Bring to mind your last straight-out-of-the-box experience with a disposable medical device of any kind. Without a doubt, everyone has experienced the same frustrations: ambiguous instructions printed too small to read easily, and difficult assemblies that simply don't match up with human capabilities. As an industry and a profession, medical product developers have vast knowledge on how human beings perceive and process information and on how human hands work. Surprisingly, not much of that knowledge manages to inform the design of medical disposables, test kits, and instructions for use (IFUs). With an eye toward higher functionality and usability in disposables, test kits, and IFUs, this article reviews fundamental factors critical to successful design plus common oversights that lead to design disasters.

Globally, the use of medical consumables continues to rise due to an aging population and the increasing prevalence of day surgeries. As the use of medical consumables continues to rise, the testing required to ensure that these products meet specifications also increases. Syringes and other medical products with Luer connectors are the most common medical consumables found in the industry, as they are used to connect a wide variety of medical products. Luer connections come in two forms: either a slip or tapered connection, or a threaded locking connection. Most commonly, Luer connectors are used to connect a needle to a syringe body or to connect various types of medical tubing (such as a catheter) to an IV bag, or a needle to catheter.

Medical device manufacturers often use silicone adhesives to bond parts together when assembling products such as catheters, pacemakers, cochlear implants, aesthetic implants, and gastric balloons. In addition to evaluating the different types of adhesive formulations, device manufacturers also need to critically assess several other factors in the adhesion process, including the substrates to be bonded, their surface energy, and even the overall device manufacturing process. Without addressing these factors early in the design process, medical device manufacturers risk costly delays and potential device manufacturing issues.

Walking up the stairs to your room one evening, you stop to catch your breath and think “I haven't always felt this tired.” Week by week, you start to notice even going out to get the mail is exhausting. Eventually, you can't keep up with your kids without being completely worn out. A few months go by. One night, you wake up gasping for air, feeling like you are drowning despite being asleep just moments before. This is the normal progression of heart failure, a disease that results in over 1 million hospitalizations in the United States each year.¹

Healthcare-related tubing is used for fluid management and drainage as well as with anesthesiology and respiratory equipment, IVs, catheters, peristaltic pumps, and biopharmaceutical laboratory equipment. It is essential that the materials employed meet the highest quality requirements.

The 16th annual “Create the Future” Design Contest for engineers, students, and entrepreneurs worldwide, sponsored by COMSOL, Inc., and Mouser Electronics, drew many innovative product ideas from engineers and students in 60 countries. The Medical category itself received 62 outstanding entries from 18 countries. Analog Devices and Intel were supporting sponsors, and Zeus sponsored the Medical category. The contest, which was established in 2002, recognizes and rewards engineering innovations that benefit humanity, the environment, and the economy.

Medical technology continues to evolve toward diagnosis and treatment devices that are closer to the patient, or even in the patient's home. Compression therapy, wound therapy, dialysis, point-of-care testing, and portable oxygen concentrators are just a few such instruments. Many of these instruments include active components that create noise that can impact a patient's sleep quality and level of comfort and can create stigma around using device. A diaphragm pump, which produces gas flow and pressure, is often one of the main sound contributors, and reducing the noise it makes can significantly affect the overall noise generated by the device. Engineers must balance performance needs and sound quality with increasing demands for miniaturized and application-specific equipment. These concerns have created a growing challenge to reduce the amount of noise generated by the device and its components.

As the miniaturization trend continues to take the medical device world by storm, manufacturing with metal injection molding (MIM) and additive processes such as 3D printing are gaining widespread acceptance, allowing designers more options for creating parts economically that would otherwise be impossible to manufacture. In many instances, these state-of-the-art MIM and 3D printed processes are not possible without the use of special cleaning and or solvent-based process treatments.

Meeting the requirements for patient-connected medical devices can present challenges for power system designers. There are several key elements to consider, including isolation, leakage/touch currents, electromagnetic compatibility (EMC), number of power outputs required, and the environment for use. This article discusses approaches for power architectures within medical devices for patient-connected applications.

The medical device and engineering industry continues to grow and evolve year over year. As technology improves, the population expands, and the depth and breadth of medical knowledge and treatments grow, so does our need for better devices and equipment. As such, current trends spanning all industries, like electronics getting smaller and more powerful, as well as increased focus on improved customer experience, have greater implications and challenges for the medical industry. Should a device fail, a patient's well-being could be endangered. Additionally, medical devices need to be portable, costs need to be judiciously managed so that treatment can be made available to the populace, and reliability is crucial.