Medical Device Prototyping: FAQ Guide

Prototyping is generally testing your product before launching it publicly. In many cases, the designers feel so much disappointment when their designs don’t fulfill their demands.

To avoid such cases, every new technological device should undergo prototyping to ensure the high-quality performance of the specialized equipment.

Medical instruments are one of the most important and useful technological equipment because they are to be used somewhere to treat your health. Manufactures must pass the new product through proper prototyping programs so that no future complications that may arise.

1. What Are the Basic Steps for Medical Device Prototyping?

Every successful task requires a person to carry on everything smoothly in an organized way. The same is the case with the prototyping of medical devices. There are specific basic steps that a design passes through before becoming a public product.

● Appearance of The Design Is Finalized in The Initial Step

The first and the most crucial step of medical device prototyping is the choosing of the appearance. It is the appearance that attracts the people before it gets launched in the market. The appearance is chosen from the various designs prepared by the engineers.

Once a particular design gets selected, a real model of the instrument is created from foam or other dummy materials. The model is made the same as the person expect it when it gets launched in the market.

● Creation of The Test Design

In the second step, a new design is created that looks totally the same as the original and performs the basic functions as well. This is the final product test version, which is called an alpha stage of medical device prototyping.

● The Product Is Made Ready to Be Released

In the third stage, also known as the beta stage, the product is completed and made ready to release in the market. The manufacturer does some important documentation as a part of the beta stage in medical device prototyping.

● The Test Version of the Product Is Released

In the next step, the medical device is released in the market but is available only for test trials. It is vital to get a broader idea of the practical use of any instrument. So to ensure better quality, the medical devices are sold to clinics, and their review is taken. This stage is also termed “the pilot stage.”

● Finally, The Product Is Launched

By passing a medical instrument through all these steps, the instrument is launched in the market with greater development made after the pilot stage. The final product is prepared in such a way as to cover up all the shortcomings in the earlier stages of medical device prototyping.

2. How Is a Medical Prototype Prepared Using Vacuum Casting Technique?

This technique is a popular prototyping technique in China. Vacuum casting is a modern prototyping technique that quickly allows a manufacturer to produce a small quantity of smaller prototypes. So if a manufacturer wants early results, he or she can go for using the vacuum casting technique. This technique requires the preparation of the model using the SLA process. After that, the silicon rubber is used for

covering up the model, and this whole process of medical device prototyping takes some 6 to 7 days.

3. Why Is Vacuum Technique Considered the Best for Medical Device Prototyping?

Usually, the prototyping will take a lot of time to get fully completed. So to make your work faster, most manufacturers prefer the vacuum casting technique. Here are some more reasons that make this technique the best for medical device prototyping.

● Time-saving process

The vacuum technique can help you out to create the mold right after two days once your model gets ready. This saves you a huge amount of time. Even the time required is less than as compared to prepare a syringe prototype. Thus provide you more time to go for your beta and pilot stages.

● Prepare the Best Product

The vacuum technique of medical device prototyping focuses on all the things that are required for manufacturing the best product. For medical instruments, it bears massive importance that the product should be made of such materials that could be resistant to heat and can be sterilized easily. The vacuum casting allows a manufacturer to take care of all these things while preparing their medical instrument prototype.

● Cost-saving

For medical device prototyping, you will sometimes require a good amount of money. Still, in the case of vacuum casting, you’ll definitely save a lot of money. So if a manufacturer wants his medical instrument to be prototyped at a low cost, he should go for vacuum casting. This process is even cheaper than CNC machining.

4. How to Use CNC Machining for Medical Device Prototyping?

CNC machining is another kind of medical device prototyping technique by which you can create complex medical prototypes. This modern technique involves the use of computers for cutting or bending materials to transform them into prototypes. The best thing about CNC machining is that the whole process is automatic, and you don’t need to monitor it all the time.

