Elevating Human Factors Excellence in MedTech

Our Mission

Successful Human Factors™ is committed to ensuring the successful integration of human factors (HF) engineering principles within the MedTech industry. Our primary mission is to foster success by offering innovative solutions to enhance medical HF projects. 

At the core of our mission is the groundbreaking SHF 2.0 framework, a meticulously designed maturity model aimed at guiding MedTech organizations to achieve excellence in HF projects. We are dedicated to helping stakeholders, including regulatory and HF teams, optimize and standardize their human factors approach, ultimately leading to improved outcomes and a culture of optimal innovation

Our Founder

Dr. Katia Rojas is the Founder and Principal Consultant of Successful Human Factors, and was the visionary and original proponent of utilizing and developing a maturity framework in the context of medical human factors.  She conducted groundbreaking research characterizing  practices and key success factors in FDA HF validation projects, which led to the development and validation of the pioneering industry-focused SHF 2.0 maturity framework. 

Dr. Rojas has over 14 years of multidisciplinary project management and operational excellence experience, working  for industry leaders such as J&J/DePuy Mitek Sports Medicine, and Bristol Myers Squibb, successfully implementing, optimizing and improving processes in diverse settings from start-ups to Fortune 100.  

Dr. Rojas graduated with a PhD in Industrial and Systems Engineering (Healthcare/Medical Devices/Human Factors Engineering focus) and is a Certified Project Management Professional (PMP) by the Project Management Institute, as well as a certified Six Sigma Blackbelt Professional by the Management and Strategy Institute.

Dr. Katia M. Rojas
Dr. Katia M. Rojas Founder & Director

Our Services

At Successful Human Factors, our specialized expertise empowers medical device teams to focus on core human factors engineering work. Our research-backed approach mitigates program risks, accelerating timely product submissions.

Our flexible, customized services include:

  • Rescuing struggling human factors programs via our Successful Human Factors Maturity Framework (SHF 2.0). This fit-for-purpose benchmark identifies targeted improvements to systematically boost HF quality and compliance, enabling project success.
  • Interim or ongoing SHF 2.0 project management by trained PM specialists equipped to expertly lead validation efforts and drive success.
  • Tailored PM processes, audits of PM or HF systems, establishment of high-functioning Project Management Offices (PMOs) – our frameworks cultivate consistent human factors excellence.

In addition, we conduct vendor audits evaluating human factors capabilities and quality systems compliance.

Whether the need is HFE project recovery, specialized project leadership, PM transformation, or uplifting entire HF programs, we have the experience and framework to steer Successful Human Factors.

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

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