelor of Arts degree and chemistry major in 1955, he entered the University of Pennsylvania School of Medicine graduating in 1959. There, he developed an interest in medical research and realized that coming technologic advances would provide opportunities for innovative products having breakthrough diagnostic and therapeutic potential. After medical school graduation, he completed a general medical internship in 1960. During this time, a prominent cardiologist from the Cleveland Clinic showed him an early version of an x-ray movie of blood combined with iodine-based contrast medium moving through a patient's heart. Heilman immediately recognized that angiography, the field of providing contrast media enhanced moving images of a patient's heart, arteries and veins would provide physicians with an extremely valuable diagnostic tool. Having already decided to pursue a career developing medical devices, Heilman opted to forgo a specialty residency. Instead, he joined the US Air Force to satisfy a deferred military service obligation and was stationed at the Soesterberg Air Force base in Holland, where he spent two years as the Military Officer in charge of the 654th Air Force Tactical Hospital. This facility offered first level medical care for approximately 3,500 US military personnel and dependents stationed in Holland. Specialty care for military personnel was provided by air flight to the USAF Wiesbaden Hospital in Germany and the military dependents received their specialty care from the Dutch economy. The Soesterberg air base supported both Dutch and American aircraft as part of the NATO defense system during the cold war. The American aircraft were supersonic fighter interceptor F-102s having air-to-air guided nuclear missiles.

Early career

After finishing his tour of duty with the Air Force in the Netherlands, Heilman returned to Pittsburgh, Pennsylvania. To support his family, he took part-time jobs working as an emergency room physician. Medrad Inc was incorporated in February, 1964. The name Medrad is an acronym for medical research and development. Medrad rented space in the Saint John's Health and Emergency Center, located in Pittsburgh's North Hills. Rudy Kranys, Heilman and a few consultants began developing Medrad's first product, a flow controlled angiographic injector. The "better mousetrap' injector had two important innovations. The first was to measure the flow rate of the injected contrast media, and adjust, in real time, the injector's power to insure that the actual injection flow rate was as desired. Image quality was optimized when the proper concentration of contrast medium was reached in the blood stream. The other innovation was to use special transparent syringe reinforcing jackets to enabled disposable syringes to withstand injection pressures as high as 1,000 PSI. The ability to use disposable syringes prevented blood borne infection transmission from patient to patient. In Medrad's first six years, there were financial losses but expenses were kept to a minimum. In addition to part-time emergency room employment, Heilman worked as a consultant to the Westinghouse Electric Corporation on a National Institutes of Health funded effort to develop an intra-aortic balloon heart assist device.^[4]

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 of medical imaging injectors and syringes. Under the leadership of subsequent Medrad CEOs Tom Witmer and John Friel, Medrad became a two time winner of the prestigious US Department of Commerce Malcolm Baldrige National Quality Award, the first occurring in 2003 and the second in 2010 www.baldrige.nist.gov/PDF files/2010 MEDRAD Award Application Summary.pdf. Each year, across the US, only 10 or so non-profit or profit making organizations receive this award.

Defibrillators and Personal Defibrillators

A new class of defibrillators was invented by Dr. Michel Mirowski, an Israeli cardiologist who imagined shrinking a 20 pound or so defibrillator to a size that could be implanted in high sudden cardiac death or SCD risk patients. In addition to the shrinking, this imaginative device had to automatically detect and effectively treat (correct) the otherwise lethal arrhythmia known as ventricular fibrillation of VF. The device would be with (in) the patient and would therefore be a 'personal' defibrillator as opposed to a non-personal bystander operated defibrillator. Personal defibrillators were first called automatic implantable cardioverter defibrillators or AICDs. Later this acronym was shortened to ICD. Mirowski emigrated from Israel to the US to pursue his dream of making the implantable defibrillator become a reality. Mirowski was a survivor of the Holocaust and was an extremely dedicated and brilliant individual.

During a business trip to Singapore in 1972, Heilman and Mirowski met. Mirowski, with his cardiologist partner, Morton Mower, had been working for three years with Medtronic attempting to develop the ICD, but Medtronic was giving up, believing there was an insignificant market for the ICD. Heilman, like Mirowski, saw the potential for a successfully developed ICD and offered to help Mirowski develop the product. Heilman put together a team consisting of himself, Mirowski, Mower and Dr. Alois Langer, a PhD biomedical engineer along with several other Medrad employees, thus the Medrad spin-out company, Intec Systems was created to develop the ICD. Several additional individuals, including Steve Kolenkik, having implantable pacemaker experience were recruited from ARCO Medical Corporation located near Pittsburgh, PA. From 1972 to 1986, these individuals overcame the multiple technologic and regulatory hurdles associated with creating this new personal defibrillator device. Among other challenges, the device had to be small enough to implant, have a battery that would last for years, have sufficiently reliable capacitors to quickly store and supply electric charge and be enclosed in a hermetically sealed biocompatible encasement. With funding from both Medrad and outside venture capital totaling over $25 million, the tam was able to qualify the ICK for the first human implant at Johns Hopkins Hospital in 1980 and for FDA marketing approval in 1985. In 1986, the ICD technology was sold to Eli Lilly and its subsidiary Cardiac Pacemakers Inc. and subsequently placed in the Guidant Corporation, now part of Boston Scientific. According to Hauser,^[5] in 2009, 140,000 patients received their initial ICD and some 30,000 to 40,000 patients received replacement ICDS. Millions of patients have now been ICD protected from sudden cardiac death, including former Vice President Dick Cheney. In 2002, based on an ICD invention, Heilman, Langer, Mirowski and Mower were inducted into the United States Inventors Hall of Fame www.inventorg/induction/video 2002.html.^[6]