You have to create a CAD design of the product that you want to make a prototype of. Then enter the design into the computer operator, and the CNC machines will automatically perform the whole task for you. The CNC machines operate with a language called the G-Code. It is the language in which the computer reads your CAD design and commands the machines to run accordingly.

CNC machining is one of the most popular and widely used techniques for building medical prototypes. This technique has higher accuracy and versatility that had made it the best prototyping technology. The prototypes produced using this technology are too much descriptive as compared to that of other technologies. China is also the supplier of modern CNC machines.

5. How to Make Medical Device Prototype with 3D Printing?

3D Printing is another technique that is used for creating medical device prototyping.  3D Printing is also a cheaper technique for prototyping, so if you want to prototype your medical device for cheaper rates, you can use 3D Printing.

3D Printing is generally useful if you just need a simple model for your prepared design. The 3D printing technology can be used to create medical prototypes made of plastic glass or even metal. The prototypes produced with 3D Printing can be the best for small medical products.

6. Why Should You Use 3D Printing Techniques for Medical Device Prototyping?

Using 3D printers for creating medical device prototyping is the best due to the following reasons.

• Faster and Efficient

The 3D printers are considered to be much faster and efficient than any other technology, especially for medical device prototyping. If you order a prototype for your medical device from a manufacturing company, it will take two to three weeks to complete your order and make the prototype of your medical device. However, in the case of 3D Printing, the situation is different. The 3D printing technology will create your prototype within 24 hours.

• Cheaper Price

In comparison to other technologies for making medical device prototypes, the 3D printing technology is considered to be the best in terms of price too. 3D Printing can be done in some 100 $ or nearly that figure. The prices are increased as you increase the number and types of functionalities in your device. Due to such a low cost and high quality, this technology is recommended by most of the experts.

• Material Choosing

One of the best things about 3D Printing is that you can choose different kinds of materials for making a prototype of your medical device. You can use plastic, metal, or any material for manufacturing your medical prototype. Using the 3D printing technology, you can also create different parts of the material and then fixing them together to make a functional medical device prototype.

• Designs Can Easily Be Changed

In other medical device prototyping technology, the worst thing is that the designs once made cannot be changed later. Or sometimes, changes can be made to them, but it takes a lot of struggle and time (usually weeks to months) to make changes to the prototype. But in 3D Printing, it doesn’t happen. You can still make changes to your design quickly. You just have to make changes to the CAD design of your medical device and use that new CAD to change your old design.

7. How Is Medical Device Prototyping Done Using Clear Acrylic Machining?

This method of prototyping is used in most of the areas of China. Being the acrylic machines suppliers, China supplies the best machinery to the world. This technique is advantageous to get the clearest prototypes of your newly designed medical instruments. This technique is handy for making plastic or glass prototypes. The process of clear acrylic also costs a manufacturer less and provides you the best results.

The whole process of acrylic prototyping is completed in two simple steps,

● CNC machining

In the first step, computer numerical control is used for manufacturing the basic model for prototyping your new medical instrument. After the production of the model, it is polished with various methods to make it smoother before manufacturing.

● Transformation to regular prototypes

In the next step, the model prepared using CNC is transformed into regular medical prototypes using various strategies. Additional polishing is done to make the prototype clearer and enhanced.

8. How Can I Prepare the Best Prototype for My Medical Device?

Before launching your newly designed medical instrument, you will be looking for some tips for preparing a prototype. Here are some of the best and practical steps to follow for preparing a prototype of your medical device that can be used in China.

● Draw A Sketch of Your Thoughts

The first step in building your medical device prototype is to draw a rough sketch of the new medical instrument that you want to launch in the market. Your sketch should be of a broader spectrum that can tell much about the medical device you want to create. Some people draw the general sketch directly using the computer, but it is much better to first draw on a piece of paper before making it on your PC.

Once your sketch is ready on a piece of paper, you should move towards preparing your sketch with tools on your computer. There are lots of tools that let you prepare and study your design from all angles.

