Quanta Dialysis Technologies Ltd, a British medical technology company developing a personal haemodialysis system for patient use in the clinic and the home, announces that it has begun human factors testing of SC+ in the United States with Design Science, a leading specialist in medical device usability.
Alcester, Warwickshire, UK, 7 August 2019: Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a British medical technology company developing a personal haemodialysis system (SC+) for patient use in the clinic and the home, today announces that it has begun human factors testing of SC+ in the United States with Design Science, a leading specialist in medical device usability.
Human factors testing (HFT) is used to assess how intended users interact with a medical device in representative real‐world conditions. The HFT study will be conducted in the US with end users representing a diverse range of age and ethnicity of the adult US population, to evaluate the safety and effective use of Quanta’s updated SC+ system. This represents an important step towards Quanta’s 510(k) submission to the FDA planned for later this year and, ultimately, US market entry.
From the beginning, SC+ has been designed with ease-of-use and patient safety as core attributes. Quanta has systematically applied state-of-the-art human factors engineering principles to develop a device that is simple and intuitive to operate, with the objective of empowering more patients to take control of their lives through self-care and home haemodialysis.
This study builds on earlier human factors testing conducted in the UK, as reported in Quanta’s previously published human factors paper in Hemodialysis International (click here).
John E. Milad, Chief Executive Officer of Quanta, said: “We are delighted to be working with world-leading experts at Design Science on this important study that will help us bring SC+ to American patients and healthcare professionals. Results from this study will form an important part of our FDA submission strategy. Meanwhile, following the recently announced American Kidney Health Initiative, there has never been a stronger imperative for Quanta to bring SC+ to the US.”
Katie Hansbro, Chief Executive Officer of Design Science, said: “When we design usability studies during which users get to interact with novel medical technology, we are able to see first-hand how patients become excited by products with the potential to drastically improve their care experience. In all our work, we seek to amplify users’ needs to cultivate advancements in healthcare technology—and evaluating novel systems for companies like Quanta enables us to do that.”
