IOPI Northwest

Mission Statement

IOPI Medical LLC, founded by the co-inventor of the IOPI, is dedicated to providing and supporting instrumentation useful to clinicians who are primarily involved with diagnosis and treatment of individuals with oral motor problems. Deficits in oral strength can affect chewing, swallowing and speech. Central to these purposes is the normal muscular strength of the tongue. The Iowa Oral Performance Instrument (IOPI) was specifically developed to accurately and objectively measure the strength and fatigability of the tongue while being, at the same time, easy to use by clinicians.  Ultimately, the degree to which the Company is successful in its mission is based on the degree to which the IOPI proves itself to be an effective instrument to help clinicians help people.

Invention History

Initial steps

As the result of a question posed by a fellow faculty member, “can you think of a way to measure the strength of the tongue in children?” Erich Luschei* (subsequently “I”) began experimenting with various transducers in 1988. Methods based upon strain gauges applied to various “beam” substrates had been used effectively in the laboratory of other scientists, but they did not seem easily adapted to widespread clinical measurement, particularly of children. One of the problems of using a strain-gauge based system to measure the strength of a push with the tongue is that the “beam,” whatever its shape, needs to be a rather rigid material having some degree of “spring” to it. In this case, the tongue, a soft complaint tissue, comes into contact with the edge of the rigid beam or its appurtenances, e.g. a “cradle” attached to the strain gauge beam. I discovered, in experiments using myself as the subject, that no matter how the strain gauge “beam” was shaped, the interface between the tongue and its contact with the strain gauge was always painful, or at least uncomfortable, during a maximal strength effort with the tongue. This was significant because, if the response was painful, one would be measuring pain tolerance rather than strength. A painful response would be particularly critical when testing a child. This observation, along with other problems with using a strain gauge system, made me try to think of other approaches to the problem, and it occurred to me to measure the pressure created in a small, compliant bulb when it is pushed against the roof of the mouth with the tongue. It is unusual to use pressure rather than force to measure strength, but it is to be remembered that “strength” is a concept, not the method that is used to measure it.

*People are often unsure how to pronounce "Luschei." It is actually pretty easy: "Loo-shy." Just think of an Englishman who is afraid of bathrooms.

IOPI design and first tests

I began to work with Professor Donald A. Robin, a faculty colleague, at this stage of the IOPI’s development. He suggested that it would be possible to measure tongue fatigue as well as tongue strength by measuring how long a subject could sustain a tongue pressure of 50% of their maximum pressure. I then developed an electronic circuit that would measure tongue strength and fatigability while, at the same time, would be portable and easy to use by someone not familiar with electronics. I built several of these units and Dr. Robin began to use them with students and normal volunteers of various ages and gender. These measurements established that the measures of tongue strength, in any one person, were very reliable (repeatable), and the maximum tongue strength and fatigability compared between different people, while variable, showed a clear central tendency.

The IOPI Patent and FDA Registration

The University of Iowa Research Foundation applied for and was granted a patent for the IOPI. Soon after patenting, an application to register the IOPI as a medical device was submitted to the FDA. After conducting tests in our lab to show that the blue bulb is very firmly attached to the stem (tube) of the tongue bulb, the FDA registered the IOPI as a Class I (low risk) medical device, and allowed its sale to the public.

Company History

I retired from the University of Iowa in 1998, and my wife and I moved to Carnation, Washington (near Seattle). About this time, the Iowa-based company that had been manufacturing and selling the IOPI, Breakthrough, Inc., made a decision to go in another business direction, and they dropped the IOPI. A significant number of Speech Pathologists, especially researchers, still wanted to obtain an IOPI, so I started IOPI Northwest Company in 2001. From 2004 to 2008, the IOPI was sold through a distributor, but in September of 2008, a decision was made to make it a family business and to sell the IOPI directly. My wife, Nancy, Ed.S, is Vice-President. Our daughter, Tara Hart, Ph.D, is the CEO, and our son, Edward Luschei, Ph.D, became our IT Consultant. I became Production Manager and Corporate Philosopher (aka President). 

Due to many foreign requests to purchase the IOPI, we decided in 2009 to begin the process of getting the IOPI CE Certified.  We are now in the midst of this process and hope to have the product ready for shipment by Summer of 2010.  To reflect this shift in market, we also decided to change our company name to IOPI Medical LLC.