Meet Your Team 2 - IOPI Medical

MEET YOUR TEAM

Quality Product | Family Owned

Dr. Erich Luschei, PhD

- Founder & Advisor -

Dr. Erich Luschei, PhD founded IOPI Medical LLC (fka IOPI Northwest LLC) in 2001. He developed the IOPI while a professor in the speech department at the University of Iowa in 1992. Erich specialized in research on the neurophysiology of oral motor control. After being President of the company for 17 years, he now performs the role of Advisor.

Dr. Tara Mythen, PhD

- President & CEO -

Dr. Tara Mythen, PhD, has been the CEO of IOPI Medical LLC since 2010 and President since 2018. She has a PhD from the Department of Environmental Health from the University of Washington. She is also Dr. Erich Luschei's daughter and became inspired by the global potential of the IOPI device after she joined the Board of Directors. She has been instrumental in developing the new Series 3 product line as well as establishing IOPI® as a global brand. In her spare time she enjoys anything active, particularly escaping to the mountains.

Amy Temple

- Chief Operating Officer -

Amy Temple is the Chief Operating Officer of IOPI Medical. She oversees IOPI Medical's ongoing operations and procedures, collaborating with the leadership team to develop and implement plans for the operational infrastructure of systems, policies, processes, and staff, including establishing policies that promote company culture and vision. She is responsible for designing and implementing business strategies, plans and procedures. Amy works directly with employees to encourage maximum performance and dedication. Amy was responsible for IOPI Medical’s selection as one of only 39 companies nationwide to receive the President’s “E” Award for exports, the highest recognition any U.S. company can receive for making significant contributions to the expansion of U.S. exports.
She is passionate about ensuring IOPI Medical’s customers are provided with the highest quality attention, care, and products. When not in the office Amy enjoys spending time with her friends and family, visiting local wineries, and experiencing all that the Pacific Northwest has to offer.

Meghan Rauch

- Biomedical Engineer & Quality Manager -

Meghan Rauch is the Biomedical Engineer and Quality Manager of IOPI Medical. She oversees IOPI Medical’s quality and regulatory department and provides support for research and development. She is responsible for developing and implementing procedures and policies to achieve state-of-the-art compliance with global quality standards and regulations for medical device design and manufacturing, as well as facilitating development activities for future IOPI products.Meghan was integral to the final release of the current Series 3 product line and the updating of the quality management system to the ISO 13485:2016 standard. She is committed to advancing the high standard of excellence that is associated with IOPI Medical products, both present and future.When she’s not working, Meghan likes to explore the greater Seattle area with her partner and their rescued pit bull mix; her favorite destinations are parks and craft breweries.

Amman Berhe

- Production Assistant -

Amman Berhe is a Production Assistant for IOPI Medical. He is responsible for assisting the manufacturing supervisor as well as various administrative tasks. These duties include light manufacturing, shipping and receiving products and ensuring raw materials are stocked. Amman also assists in the quality control process and helps troubleshoot technical difficulties related to activities in the production arena. A United States Air Force veteran as an F-16 Aircraft Armament Systems Craftsman/Load Crew Team Chief, Amman has 6 years of experience working on a multitude of mechanical and electrical mechanisms. Outside of the office, Amman enjoys working on his project car, exploring local museums and catching up with family and friends.

Ara Lunsford

- Purchasing Officer -

Ara Lunsford is the Purchasing Officer for IOPI Medical. She is responsible for working with a variety of vendors to acquire the supplies necessary for the production of IOPI products. She believes that being prepared is the best way to provide excellent customer service to our customers. In her free time, Ara enjoys being a mom and wife. As a family they enjoy road trips, coffee shops and exploring unique Pacific Northwest towns.

Caitlin Devereaux

- Regulatory Specialist -

Caitlin Devereaux is IOPI Medical’s Regulatory Specialist. She ensures that IOPI products comply with medical device regulations in established and new markets. Along with the rest of the IOPI Medical team, she is dedicated to delivering consistently safe and effective products that improve patients’ quality of life. Caitlin’s attention to detail and talent for organizing information are valuable assets in the evolving world of medical device regulations. She brings 15 years of medical device experience to IOPI, with particular emphasis on design controls and medical writing. Outside of work hours, Caitlin enjoys spending time with her children, gardening, reading dystopian sci-fi, and bingeing the latest TV show on Netflix.

Ed M. Bice, M.Ed., CCC-SLP

- Clinical Consultant -

Ed M. Bice is IOPI Medical’s Clinical Consultant. He provides support to IOPI Customers worldwide to those who have questions concerning the use of the IOPI as well as helping clinicians to problem solve complex patient cases. He offers online courses related to the IOPI family of products. Ed also provides clinical insight to the product development and regulatory compliance teams. He has a passion for helping patients regain their ability to eat and drink and educating clinicians who provide them treatment. He is an author of research in peer-reviewed journals and a guest blogger. You can hear him on podcasts, and at state and national conventions. Away from work, Ed enjoys gardening, playing with his four-legged family members, and spoiling his granddaughter.

Harley Hart

- Office Manager & Senior Customer Service Representative -

Harley Hart is the Office Manager & Senior Customer Service Representative at IOPI Medical. Processing orders, assisting customers, coordinating office operations, and supporting staff are some of the things she can be found doing around the office. Harley is passionate about providing the best customer care possible and enjoys supporting the IOPI team with accomplishing their goals. Responsible for developing IOPI Medical’s culture and values, Harley enjoys the interpersonal aspect of her role above all else. Outside of the office, Harley loves spending time with animals and her family.

Jason Hart

- Account Executive -

In Jason Hart’s role as IOPI Medical’s Account Executive, he assists customers in determining how best to meet their requirements, from providing quotes to product acquisition. When he is not assisting customers, Jason works on a variety of projects in support of the growth of IOPI Medical. Providing exceptional customer service drives Jason to work hard and, with the help of his wife Harley, turn around orders as quickly and efficiently as possible. When not in the office, Jason can be found outside with his Chihuahua-Pug mix JoJo, strumming his guitar, or watching one of Gordon Ramsay’s many shows.

Kellan Mythen

- Head of User Experience -

Kellan Mythen is the Head of User Experience at IOPI Medical. His job includes conducting user research, collaborating with clinicians and experts, and developing the next generation of software products for IOPI using C++ and Unreal Engine. Before working at IOPI Medical, Kellan studied game design and development at DigiPen Institute of Technology and worked as a VR developer at Chronos Development Studios. As a passion project, Kellan developed the world's first integration of OpenAI's language model, GPT-3, in Unreal Engine and released it as an open-source plugin. He is passionate about using emerging tech for social good. In addition to his career, he co-founded the Immersive Learning Initiative. a non-profit organization specializing in creating VR experiences for teaching literacy skills to kids with learning disabilities.

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 as CEO in order to take the company global . 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 Luscheis 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.