Successful Human Factors™ Unveils Services Addressing Project Delays and High FDA Failure Rates in MedTech

Middletown, NY, October 25, 2023 --(PR.com)-- Successful Human Factors™, the leader in specialized human factors project optimization for MedTech product development, has recently launched groundbreaking services aimed at empowering healthcare stakeholders to excel in executing successful human factors (HF) and usability testing initiatives.

These solutions are a response to research uncovering significant project delays for most medical product manufacturers and 70% of external Human Factors service providers (HFSPs). Notably, FDA data reveals alarmingly high failure rates in HF submissions, with rates as high as 96.1% (Rojas et al., 2020).

The carefully crafted services equip teams with specialized project management strategies customized for healthcare human factors. Dr. Katia Rojas, the founder, underscores the objective: "Our goal is to provide practical solutions that enhance HF project quality and productivity without requiring budget or staff expansion." We don't rely on one-size-fits-all approaches; instead, we provide tailor-made solutions that promote compliance, safety, and usability excellence through our industry-focused framework, Dr. Rojas noted.

This suite spans the entire HFE project lifecycle and includes:

- Full Spectrum PM: Tailored PM with a healthcare focus, aligned with the key HF practices to enable success.
- Fractional PM: Scalable project management resources to meet specific needs.
- Strategic Advisory: Guided, measurable approaches to streamline processes and meet objectives.
- Vendor Matching: Facilitating access to a curated network of HF quality-oriented HFSPs.

The services are also available in Spanish, serving teams in Spanish-speaking countries aiming to introduce medical products into the US market.

This suite is built in alignment with the pioneering, research-based SHF 2.0 framework by Successful Human Factors™, an evidence-based maturity model that strives to standardize HF practices in healthcare systematically. The framework achieves this through the seamless integration of essential HFE practices with proven project management principles and success factors, determined through scientific research.

The offerings are tailored to meet the needs of medical device and pharmaceutical companies, product developers, quality, regulatory, consultants, and service providers all seeking to optimize HF. Furthermore, Successful Human Factors has established partnerships with premier HFSPs to broaden capabilities and offer a more extensive range of services.

Don't risk your healthcare project success with generic approaches. Successful Human Factors™ unlocks deep HF domain knowledge with proven PM principles tailored to the unique needs of HF initiatives in the MedTech sector.

Discover more on advancing human factors excellence at https://successfulhf.com

References:

Rojas, K. M., Cosler, L., & Santos, D. L. (2020). Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings. Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care, 9(1), 166-175. https://doi.org/10.1177/2327857920091042