Medical Device Design and Prototype Development

Medical Device Design and Prototype Development

Medical Device Design and Prototype Development

1) Medical Device

  • What is a medical device?

According to the World Health Organization (WHO), instruments, machines, appliances… that are used for diagnosis, prevention, monitoring, treatment or alleviation of a disease, supporting or sustaining life, and disinfection are considered to be medical devices. Here are some examples of the medical device:

  • Syringe: a syringe is a medical device that is basically a pump that is able to take in or expel liquid or gas through a discharge orifice.
  • Catheter: is a medical device that is in the form of a thin tube. A catheter is used in various applications such as drainage, administration of fluids or gases…
  • Thermometer: a thermometer is one of the most if not the most common medical devices in the world. It basically allows the user or the doctor to measure the temperature
  • Classification of medical devices  

According to the US Food and Drug Administration (FDA), medical devices can be classified into three different classes based on the regulatory control which is based on a risk.

  • Class I: the first class contains devices that require general control such as adhesive bandages or glasses…
  • Class II: the second class contains devices that require special control such as a syringe or surgical mask…
  • Class III: this third class contains medical devices that require premarket approval such as heart valves…

2) Prototyping

  • what is prototyping? 

Prototyping is an initial stage in creating and producing a product. Usually in this stage changes and fixing may occur in order to produce a more sophisticated and complete product or system. So, what are the steps in creating a prototype?

  • The first step in prototyping is to gather enough information and data, this step is very crucial because it is a gateway to understanding the needs and demands of the clients.
  • The next step is to manufacture the prototype. Using the gathered information, designers and engineers begin the prototyping process.
  • The third step is to provide the clients and the testing team with the beta product, and take notes of any complains or flaws that are noticed by the testing team or the users in general.
  • The final step is to try and fix these problems and flaws if possible.


There are various types of prototyping and they are used for different reasons and purposes such as:

  • Concept Prototype: which is used for analyzing the system’s approaches.
  • Feasibility prototype: which is used in order to determine the feasibility of the chosen solutions.
  • Horizontal Prototype: which is used in clarifying the requirements.

3) Device design

  • what is the medical device design?

Medical device design is simply the designing of a device. This includes defining the device, what its purpose is, where it can be used, what benefits it can bring to the table, …  Designing a product or a device requires a team of engineers and developers that would spend a significant time working together with a great communication. 

  • how to design and develop a medical design?

It is never easy to satisfy the needs and demands of customers, especially in the medical field. In order to produce a medical device, it requires the combined effort of experts in Engineering and design, Intellectual property law, Regulatory affairs and quality assurance. With these simple steps, it is possible to achieve all of them.

  • The first step is to identify the needs and demands. This first step can be achieved by gathering enough information and data that the customers and the market would provide.
  • The next step is to classify the device. As stated before, all medical devices are classified into three major classes all based on the control that they require. Based on the gathered information, it is possible to do this step.
  • The third step is to address the regulations and compliances. In order for a medical device to get to the market, first, it has to go through rules and regulations. This can be achieved by the International Organization for Standardization (ISO) which provides the standards that any medical device has to follow. These regulations are ISO 13485 and ISO 14971. However, FDA has its own standards. FDA only accepts devices defined under FDA 21 CFR 820.30
  • The fourth step is to manage risk. This step includes evaluating certain factors such as raw materials and electronic or mechanical parts.
  • The last step is to simply test the medical device in order to make sure that the new product meets the functionality and usability objectives. This can only be achieved by prototyping.

4) Prototype development in medical devices

As stated before, even after going through rules and regulations by International Organization for Standardization (ISO) or the Food and Drug Administration (FDA), medical devices have to be tested in order to be validated. The designers, developers, and engineers will create a prototype or an early model of the medical device and this beta version will be used for a handful of purposes. For example, in order for the device to pass through the regulations, an early version or an early sample of the device must be released. This prototype can also be used for spotting problems and flaws to simply better the overall functionality of the device. This can be achieved by providing this early version of the device to a professional testing team or to provide it to customers that are interested in buying and using the device.

5) Conclusion

In conclusion, the medical field is a vast and still growing domain that uses various other fields and specialties to prosper. According to the information provided and stated before, prototyping is a vital thing in producing and manufacturing a successful medical device that will ensure the safety and stability of this product. This can show how important mechatronics is in the life of engineering and designing.

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