Develop Safe and Effective Medical Devices with Collaborative Design and Simulation

Medical devices play a critical role in the healthcare industry, helping patients to recover from illness or injury or manage chronic conditions. The development of medical devices requires an extensive understanding of medical regulations, clinical practices, and engineering principles. The design process is a complex one that involves multiple stakeholders, from clinicians to engineers, regulatory bodies, and patients. To ensure the safety and effectiveness of medical devices, collaborative design and simulation tools such as the Engineering to Cure with 3DEXPERIENCE have become a crucial part of the development process. 

Develop Safe and Effective Medical Devices with 3DEXPERIENCE 

The 3DEXPERIENCE platform acts as a single source of truth to anchor outcome-based processes and captures all activities in one place. It securely connects individuals, teams, departments, and external collaborators working together to transform ideas into innovative products, services and experiences. 

The 3DEXPERIENCE platform offers a single, intuitive interface that empowers: 

• Design & Engineering: 3DEXPERIENCE CATIA can model any product, at any scale, so engineers, designers and contributors can effortlessly imagine, define and shape products virtually before committing to a prototype. 
• Simulation: Seamlessly integrate simulation technologies with SIMULIA, including structures, fluids, plastic injection molding, acoustics, and structural applications, into your daily product design activities. 
• Governance & Collaboration: Accelerate cross-team collaboration and product development in a fully connected on-line environment where a single, shared product definition ensures teams are always seeing and working on up-to-date information. 
• Manufacturing & Operations: DELMIA on the cloud provides solutions to leverage the virtual world of modeling and simulation with the real world of operations. Connect all layers of the value network, from manufacturers to logistics and transportation providers, to service operators and workforces. 
• Marketing: 3DEXCITE leverages the product information model (PIM), to unleash creative freedom that results in diversified assets for digital, interactive marketing, and sales experiences. 

Our Dedicated Engineering to Cure Package 

Our Engineer to Cure package – powered by 3DEXPERIENCE – is a software suite that enables the collaborative design and simulation of medical devices, from ideation to commercialization.  

The platform provides a range of tools for design and simulation, allowing engineers and clinicians to work together on the development of medical devices in a virtual environment. This approach helps minimize the risk associated with traditional trial-and-error methods while reducing costs and development time. 

Key Benefits of the Engineering to Cure include: 

• Implement fully integrated and standardized simulation-driven design processes and methods and make them available to a larger user community. 
• In a realistic virtual human environment, evaluate device safety and efficacy. 
• Develop and maintain complete traceability and defensibility from requirements through certification. 
• Allow for early-stage virtual evaluation of patient, caregiver, and practitioner experience. 
• Investigate device and patient variability to optimize device performance for individuals and populations. 

Several vital steps exist to develop safe and effective medical devices with the Engineer to Cure with 3DEXEPRIENCE. 

Ideation and Concept Design 

The first step in developing a medical device is to define the problem the device intends to solve. This can be achieved through brainstorming sessions with clinicians and other stakeholders, who can provide valuable insights into the needs of patients and the clinical environment. Once the problem has been defined, the next step is to develop a concept design that meets the requirements of the problem. The Engineer to Cure with 3DEXPERIENCE provides various design tools that can be used to create 3D models of the device, such as 3D Design, systems engineering, Multiphysics simulations, and virtual human modeling. These models can be refined and modified based on feedback from clinicians and other stakeholders, allowing for iterative design and refinement. 

Simulation and Analysis 

Once the initial design has been created, testing and analyzing the device’s performance in a virtual environment is essential. The Engineering to Cure with 3DEXPERIENCE provides a range of simulation and analysis tools that can be used to evaluate the device’s performance under a range of conditions. Designers and engineers can easily explore the device design space, virtually test good designs in real-world scenarios, and validate designs against product requirements and business objectives. This simulation can help to identify potential problems and refine the device’s design before it is built. This approach helps minimize the risk associated with traditional trial-and-error methods while reducing costs and development time. 

Prototyping and Testing 

After the initial design has been refined and tested through simulation, the next step is to create a prototype of the device for physical testing. The Engineer to Cure with 3DEXPERIENCE provides a range of prototyping tools that can be used to create physical models of the device for testing. These models can be modified and refined based on material testing results, allowing for iterative design and refinement. 

Regulatory Approval

Once the device has been refined and tested through simulation and physical testing, the next step is to seek regulatory approval. The Engineering to Cure with 3DEXPERIENCE provides a range of tools that can be used to create documentation and other materials required for regulatory approval. These tools help to ensure that the device meets the necessary standards for safety and effectiveness, minimizing the risks associated with regulatory non-compliance. 

Commercialization 

After regulatory approval has been obtained, the final step is to bring the device to market. The Engineering to Cure with 3DEXPERIENCE provides a range of tools that can be used to create marketing materials and other documentation required for commercialization. These tools help me ensure the device is marketed effectively, maximizing its potential success. 

Conclusion 

In conclusion, developing safe and effective medical devices requires a collaborative approach involving multiple stakeholders, from clinicians to engineers, regulatory bodies, and patients. The Engineer to Cure with 3DEXPERIENCE provides various tools for collaborative design and simulation, enabling engineers and clinicians to ensure the safety and effectiveness of medical devices. 

3DEXPERIENCE with TriMech Enterprise Solutions  

Our TriMech Enterprise Solutions team is experienced with implementing The 3DEXPERIENCE platform, which can be installed as an in-house or cloud-based solution for globally dispersed enterprises. 

Learn more about the 3DEXPEIRENCE platform in the medical device industry by reading our E-Book!