Challenges faced by designers of medical devices are among the most stringent in the world. Everything designed and manufactured must be safe for the patient and safe for the operator.
You have the biggest challenges. Medtech designers face some of the most stringent requirements in the world. Everything must be safe for the patient and safe for the operator. In addition, devices can be put through years of U.S. Food & Drug Administration (FDA) trials and trials in Europe, so reducing the risks associated with any device is paramount in the designer’s approach.
Every device must satisfy a different set of parameters, because every detail is based on how the device will be used, who will be using it, and how long it will be used. The design team needs to know whether trained medical professionals will be operating devices now, or whether patients are the end users. Is it meant to be disposed of after a few uses, or is it expected to last for years? New in the question set: Will it be used in a dedicated clinical/hospital setting, or will it be carried from place to place? All these usability questions must be answered early in the design cycle, because you certainly don’t want to start thinking about this just before trials.
Along with ensuring a device is low risk, reliable, and functions to the highest expectations of a diverse base of medical professionals and their patients, manufacturers must meet another level of design challenges. Devices must look modern, provide a positive patient experience, include more technology and functionality in a smaller space, and work in an increasingly global market.
Connectors and cable assemblies play an important role in all these trends, as they deliver power to hand tools and handheld diagnostic equipment, and return signals to mobile consoles and surgical systems. They work with sensors to keep warming blankets at the right temperatures and can even be part of vests, jackets and other clothing that is important to measuring and maintaining a person’s health. Selecting the right connector and cable assembly solution can help build small, safe, stylish, and functional devices that hit the right price point to keep manufacturers competitive while keeping risk low for both the patient and the operator.
Because Class III medical devices (implantables) carry much more stringent FDA rules and oversight, this white paper addresses the challenges of designing Class I and Class II devices only.
- Meeting FDA Requirements
- Critical Considerations
- The Patient Experience
- Appearance Matters
- Miniaturization in Medical
- Chart: Miniaturization Application Examples
- Counting the Cost
- The Complete Cable Assembly
- A Global Approach