Stages of the medical device process

ByLance T. Lee

Sep 12, 2022

Why is the design process of a medical device divided into stages? How can this help creators stay on course and match the initial idea with medical regulations? As our bodies are complex, so are some medical devices. This is why a medical device prototype design process must always remain under control to obtain a certificate, but at the same time it must bring unique value to the market for the treatment or diagnostic process.

Paweł Zieliński – Consonance Marketing Manager

Photo by Daniel Frank

What is Medical Design?

When you think of a medical device, do you see something nice, sympathetic, or desired? I’m guessing here – the answer is “no”. Unfortunately, for years there was no connection between design and medicine. Instead, medical technology has prioritized technical advancements, placing less emphasis on product design and how it might benefit mental support for patients. This is now gradually changing. A growing number of medical companies believe that good design can improve their carefully crafted products. Medical design has garnered wide attention thanks to several design awards and the feeling that just as we love well-designed cars, mobile devices or kitchen appliances, we also appreciate good design in healthcare. After all, even a treatment or diagnosis can be more fun, right?

Medical design is the use of design principles in the practice of medicine with the aim of also improving patient satisfaction in some cases – primarily healthcare professionals. There seems to be no field in which design would be more essential or useful than in medicine.

Why is the design of medical devices important?

There is a huge difference between, for example, the design of a mobile device and that of a medical device. Misuse of the latter can lead to unintended health consequences, which is the last thing the developers would want.

The design can help reduce anxieties and promote acceptance over sterile environments or cold technical equipment. It will produce more easy-to-use items, sometimes proving function by form. Medical architecture has a beneficial psychological impact and improves patient-doctor interactions. Finally, patients feel more comfortable, which improves the quality of medical care.

How to design a medical device?

A medical device prototype design Despite some local differences or certain practices imposed by FDA or MDR regulations, the primary goal of the process is to maximize safety and effectiveness. Around the world, teams of software, biomedical, electrical and mechanical engineers follow parallel development paths for medical devices.

Generation of ideas and concepts

The first phase is to work together. A medical product design company will work closely with their client to understand how the gadget will work and how it will solve a particular problem. Risks, rewards and convenience will all be considered.

Specification development

Mechanical, electrical and software specifications required for the gadget are currently being developed by engineers. Scalpels are an example of a basic device that has only one mechanical component, but more sophisticated devices like high frequency ventilators need all three.

To avoid making costly mistakes later, accuracy is crucial at this stage. The connection between structure and function of the device should be well understood by the design team. This will help them select appropriate materials and identify potential drawbacks.

Design and development

This stage is divided into two segments that help define design inputs and outputs as well as plan the development process. The performance and physical attributes of a medical device are both influenced by design elements. The design of the gadget is based on these qualities. For example, the design should specifically consider the weight and size of medical equipment if portability is required. Additional specifications include functions, performance, physical characteristics, safety, maintenance, regulatory requirements, human factors, labeling and packaging, etc. These above items, in the process, need to be translated into results which can be described as the final design results to cover device specifications, diagrams, drawings, user manual, test results. study, risk assessment and more.

Design review and validation

The production of medical devices is a painstaking and expensive process. Time and money can be saved by resolving issues during the pre-production phase. Because it allows engineers to ask themselves: “Is this true? “, the review and validation stage is a crucial turning point in the design process.

The group will study (via experiments, simulations, etc.) against important standards (usability, consistency, durability, etc.). Designers will repair faults, fix failures, remove redundant parts, and add new features if any issues are found. The system will be subject to further review once the changes have been made. This iterative process continues until the exam is successfully completed.

Product launch

The final phase is the result of research, design process, development, if necessary – clinical trials, certification, manufacturing and shipping.

It is at this stage that the marketing and sales strategy comes into play and leads to the execution of the product market adjustment. Although engineers and designers are still somewhere behind if recalls appear or if a product is slated for future updates and investments. It is also a stage where, as in the research and development phase, we must listen carefully to the first users of products who can share their experience, which could bring two advantages: great stories to tell for the marketing department or good ideas for engineers on how to improve the next version of the product.


Source link