After the official opening of ESAO 2025, the conference will kick off with an inspiring keynote during the first plenary session. We are proud to welcome Dr. Stephen R. Ash, a true pioneer in the field of nephrology and medical technology.
Medical device development: from frustration to failure to success
Everyone knows that necessity is the mother of invention. The question is, who is the father? From personal experience, I can tell you that it is frustrating. That is, frustration with devices and medications that fail to help an ailing patient. We feel extreme disappointment when our tools and methods fail the patient. Frustration turns to despair and grief when treatments fail to halt the progression of organ failure.
Many physicians abandon the technology or stop treating patients at this time. Fortunately, some physicians use their medical knowledge and experience and collaborate with engineers and scientists to find or invent new and novel approaches. When the new approach causes problems or fails to help the patient, those physicians keep looking for modifications or new components to fix it. That process may take years or even decades of effort.
Willem Kolff was one of these pioneers. He realized that it is the early adopters who convert an invention to an innovation. He encouraged physicians and scientists such as John Merrill, Belding Scribner, Wayne Quinton and Chris Blagg to prove that dialysis could be workable as long-term therapy for kidney failure. They contributed new inventions and dialysis schedules to make dialysis more practical, therapeutic, and workable in the home environment.
When I graduated from Fellowship in Nephrology in 1975, it was obvious that dialysis worked to sustain life in patients with kidney failure. But 3-per-week sessions of dialysis caused adverse symptoms, and the new equipment was even more difficult to implement in the home. I committed my research career to finding ways to make dialysis simpler, safer, and more suited for the home environment. I went to the University of Utah as a temporary staff member that summer to work with the Nephrology Department and Dr. Kolff in the development of his Wearable Artificial Kidney (WAK).
In the following decades, while in Lafayette, Indiana, I led a research team to find new technology and invent new devices to improve dialysis therapy. Twelve projects were dedicated to hemodialysis, and these are described in Editorials in the Artificial Organs journal and in a book (1) (2). Two of the projects were highly successful, resulting in widescale changes in nephrology practice (the Ash Split Catheter and oral zirconium cyclosilicate for potassium control). Others were technically successful but did not change medical practice widely. I will discuss these projects and the reasons for their success or failure in my presentation at ESAO 2025.
Along the way, I came up with 10 suggestions on how to develop new medical technologies (3):
- Know the problem
- Know but doubt the paradigm
- Train with the best in scientific method
- Use the newest tools, model all you can
- Focus
- Collaborate
- Communicate, Publish
- Be patient
- Be careful
- Keep balance in your life, strong family ties and faith, but maintain humility.
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1. Ash SR, Artificial Organs 2022, Editorials Jan-Dec 2. Ash SR, “Success is Just Running Out of Mistakes”, Moon Shard Media, 2024 3. Ash SR, ASAIO J. 2006 NovDec;52(6):e3-9
Biography
Dr. Ash recently retired from the Nephrology Department at Indiana University Health Arnett in Lafayette, Indiana. He is CEO of HemoCleanse Technologies, Chairman of the Board of Ash Access Technology and co-founder of a number of spin-off biotechnology firms. He has a long history of research and product development in the field of sorbents, resulting in devices for the treatment of kidney failure (Allient™ by Renal Solutions) and for liver failure (Liver Dialysis™ by HemoTherapies). He was instrumental in the development of an orally ingested sorbent for potassium (zirconium cyclo-silicate, now marketed by AstraZeneca as Lokelma®). Dr. Ash has also invented a number of new catheters for dialysis access, including the Ash Split Cath®, CentrosFLO® and Channel™ peritoneal catheter.
Dr. Ash is a co-founder and Past President of the American Society for Diagnostic and Interventional Nephrology (ASDIN). He is the Past President of ASAIO and, until recently, served as Secretary-Treasurer of IFAO. He is the recipient of the Lifetime Achievement Award from ASDIN, the Celebration of Life Honor by NKF of Indiana, the Lifetime Achievement Award from the Annual Dialysis Conference and recently the KidneyX prize from HHS and ASN for his work on uremic toxin sorbents.