Preliminary development of an advanced modular pressure relief cushion: Testing and user evaluation Tyler Freeto, M.S. a, b , Steven J. Mitchell c , Kath M. Bogie, D.Phil a, b, d, * a Advanced Platform Technology Center, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH 44106, USA b Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH 44106, USA c SCI/D Service, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH 44106, USA d Department of Orthopaedics, Case Western Reserve University, Cleveland, OH 44106, USA article info Article history: Received 9 January 2017 Received in revised form 6 March 2017 Accepted 14 March 2017 Keywords: Wheelchair cushion Value drive engineering Standardized biomechanical testing abstract Study aim: Effective pressure relief cushions are identified as a core assistive technology need by the World Health Organization Global Cooperation on Assistive Technology. High quality affordable wheel- chair cushions could provide effective pressure relief for many individuals with limited access to advanced assistive technology. Materials: Value driven engineering (VdE) principles were employed to develop a prototype modular cushion. Low cost dynamically responsive gel balls were arranged in a close packed array and seated in bilayer foam for containment and support. Two modular cushions, one with high compliance balls and one with moderate compliance balls were compared with High Profile and Low Profile Roho ® and Jay ® Medical 2 cushions. Methods: ISO 16480-2 biomechanical standardized tests were applied to assess cushion performance. A preliminary materials cost analysis was carried out. A prototype modular cushion was evaluated by 12 participants who reported satisfaction using a questionnaire based on the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) instrument. Results: Overall the modular cushions performed better than, or on par with, the most widely prescribed commercially available cushions under ISO 16480-2 testing. Users rated the modular cushion highly for overall appearance, size and dimensions, comfort, safety, stability, ease of adjustment and general ease of use. Cost-analysis indicated that every modular cushion component a could be replaced several times and still maintain cost-efficacy over the complete cushion lifecycle. Conclusion: A VdE modular cushion has the potential provide effective pressure relief for many users at a low lifetime cost. © 2017 Published by Elsevier Ltd on behalf of Tissue Viability Society. 1. Introduction For most wheelchair users, a cushion is essential due to the increased risk of minor skin breakdown during sitting, which can rapidly deteriorate into extensive tissue breakdown, further reducing mobility and producing psychological distress. As the World Health Organization Global Cooperation on Assistive Tech- nology (WHO-GATE) mission states: access to high quality afford- able assistive products enables the individual with disability to lead a healthy, productive and dignified life [1]. Core assistive technol- ogy identified by WHO-GATE includes a wheelchair seating system, comprising both a wheelchair and an effective pressure relief cushion. Numerous studies have shown that although no single cushion can meet every user's needs, pressure relieving cushions are a critical component in all wheelchair seating systems in order to maximize function for individuals with mobility restrictions and decrease the risk of pressure injury (PrI) development [2e6]. Ill- fitted cushions and wheelchairs increase the risk of PrI formation [4]. The provision of appropriate cushions is an integral part of any wheelchair seating program. Pressure relief cushions are generally classified as foam, visco- elastic foam, gel or air (‘flotation’) based. The construction and design of a cushion affects its performance. Pressure relief can be * Corresponding author. Cleveland Advanced Platform Technology Center, Louis Stokes Cleveland VA Medical Center, 10701 East Boulevard, Cleveland, OH 44106, USA. E-mail address: kmb3@case.edu (K.M. Bogie). Contents lists available at ScienceDirect Journal of Tissue Viability journal homepage: www.elsevier.com/locate/jtv http://dx.doi.org/10.1016/j.jtv.2017.03.001 0965-206X/© 2017 Published by Elsevier Ltd on behalf of Tissue Viability Society. Journal of Tissue Viability xxx (2017) 1e8 Please cite this article in press as: FreetoT, et al., Preliminary development of an advanced modular pressure relief cushion: Testing and user evaluation, Journal of Tissue Viability (2017), http://dx.doi.org/10.1016/j.jtv.2017.03.001