Six Major Processes in Medical Device Development

General Development Manual / Training Materials for Diagnostic Reagents Six Major Processes in Medical Device Development An Yue’s Shop159

Source: Yizhiqiao, Medical Device Quality and Testing

Medical device development is a relatively long and complex process that may integrate multiple disciplines such as chemistry, physics, mechanics, electronics, computer software, and artificial intelligence. The concept of medical devices is very broad; it includes not only means and tools used in hospitals and other medical institutions to treat patients but also implantable, wearable, and portable home medical devices. These instruments can be used to restore the function of human organs, administer medication, or monitor patients’ vital signs in real time. In China, medical devices are classified as active and passive. Many surgical instruments, such as scalpels, clamps, retractors, and cardiac stents, are purely mechanical devices, referred to as passive devices; those that require a power source, such as X-ray machines and electronic blood pressure monitors, are called active devices. Active devices are more complex, have a longer development process, and require consideration of more factors. This article mainly describes the development process of active devices. Factors to Consider in Medical Device Development In addition to the functional requirements necessary to complete the medical device, the three main aspects to consider in medical device design are: mechanical, electrical, and software. Not all devices need to consider all three aspects. For instance, a powered bone saw only requires consideration of electrical and mechanical components and can operate without software. However, most modern medical instruments need to perform complex functions, so a reasonable collaboration of mechanical, electrical, and software functions must be considered during the design process. The mechanical aspect of medical device design must take many factors into account: First, the strength required by the instrument, including its ability to withstand tension and torque, will influence the choice of materials and bonding types; second, materials must meet the biological requirements of the product, especially for materials that come into contact with patients, where biocompatibility must be considered; third, the expected lifespan, as single-use instruments have different requirements than those designed for years of use.Medical device design also includes electrical engineering. Instruments with moving components need to provide power for mechanical movement, such as pumps in drug delivery devices. Sensors are used to obtain physiological data about the patient or monitor various aspects of the instrument itself. Some devices may also require wireless communication or one-way or two-way communication with networks or other instruments via data ports. Electrical engineering must ensure the reliability and lifecycle of the instrument’s electrical components.Electronic design must consider not only the wiring, structure, and selection of electronic components on the circuit board but also electromagnetic compatibility, as some restricted locations have strict requirements for electromagnetic compatibility.Software is an important part of medical instrument design. Today’s medical components are becoming increasingly complex, usually controlled by internal operating systems, ranging from programs that handle simple instrument operations and data collection to complex systems with algorithms to make critical decisions related to the instrument’s functions. However, software design must also consider the physical characteristics of the instrument itself. Feasibility Study of Medical Devices The feasibility stage of medical device design focuses on determining functional, performance, and design parameters. The needs of customers (clinics, patients) are the starting point for device development. The feasibility study requires research on the following factors: 1) Technical uniqueness and advancement; 2) Market size and acceptable market price; 3) R&D and production costs; 4) The usage environment of the equipment: whether the instrument will come into contact with patients, the operating environment of the instrument, and the lifecycle of the instrument; 5) Necessary risk assessments; 6) Review of applicable medical device regulations and quality system standards for this instrument, and requirements for device registration and approval; 7) Considerations regarding intellectual property, such as the scope of patent protection. Developing Equipment Specifications Once the feasibility study is completed, engineers can develop the specifications for the instrument. These specifications cover all engineering parameters of the project, including mechanical, electrical, software, and firmware parameters. They address issues such as instrument functions, material requirements and limitations, operational tolerances, safety performance, and usability. Systems engineers create definitions for the instrument, including the functional and structural relationships between components. Accuracy in this process is key to avoiding potential late modifications to the project. If a medical device manufacturer is developing its own products, the R&D team will not only include personnel with medical expertise but also talents in mechanical engineering, electrical engineering, and software engineering. If the R&D occurs in hospitals or other medical institutions, the latter two types of talent may be lacking; at this point, the involvement of an experienced CRO/CDMO medical device design team can fill the gaps in the team. Contract outsourcing companies can help define clear parameter specifications and participate in early planning and design, thus saving time and costs. Medical Device Design With appropriate parameter specifications, engineers will begin the specific design of medical devices. Mechanical engineers are responsible for all physical aspects of the instrument’s design. They use traditional design tools and modern 3D-CAD software to draw the shape and physical characteristics of the object. They select materials that meet specifications and break down the instrument design into various modules. Throughout this phase, engineers should always be clear about the impact of their design decisions on the manufacturing process and project costs.Electrical engineering is the second part of medical instrument design. Once the project requirements are determined, schematic capture will be used to plan the layout of the circuits. Power sources, such as alternating current or direct current, batteries or external power sources, as well as voltage and amperage, will be constrained by the size, portability, and functionality of the instrument. Discussions with mechanical engineers regarding all structural and interaction interfaces of the instrument will determine whether standard interfaces can be used or if proprietary connectors need to be designed. Complex instruments may require the design of dedicated integrated circuits to control various aspects of instrument operations. Digital and analog simulations during the design phase can ensure that device specifications are met.Many modern instruments require the development of dedicated software to operate the instrument and process data. After determining the programming language to be used for the project, software engineers will select the appropriate operating system. The most commonly used programming languages are Visual C++, C, Java, MS Visual Basic, and various open-source languages. MYSQL is used to implement client/server relational database systems. Ultimately, software design decisions are developed after consultations with electrical engineers. Prototype Manufacturing After the engineering design phase is completed, the next step is to manufacture the prototype. A prototype is a complete design version produced in limited quantities. The prototype validates and evaluates the design results, confirming whether the design process meets the instrument specifications and performance, ensuring that every aspect of the design: mechanical, electrical, and software passes testing, verifying the product’s manufacturability. On the other hand, validation checks the overall functionality of the instrument to ensure its functions meet customer needs while complying with all applicable medical device standards and regulations, perfecting the documentation required for registration to use during the registration process. Product Usability and Reliability Validation Any issues discovered during prototype testing need to be improved or even redesigned. The design will return to the mechanical, electrical, and software design teams for refinement. After resolving design issues, another round of prototype design and testing will begin. This process is repeated until the medical device product meets all requirements and passes validation and testing. This iterative modification of the design helps correct issues before full production begins.Medical device development is a complex multi-stage process. The feasibility study phase can determine customer needs and review applicable regulations, anticipating possible risks, and serves as an important foundation for medical device design. Design specifications and parameters are developed through collaboration between mechanical, electrical, and software teams. Prototype development can validate working models through testing and resolve design issues through upgrades. Once the final product is approved, production transformation can begin, entering the manufacturing process.

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