The Accidental Medical Device

Over the years, the medical community has achieved advancement through carefully planned, tested, and developed methods.  While many industry innovations have directly resulted from a direct solution methodology, innovation has often emerged from the unintended consequences of a deliberate approach to a problem.  The artificial, implantable pacemaker emerged as a critical medical device implementation by the developer intending to use a device to record the human heartbeat.

History of Pacemakers

In the early 1900s, scientists and medical researchers began studying the impacts and use of electricity to regulate heart rates (Allan, 2003).  Initial implementations of pacemakers proved to be very unwieldy due to their design's complex nature and required operational dependencies.  While useful in concept, the first pacemaker consisted of cumbersome vacuum tubes and needed a direct external power source creating a traumatic experience for the patient and lacked practicality in mobility (Allan, 2003). 

In 1956, Wilson Greatbatch's mistake of using an incorrect resistor for a device designed to record the heart's electrical rhythm emitted an electrical pulse that coincided with a normal heart rhythm (Medihelp, 2020).  In using the wrong component, Greatbatch discovered the device could regulate a heartbeat rhythm and provided an innovative solution to hospitals' unwieldy external devices. Through strategic placement of the wires and leads, the new pacemaker provided a long-term, mobile solution for patients requiring regulation of their heartbeat (Medihelp, 2020).  

Supporting Factors and Forces

Despite the proof of concept solution of the external pacemakers, the demand for an improved quality of life among those requiring heart rhythm regulation began to drive Greatbatch's discovery.  Before the innovation, pacemakers limited patients to remain in hospitals for the required treatment with limited mobility prevented them from living a fully active life.  In addition to the social demand for mobility among patients, the tests necessary to ethically obtain approval for implementation in humans presented challenges for commercializing the device (Medihelp, 2020).  Initial tests conducted on dogs paved the way for human testing in the mid-1950s.  

Shortly after the initial development and approved testing, approximately 100 people began using the device (Medihelp, 2020).  The device's initial success and technological advancements provided opportunities for future improvement and innovation on the internal pacemaker.  In 1969, the use of a lithium battery increased the pacemaker's life and reduced the frequency of pacemaker replacements and associated medical procedures (Wish, n.d.). Wish (n.d.) noted the advancements in technology improved the device's efficacy by expanding on the initial lower chamber approach to regulating the heartbeat by improving on a dual-chamber system in subsequent enhancements.  Subsequent advancements in technology provided sensoring capabilities that facilitated a "demand-based" pacemaker device that only induced the heart's electrical regulation only at instances when necessary and not in a consistent manner (Wish, n.d.).  

As experienced in the internal pacemaker development, innovation often emerges from accidental or unintentional results in attempts at another solution.  While failure may not serve as the desired result from approaching a proposed solution, success rarely materializes on the first attempt.  Through failed approaches, learning experiences emerge and, in some cases, unintended results present an opportunity for the discovery of innovations designed to increase longevity and quality of life. 

References

Allan, R. (2003, October 26). A Short History of the Pacemaker. Retrieved December 16, 2020, from https://www.electronicdesign.com/technologies/components/article/21773534/a-short-history-of-the-pacemaker

Medihelp. (2020, October 03). The Accidental Invention Of The Lifesaving Pacemaker. Retrieved December 16, 2020, from https://medihelp.life/the-accidental-invention-of-the-lifesaving-pacemaker/

Wish, M. (n.d.). Inova Heart & Vascular. Retrieved December 16, 2020, from https://www.inovaheart.org/heart-care/pacemaker/history