For the UK’s medical device manufacturers, creating a medical device prototype is a meticulous and essential process. Every stage of the process is carefully designed to ensure that the device delivers optimum functionality and usability while complying with the most rigorous safety and regulatory standards.
But what does the development process involve and why is it important to work with an experienced fabrication specialist when creating prototypes of new medical devices?
Step 1: Establish Deliverables
At the start of the process, you should define deliverables - documents, drafts, and models that form the foundation for the prototype's design and functionality. These range from initial low-fidelity sketches to fully functional prototypes for testing and validation. Key considerations at this stage include identifying the stages of product development, defining success criteria, and assessing the risks that may affect users and the device's functionality. By understanding the scope of the project and its participants, the process can be structured to achieve optimum outcomes.
Step 2: Develop 3D-Printed Prototypes
3D printing is a transformative tool in the development of medical device prototypes, allowing the creation of accurate iterations at every stage of the design process. These mock-ups, which are typically introduced in the early stages of the process, provide a tangible representation of the device's form, size, and functionality. Designers can quickly refine their concepts, ensuring that the final prototype closely aligns with project specifications. An iterative approach to prototype development minimises process costs, enhances precision, and reduces avoidable waste.
Step 3: Test Rigorously
Effective testing underpins a prototype’s performance and regulatory compliance. Throughout the development process, prototypes are subjected to rigorous testing to assess their functionality, design, and structural integrity. Amongst those tests figure user trials which help to ensure that the prototype meets the usability requirements around the functionality. Testing identifies flaws and allows for adjustments before committing to production. By promptly identifying and addressing issues, developers can avoid costly mistakes, ensuring the final device meets the highest quality standards.
Step 4: Choose The Right Prototype Type
The type of prototype created depends on the project’s needs and the deliverable requirements. Generally, prototypes fall into three categories:
- Works like prototypes, which focus on functionality.
- Looks like prototypes, which emphasise appearance.
- Looks like, works like prototypes, which combine both elements.
These categories can be further refined using manufacturing methods such as CNC machining, vacuum casting, or painted finishes. Selecting the right approach ensures that the prototype aligns with both technical and aesthetic requirements.
Step 5: Review Regulatory And Material Considerations
Medical devices must adhere to stringent regulatory standards and biocompatibility requirements. Therefore, it is critical that designers understand how, where, and with whom the final product will be used. Materials must be carefully chosen to comply with FDA standards as well as regulations and biocompatibility requirements and can be manufactured within an agreed Standard Operating Procedure (SOP) process. Certificates of Conformance (CoC) document the prototype’s compliance, ensuring that it closely resembles the final production device in terms of quality and safety.
How We Can Help You
At Complete Fabrication, we can turn your medical equipment concepts into functional prototypes. Our in-house team creates designs suited for real-life testing, analysis, prototyping, and low-volume manufacturing, ensuring practical, test-ready solutions that are ideal for medical applications.
If you’re ready to bring your ideas to life, please get in touch with Complete Fabrication to find out how we can support the development of your organisation’s medical device prototypes.