Lifecor and the LifeVest® Wearable Defibrillator

In November 1986, Heilman and Larry Bowling founded Lifecor Inc. to develop a wearable defibrillator. Like the ICD< a warable defibrillator is a personal defibrillator being continually with the patient (~22 hours a day), monitoring the patient's heart for the onset of ventricular fibrillation or VF, the extremely lethal heart arrhythmia. With VF onset, unless defibrillated, patients die in about 10 minutes. With the detection of VF, an ICD or a LifeVest® defibrillator automatically sends an electric charge through the patient's heart to reset the heart's abnormal rhythm to normalcy and thereby save the patient's life. Thus, Lifecor's LifeVest® defibrillator is similar to the ICD, except that it is worn by the patient and thus surgery is avoided. Like the ICD, developm3ent of the wearable defibrillator required overcoming many technologic,^[7] reimbursement and market adoption obstacles www.post-gazette.com/business/businessnews/2012/04/13/Medical-device-company-continues-to-grow-with-a-wearable-defibrillator.html. It took well over a decade to develop and clinically test the LifeVest® defibrillator to achieve FDA marketing approval and reimbursement. The LifeVest® defibrillator fills the gap between virtually no SCD protection and ICD therapy. Indications for LifeVest defibrillator use include before and after coronary artery bypass surgery or CABG, before and after angioplasty, for high SCD risk patients having less than one year life expectancy and in patients suffering a low ejection fraction heart attack during a 30 day triage period to ICD> If the ejection fraction remains low, the ICD is indicated. In 2001, the LifeVest® defibrillator received FDA marketing approval. In 2006, Lifecor's LifeVest technology was purchased by the Zoll Medical Corporation and in 2012, Zoll in turn, was acquired by the Japanese company Asahi Kasei. Use of the LifeVest has increased rapidly in the past few years to over 40,000 patients in 2013 receiving prescriptions for LifeVest® defibrillator use^[8] MSH personal communication with Zoll's LifeVest marketing department www.post-gazette.com/business/businessnews/2012/04/13/Medical-device-company-continues-to-grow-with-a-wearable-defibrillator.html An interesting personal account of an actual LifeVest® defibrillator save, entitled Blue Gel, is told by the sister of a patient wearing the LifeVest® defibrillator, see "Testimonials" under www.zoll.lifevest.com.

VASCOR and Its Failsafe Ventricular Assist Device

Heilman, with several Medrad Intec employees, formed VASCOR in 1986 to develop an implantable left ventricular assist device or VAD to help patients suffering from advanced heart failure. VASCOR has explored several potential heart assist methods, including devices that would push on the outside surface of a failing left ventricle, using magnetic levitation for supporting a bladed rotor in an axial or mixed flow pump and the use of a moving valve placed in series with the heart's failing left ventricle. Finding none of these approaches fully satisfactory, VASCOR has settled on a unique method for using a failsafe counter-pulsation heart assist device powered by a transcutaneous electrical transmission system or TETS. The TETS eliminates driveline infections, a common adverse event experience with existing heart assist devices. The TETS technology has been found fully satisfactory in animal testing and pump animal testing is expected in 2014. Avoiding the spinning rotor of the now commonly used rotary pumps eliminates the associated blood shear with its blood shear related clotting and bleeding complications.

Recognitions -1987, Entrepreneur of the Year Award from Arthur Young and Venture Magazine^[9] -1992, Outstanding Venture Capital Achievement Award, Pittsburgh Venture Capital Association -1995, Michel Mirowwski Award for Excellence in Clinical Cardiology and Electrophysiology www.bostonscienfific.com/cardiac-rhythm-resources/news/mirowski-award.html -2001, Entrepreneurial Excellence Award from the Carnegie Science Center and Pittsburgh Technology Council -2002, US Department of Commerce Award for Contributions to American Innovation www.uspto.gov/web/offices/ac/ahrpa/opa/bicentennial/inductees.htmlwww.uspto.gov/news/pr/2002/02-66.jsp -2002, Induction in to National Inventors Hall of Fame www.inventorg/induction/video 2002.html -2003, Tri-State Inventor of the Yar Award from the Pittsburgh Intellectual Law Association www.piplaonline.org Inventor of the Year Award, Inventor of the Year recipients -2003, Pittsburgh Innovators Award from Pittsburgh Magazing -2004, Visionary Award from the Pittsburgh Life Sciences Greenhouse -2012, Zoll Lifetime Achievement Award

References

External links

• Lifecor