Medical Device Design - What Is It ?
Medical Device Design
Advances in medical device design & development over the past few decades have greatly propelled the medical device industry and improved people’s health. The medical device design processes are interrelated and mutually reinforcing. Let’s take a look at how these two processes complement each other.
What is Medical Device Design?
Medical device design is the process of designing instruments for medical purposes. Typically, some key steps are performed during the device design process. First, instrument requirements must be collected and defined. In a design and development project, this step includes defining each constraint for the product. We often use these criteria to describe the design scope:
- Performance
- Manufacturability,
- Intellectual Property Constraints,
- Regulatory Constraints,
- Material Requirements,
- Cost of Goods,
- Aesthetics and Usability
During the early product definition, at the concept development phase, technical issues, regulatory, business and other requirements must begin addressing. Teams collaborate and communicate with each other and come up with solutions, how to develop design concepts that meet customer needs and market requirements. The medical device design must then go through a Proof-of-Concept to (As the name suggests) will prove that all the design key properties are feasible and function as intended.
Furthermore, develop prototypes to evaluate performance and address design challenges while evaluating instrument specification, fit, and functionality. The purpose of a proof-of-concept prototype is to demonstrate through testing that a design is feasible from a technical perspective. Then, further refine the design based on the results of the early prototyping and proof-of-concept testing. Once it is determined that the design concept is feasible, no major changes will be made to this later.
What is Medical Device Development?
Medical device development is the process of turning a medical device design into a commercially viable product. In the medical device industry, product development engineers must follow all stages of medical device development, comply with strict regulatory requirements and fully document their work.
Because medical devices directly affect the health and life of patients, the design and development of medical devices always entails a degree of risk. Medical device manufacturers must carefully follow regulations, risk management, assessment processes, meet product application scenarios and user needs in order to develop and produce safe and effective products.
How to Start Designing Medical Devices?
It starts with the planning phase. Formally document the design plan in accordance with regulatory requirements to describe the development process. Then, start the design stage in which the requirements and specifications put forward in the design process need to be formally recorded as user requirements and product requirements.
During the design output stage, it is converted to engineering design specifications under the design control program. Create detailed product specifications using CAD and 2D drawings. At this point, small-scale instrumentation moves into manufacturing so that prototypes can be produced using commercially representative materials and methods.
Based on early prototype iterations and engineering evaluations, generate a formal test method and protocol for the instrument, including a design verification and validation plan. Design verification and validation is one of the most important steps in medical device development. Design verification determines whether the instrument design meets product requirements and user needs.
Although obtaining regulatory approval typically occurs at the last step in medical device development, regulatory planning should begin early in the process. Different types of instruments have different regulatory requirements, and medical device regulations may vary from country to country.