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The Development of Medical Device Prototyping

Prototyping of medical devices is gaining importance in the modern world. It offers readymade solutions and innovations that have resulted in saving lives.

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Posted on: July 30, 2018, | By Fancy, WayKen Marketing Manager

Prototyping is the initial testing, sample or model of a product. It is used in electronics, software’s, and design of devices etc. Developers doing research on a project that may become a vessel for medical procedures need to develop a prototype. Once the prototype is made, next step is to make an acceptable product. Some of medical device services include Procurement advice, testing and design of components, assembly, complex PCB design etc. Prototyping is a valuable tool in the market research and product development processes.

Uses and applications

Prototyping of medical devices is gaining importance in the modern world. It offers readymade solutions and innovations that have resulted in saving lives. From injection molds, 3D printing, pace makers etc. These devices are sold all over world markets. It also saves cost and time. It gives professionals more than just visualizing and designing these products. They are able to make prototypes that test their ideas. Giving them room for errors before they finalize the product. Also having a test model helps the customers to understand what their product will be and increase the confidence of customer and developers. Many different models can be made through the same CAD structure that shows different geometries. Its best application is to enable you to develop customized products according to your needs. The future for medical device prototyping is infinite by using bio-compatible materials.


Medical Device Design and Prototyping

The food and drug administration has classified medical devices into three classes. The FDA labels these first class devices by testing them through misbranding, banned devices, good manufacturing practices, how they are manufactured. These devices are the lowest ranked at harming its users.


The devices under second type are more likely to cause the user harm. This means that the criteria of checking such as making, manufacturing are not fulfilled by them. They undergo a pre marketing produce that make them fit for the market. The third type is at the highest risk as they include devices such a pacemakers, heart pacers etc. These devices are used at crucial times when patients’ lives are at risk so they have to go through pre markets approvals and general controls to be legally marketed. All of the above three types are important and sold all over the world.

3D printing solutions provide the flexibility to optimize designs quickly and cost-effectively so you can validate and verify your products sooner, and go to market faster. For successful prototyping we require a clear understanding of what we want and our purpose and to understand our customers and their requirements. Also definition of functional methods of prototyping and selecting a suitable process of fabrication of each component.


Manufacturing and assembly

The crucial part of manufacturing the product or its model is the key to minimize its cost and liability. Professionals look for the optimum solutions and software’s to make it a successful product. Also market values and demands are also kept in mind. Customer’s knowledge and good design is essential. Most software’s used are solidworks, AutoCAD, Microsoft. The commands are sent through them and the machines develop it. The 2D CAM system involves CAD tools that let professionals design virtual products or parts of machines. They can manufacture one or thousands of copies. Some of the devices manufactured are cable fabrication, Computer-based manufacturing control system (ERP), packaging, wiring, Repair depot, Insulin pumps.


Medical device manufacturing offers a platform for engineers as they work on both software’s and hardware. Medical device engineers work and develop under FAD guidance and satisfy its customers along the different stages of development. Along with the range of plastic and metal medical products, simple products such as surgical tools, laboratory equipment are also made.

Medical Devices Development

Now a days professionals construct three dimensional models of human bodies by the anatomical data from various devices such as computerized tomography (CT), resonance imaging, Laser. As discussed earlier the applications for prototyping in the field of biomedical models and technology are limitless. They also contribute to the development of surgical tools, models which are important as they are used by students to study. Thousands of these surgical models can be made which can provide training skills of medical education. This is not only time sufficient but reduces the cost as well. Based on what institutes and clinics require, their devices are manufactured such as elbow and ankle-foot orthotics.


If three dimensional anatomical structures are constructed then RE and medical processing data is used. The data collected from these are then fed into the computer aided design (CAD/CAM). These are essential for the design and manufacturing of surgical tools and medical devices. The four main steps for RE and medical imaging are:

  • First data is a accumulated
  • Registration of the data and processing
  • Design and manufacturing of a prototype
  • Medical final development

 Methods of prototyping

When the design, purpose and requirements for the prototype are determined, its fabrication starts. One of its approaches is conventional machining that involves more manual labor but has high accuracy and low tooling cost. Before proper manufacturing its model or part is created using liquid (silicone) that is known as casting. The liquid is poured in a mold and hardens. This is done to get an idea of the finished product.

3D prototyping is also known as additive manufacturing. The design is made in CAD and that is used to create a prototype that manufactures it in a day or less.

Another method is thermoforming that uses a plastic sheet which is heated two-dimensional mold using vacuum. This creates plastic molds that have a solid shape when cooled. But its disadvantages are less accuracy and only used to make small parts.

Apart from what have been mentioned above, another pretty welcomed method is CNC machining.  The machine substracts a block to a certain shape according to the CAD design. This technology wins a lot of followers because it can process various prototypes that engineers and designers need, no matter how complex the prototypes are in structure and what material they are expected to use.  For these reasons,  a wide variety of medical device prototypes are manufactrued by cnc machines.


Better fabrication is essential for the growing industry of medical device prototyping. Today patients are better treated because of the facilities provided by this. And the upcoming generation of medical students benefit also. It provides higher tolerance, uniform production, better safety and maintenance.



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