Quality Policy

IOPI Medical is committed to designing, manufacturing, and marketing high quality instruments that are reliable, safe, and easy to use by health professionals working with patients with oral motor problems affecting swallowing and speech. IOPI Medical strives to provide excellent customer service throughout the lifetime of its products, including technical advice about the device, its uses, and relevant research. IOPI Medical’s policy is to implement a quality management system and processes to meet the regulatory requirements and standards where IOPI Medical products are sold.

Company History

Dr. Erich Luschei founded IOPI Medical LLC (fka IOPI Northwest LLC) in 2001. Dr. Luschei was President of the company, and his wife, Nancy, was Vice-President. In 2008, their daughter, Dr. Tara Mythen, joined the team to take IOPI Medical global, and in 2010 she became CEO. In 2011, the company became certified to ISO 13485:2003 under the Canadian Medical Device Regulation and the IOPI System became CE marked. When the Luschei's retired in 2018, Tara became President and CEO and Dr. Luschei transitioned to the role of founder and advisor.

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?” Dr. Erich Luschei 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 to measure tongue strength, but they did not seem easily adapted to widespread clinical measurement, particularly for 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. Dr. Luschei discovered, in experiments using himself as the subject, that no matter how the strain gauge “beam” was shaped, the interface between the tongue and its contact with the edge of the strain gauge beam 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, led Dr. Luschei to try to think of other approaches to the problem, and it occurred to him 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.

IOPI design and first tests

Dr. Luschei began to work with Professor Donald A. Robin, a faculty colleague, at this stage of the IOPI’s development. Dr. Robin suggested that it would be possible to measure tongue endurance as well as tongue strength by measuring how long a subject could sustain a tongue pressure of 50% of their maximum pressure. Dr. Luschei then developed an electronic circuit that would measure tongue strength and endurance while, at the same time, would be portable and easy to use by someone not familiar with electronics. Dr. Luschei 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 endurance compared between different people, while variable, showed a clear central tendency.