● Manufacture A Prototype at Your Home

The next step is to get a little more practical and prepare your medical device prototype from scratch materials. It doesn’t need to look like the exact medical device that you have imagined. But still, it should be able enough to create a picture of what to expect from the manufacturers.

● Contact A Prototyping Company

In the next step, a manufacturer should contact the best prototyping company to manufacture his prototype with modern machines. These companies will help you prepare your model exactly what you have designed.

You can choose any design among templates or use your own homemade prototype to provide an idea to the manufacturing company about what you actually need and what you expect from them. You will find a number of prototyping companies working in China by searching a keyword like “Best China prototyping companies” on google.

9. Why Is There a Need of Prototyping a Medical Device?

Prototyping your new medical product is an important step towards the development of the health status of a particular nation. If your instrument is passed from several processes, you’ll be more likely to get what exactly you wanted from your ideas.

This will make you feel more confident and victorious about your dream of launching a new medical device.  In prototyping, the exact sample of your design is prepared to make only a small investment in it.

This is for the purpose of giving you an idea about the design so that it will meet the needs of the majority of the masses.

●Medical device Prototyping Give You an Idea of the Shortcomings in Your Design

Before getting into preparing the main product, prototyping your medical device will help you find out most of the flaws in your design. Your model will be perfect in your theory, but in practice, there are greater possibilities of facing various kinds of challenges to give a practical shape to your approach.

Not only it finds the flaws in your idea, but it also helps you make some more creativity if the instrument you are making is in front of you in the form of a realistic model.

So if you want to create more convenience for your users, it is important to create a medical device prototype of your medical instrument. After its creation, find out the places that need some improvements and try developing your model more and more.

● Prototyping Helps to Reach the Public Before the Product Is Ready

If you prepare a prototype of your medical device, there is a chance it will get popular even before it is launched in the market. This will make an image of your product in the minds of your customers, and there is a greater possibility that your newly launched medical device will make a great number of sales.

Prototyping also makes you appear more professional and dedicated to your work. And most importantly, creating a prototype of your device will enhance your motivation to work with designing.

● Prototyping Can Reduce the Cost of Your Main Product

The best thing about prototyping is that it can also reduce the net expenses on your product. You might think of one material as a perfect part, but actually, there may be a possibility that using another material would be better, efficient, and cheaper than the one that you have chosen.

So if you want to prepare a medical instrument at a low cost, you should not shy of spending money on creating the best prototype for your device.

10. How to Spend Least On Prototyping Medical Device?

Before contacting a prototyping company, it is important for you to calculate the total cost of the process. For spending the least amount of money on prototyping, you can consider following the steps below.

● Select A Cheap but High-Quality Material

For medical devices, you will need a material that is definitely of high quality. So you cannot compromise the quality in any case, but still, you can use different materials that are the best alternatives to the material that you selected earlier. Even in some cases, the cheaper materials are much better to be used in a particular medical device.

Selecting the right, best suitable, and budget material are important to ensure better quality and cost-saving.

● Choose Cost-Saving Prototyping Technique

There are lots of prototyping techniques like vacuum casting, CNC machining, plastic 3D printing, but you have to select only that one which you can afford. You will find a great amount of inspiration after contacting the manufacturing companies.

● Decrease The Functionalities in your medical device prototype

You are going to merely create a prototype of your medical device and not the actual product. So if in case you are going out of money, it is okay to decrease the functionalities in your prototype. Those large prototyping pieces of machinery are made to charge you a huge amount of money, but if you take everything humbly, you’ll definitely save a reasonable amount.

11. What Is the Average Cost of Medical Device Prototyping?

Prototyping a medical device can cost you $100, which is almost 648 yuan in China currency. That’s totally depended upon the type of material and the type of technique that you use to create a prototype.

One thing that you should always remember is that you don’t actually need to use expensive materials to create a prototype. It’s just a model and can be created by spending the least amount of money on material. If you use complex machinery, you will definitely have to pay the large prices, but if you make it simple, you will save a good amount of money.