Quanta Begins Study in US to support FDA Submission
7 August 2019: Quanta Dialysis Technologies Ltd, 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
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.