Human factors and usability engineering in the development of SMT-101 for the treatment of pulmonary arterial hypertension

ABSTRACT

Background: SMT-101, a novel, proprietary, water-resistant wearable infusion pump prefilled with a preset dosage of treprostinil, was designed to address many of the administration-related shortcomings of existing parenteral therapy for pulmonary arterial hypertension (PAH). The objective of the human factors (HF) program was to demonstrate that the SMT-101 system is safe and effective when used by patients with PAH, their caregivers, or healthcare providers.

Methods: The HF program for SMT-101 consisted of 8 studies (148 participants): an ethnographic study, an online survey of patients with PAH, 4 formative studies, a study of the instructions for use (IFU), and a summative study for validation. The pump and IFU were iteratively modified using observational data and participant feedback to inform subsequent improvements throughout the HF program to optimize safe use of SMT-101 before the final study.

Results: The results of the summative study demonstrated that the design of the SMT-101 wearable, pre-filled infusion pump and IFU are safe and effective for use.

Conclusions: In accordance with regulatory guidelines, the usability and HF aspects of SMT-101 were developed and refined through a rigorous HF program in patients with PAH and healthcare providers, which culminated in a summative study that validated the usability and use-safety of SMT-101.

KEYWORDS:

• Human factors
• parenteral
• pulmonary arterial hypertension
• SMT-101
• treprostinil
• wearable infusion pump

Acknowledgements

The authors gratefully acknowledge the contributions of Rob Fernall and Michael Penman of Team Consulting to the conduct of the SMT-101 HF studies and of Marylyn Rigby of SteadyMed Therapeutics to the preparation of this manuscript. Stewart Fox and Michael Penman contributed to device design and executing HF program studies. Marylyn Rigby contributed to the final version of the manuscript.

Declaration of Interest

P Noymer is an employee of SteadyMed Therapeutics, Inc., a wholly-owned subsidiary of SteadyMed Ltd. A Shaked is an employee of SteadyMed Ltd. K Newell is an employee of Team Consulting. These studies were sponsored by SteadyMed Ltd. Team Consulting, under contract with SteadyMed Ltd., designed and performed the HF studies, monitored and analyzed the data, and wrote the study reports. All studies had informed consent. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was funded by SteadyMed Therapeutics

Notes on contributors

Peter Noymer

Peter Noymer and Assaf Shaked wrote the manuscript and provided overall direction and planning to the Human factors Engineering program.

Kay Newell

Kay Newell planned and executed the Human factors Engineering program, designed and performed the individual studies and generated the reports. All authors provided critical feedback and helped shape the research, analysis and manuscript.