About AAMI

Medical Device Pioneer Embraces Scientific, Spiritual Healing

When 8-year-old Earl Bakken saw the classic horror movie Frankenstein in 1932, he didn’t cringe or look away when the monster’s arm started to move after receiving a jolt of electricity.

Earl Bakken, with Mary Logan, President AAMI, and Charles Sidebottom  
Mary Logan, President of AAMI, and Chuck Sidebottom, Medtronic, with Earl Bakken at award ceremony.  
   

Instead he sat there, eyes wide with fascination, as he took in Dr. Frankenstein’s laboratory full of electronic equipment that shot out sparks everywhere.

“I came away from that movie with the idea that I would like to be an electrical engineer, and do something to help people electrically,” Bakken said. He did more than “something” when he invented the first wearable, external pacemaker. The device is now used all over the world, helping millions of people including Bakken himself, who is on his second pacemaker.

“I’m so glad I invented it,” the 87-year-old chuckled.

He also co-founded device manufacturer Medtronic, and played a pivotal part in the formation of AAMI and the association’s early role in the device industry. After he retired to Hawaii, Bakken’s philosophy shifted from sparks to the spirit, as he started to advocate the benefits of spiritual healing.

This summer, the AAMI Board of Directors selected Bakken as the recipient of the prestigious
AAMI Leadership and Achievement Award — an award that has only been bestowed on six individuals in AAMI’s 44-year history.

Keeping Children Alive

Earl BakkenBakken was born in Minneapolis, MN, in 1924, and invented all kinds of things throughout his childhood. His inventions grew from creating a telephone system to speak to a friend across the street to a Taser that shocked bullies.“I even built a kiss-o-meter to measure the intensity of a kiss between a boy and a girl,” said Bakken, who now lives in Kiholo Bay on the island of Hawaii.

In 1949, he dropped out of graduate school at the University of Minnesota to form Medtronic with his brother-in-law Palmer Hermundslie. The first month’s income for the electronic equipment repair company was $8. Now it generates more than $15 billion a year.

But back then, Medtronic was based out of a 600-square-foot garage in Minneapolis. Things began to quickly change for the fledgling company, and its first breakthrough was right around the corner.

In 1954, C. Walton Lillehei, MD, started to operate on infants at the University of Minnesota Hospital to repair heart defects. The procedure required Lillehei to use an alternating current (AC)-powered pacemaker, which was large and bulky, and had to be plugged in to a generator.

On Oct. 31, 1957, a blackout struck Minneapolis. The hospital lost one child who was on the device. Enough was enough for Lillehei, who “wasn’t going to chance losing another child on an AC-operated pacemaker,” Bakken said.

So the doctor sought out Medtronic to create a battery-powered version.

“When I went back to my garage, I found this copy of Popular Electronics that had a design for a circuit for a metronome, which operates at the same rate as a pacemaker,” Bakken told AAMI News recently.

The circuit was transistorized, meaning it could amplify or switch electronic signals. The circuit would transmit electronic clicks through a loudspeaker, and the rate of clicks could be adjusted to fit the music, according to a description on Bakken’s website.

He modified the circuit and placed it in a little box without the loudspeaker. The box, about the size of a paperback book, would be taped to the patient’s chest, and wires could transmit a pulse to the heart through the patient’s chest wall. The box didn’t need to connect to any generator.

One month later, Bakken delivered the pacemaker to Lillehei.

The next day, Bakken was walking through the hospital on another task when something caught his eye in a nearby room. There lay a small child wearing his pacemaker.

The feeling was indescribable. “Here was something you had made with your own hands that was keeping this child alive,” Bakken said. The invention had to go through some further modifications, including putting tape over the dials and switches to make sure the children didn’t play with them and inadvertently change the settings.

Bakken didn’t know at the time how successful his invention would become.

Apparently neither did the Mallory Battery Company, which wanted to buy Medtronic because it was interested in the device. “The company commissioned a study on how many pacemakers would be used in the U.S., and the study predicted it wouldn’t be more than 10,000 units,” Bakken said.

Mallory then backed out of the deal. Medtronic grew to produce millions of pacemakers, and now has operations in 120 countries.

Creating Consensus

As Medtronic grew, Bakken became more involved in the fledgling device industry and learned about evolving regulations from the U.S. Food and Drug Administration (FDA).

He understood the need for compromise and consensus between the device industry and regulators. He saw AAMI as an organization that could foster this collaboration. That is why Bakken agreed to serve as AAMI’s secretary/ treasurer.

When AAMI was in great financial trouble, Bakken recognized that the industry needed to step in financially and so he made the first move by committing significant financial resources to keep AAMI going. Bakken also played a major role in getting groups together.

Michael J. Miller, who served as AAMI’s president for 40 years, recalled Bakken’s role during a 1969 National Institutes of Health conference in Bethesda, MD. “AAMI, and many other organizations, were able to outline the basic and related concepts for legislation, regulation, and standards for devices because of the leadership and support of Bakken,” said Miller.

Bakken also saw standards as a key way of engaging clinicians and industry in the development of new devices. He helped to “shape the future rather than merely react, as is so common in industry,” said Robert Flink, an early leader of AAMI’s standards program.

The Spiritual Side of Healing

BakkenBakken spent most of his life rooted in creating the electrical components of healthcare, but it wasn’t until he retired from Medtronic and moved to Hawaii in 1989 that he learned more about the spiritual side of healing.

“When I came here, I had a mentor called Papa Henry Auwae who said that healing is 20% science and 80% spirituality,” Bakken said. “We tend to go far into science in our hospitals and we don’t get to the spirituality.”

So Bakken helped create the North Hawaii Community Hospital, which combined hightech western medicine with an eastern approach to treating a person’s body, mind, and spirit.

He gets the same feeling practicing spiritual healing that he got when he saw the pacemaker hooked up to that small child.

As he wrote in his 2000 autobiography One Man’s Full Life: “When people wonder what an electrical engineer from the Snow Belt is up to preaching spiritualism and holistic medicine in Hawaii, I have to laugh and say I’m doing pretty much what I’ve done all my life—only nowadays I don’t have to wear a necktie!”

AAMI News: September 2011, Vol. 46, No. 9

RETURN TO AAMI LEADERSHIP