How to design medical equipment from start to finish Designing medical equipment is no easy endeavor. In this article, we are not aiming to cover all aspects of designing medical equipment. Our aim is to create a general overview of the process from start to finish, so you have a general idea of what a project outline could look like. These are some of the steps towards bringing new medical equipment to the market:
These are some of the steps from getting an idea for a product or device and then realizing it and bringing it to the market. Below, we will go through the steps in brief, so you get a better idea of each step.
It all starts with a good idea. It does not have to be completely new, it can also just be an improvement of something that already exists. All new devices fill a gap in the market – they meet a requirement or perform a function that is not already being met or performed. Or sometimes the idea is simply a way to do something we already do faster and better. So, the first step is to identify a need on the market. After this you will have to dive into the different specifications, regulations, standards and requirements that apply to the field that you are operating within. One common requirement for a lot of medical devices or medical equipment is hygiene. The equipment must be designed with hygiene in mind – so that the equipment does not cause contamination or spread of bacteria or viruses.
It is important that each machinery part lives up to the general standards and requirements for hygiene. Everything from the larger parts of the equipment to the smallest details such as maybe the wheels or the hygienic machine feets on the floor. These need to be washable at high temperatures, and they must be protected against moisture, temperature fluctuations, rust, oil, salt, damp etc. All this for them to meet requirements for hygiene.
When you do product design, safety will always be a top priority. Especially when it comes to medical equipment design, you must be careful and mindful that the equipment lives up to standards and goals of safety, reliability and functionality. When it comes to equipment for the health sector, it may be a matter of life or death. The patients’ lives depend on the safety and efficiency of the equipment. Thus, a lot of testing is necessary. You both test functionality, efficiency and safety. Repeated testing is the only way to develop and design medical equipment in a sound, morally justifiable way. One way to get an overview of safety (or lack thereof) is by doing risk assessments. In doing this, manufacturers of medical equipment identify different hazards that are related to the equipment, they estimate the risks, they identify ways to control and manage the risks, and finally, they constantly report on how efficient the risk management procedures are – to see if they can be optimized. Finally, quality assurance is important as this influences all stages of the development and design process.