Human Factors and the FDA's Goals:Improved Medical Device Design
Human factors engineering (ergonomics) is all about designing tools for human use. More formally, it is the scientific discipline concerned with the interaction between humans and artifacts and the design of systems where people participate. We have long believed that the FDA, once it resolved its hardware and software design & maintenance safety and effectiveness issues, would turn its attention to ergonomics. In fact, many believe that user errors may be the last bastion of equipment safety and effectiveness problems. The CDRH has recently put up a new section on its web site "Reducing Use Error". Even before the recent Institute of Medicine's report "To Err is Human", the FDA was beginning to interpret the recent Quality System Regulation (21CFR820) in the context of ergonomics issues. Consider the following examples:
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| Human Factors and the FDA's Goals:Improved Medical Device Design |
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Establishing and promoting an effective corporate human factors engineering program is not only a current regulatory compliance issue; it is very good for the Corporate bottom line. Products that are "ergonomically correct" are:
| much more desirable to users (users become more productive), |
| intrinsically safer to use (users become less error prone), and |
| more competitive in the market place (customers are smart). |
They are SAFE, EFFECTIVE, EFFICIENT and SATISFYING to USE. This translates into more sales, fewer recalls, less training, less support & maintenance, lower warrranty costs, and (ultimately) increased profits (for BOTH the vendor AND the customer). There are three, essentially orthogonal, reasons for implementing a systematic, iterative human factors engineering program: profitability, market share, and regulatory compliance.
We specialize in medical device and pharmaceutical manufacturing equipment ergonomics, especially where automation is a critical component. We understand not only the user characteristics of your system, but also your equipment application and its engineering. Our primary emphasis is assisting you in incorporating human factors engineering into the validation lifecycle. We can assist you in all aspects of product development - conceptualization, design, development, and evaluation (customer requirements analysis, task analysis, information flow, work flow diagrams, user interface design, usability testing, prototyping, etc.) - from biomechanical & biodynamic issues to graphical user interfaces and user documentation. For existing products and systems, we can help you in usability testing, both in establishing, managing, and interpreting the results of work by in-house personnel, the work of expert judgement panels (generally believed to capture only about 50% of the important ergonomic issues) and conducting empirical user testing (assisting you in identifying firms for empirical usability testing, evaluating their experimental design, and evaluating their empirical results). In all cases, we will strive to identify and recommend the most cost-effective approach for your particular endeavor. Human factors engineering need not be expensive to be highly effective; but, it must be considered very early in the validation lifecycle for it to have the maximum benefit!
In concert with a number of ergonomist colleagues, we offer specialized human factors consulting services to FDA-regulated firms. Our expert team provides an understanding of your company's business model, the pertinent federal regulations, and a modern understanding of the engineering technologies to integrate human factors engineering into your current quality system lifecycle processes. The initial consultation is a fixed price, 2½ day, on-site consultation and evaluation effort. The emphasis will be on human factors engineering, but in the context of the complete product development lifecycle. The team will address the needs you identify and any others that they encounter while on-site. They will meet with your staff, conduct a review of your GMP/QSR processes and procedures with special emphasis on human factors engineering, identify areas of current strengths and areas where improvement would benefit product quality. They will provide a draft report and debriefing prior to their departure and a final report within 15 days. Follow-on consulting services from any of the three participating firms may include the following range of services:
a) Technical Management consultations and assistance
b) Engineering consulting/training (hardware, software, human factors, and validation engineering)
c) Documentation consulting/training (technical manuals, operator interfaces, and other labeling)
Dr. George Samaras is a board-certified Professional Ergonomist (BCPE#950), a registered Professional Engineer (MD#13006), and a Certified Quality Engineer (ASQ #47957). He received his basic training in Electrical Engineering (BSEE) and earned doctorates in both Physiology (PhD) and Industrial Engineering (DSc); he has a number of biomedical equipment patents and an extensive list of scientific publications in biomedical research. Dr. Samaras worked for the U.S. FDA/CDRH as a scientific reviewer and as Associate Director of Electronics and Computer Science. He was the CEO of a FDA-listed biomedical engineering firm for a decade. He has conducted clinical and laboratory biomedical research, while on the faculty of a major medical school; he has been on the faculty at two major engineering graduate schools teaching technical management, project management, and ergonomics. He is a member of the NSPE, IEEE, IIE, IVT, and ISPE.