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 research regarding the concerns, underlying variables, key success factors, and best practices pertaining to Human Factors (HF) projects for medical devices and combination products that seek Food and Drug Administration (FDA) approval. Because of this research, it was observed that the great majority of HF submissions to the FDA fail. An industry-focused project management (PM) maturity assessment tool was proposed, to enable much needed alignment and improvement. In this occasion, the overall architecture of the developed framework is briefly introduced for the purpose of testing/validating, and to try and answer the last of several questions that prompted this multiphase research: what is the average (and what would be the ideal) maturity level for more successful HF projects? The resulting average was 2.65, which corresponds to “Level 2 – Childhood” of the framework. It indicates a lack of standardization of the practices assessed. As per participants’ feedback, the tool was useful and could help improve the success of HF validation projects. Other interesting findings, recommendations for practice (adoption) and future research, are discussed. On that last note, the author hopes (and suggests) that key stakeholders leverage this work to get past the exploratory stage in which they have been stuck for the last decade (whys and wherefores have been already asked and answered). The results of this work prescribe that the next urgent step is to start developing metrics around the adoption and standardization of the identified set of emerging best practices and key success factors. We have heard it before: “You can’t improve what you don’t measure.” Well, here is an industry-focused, feasible starting point to do just that.

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