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.

Get in Touch Today

Let our team empower yours and take your HF initiatives to new heights. Our singular focus is your continued success. 


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

Providing fractional, interim or full-time HF project managers to lead specific projects or initiatives. Bring in SHF 2.0-trained PMs, and increase your capabilities for better outcomes, without even adding full-time staff.
HF Project Managers

Strategic HF Program Management

HF PMO Solutions

Align your strategic goals with a robust program management structure for Human Factors. We collaborate with HF teams, offering fractional PMO services, expert guidance, and the systematic integration of HF project management processes, tools, and templates for success. Benefit from comprehensive support, including training, oversight, and governance, to ensure the success of your HF projects.
HF PMO Solutions

Network of Quality-Oriented HF Partners

HF Vendor Matching

Human Factors Service Providers (HFSPs) are critical suppliers! Don’t risk product success with just any HFSP. We leverage our network of successful human factors partners and groundbreaking, industry-focused maturity assessment to pair you with the right HFSP for your needs!
HF Vendor Matching

Supplier Audits, Project Health Check & Rescue

Continous Improvement

Struggling with consistent HF projects? Get back on track with our audits and assessments of troubled or challenged HF projects. We identify issues and provide recommendations to identify gaps and get projects back on track for successful outcomes. Advance maturity following a systematic and validated approach, SHF 2.0 framework.
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.

0 %
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).

0 %
Behind Schedule

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


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.


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!!

Ideal for both MedTech companies and HF consultants (internal or external), the SHF 2.0 assessment provides clear benchmarks for targeted improvements that will enable consistent excellence in the implementation of human factors engineering programs.
SHF 2.0

More Insights

Our Latest News & Insights

November 20, 2023

Navigating the Shadows: A Tale of Innovation, Plagiarism, and the Battle for Ethical Standards in Human Factors and Usability Engineering

“Imitation may be the sincerest form of flattery, but originality is the mark of true innovation.” – Coco Chanel

Discussions & Trends
October 18, 2023

Announcement: Introducing Suite of Services to Support Healthcare Teams with Innovative Solutions!

Full spectrum of expert, industry-focused human factors & usability engineering services to drive excellence in healthcare!

Industry News Updates & Announcements
September 24, 2023

From Research to Policy: Exploring Precedents of HFES Maturity Framework Policy Recommendations to the FDA

“The opinion of 10,000 men is of no value if none of them know anything about the subject.” (Marcus Aurelius)

Discussions & Trends Industry News
August 23, 2023

Introducing Suabix™ by Successful Human Factors™ – First AI Solution to Optimize and Standardize Human Factors in Medical Device Design

Suabix™ is the ultimate AI-enhanced usability mate for achieving human factors excellence in medical device design.

Industry News Updates & Announcements

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

error: Content is copyrighted!!