BMED Essay

McKenzie Barlow

Dr. Crockett

BMED 212

26 January 2015

Importance of User Centered Medical Devices

            When designing a medical device, for a start-up company for example, there are many aspects of a product’s design to keep in mind: safety, effectiveness, and usability. Usability, often for a start-up, is overlooked, which is a huge mistake for a business or a product’s design. According to Medical Device and Diagnostic Industry’s article User-Centered Design and the Medical Device Start-Up, “start-ups lack seasoned marketing teams that have access to customer feedback,” which results in unsatisfied users. Usability, safety, and effectiveness are all related to one another in many ways, so if usability is not addressed, then the safety and effectiveness of the product are compromised, which can lead to adverse patient outcomes. Medical devices such as a glucose monitor are designed in such a way that the product is safe and easy to use, but adjustments should still be made to decrease the number of errors patients make.

Human factors engineering (HFC) is the application of knowledge about human characteristics and abilities, according to an article from Medical Device and Diagnostic Industry called User-Centered Design: A Clinician's Perspective, and addresses user interface. User interface is the key to making and designing a successful product. Businesses and entrepreneurs must rely on its customers to help them design the most user-friendly device possible to not only satisfy the customers, but also to make the product more safe and effective. A very important aspect of a successful design is knowing that “the user's understanding of the function and operation of a device will critically influence the effectiveness of the system,” according to Medical Device and Diagnostic Industry, as well as designing for expected human error. In addition, the environment in which the user will be using the product is also important to the design and how the design will meet the needs of the customer, as mentioned by the US Department of Health and Human Services. In an archive chapter titled “Human Factors and Medical Devices,” it states “Idiosyncratic features of the environment, such as excessive noise or poor lighting, and differences in user skill or acuity due to fatigue or otherwise, may affect safety and the device's in-house usability.”

The invention of the glucose monitor was a big breakthrough in the medical world because it gave people a way to check their glucose levels several times a day without going to see a doctor. However, there are still many design flaws with the glucose monitor that need to be updated for the best possible, user centered product. According to the FDA, blood glucose monitor accuracy depends on the quality of the meter and strips, your hematocrit (the amount of red blood cells in your body), how well you perform the test, your environment (altitude, pressure, and humidity), among other things. What seems to be a simple device, however, is not so simple. After reading Analysis of a “Simple” Medical Device, you would know that there are dozens of steps to take to use a glucose monitor every time it was time to take a blood sample. The document describes despite having only three basic steps, a basic glucose monitor has about 52 substeps that are required to follow for the user to test one’s blood. Often times there are three different instruction manuals that come with the product, which can be difficult to follow without making any mistakes or skipping a step.

From the glucose monitor analysis article, one can see there are many options to improve the design to be more user-friendly and therefore more user-centered. Some solutions include modifying the strips, meter, monitor features, blood sampling procedure, and its major systems. By modifying the strips, for example, to make them longer would make it easier for the user to hold and have a larger surface area for the blood to be collected on. Another example of a modification that would improve the device tremendously would be to make the monitor store the collected data through added memory and to add the date and time as a way to remember when the last test was made.

Having a product be user-centered is one of the most important, if not the most important, aspect when designing a product. Everything depends on the user and if the user will be satisfied with the product, so every design must be user-centered to be a successful, safe, and effective product.

Works Cited

"Blood Glucose Monitoring Devices." Blood Glucose Monitoring Devices. U.S. Food and Drug Administration, 5 June 2014. Web. 21 Jan. 2015.

Murff, Harvey J., John W. Gosbee, and David W. Bates. "Human Factors and Medical Devices." Agency for Healthcare Research and Quality. US Federal Department of Health and Human Services, n.d. Web. 24 Jan. 2015.

Rogers, W. A., A. L. Mykityshyn, R. H. Campbell, and A. D. Fisk. "Analysis of a "Simple" Medical Device." Ergonomics in Design: The Quarterly of Human Factors Applications 9.1 (2001): 6-14. 2001. Web. 24 Jan. 2015.

"User-Centered Design: A Clinician's Perspective." Medical Device and Diagnostic Industry. UBM Canon, Jan. 2000. Web. 24 Jan. 2015.

"User-Centered Design and the Medical Device Start-Up." Medical Device and Diagnostic Industry. UBM Canon, 1 Sept. 2007. Web. 24 Jan. 2015.