Rolling Stones Team

We wish to nominate the “Rolling Stones team” for the Distinguished Staff Award for inventing a revolutionary treatment for kidney stones and initiating a human clinical trial. They are the first UW team to invent a device and pursue an investigational device exemption from the U.S. Food and Drug Administration (FDA) to test on humans. This accomplishment brings recognition, funding, and potentially royalties to the UW and is well beyond their job descriptions.

This letter describes each team member’s contribution. The three support letters explain 1) the challenge of the trial and value of their invention, 2) how they excelled at their jobs while pursuing the Rolling Stones project, and 3) the impact of this team.

The Rolling Stones team invented a non-invasive way to push stones out of the kidney (apl.uw.edu/pushingstones). Kidney stones can be painful and injurious; one in 11 Americans suffer from them. Kidney stones can be debilitating, resulting in the need for narcotics, repeated x-rays, and, when large, surgery. The team invented ultrasonic propulsion (UP) to move small stones out of the kidney before the stones require surgery, move large stones from an obstructing location back into the kidney to avoid pain and emergency surgery, and expel little fragments from surgery, which will grow to a new stone.

UP is elegant in how smoothly it works. With a handheld probe on the skin, the user sees the stone and kidney on an image on the screen, the user touches the screen where he/she sees the stone, the machine sends ultrasound waves through the skin to the stone, and the user watches the stone move. Urologists called UP a “game changer” in the summary of the 2012 annual AUA meeting. NASA has invested because astronauts are at increased risk of stones in space, and one mission nearly de-orbited before the cosmonaut’s stone finally passed. The UW Center for Commercialization, the Life Science Discovery Fund, the Coulter Foundation, the Washington Research Foundation have recognized a commercial opportunity that will generate revenue for the UW and have added funding to that of NIH and NASA.

Many people contributed, but the core team who have carried this project for the past 4 years, includes these 5 members. Their job descriptions are to carry out research tasks defined in funded grant proposals, specifically, to laboratory test the concept of repositioning kidney stones. They did much more than that: they designed new tests and experiments, generated and received funding for new proposals, conducted hands-on demonstrations, presented results, wrote papers, developed patents, obtained FDA approval, conducted a trial, and contributed to NASA, AUA, and UW press releases. All of these tasks are well beyond the job requirements, and perhaps the comfort zone, of research scientists.

Barbrina Dunmire voluntarily assumed the role of determining what needed to be tested and preparing the regulatory paperwork. She read regulations and wrote documents in the evenings while watching sports on TV. On her own time, Barbrina took the UW’s medical regulatory course. Barbrina’s 350-page application was approved by FDA: she succeeded where others give up. She has since guided the paperwork through the Urology department, UW IRB, and UWMC’s CRBB, and prepared the reporting documents for FDA. Her work was so good that we have positive contacts in the regulatory bodies, enthusiasm within CIMU, and a template to repeat the process. The UW can now build a device and test it in a human trial.

Bryan Cunitz envisioned and built the device on his own and designed and documented it to FDA’s satisfaction. He designed and conducted the tests for FDA to characterize the output. These tests required moving a receiver throughout the field repeatedly. Bryan automated the test system to run around the clock. He controlled it from home on nights and weekends, but equipment limitations required him to reset it every 3-4 hours. He never mistakenly rammed the sensitive receiver into the wall—an easy mistake even when the operator is in the room with the moving experiment.

Marla Paun is an ultrasonographer—an operator of ultrasound imaging equipment. She operated the system for hundreds of experiments, and her expertise guided the development of the professional high quality image. Her skill obtained the positive results with early prototypes, which kept the project going. She was always on call. She was on her feet all day starting with pre-experiment determination of kidney health, operating the system for long hours, and making herself invaluable at the end of experiments. Marla dug a machine out of her garage, which she used to create a system to pressure-fix the tissue, and she stayed to the end of each day to operate her machine. In addition, Marla established positive relationships for the clinical trial by being on call to conduct additional human studies. She maintained all her credentials at several hospitals, including paying for her own CME credits, and would arrange for a truck to transport her equipment. She would integrate herself into a new tense OR environment and professionally collect data without interrupting surgery. Many studies fell on days Marla had off for holidays or vacation or because she had reduced her hours because of lack of funding, yet she always participated often on short notice.

Frank “Rusty” Starr hyper-extended his knee in the line of duty so badly that it led to an artificial knee replacement within 2 years, yet he continued to work the most intense week of the effort without complaint before seeking medical help. His expertise was needed, and he stuck it out. Rusty’s role was to oversee all aspects of the preclinical safety testing. In addition, Rusty helped locate a used x-ray imager that he recognized was needed for the study. He repaired it, obtained UW, state, and federal approval for use, and expertly operated the system.

Yak-Nam Wang’s job description differs slightly, and as a PhD, she is expected to develop and fund her own research program, which she does very well. She is funded by more grants than anyone in CIMU. However, in addition, she single-handedly provides CIMU the capability to assess bio-effect by selecting and conducting the appropriate biological assays. For this project’s experiments, Yak-Nam participated from beginning to end, and no job was too small. She collected the animals and cleaned up after them. She developed and perfected a tissue collection technique. She utilized several staining techniques. She sent over 400 blood, urine, and histology samples around the country for preparation and analysis. She recruited a board-certified pathologist and helped write a specific proposal to fund him. All this effort was a logistical nightmare over many months yet Yak-Nam kept it organized and continued to conduct research the whole time on her own grants.

In summary, the Rolling Stones team invented a revolutionary solution for kidney stones, obtained approval to test UP on humans, and now conduct the human trial with urologists. The major effort was the middle step, which could not have been defined, or therefore funded by a grant, because it required negotiation with the FDA. As such, carrying UP to demonstration in humans was outside their job descriptions, and makes it possible UP will help patients.