Boost Human Factors Success in MedTech Product Development
Enhance your team’s capabilities and empower them to focus on mission-critical HFE work. Rooted in the pioneering SHF 2.0 framework, we skillfully handle the intricacies of project management, offering a systematic approach and tailored execution. You’ll experience the perfect balance of rigor and responsiveness. We combine operational excellence with custom-fit solutions designed around your specific needs. Our specialists understand the nuances that make HF projects succeed.
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Let our team empower yours and take your HF initiatives to new heights. Our singular focus is your continued success.
WHAT WE DO
Optimize Human Factors Project Lifecycle Management with Industry-Focused Solutions
According to a study conducted by Rojas et al., it was found that 70% of participants who employed structured project management for human factors validations encountered zero rejections in their FDA submissions. In stark contrast, all respondents lacking formal project management reported experiencing submission rejections. Eliminate risks by infusing industry-focused capabilities to deliver more HF projects successfully without even adding employees!
SHF 2.0 Empowered PM
HF Project Managers
Strategic HF Program Management
HF PMO Solutions
Network of Quality-Oriented HF Partners
HF Vendor Matching
Supplier Audits, Project Health Check & Rescue
Continous Improvement
Addressing Critical Needs
Rise above inconsistent outcomes and embrace HF excellence. Partner with the pioneers whose research formed the only proven, powerfully effective maturity framework integrating industry-focused project management with key HF best practices for optimal outcomes.
According to FDA data, failure rates per HF submission type are as follows: 96.1% for Q-sub, 93.5% for PMA, and 89.5% for 510(k).
All medical products manufacturers experience delays in completing HF projects, and a significant 70% of HF service providers or consultancy firms encounter similar challenges.
HOW WE DO IT
Leveraging Industry-Focused Framework
Our services drive human factors project success by leveraging the industry-focused SHF 2.0 framework. This trailblazing framework, developed through our pioneering research, integrates proven project management practices with essential human factors pillars. Through groundbreaking work, we characterized the key SHF 2.0 categories: Planning and documenting, People, Tools and methodology, Timing and integration, Communicating and Reporting.
By leveraging our research-based proven framework, we impart the key success factors for excellence in human factors project delivery. This equips teams with the insights and tools to manage complexity and achieve strategic objectives.
Clients gain a competitive advantage when they partner with us, as our services are built on a uniquely tailored framework designed to meet their specific needs.
INSIGHTS
Key Success Factors
We pioneered the identification of the key best practices and challenges involved in successful human factors engineering projects for medical devices, through rigorous research and collaboration with leading HFE experts.
For a Limited Time: Claim your Complimentary and Confidential SHF 2.0 Maturity Assessment!!
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