Many people are unaware of what exactly goes into creating a new medical device, particularly with regard to devices used in the healthcare industry. In this article, we’ll explore the process taken to create one such product, addressing specific questions and concerns along the way to give you insight into how these devices are made and how long it takes to develop them from start to finish. If you’re looking to get into medical device development or want more information about what goes into creating these types of products, this article will serve as an excellent resource.
Tracks
Creating a medical device can be a complex and time-consuming process. But with the right steps and guidance, you can make the journey easier. There are various tracks to work on when developing a medical device. Those tracks include:
- Intellectual Property Support
- Product Design
- Risk Management
- Manufacturing
- Usability
- Compliance and Regulatory Support
Each track plays a crucial role in the development of medical devices throughout each stage of development.
Mockup, App Model
Creating a medical device requires a lot of research, planning, and engineering. Before embarking on this complex task, creating a mockup or app model is important to help visualize the device and understand how it will work in practice.
The first step in creating a mockup is researching existing medical devices to gain an understanding of design elements that are common among them. This could include exploring features such as ergonomics, button placement, display designs, and overall usability. This step can help inform decisions when creating the mockup.
Creating a mockup is a great way to better understand how your medical device will look and work in practice. Investing the time to create an accurate mockup can help save money in the long run and ensure that the end product is functional and meets all safety requirements.
Proof of Concept Prototype
This prototype allows you to test it for safety, functionality, and other regulatory requirements before bringing it to market.
A POC prototype should be developed using the best available technology and materials. It should be built in such a way that it will provide a safe and effective solution to the intended application. It should also meet the necessary design specifications and regulatory requirements.
Alpha Prototype
An alpha prototype is a physical model of the device used for testing and getting feedback from potential customers.
Creating an alpha prototype involves several steps, including creating a design and using 3D printing to create the prototype. Once you have a prototype, you can test it to ensure it works and make any necessary adjustments.
Creating an alpha prototype is the first step in designing a medical device, and it’s essential to ensure that your device works properly and is ready for the next steps. By developing and testing a prototype before moving on to full production, you can ensure that your device meets all necessary standards and regulations.
Beta Prototype
Once the alpha prototype is completed, you should test it thoroughly to ensure it works as intended following modifications found during alpha prototyping. If there are any issues with the prototype, this is a great opportunity to make modifications before bringing the device to market.
By carefully planning and constructing a beta prototype, you can take the next step toward creating a successful medical device. With the right resources and attention to detail, you can create a prototype that you can use to refine your design and bring your product to market.
Production Ready Design
After successfully testing a beta prototype, your design will be ready for production. This includes selecting a manufacturing partner, sourcing materials and components, finalizing the design, and conducting quality assurance testing. Throughout the production process, it’s important to ensure the device meets all necessary standards and performance requirements. Designing and producing a medical device is a complex undertaking that requires a considerable amount of expertise.
Pilot Production
When creating a pilot production run of medical devices, you must ensure that all regulations and standards are met. Additionally, it’s important to choose the right components and materials and consider any special needs of the user or environment in which the device will be used.
During the pilot production stage, several thousand units or prototypes will be made as well as materials and processes equivalent to those planned for the manufacturing stage. The purpose of the pilot production stage is to verify that all aspects of your design can be successfully produced. With this knowledge, adjustments can be made before mass-producing your final product on a large scale.
Resources:
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/device-development-process
https://www.fda.gov/patients/device-development-process/step-1-device-discovery-and-concept
