Designing and creating a medical device is no small task with long lead times, in-depth development, and product rollout. Each of these phases on its own is a complex endeavour but altogether requires an experienced team who understand the end users’ needs.
At Europlaz, we offer a complete medical device development service to support your endeavours and ensure your product reaches the intended market. Prototyping is a critical part of this process and one we pride ourselves on. But what is medical device prototyping, and how does in-depth planning and a medical device prototyping design process ensure your medical devices success? Join us as we investigate this process and how it benefits the medical community.
What is medical device prototyping?
Prototyping is a critical step in the medical device design process. As an important tool in feasibility, prototypes allow you to revise design flaws, reduce production lead times, and bring your vision to life.
Why do manufacturers and designers use prototypes?
Given the time it takes to develop a prototype, why should companies invest in making prototypes?
The answer. Assurance and performance.
Prototyping gives you a preliminary vision of what your product will look and feel like. It allows you to prove a design concept and note any flaws or issues before rolling out products to the public.
This is accomplished through several tests including real world testing and fault finding. These are two different testing methods designed to measure usage. In fault finding, products are pushed to breaking point to see what pressure or action causes breakage. In real world testing, the product is tested with the pressures and regularity expected on the market to test the efficacy and longevity of your product.
This stage also allows you to test the production phase to see how quickly a product is produced and note any other issues or concerns in the process. This varies from product to product and can make all the difference by allowing you to spot any issues or concerns before they become larger problems such as approval failures, misuse, or product recalls.
What is the medical device design process?
At Europlaz, our expert team use the latest design technology to offer rapid prototyping for your medical device. We run through several stages to cover all bases starting with the CAD design.
CAD allows us to create concepts for 3D printing to explore various sizes, shapes and designs and eventually discover the best iteration.
From here, we create proof-of-concept models using our state-of-the-art 3D printing machines for further testing and validation before deciding on functional prototypes. Along with 3D printing, we also offer CNC machining and Stereolithography to offer rapid prototyping services that offer all of the benefits of prototyping with a much faster development time.
These functional prototypes then undergo rigorous testing before moving on to a final decision and manufacturing.
On every step of this journey our design team design, assess, and monitor your journey from polymer selection to mould flow analysis to ensure a high-quality product that perfectly meets the needs of your intended patient.
How do medical devices get approved?
The above prototyping helps you prepare your product for any testing and ensure it has a greater chance of being approved. This approval often takes the form of various marks such as CE marks or UKCA marks. You can find out more about what these marks mean, and how to get your medical device approved here.
Europlaz: Over 50 years of medical design success
With over 40 years of experience, we have extensive knowledge and insight into the medical device design and manufacturing process. Our expert design team assists clients with every step of the medical device design process to make sure you understand what it is and how it gives your product the required standard, versatility, and speed of production required.
If you’re interested in finding out more about our services or want to know more about how we adapt solutions to your needs please contact us now. We look forward to assisting you on your next medical device project be it local, regional, or international.
