Medical Device Design: Getting it right the first time

YW Managing Director, Barry Warden, explains some of the key considerations for medical device design, including a recent project.

Over the past 16 years we have worked with numerous medical device manufacturers to help them bring their innovations to market. During this two things came to the fore – the importance of prototyping and testing.

Medical device design and manufacturing is highly regulated and heavily regulated. A mistake in design or construction can literally mean life or death.

There are several questions to consider:

• Is there a market need for the device, does it solve a medical/diagnostic need?
• What is its potential impact on the market and has anyone developed something similar?
• Is the IP properly protected?
• Patient safety and comfort in product use
• What is the regulatory framework and which certifications govern the production, marketing and use of the equipment?
• The manufacturing will be in low, medium or high volume. This will determine the nature of the supply chain and the selection of components and materials.
• Testing, Traceability, Verification and Quality Assurance.

Once the initial design and specifications have been chosen, production of the prototype can begin. Fortunately, with the advent of techniques such as 3D printing and selective laser sintering working models can be cost-effectively produced to be as close as possible to the real thing. Be prepared to build multiple iterations of the device. Ideas that look good on a CAD system can fail in the hands of potential users. In many cases it is not only the functionality of the device that is important, but also the look and feel; The patient should feel comfortable using the device.

Rapid prototyping is now an established process where a full-scale model of a device or product is manufactured from polymeric materials bonded together to form a solid object, usually in a very short period of time. While a plastic version of a product that is designed to be made from metal may not have the same properties, the fact that a designator is able to hold the article to the exact size is an important factor in validating the design. Goes a long way. Rapid prototyping is an important tool and is now available in a variety of forms and formats, so it is possible to choose one to meet any budget.

Having a physical product to try is a huge advantage in gathering feedback from others and your market research. Even the best designers make mistakes and the sooner any issues are exposed the better. Even the smallest mistake when transferred to a production environment can be costly in terms of rework or re-tooling.

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

The idea behind the authorized project LUSS (LED based Ultra-Violet Exposure to Safe Surfaces) was to create an affordable solution to combat COVID-19 infections in public places, while also disinfecting other viruses and bacteria such as MRSA and C.diff There was an added benefit of doing so. ,

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

The device consists of a mechanical arm that automatically moves across a surface (such as a door panel) after each use and kills viruses using a powerful ultraviolet-C light. It aims to remove the need for frequent manual cleaning of hospital door panels and other surfaces that come in contact with the public.

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

Finally, prototyping is now easier and the benefits of building a realistic model far outweigh the associated costs. Typically, only one CAD file is required for a rapid prototyping model and because such files can be sent via email to a manufacturing company, your design can be sent to any company you choose, regardless of Wherever 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 series of sketches can. Prototyping will help you hone in on your product’s features and iron out any problems before you commit to a final design.

WiW will be exhibiting at the Med-Tech Innovation Expo at the NEC on 7-8 June 2023 in Hall 2 on stand E52. Register for free at www.med-techexpo.com