#190 from R&D Innovator Volume 4, Number 12          December 1995

Unconventional R&D
by Wilson Greatbatch

Mr. Greatbatch is the inventor of the implantable cardiac pacemaker.  He has over 150 patents and has published over 100 technical papers.  A National Medal of Technology awardee, hes been inducted into the National Academy of Engineering, the National Inventor's Hall of Fame, and the National Aerospace Hall of Fame.  He has four honorary degrees and holds adjunct professorships, including one at Cornell University.  He is president of Greatbatch GEN-AID Ltd., a company in Clarence, New York.

Researchers in academia generally obtain their funds through government grants to fund the development of their ideas.  In industry, it takes a management hierarchy to review and recommend whether an idea should be pursued.

A few of us disdain the formality and bureaucracy inherent in these approaches, and take off--Edison style--on our own.  It's a lonely road, satisfying only to those who have no ego and thrive on failure.  I am one of these.  Nine things out of ten that I try never work.  But when I persevere, the tenth pays for the other nine.

My philosophy is very simple:  try hard, that's all that the Good Lord requires of you.  It doesn't matter if you succeed or fail.  Failure is a learning experience to help you succeed in a subsequent attempt.

Our mental hospitals are full of people who couldn't stand failure, or who couldn't stand success.  That will never happen to me because I just don't care!  But I do care that I try, and try hard. 

If I demand to be paid for what I do, whether it be in the form of money, or peer approval, or just to have a pesky experiment work, I'm asking to be paid for what I feel is an act of love.  I do it because I feel it's a good thing to do.  The reward isn't in the results.  It's in the doing.  Just to have the total joy of immersing yourself in a good project, irregardless of whether it works or not, or if it makes any money.  Strangely enough, if you tell lots of people about it, if your invention is really needed, and if it solves the problem in an eminently satisfactory way, it will make money in spite of you.  I know.

Many Jobs at Cornell

In the late 1940's, I was a student at Cornell.  I talked my way into the engineering school, but was turned down by campus housing that had no room for married students who didn't live in the county.  So I went out six miles from campus and bought a small farm.  Then I came back a "resident" of the county, and they then let me into the university.  Mom always told me, "There's always a way."  Mom was right.

After my wartime years flying in the rear seat of a carrier-based Navy dive-bomber, it was wonderful just to walk around that beautiful campus, to attend classes, and be able to learn.  But the GI Bill gave me only half of what I needed to feed my family of four.  I worked all kinds of jobs.  That was wonderful too.  Cornell hired me, with experience in radar, to help build the amplifiers that went into their radio telescope.  It sure was thrilling, as an undergraduate, to participate in that cutting-edge science and engineering.  Since I had a radiotelephone license, I got another job running the Cornell transmitter on weekends.  That was eighteen hours on Saturday, eighteen hours on Sunday, and then driving down the mountain to an 8:00 a.m. class on Monday!

But my favorite job was working for the psychology department.  They had an animal behavior farm, studying Pavlovian conditioned reflex.  My job was instrumenting the animals for heart rate and blood pressure.  That experience came in handy a few years later when I got a chance to instrument the first U.S. animals in space, but that's another story.

Two neurosurgeons from Boston were doing experimental brain surgery on some of our animals.  They brought their lunches in brown paper bags, as I did, and we sat in the sun talking about the experiments.  They told me about complete heart block.  A nerve, the atrioventricular bundle, malfunctions and no longer sends the "beat" signal from the auricle to the ventricle.  Complete heart block can be fatal to 50% of sufferers in two years.  But if you apply a 2-volt pulse of 1 to 2 milliseconds duration directly to the heart each second, the patient can return to an active life and can have a near-normal life expectancy.  Artificial pacemakers existed, but they were the size of a TV and had to be plugged into an outlet.  They rolled around on wheels, and delivered a painful 100-volt shock to skin electrodes on the chest.

I knew immediately that I could build a much better and smaller implantable device; but not with the vacuum tubes and storage batteries that we had in the 50's.  But I kept all this in my mind, and went off into aerospace work, building flight-line computers for fighter jets.

My First Pacemaker

By 1956, transistors had been invented and became readily available.  Here was my opportunity to invent a better cardiac pacemaker.  By then I was teaching engineering at the University of Buffalo and working with Dr. Simon Rodbard, detecting and measuring fast heart sounds.

Transistors were an oddity then, but I built a one-transistor 1 khz sine-wave oscillator as an oscilloscope timing marker for fast heart sounds.  When I built my next oscillator, I reached into my resistor box for a 10K base bias resistor, but accidentally picked up a 1 megohm resistor.  The circuit proceeded to give a 2 millisecond pulse every second instead of the 1 kilohm sine wave I was expecting.

