Why is the medical device design process divided into stages? How can this help creators to keep the track and match initial idea with medical regulations? As our bodies are complex so some medical devices are. That’s why a medical device prototype design process always needs to stay under control to obtain a certificate, however at the same time it should bring to the market a unique value for the treatment process or diagnostics.
Paweł Zieliński – Marketing Manager Consonance
What is medical design?
When you think about a medical device, do you see something nice, likable or desired? I’m guessing here – the answer is “no”. Unfortunately for years, there has been no connection between design and medicine. Instead, medical technology has prioritized technical advancements, putting less emphasis on the goods’ designs and how it could benefit patients’ mental support. This is now gradually changing. A growing number of medical firms believe that good design may enhance their carefully manufactured goods. Medical design has earned widespread attention thanks to several design awards and the feeling that as we like well designed cars, mobile devices or kitchen appliances we also appreciate a good design in the healthcare industry. After all, even treatment or diagnosing can be more fun, right?
Medical design is the use of design principles to the practice of medicine with the goal of improving patient satisfaction as well in some cases – mostly healthcare professionals. There seems to be no subject in which design would be more essential or useful than in medicine.
Why is medical device design important?
There is a huge difference between for example the design of a mobile device and a medical device. A misuse of the second one can bring unexpected health consequences which are the last thing developers would want.
Design may assist lessen anxieties and foster acceptance rather than sterile environments or chilly technical equipment. It will produce more items that are easy to use, sometimes proving function by form. Medical architecture has a beneficial psychological impact and enhances patient-doctor interactions. Finally, patients feel more at ease, which improves the quality of medical care.
How to design a medical device?
A medical device prototype design process despite some local differences or some practices forced by FDA or MDR regulations, the process’s primary goal is to maximize safety and effectiveness. Worldwide, teams of software, biomedical, electrical, and mechanical engineers follow parallel development paths for medical devices.
Idea and concept generation
The first phase is all about working together. A medical product design business will closely collaborate with their customer to comprehend the intended functioning of the gadget and how it will solve a particular problem. Risks, rewards, and practicality will all be taken into account.
Specification development
The mechanical, electrical, and software specs required for the gadget are presently being developed by engineers. Scalpels are an example of a basic device that just has a mechanical component, but more sophisticated devices like high frequency ventilators need all three.
To prevent making costly mistakes later, accuracy is crucial at this point. The link between the device’s structure and function must be thoroughly understood by the design team. This will assist them in selecting the appropriate materials and identifying any potential drawbacks.
Design and development
This stage is divided into two segments which help to define design inputs and outputs as well as plan the development process. A medical device’s performance and physical attributes are both influenced by design inputs. The design of the gadget is based on these qualities. For instance, the design must take special account of the weight and size of the medical equipment if portability is required. Additional traits include functions, performance, physical features, safety, maintenance, regulatory requirements, human factors, labeling and packaging and more. These above, in the process should be translated into outputs which can be described as the final design outcomes to cover device specs, diagrams, drawings, user manual, study results, risk assessment and more.
Design review and validation
Medical device production is a careful and expensive process. Time and money can be saved by resolving problems during the pre-production phase. Because it enables engineers to ask, “Is this right? “, the review and validation step is a crucial turning point in the design process.
The group will investigate (via experiments, simulations, etc.) against important standards (usability, consistency, durability, etc.). Designers will repair defects, fix failures, remove redundant parts, and add new features if problems are found. The system will be subject to yet another examination when the modifications have been made. This iterative procedure keeps on till the review is successfully finished.
Product launch
The last phase is the result of research, design process, development, if required – clinical trials, certification, manufacturing and shipment.
This is the stage when marketing, sales strategy comes into play and drives the execution of product market fit. Although engineers and designers are still somewhere behind if any recalls show up or product is planned for future updates and investments. This is also a stage, when – like in the research & development phase – we should listen carefully to early product adopters who can share their experience which could bring two benefits: great stories to tell for the marketing department or great insights for engineers on how to improve the next product release.
