Healthcare and Medical Device Companies, Product Design and Engineering Teams, Pharmaceutical Companies, User Experience (UX) Teams, Regulatory Compliance Teams, Quality Assurance Teams, Project Management Teams, Human Factors Service Providers, MedTech Startups, Product Design & Development, Regulatory Affairs

Boost Success in MedTech Product Development

We understand the nuances that make medical human factors projects succeed. Reduce risks by infusing industry-focused, fit-for-purpose capabilities, designed to carefully and efficiently align you with key standards (ISO 13485, IEC 62366-1…) and best practices.

services

Fit for Purpose Solutions

Rooted in the pioneering framework Successful Human Factors 2.0, we skillfully handle the intricacies of your human factors projects, offering a unique systematic approach and tailored execution. Enhance your team’s capabilities and empower them to focus on mission-critical work.

User-Centered AI Integration Pioneers

As the creators of the groundbreaking for AI-driven excellence in life sciences product development, Suabix, we are not merely improvisers led by the AI hype—we are at the forefront of AI-driven human factors and usability engineering solutions, shaping the future of user-centered AI for life sciences. By leveraging our innovative artificial intelligence solutions and unique expertise, you can streamline product development processes to enhance efficiency, safety, and quality.

Program Management / PMO

Align your strategic goals with a robust program management structure for Human Factors. We collaborate with HF and/or product development 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.

Human Factors 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 HF partners and groundbreaking, industry-focused maturity assessment to pair you with the right HFSP for your needs!

Continuous 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 (carefully aligned with best practices and key standards, e.g.:- ISO 13485).

Rise Above Inconsistent Outcomes

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.

Failure Rate

0 %

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).

Behind Schedule

0 %

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

Pioneering Industry-Focused Framework Based on Key Standards & Success Factors

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, masterfully aligning them with key practices and industry standards (ISO 13485, ISO 14971, IEC 62366-1).

ORIGINAL INSIGHTS

Key Success Factors

We pioneered the identification of key best practices for successful human factors engineering projects through original, rigorous research and collaboration with leading HFE experts.

"Experience level, size of staff and having a good quality process"

“The FDA loves to have data presented in their format…HFE report should follow format defined in FDA HFE guidance. FDA likes to see tables and table help map critical tasks to both acceptable performance and identified risk (unacceptable task performance) for instance.”

“Tools & Methods are another essential component of the FDA HF validation process. The FDA guidance provides a standard approach to the validation process, which in itself, is a high-level methodology."

“Previous experience and success with FDA HF submissions/type of products we work on (e.g. combination products as opposed to pure medical or surgical devices).”

For a Limited Time

Align with best practices and key industry standards such as: ISO 13485, ISO 14971, IEC 62366-1…

Complimentary & Confidential Assessment

Do you need a human factors assessment at the organizational or project level? The SHF 2.0 framework offers adaptable insights, fostering excellence in the implementation of HF engineering programs

Request a Free Assessment

SHF 2.0

Original Insights

The Latest News & Insights from Real Innovators

March 27, 2023

Validating a Project Management Maturity Framework Based on the Emerging Best Practices for Successful Human Factors Projects that Require FDA Approval -Summary of Key Findings

Previously, this author pioneered exploratory

Past & Ongoing Research

May 26, 2022

Assessing Organization’s Human Factors Maturity (Capabilities) with the SHF 2.0 Framework

SHF 2.0 maturity model provides a comprehensive framework for HFSPs to assess their maturity levels, understand the necessary steps for improvement, and establish best practices for successful HF validation projects.

HFE Strategy & Implementation

October 15, 2020

How Often, and Why, Will the FDA Reject your Medical Device Human Factors Submission?

The Food and Drug Administration

Discussions & Trends Past & Ongoing Research

September 22, 2020

Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings

The quality and success of human factors validation projects have put a strain on key stakeholders since the FDA published guidance. Learn about a new study on the characteristics, practices, and critical success factors in this field. Findings are presented to inform an industry-focused project management maturity assessment tool.