Medical Device Design: Getting it right the first time

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Over the past 16 years Wideblue has worked with dozens of medical device manufacturers to help them bring their innovations to market. During this time two things have stood out: the importance of prototyping and testing.

The design and manufacturing of medical devices is highly regulated and rightly so. A flaw in design or construction can literally mean life or death.

There are a number of questions to consider:

Is there a market need for the device, does it solve a medical/clinical need? What is its likely impact on the market and has anyone developed something similar? Is the IP adequately protected? Patient safety and comfort in using the product What is the regulatory framework and what certifications govern the production, marketing and use of the device? Production will be low, medium or high volume. This will determine the nature of the supply chain and the selection of components and materials. Testing, traceability, validation and quality assurance.

Once the initial designs and specifications have been chosen, prototype production can begin. Fortunately, with the advent of technologies such as 3D printing and selective laser sintering, working models can be produced cost-effectively to be as close to reality as possible. Get ready to build different iterations of the device. Ideas that look good on the CAD system can break down when it’s in the hands of potential users. In many cases it is not only the functionality of the device that is important, but also the graphic aspect; the patient should feel comfortable using the device.

Rapid prototyping is now an established process in which a full-scale model of the device or product is fabricated from a polymeric material bonded together to create a solid object, usually in a very short time. While a plastic version of a product that is designed to be made from metal may not have the same properties, but the fact that a designer is able to hold an exact sized item in their hand goes a long way in verifying the design. Rapid prototyping is an important tool and is now available in many shapes and sizes, so you can choose one to suit any budget.

Having a physical product to try is a big plus for gathering feedback from others and from your own market research. Even the best designers make mistakes, and the sooner any problems are discovered, the better. Even the smallest mistake when transferred to a production environment can be costly in terms of rework or retooling.

A great example of a project where prototyping was essential was the development of an automated surface disinfection system for use in hospitals.

Entitled Project LUSS (LED based Ultra-Violet exposure for Safe Surfaces) the idea was to create a cost-effective solution to fight COVID-19 infections in public spaces, with the added benefit of also disinfecting other viruses and bacteria such as MRSA and C.diff .

Funded by Innovate UK, the project brought together the Microlink Devices and Compound Semiconductor Applications Catapult Consortium with Wideblue as product designer.

The device consists of a mechanical arm that automatically passes through the surface (such as a door panel) after each use and kills viruses using powerful ultraviolet-C light. This is intended to eliminate the need for frequent manual cleaning of hospital door panels and other surfaces that come into contact with the public.

A key part of the project was the production of several prototypes that could be tested in a hospital environment. Several iterations of the design were tested until a final version was chosen.

Bottom line, prototyping is now easy to do, and the benefits of creating a realistic model far outweigh the associated costs. Normally, rapid prototyping models only require a CAD file and since those files can be sent to a manufacturing company via email, your design can be sent to any company of your choice no matter where they are in the world.

Creating a prototype product will give you the ability to visualize your product in a way that no computer program or sketchbook can. Prototyping will help you improve the features of your products and fix any problems before committing to a final design.

Wideblue will be present at the Med-Tech Expo at the NEC (7-8 June 2023): Pavilion 2 stand E52. You can register for FREE here.

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