The Overview of Medical Device Prototyping


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, the next step is to make an acceptable product. Some medical device services include Procurement advice, testing, and design of components, assembly, complex PCB design etc. Medical device prototyping is a valuable tool in market research, medical innovations review, 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, pacemakers, and etc. These devices are selling and marketing all over the world. It also saves costs and time. It gives professionals more than just visualizing and designing these products. They are able to make a prototype that tests 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 customers, and developers in the early product process. 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 of medical device prototyping is infinite by using biocompatible materials for clinical engineering production services.


Medical Device Design and Prototyping

The food and drug administration has classified medical devices into three classes. The FDA labels, this first-class device service by testing them through misbranding, banned devices, good manufacturing practices, how they are manufactured. This kind of device services is the lowest ranked at harming its users.


The device services under the second type are more likely to cause harms for the users. This means that the criteria of checking such as making, manufacturing are not fulfilled by them. They undergo a pre-marketing production that makes them fit for the market. The third type is at the highest risk as they include devices such as pacemakers, heart pacers, and etc. This type of devices is used at crucial times when a patient’s life is at risk so they have to go through pre-market approvals and general controls to be legally marketed. All of the above three types of clinical devices are important and being 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 product innovations, we require a clear understanding of the demands, the purpose, also the target customers and their requirements. Also the definition of functional methods of clinical or medical engineering production in an early review, and selecting a suitable process of fabrication of each component as well.


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 for the early process review. Customers’ knowledge and good thoughts are essential for product innovation. 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 help professionals design a virtual product or some parts of the machine. 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 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 the surgical tool, laboratory equipment are also made.

Medical Device Development

Nowadays, with medical device development,  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 in 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 an accumulated
  • Registration of the data and processing
  • Design and manufacturing of a prototype
  • Medical final development

Methods of Medical Device 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 the 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 has 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 manufactured 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 benefits also. It provides higher tolerance, uniform production, better safety, and maintenance.

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