Challenge icon

The Challenge

In 2024, Innovenn’s Human Factors affiliate, Improvita, initiated a Human Factors (HF) Summative Validation program for a combination product intended to treat users with rheumatic disorders and other diseases involving chronic inflammatory and allergic processes. This effort involved the recruitment of participants with several rare disease states, such as optic neuritis and systemic dermatomyositis. The study provided essential Human Factors validation data demonstrating that patients and caregivers can use the prefilled syringe correctly and without serious use errors, as required under Food and Drug Administration (FDA) guidance for the usability of combination products. As recommended by the FDA, the study included five distinct user groups, each corresponding to a unique indication and incorporating a balanced mix of injection-experienced and injection-naïve participants. This design strengthened the evaluation and captured a representative range of intended users and use scenarios, allowing assessment of potential use-related risks across all relevant populations.

Doctor holding syringe filled with blue liquid

Recruiting 75 participants with rare diseases posed a significant challenge, particularly under an aggressive study timeline. Due to the inherent complexities of rare disease populations, including geographic dispersion, limited patient availability, and varied physical capabilities, traditional recruitment and study execution methods were not sufficient. To address this, we leveraged our unique participant empathy program, in which we emphasized personalized accommodations to meet patients where they are. This included traveling to participants’ locations in 13 different cities, understanding individual needs, and adapting logistics accordingly. The program was instrumental in both successfully recruiting a diverse participant pool and ensuring the trial could be conducted smoothly. Moreover, the study was designed to accommodate varying levels of dexterity and vision among participants, ensuring that all users, including those with physical limitations, could safely and effectively use the prefilled syringe.

Solution icon

What We Did

  • Designed a Human Factors program based upon the client’s risk management documentation (i.e., task analysis, risk assessment, etc.)
  • Revised the protocol and recruitment materials to include additional user groups and rare disease states. Submitted both the revised protocol and recruitment materials to the IRB for re-review
  • Coordinated outreach to potential participants with specific rare diseases to recruit a targeted, yet robust, pool of participants. Recruitment efforts were customized for each region to tap into local communities and rare disease networks, including advocacy groups
  • Created a revised recruitment plan to incorporate these additional user groups, and travel planning to accommodate participants’ needs. Many of these participants experienced symptoms that limited their mobility. The Innovenn team accommodated participants’ needs by traveling to the patients
  • Managed the logistical complexities of conducting the study across 13 cities. This involved planning and scheduling visits with participants, coordinating local facilities, and ensuring that the study was consistent across all sites. Our team traveled to each city to oversee the study, ensuring consistency in data collection and participant experience
  • All Human Factors data were meticulously collected and analyzed. This included error rates, participant satisfaction, and suggestions for product improvement. Our team used this data to provide the client with actionable insights and recommendations for design adjustments
Results icon

Results Delivered

  • A full recruitment of 81 participants as part of our recruitment plan to account for scheduling changes, including those with rare diseases and caregivers
  • Alignment with the FDA on Human Factors Validation protocol
  • Tailored recruitment strategies and expert coordination enabled the inclusion of rare disease participants, ensuring comprehensive data for the client
  • The prefilled syringe was refined based on real-world usability data, helping the client meet critical regulatory milestones
  • Produced HF Validation Report and HFE Summary Report
  • The medication, administered via prefilled syringe received FDA approval on first submission, with no significant comments or deficiencies
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Key Outcomes

Innovenn’s study report provided robust data that supported the client’s regulatory submission, ultimately demonstrating that patients and caregivers can use the prefilled syringe correctly and without serious use errors in real-world settings.

The client advanced to market with confidence in the product’s safety and usability, supported by successful FDA review. The medication administered via prefilled syringe received FDA approval on first submission, with no significant comments or deficiencies, and is on track to launch commercially in 2025.

  • Innovenn’s expertise in Human Factors studies and regulatory compliance supported the successful execution of a complex multi-city study with a very difficult to recruit population
  • Tailored recruitment strategies and expert coordination enabled the inclusion of rare disease participants, ensuring comprehensive data for the client
  • Rapid approval from the FDA which allowed the client to get the product to market quickly and in the hands of patients who need it