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Designing medical equipment and devices – an overview

medical equipmentDesigning medical devices is a complex process

Companies that design medical devices or equipment know how complex of a process it is. There are a ton of specifications, requirements and regulations – not to mention the needs of the end users: the clinicians and the patients. All these different aspects have to be balanced and weighed against each other, and companies that design devices must stick to them in order to create a successful product that will find its way – and perform well – on the market. Imagine if you design a device that is not user-friendly or where you have not considered the user experience? Then you will not succeed on the market because the users will not adopt your product. In turn, if you fail to comply with guidelines, standards and regulations, your product will never even be on the market. Designing medical devices and equipment is much more than just having a great idea, fashioning the product and then taking it to the market.

Step-by-step – the most important considerations for medical device design

When creating new medical devices, waterproof bearings and equipment, two main groups need to work together: designers and developers. These two groups must then evaluate the medical needs, the functional requirements, while still ensuring quality and handling risks. These are some of the protocols for designing new medical equipment:

  • Discovering and conceptualizing the device
  • Complying with regulations for medical devices and equipment
  • Designing controls and usability
  • Testing the medical device or equipment
  • Assessing and managing risk
  • Assuring quality

 

How to bring a new medical device to the market

When you get a good idea for a device, it is usually a result of discovering that there is a need on the market that has not yet been met by the industries. In the health sector, this is usually a product that help people monitor and manage health, providing aid, improving care or devices that improve the administration of treatment. A need is not all the time something that the end users are aware of. The problems that they face in every day life might just be regarded as unavoidable nuisances or inconveniences – problematic occurrences that they have to accept. That is, until someone comes up with an idea on how to solve it.

Demands on hygiene

There are a lot of regulations when designing medical equipment. One area of regulations has to do with hygiene. It is crucial to design medical equipment with hygiene as a top priority. All the machine parts that make up the medical equipment or device have to be designed with smooth surfaces, no unnecessary ribs, flanges, recesses or mounting holes. This diminishes the risk of the equipment being a growth point or breeding ground for bacteria and micro-organisms. When the design is done right, the cleaning of the parts will be as easy as possible. These principles hold for all machine parts in the medical equipment – everything from feet, bearings and conveyor parts.