With the growing demand for delivering test results as soon as possible to the patient and physician, more complex point-of-care instrumentation is hitting the marketplace at a rapid pace. Now medical device design is more complicated due to myriad considerations that must factor in to the development and design of near-patient and in-home devices.
In an article published in Med Device Online, Ashley Sutherland and Matt Cavanagh, Design Science, weigh in on how and why designing a product for its use environment is as critical as designing with the end user in mind. "Where a product is used, and who is using it," they state, "are inseparable factors, and anticipating how they interplay in device use is a critical and complex task. Designing instruments for laboratory and medical professionals is a technical process with many considerations... Clinical needs, workflow impact, and environmental considerations are all thoroughly understood and addressed...The development approach for [home use] devices needs to consider an entirely different set of factors."
Understanding these differences is key for medical instrument companies who wish to remain competitive in the point-of-care market. "There is a major push toward more over-the-counter (OTC) devices, monitoring solutions, and devices aimed at reducing hospital admission," state Southerland and Cavanagh.
Clearly hospital, laboratory and medical office operators and environments contrast greatlywith patient home users and environments. In their Medical Device Online article, Southerland and Cavanagh outline the key veriables that designers consider when assessing users and environments.
- The physical, sensory, cognitive, and emotional characteristics of users
- Atmospheric conditions in which a user will operate a device or conduct a test
- The user's knowledge, training, education, literacy and the availability of instructions
"Although clinical environments are exceptionally complex and busy workspaces, they offer a level of consistency and professionalism that designers can rely on, state Southerland and Cavanagh, "Home environments offer no such consistency, and any human factors professional will tell you that simulating these environments is no easy feat. Conditions are incredibly varied from household to household. Even within households, conditions vary considerably depending on the location within the home and the time of day."
In his article, Point-of-Care Testing Continues Growth, Gary Tufel states, "Sometimes referred to under the heading of “near-patient” or “bedside” testing, point-of-care (POC) diagnostics encompass a variety of test platforms that sometimes appear to have very little in common with one another. What they do have in common is their focused ability to provide simple, rapid testing, often of blood or urine samples, and to be administered physically close to the location of the test subject. Some are administered in medical settings, and some at home."
Trufel's article also highlights the evolution and complexity of testing materials and equipment that are now used in patients' homes. He states that the majority of home POC tests have included, "a wide range of small, lightweight, uninstrumented kits that can provide rapid results for many diseases and conditions, including blood glucose, drugs of abuse, infectious diseases, and pregnancy," and points out that the growing POC market, "encompasses a growing number of more complex and sophisticated countertop instruments, each capable of performing tests for a defined menu of diseases and conditions."
Trufel's article sites many important benefits of point-of-care testing, including the key three as stated by Thomas I. Koshy, PhD, senior director for scientific affairs at Alere Inc, Waltham, Mass. (read the full article here)
- Providing clinical information in acute care settings faster than it could be delivered by a conventional laboratory.
- Providing clinical information that enables the healthcare provider to take advantage of a teachable moment.
- Providing clinical information in settings where conventional laboratory equipment and facilities are unavailable or impractical.
Now medical instrument companies and their developers, designers and manufacturers have a whole new set of complexities and variables to consider as medical instruments and medical testing move closer to the patient's bedside - even as close to within patients' homes.
To learn more about KMC Systems and our depth of knowledge in the many disciplines of medical device development, design and manufacture, download our brochure or contact us to discuss the challenges that you face in developing point-of-care instruments.