Go Beyond Regulatory Standards Effortlessly

Bridge the Gap: Advancing Maturity in Medical Device Human Factors

The carefully designed Successful Human Factors (SHF) 2.0 framework aligns stakeholders with industry standards and best practices (ISO 13485, ISO 14971, IEC 62366). It enables metrics, continuous improvements and benchmarks performance in key areas like Planning & Documenting, Tools & Methodology, People, Timing & Integration, and Communicating & Reporting, all carefully crafted through our groundbreaking original research work and expertise.

From supplier audits to systematic management of human factor projects, SHF 2.0 enables you to smoothly meet regulatory expectations while excelling in user-centered product development with a fit-for-purpose framework.

Addressing Critical Needs

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Behind Schedule

All manufacturers experience delays in completing HF projects, and a significant 70% of external HF service providers or consultancy firms encounter similar challenges.

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No Quality System

Half of HF service providers lack a quality system, show unawareness or have no plans to implement any kind of systematic approach for ensuring HF project quality.

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Failure Rate

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).

 

Get to Know the SHF 2.0 Framework

Rise above suboptimal outcomes and embrace consistent HF excellence

The Successful Human Factors (SHF) 2.0 framework presents a unique and unified approach to elevate and benchmark Human Factors Engineering (HFE) in the MedTech sector. Specifically designed for medical device companies and HF organizations, this framework provides unprecedented transparency into HF performance and sets the stage for enhanced regulatory compliance.

Developed through groundbreaking research, SHF 2.0 transcends standard integration by offering a common structure and language for achieving excellence in HF. It empowers the assessment of maturity across five key categories of HF project success, each evaluated on a five-level scale: Planning & Documenting, Timing & Integration, People, Tools & Methodology, and Communicating & Reporting. Furthermore, it seamlessly aligns with Project Management Body of Knowledge (PMBOK) knowledge areas, identifying precise opportunities for refining project management processes.

By harnessing SHF 2.0, teams can effectively mitigate risks, reduce errors, and expedite project outcomes. The framework goes beyond regulatory requirements, it enables organizations to harmonize procedures, cultivate a culture of quality, and unlock the full potential of HF. Embrace the future of HF excellence with the proven, industry-focused SHF 2.0 framework.

Know your Successful HF Capability?

Rise above suboptimal outcomes and embrace consistent HF excellence.

Use our quick and easy quiz and find out how you stack across the emerging best practices, organized in 5 categories as per the SHF 2.0 framework.

More! Get access to the current benchmark report and find out how you are doing in the adoption of the emerging best practices for successful HF projects in the medical device industry.

Don't Leave the Success of your Medical Human Factors & Usability Project to Chance...

Partner with the pioneers of Successful Human Factors™ and equip your team with consistent excellence!

Because when it comes to patient safety, SUCCESS is the only option