I stared at the thing in disbelief, realizing this was exactly the properties of a pacemaker.  For the next several years, most of the world's pacemakers used my blocking oscillator circuit--just because I pulled the wrong resistor out of the box!

At that time I was part of a group of volunteer engineers who were interested in problems with medical instruments.  In one trip to a hospital, I tried to fix an oximeter problem for Dr. William C. Chardack, who was chief of surgery; but I couldn't really help.  While there, I suggested my pacemaker idea.  He looked at me strangely and walked up and down the lab a couple of times and then said, "If you can do that, you can save 10,000 lives a year."

Three weeks later, I brought a prototype pacemaker to him.  It was a tangle of wires, transistors, and batteries; with two wires hanging out.

Dr. Chardack and his team created heart block in an experimental animal by tying off the atrioventricular bundle.  This is an open-heart operation, but we had no heart-lung machine.  Three surgeons gathered around the animal with the beating heart exposed.  On the "go" signal, they clamped the major vessels, opened the heart, tied off the bundle, closed the heart, removed the clamps, and restored circulation, all in some 90 seconds.  I was impressed!

Then I touched the wires of my pacemaker to the slowly beating blocked heart.  Dr. Chardack looked at the pacemaker pattern on the oscilloscope, and then said, "Well I'll be damned!"

My lab notebook shows the following entry for May 6, 1958:  "I don't think anything I ever will do will give me the elation I felt that day when my own assemble of electronics successfully stimulated a living heart."

Our first pacemaker implanted in an animal worked only four hours.  We were so naive as to assume we could hermetically seal it with nylon electrical tape.  We soon learned that any void would fill with fluid and we began to cast our electronics into a solid epoxy block.  In 1960, ten patients were successfully treated with the implantable pacemaker.

But Dr. Chardack was a little off in his predictions of patient population.  In 1994, over 400,000 pacemakers were implanted world-wide, and the company I first licensed, Medtronic, alone did over a billion dollars in global business.

What I like to point out is that we did this without any government grants.  In 1958 I had saved $2,000 and enough extra to feed my family (of seven now) for two years.  I quit all my jobs.  I gave the family money to my wife and took the $2,000 to my wood-heated workshop in the barn behind my house.  In those two years, and with $2,000, I made 50 pacemakers.  We put 40 into animals and then ten into patients in 1960.  The device worked, and we licensed it exclusively to Medtronic.

Improvements

Ten years later, it became obvious that our mercury-powered pacemakers left a lot to be desired.  The batteries which should have lasted six years, failed in two years.  We looked at all kinds of batteries:  batteries rechargeable from outside the body, biological batteries powered by body fluids, and even nuclear batteries.  We finally settled on a lithium-iodine battery, now used by all pacemakers.  Again, we did this without government grants.  Our total R&D effort on the battery problem cost $200,000, all of which came from previous profits.

But pacemakers alleviate only bradycardia (slow heart).  What about tachycardia (fast heart) and fibrillation (chaotic uncontrolled heart)?  These also had been treated with external devices plugged into an electrical outlet.  Then my friend, Dr. Michel Murowski invented an automatic implantable defibrillator that watches the heart and delivers therapeutic stimulation when irregular beats are sensed.  These devices put extraordinary demands on the battery, but we managed to build a lithium battery with a silver vanadium oxide cathode which filled the need.  This battery now powers all implantable defibrillators.  But the R&D costs keep going up.  This one cost ten million dollars and took ten years--but, again, we did this without government support.

Looking back, I don't think we could have done what we did if we had been encumbered with the bureaucratic machinery of government support.  We had to work fast and efficiently, with minimal paperwork, minimal supervision, and maximal self-inspection.  Every assembler was a quality control supervisor.

In the early days, we used to say that if you have to make your drawings before you ship, you're too big.  The key was fast response to a need.  Because of our fast response, we were able to outcompete one of the largest electrical companies.  We're now too big for ignoring drawings (regretfully), but the same spirit is still there in Wilson Greatbatch Ltd.  We have no outside ownership, no long-term debt, and rarely accept government support.  Now, after 25 years, were up to 600 people, and over $40 million in annual sales.  Were now introducing a new lithium/carbon monofluoride battery we expect to be the major implantable power source for the next 25 years.  We pride ourselves as being unconventional.  For instance we give full tuition and books to all employees and their children, wherever they want to go to school.  I hope we stay unconventional!

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