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.
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
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.
For a Limited Time
Align with best practices and key industry standards such as: ISO 13485, ISO 14971, IEC 62366-1…
Complimentary & Confidential Assessment
Original Insights
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