1) Medical device design
Designing a Product
Product design is much more complicated than what most people think. Usually people misinterpret designing as manufacturing or creating something, however, this is not a correct interpretation of the word design. The design is knowing and understanding the problems and demands of customers and finding solutions for them. In fact, to design a product the following steps should be taken.
- The first step in designing anything is to gather enough information and data. This step is the key to creating a successful product because it is vital to know what the customers and clients really need.
- The next step is to brainstorm solutions and ideas by an engineering team.
- The third step is converting the solution into a design using a design software.
- The fourth step is to create a prototype and test it with a testing team.
- The fifth and last step is to note the data and the feedback provided by the testing team, applying the needed modifications to the initial design, and making a better solution to the product. The last two steps will be repeated until the results are satisfying.
According to the World Health Organization (WHO), medical devices are devices that are going to be used for medical purposes such as, measuring a patient temperature, surgery item, checking heartbeat… according to the American Food and Drug Administration (FDA) medical devices are classified as follows:
- Class I: medical devices that do not require really much control for being used such as adhesive bandages or glasses fall into this class.
- Class II: in this class, you will find medical devices that require special control for their use such as syringes or surgical masks.
- Class III: These are devices that need approval before they are used. Medical devices such as heart valves can be classified in this category because they require premarket approval.
2) Human factors
Introduction to Human Factors
Human workers play a major role in any field or domain. You can’t create something without at least one human worker. This is true that machines are being used more and more especially with the rise of technology in general and mechatronics in particular; however, machines can never completely replace human workers, whether these workers are product designers, engineers, doctors… That’s why human factors are one of the most important factors that should be kept in mind regardless of what the product is. So! what are human factors?
Human Factors in Manufacturing and Design
When the term human factors are used, it usually refers to the limitations and errors that human workers may do. So obviously in an industry where the use of human workers is extremely vital, it is important to know and keep in mind these human factors or limitations. So what are these limitations? These limitations include:
- Impatience: there are tasks that require time and patience; however, this could be a problem especially with new and young workers.
- Limited memory: a manager or a supervisor may provide the workers with important information and advice; however, a worker may simply forget them!
- Lack of motivation: it is very hard to convince someone to do a certain job when he is not motivated to do it.
- Fatigue: even if the workers do everything very perfect and as supposed to do, after a while they may get tired.
- Limited concentration: workers may simply get distracted and lose concentration after working for some time.
- Making errors: this one is almost inevitable; As long as there are human workers in a facility, mistakes or errors are bound to happen.
3) Human factors in medical device design
The goal of considering human factors in industries and facilities is aimed at doing a job with less waste of time, less waste of money, and getting a better efficiency. However, in the medical field and industry, consideration of human factors is much more important and crucial than many other industries. The goal of considering these factors is to make sure that the safety of users under treatments or tests by such devices is guaranteed. Users should be assured that simple mistakes will not jeopardize their lives. In fact, in order for a medical device to be approved by the FDA, it must first be tested by skilled technicians. This can be done by creating a prototype and testing its proper functionality in order to demonstrate that it can be safely used and without any hazards.
Considerations for medical device design
Before designing a medical device, it is important to take a few issues into consideration to make sure that the operator of a device will do its job without making any mistake that could harm a user or patient:
- Simple user interface for the operator
- The way the operator gets the information from the device.
- The way the operator interprets the information received from the device and make decisions based on that.
- The way the operator receives information and input from the patient.
benefits of considering human factors in medical device design
Below are some benefits of considering human factors in designing a medical design:
- Medical devices will be easier to use by the users.
- Medical devices will yield more effective alarm signals.
- They will be easier to maintain and fix.
- The risk of making errors is greatly diminished.
- The training and retraining of users would be much easier.
Regulatory bodies such as the FDA are making it mandatory for medical device designers to take into consideration certain elements such as human factors. These regulations have greatly helped improvement in such designs by making them easier to use, easier to repair, and more importantly safer for users.