What is medical device prototyping and why is it useful?

Medical device prototyping is when you produce a functional version of your design that can be tested to ensure it meets the intended design specification. Producing a prototype of your medical device has many benefits and is a key step in the design and production process of bringing a device to market. Here we answer some of the most common questions about medical device prototyping.

What are the benefits of medical device prototyping?

When prototyping a medical device the aim should be to produce a preliminary model that is as close as possible to the product specification of your device, but using a method that could quickly and cheaply apply design changes to improve performance or to meet user feedback.

Feeling confident that your design meets the required performance criteria and committing to full production tooling, only to find that user feedback highlights suggested changes, could be costly and cause delays to both production and getting your device to market. You should aim to ensure all user testing and bench testing has been completed as thoroughly as possible using prototypes before committing to production tooling. Optimistic launch dates will often reduce the amount of time allocated for prototyping and testing, but then lead to significant and more costly delays further down the line should any unexpected changes be required.

What are some of the different methods of prototyping?

The prototype can be produced using a variety of different methods such as

  • Rapid prototyping such as:
    – Stereolithography (SLA)
    – Selective Laser Sintering (SLS)
    – Fused Deposition Modelling (FDM) (commonly known as 3D printing)
    – Selective Laser Melting (SLM)
    – Laminated Object Manufacturing (LOM)
  • Handmade
  • CNC Machining
  • Aluminium or “soft” injection mould tooling
  • Silicone Tooling and Vacuum Casting
  • Produced at your desk using whatever parts are available
  • Modifying an existing device

Each method of prototyping has its own advantages and disadvantages, and certain types are much better for small volume modelling, while others are able to produce a larger number of parts.

It may be that for your first initial prototype you 3D print or CNC machine, which will give you one or two parts that can be held and used for initial tests. You may then wish to produce a larger number of parts, at which point Silicone Tooling and Vacuum Casting can be an option, but if correct materials are required then soft single cavity or family tooling will be necessary. This tooling can then be more easily modified to ensure you have the correct fit and feel, before eventually moving to a full production process.

Is it always necessary to produce a prototype?

It would seem like a sensible idea to prototype any new product. However, examples where you may not need to create a prototype could be:

  • You are creating an identical copy of a competitor product
  • It’s a very small update to a device and market you understand completely
  • The product cannot be prototyped due to the materials or processes required

Who should prototype the device?

Any medical device manufacturer or medical device company should have a working prototype of their device for testing, to get end user feedback, compare against any existing products or to confirm any performance claims about your new device. Although prototyping can be costly at the start of the project, it will inevitably save time and costly modification work if the production tooling needs changing due to end user feedback or unexpected compatibility with accessories.

There are many options for medical device prototyping and in nearly all cases prototyping a device before moving to full production is an absolute must.

Creating a device prototype can be done by yourself, however if you do not have the equipment, time or knowhow, there are plenty of other options. There are also numerous companies that specialise in creating prototype products or your existing or prospective manufacturer may also be able to create your new device based on your specification. You may also be able to order parts directly from online companies where you can upload your design and then assemble and test the device yourself. As a specialist and expert contract medical device manufacturer Meridian Medical is proud to work with customers to help design and prototype their products.

Meridian Medical is an established and experienced contract medical equipment manufacturer specialising in a wide range of medical device design, development and supply services.

To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or info@meridian-medical.com.

What is medical device prototyping and why is it useful?