Design tailored for manufacturing
Prototyping
An Agile Approach to Testing Ideas
Prototyping is a crucial step in ensuring the success of your medical device. It allows you to test all relevant functionalities, validate the design concept, and provide a tangible representation of your idea to present to investors or users.
Once the engineering phase of the medical device design process is complete, the next step is to create a prototype. A prototype is a large-scale functional version of your medical device, produced in limited quantities, with several key objectives:
- Proof of Concept (POC)
- Ergonomics
- Usability
- Aesthetics
- Functionality
- Prototypes for clinical trials and certification (e.g., FDA, CE)
- MVP/pre-series production
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A Two-Step Process
At Tame-Care, we carry out medical device prototyping in two main stages:
- Initial Prototype (Proto A): Aimed at demonstrating the key functionalities of the device, typically as a proof-of-concept prototype to validate the basic design principles.
- Qualified Prototype (Proto Q): Developed after rigorous testing of the initial prototype.
This two-step approach enables development teams to systematically transition from the initial design phase to prototype validation. It reduces risks, optimizes resources, and ensures that the electronic medical device meets all requirements.
Our skilled engineers assist you throughout the prototyping process—from selecting the most appropriate technology to identifying materials, quality control, assembly, and updating the 3D file based on insights gained from the prototype.
Initial Prototyping
The mock-up phase involves materializing ideas as physical and/or digital models. Tame-Care uses cutting-edge tools to create mock-ups that reflect the product’s ergonomics, design, and basic functionalities. These mock-ups allow for rapid validation of concepts before engaging in more costly development phases. This iterative approach enables adjustments based on feedback from medical teams and end users.
Adjusted Prototyping
Once the mock-up is validated, Tame-Care proceeds to the fabrication of functional prototypes. These prototypes integrate all necessary electronic and mechanical components to simulate the product’s final performance. Leveraging advanced equipment, the company produces high-quality prototypes within short timelines. Each prototype undergoes rigorous testing to ensure functionality, compliance with client requirements, and adherence to medical standards.
Testing and Validation
Prototypes developed by Tame-Care undergo a series of rigorous tests to ensure performance, reliability, and regulatory compliance. This includes environmental tests, functional tests, electromagnetic compatibility checks, and material validations to verify the durability and safety of the components used. The goal is to ensure the product meets all applicable standards, such as those set by European and American authorities (CE, FDA).
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Offers tailored to the different stages of your project
High value-added services
Our Areas of Application
- Active medical devices Class IIA, IIB, III
- Active implantable medical devices
- Control and monitoring equipment
- In vitro diagnostic devices
- Exoskeletons
- Surgical robotics
- Imaging devices
The challenges
The development of medical devices is a complex process accompanied by numerous critical challenges. These challenges must be managed to ensure the reliability, safety, and compliance of products designed for demanding healthcare environments.
Verification and Validation of Your Device
The prototype enables the verification and validation of your medical device. Verification is the process of determining whether the device’s specifications have been met through the design process. Every aspect of the design—mechanical, electrical, and software—is tested. Validation, on the other hand, examines the overall functionality of the device to ensure that it meets customer needs while complying with all applicable international standards and CE & FDA regulations. Documentation for each step is produced for the client and is intended for use in the regulatory approval process.
Compliance with Regulatory Requirements
The medical sector is strictly regulated by standards such as ISO 13485, CE marking for the European Union, and FDA regulations in the United States. These standards require comprehensive documentation and rigorous validations at every stage, from mockups to prototyping. The challenge lies in integrating regulatory requirements from the earliest design phases to avoid delays or costly non-compliance.
Device Safety and Reliability
Medical devices are used in critical contexts where patient safety is paramount. Mockups and prototypes must therefore help identify and address any potential flaws, whether they involve technical issues, unsuitable materials, or insufficient performance. The product’s reliability must be demonstrated through rigorous testing to minimize the risk of failure in real-world conditions.
Innovation and Technical Performance
Innovation is essential in the development of medical devices to meet the evolving needs of patients and healthcare professionals. The challenge is to integrate the latest technological advancements into functional prototypes, while adhering to budgetary and time constraints. Each prototype must be optimized to deliver high performance in an ergonomic and practical format.
Cost and Time Optimization
In a competitive environment, time-to-market is a key success factor. Mockups and prototypes must be developed quickly while controlling costs to avoid budget overruns. This requires efficient management of resources, materials, and processes, while minimizing the number of iterations needed before industrialization.
Consideration of User Experience
Medical devices must not only be functional but also intuitive for use by healthcare professionals and patients. The challenge is to design mockups and prototypes that allow for testing and optimizing ergonomics, design, and ease of use, incorporating feedback from end users from the early stages of development.
Transition to Industrialization
Successful prototyping does not necessarily guarantee a smooth transition to industrialization. One of the main challenges is to design prototypes that are reproducible and easily scalable to mass production. This involves anticipating the constraints of large-scale manufacturing and minimizing costly adjustments during the transfer to production.
