Go Beyond Regulatory Standards Effortlessly

Bridge the Gap: Advancing Human Factors Maturity in MedTech

Discover the power of the groundbreaking maturity framework, SHF 2.0 . Developed through scientific research and designed to carefully align medical HF with standards (e.g.: ISO 13485, ISO 14971), essential guidelines and key success factors, it drives best practices for user-centered product development while seamlessly meeting regulatory expectations!

SHF 2.0 uniquely enables the seamless integration and streamlined approach that stakeholders demand in today’s ever-evolving landscape. From human factors supplier audits to strategic project management, SHF 2.0 is the trailblazer that positions you ahead of the game.

Ready to leverage this innovative framework? Learn more now.

Addressing Critical Needs


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.


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.


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 pioneering and original research, SHF 2.0 transcends standard integration by offering a common structure and language for achieving standardization in MedTech 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 key project management processes to enable precise and optimal HF programs.

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 and go beyond regulations effortlessly!

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.

Original Insights

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