Patient-centric design of a multivial access device using modular innovation principles to further improve the facilitated subcutaneous immunoglobulin administration experience

Facilitated subcutaneous immunoglobulin 10% (fSCIG 10%), provided as a dual-vial unit (DVU) of human immunoglobulin G 10% (IG) and recombinant human hyaluronidase (HY), is approved for treatment of adults with primary immunodeficiency disease (PIDD) in the USA. The current fSCIG 10% infusion process involves multiple steps that need repeating for patients requiring multiple DVUs per infusion. We hypothesized that the infusion process could be improved using patient-centric design and modular innovation principles. Ethnographic research was conducted to understand patient and nurse experiences of administering fSCIG 10%, and to identify opportunities to improve the infusion process. Following feedback from four patients receiving fSCIG 10% for PIDD (at-home observations and feedback sessions) and four nurses providing fSCIG 10% infusion training (interviews and mock training sessions), device design objectives were set: simplify steps for fSCIG 10% preparation and infusion, standardize equipment and infusion stages and improve patient mobility during infusions. To evaluate prototypes of a multivial access device, formative usability evaluation research was conducted with 10 patients and four nurses; observations were used to develop the final device. The final device (HyHub) appears as a tray with four DVU docks. Tubing underneath the docking stations connects HY and IG vials with separate color-coded connectors. The HY preparation process involves removing cover(s) from dock(s), inserting DVU(s) and drawing HY into a syringe from the HY connector attached to the device. To prepare IG, the pump tubing is attached to the IG connector on the device. Syringes cannot be connected to the IG connector. Infusion administration remains similar to the current method. Compared with the current fSCIG 10% infusion process, the multivial access device simplifies preparation, fewer components are required and the device carrier (developed to hold the device and infusion pump) improves patient mobility during infusions. Patient-centric design and modular innovation principles were used to develop a multivial access device to improve the patient experience of fSCIG 10% infusion. Further research will assess its impact on patient quality of life. Baxalta, a member of the Takeda group of companies funded this study. Takeda Pharmaceuticals International AG funded writing support.