by on July 8, 2022
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The integrated application of multidisciplinary and multi-technology practices, processing card payments and cross-disciplinary cooperation and learning in the medical industry have led to a more diverse development of medical devices in China, and the problems that continue to arise in the process of medical device use management have increased. empirical data, most market risks can be avoided by improving both the medical device design and development work processes.

Usability engineering applied to the different phases of a company's product life cycle, portable container combined with financial risk assessment and analysis, learning various information technology teaching tools and testing models can improve student design rationality and avoid predictable use errors, this research has become an advanced development method widely used in many of our other countries, so how should R&D engineers perform a usability design phase?

Step 1: Implement a reliable identification process

Identify instrument users: All interested users should be identified. For example, instrument users, medical device development process purchasers, and installation and maintenance personnel. The ability of the user to operate the instrument depends on the personal characteristics that the development team should assess and understand. The team should take into account any physical or cognitive limitations, education level, and any other relevant characteristics that may affect the way the user interacts with the device.

Identify the context in which the device will be used: By assessing the context in which the device will be used, you can gain insight into the environment in which the device will be used, enabling manufacturers to design more emotionally engaging products. Questions to be answered in this phase include: ambient lighting, noise, lab setup, staffing, ambient temperature, etc. These conditions, which may affect safety and effectiveness, should be taken into account.

Identify the system user management interface: The interface should be able to be analyzed and evaluated, including the interaction between the business user and the instrument. When users set up, use, or perform work tasks on the instrument, they may do so through the use of connection ports. Manufacturers should identify the potential market risk of these ports so that they can continuously improve instructional design and prevent harm to patients or users.

Identify critical tasks: Identify critical tasks that users perform correctly to ensure safety and effectiveness. Critical tasks are those that could have serious consequences if performed incorrectly. These tasks can change as the design evolves and more information can be obtained about the user's interaction with the instrument interface.

Identify known issues: Known related issues should also be identified and captured during the design process. Examples include instrument failures from other manufacturers, post-market regulatory feedback, training, and sales staff. By looking at the product lifecycle and researching similar products, developers can identify many of the issues associated with the tool and mitigate them at an early stage.

Step 2:Conduct a simplified usability study.

By having students form usability tests, developers can evaluate the interface elements of a prototype or final implementation product during the development effort. This helps ensure that elements of the instructional design culture meet expectations and identifies an area for continuous improvement.

Usability studies are used to improve initial results and to determine if design changes are needed to further expose unidentified user-related risks and errors. This allows the design team to determine that the improvements achieved are effective in reducing or eliminating risks or potential user errors.

Feasibility studies will be conducted during design and development activities, thus providing greater flexibility in terms of sample size and data collection methods used, which may include simulations, interviews, cognitive exercises (asking participants to name their thought processes and explain any difficulties they encounter with the tool) or scenario-based questioning (observing representatives of potential users interacting with a tool currently similar to the one being developed).

The test plan used in a usability evaluation typically includes: the purpose of the evaluation, a description of the interface to be evaluated, the usage scenarios and tasks involved, an end-user assessment, the data collection and data analysis methods to be used, and an explanation of the data to facilitate design changes to reduce hazards.

Step 3: Eliminate or reduce the risks associated with the instrument can be used some

Risks associated with instrument use can be identified and mitigated through the use of risk management tools.

Integrate inherent safety by design, for example by removing features that could be incorrectly selected, eliminating interactions that could lead to user error, or using specific components that cannot be properly connected.

Incorporate safeguards into the medical device design process, such as warning screens, display alarms, interlocking devices, or safety guards.

Include a safety management message, such as a warning statement included primarily in the use case statement, explaining potential hazards or providing user through training.

Step 4: Perform validation tests

During the validation process, all interface elements should be available and should be validated against simulated usage scenarios. Each group of test participants in this step has at least 15 representative participants representing a range of characteristics within their user group, such as age, occupation, usage restrictions, education level, etc. Different user groups may have different limitations that may affect the way they interact with the instrument interface and should therefore be classified as such. Examples include health care providers and patients with sensory impairments, pediatric users and adult users, etc.

During the validation process, the manufacturer should carefully record data obtained by observing the participants' performance, as well as data obtained from interviews conducted after completion of the use case.

Step 5:Perform data analysis to create usability reports.

After the validation is completed by creating the form yourself, analyze each task related to the management of the instrument can be used while we consider corporate user information errors or design some issues, research student observations of experimental results, root causes, clinical outcomes, potential hazards, and mitigation measures to reduce financial risk. Eliminate or reduce any errors or potential development issues through redesign. Understand whether they exist by assessing the risks associated with instrument use that require instructional design modifications by the instructor and why use errors occur, and determine whether system design changes will reduce the risk to an acceptable level.

Each task must be tested to determine if a redesign is required, and any redesign activities must be followed by retesting as needed to ensure that any modifications made do not contain new unacceptable risks.

Finally, a Capability Engineering Report should be prepared and incorporated into the premarket regulatory document that discusses safety-related considerations, a summary of the use process, and conclusions.Fda provides a format for this document in an appendix to the guidance that includes the conclusions of the capability study, user description, use, use environment, training and user interface, summary of known issues, hazard and risk analysis, summary of preliminary analysis and assessment, critical task description and classification, and details of human factors validation testing.

Because the benefits of usability engineering are often not realized until the product is released to product salespeople and can be used to manage the process, we currently have a tendency for developers to not pay attention to this, and regulatory research agencies and technology development committees to be negligent in this regard.

Related article reading:
Medical device manufacturing: Using corporate products for life cycle to drive sustainability of medical devices in society
The difference between design for validation and clinical evaluation in medical device development
How do medical product development companies consider medical device packaging design?
 

Posted in: Health
Topics: comprehensive
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