In medical device development, speeding up the process is vital. The more time spent on the procedure, the more it'll cost.
This method is especially true of complex devices that require clinical trials before their release. In other words, it can be challenging for the design process to take up the majority of the product development time. That's where software technology comes in.
Every medical device manufacturer aims for a smooth and productive operation on all process steps. The primary concerns in medical device development are safety, meeting manufacturing requirements, and ultimately bringing value to the customer.
So, how can software help medical device companies improve their operation? Read on to find out.
1. Accuracy In Documentation
One of the critical components in any medical device development is documentation. It's where the company shows its current state of affairs to the Food and Drugs Administration (FDA).
This documentation must be thorough and accurate. It shows every potential design flaw, manufacturing process, and other relevant information.
Every stage of medical device development must be documented, from concept to detailed design, production to testing. Since the device must meet safety standards, this documentation must be clear and precise.
The purpose of this method is to prevent any misjudgment that could become a threat over time due to design changes and assess the product's risk level.
Software technology can help with documentation during the designing phase. For example, companies can use 3D simulation to visualize the product concept and examine its functionality. The manufacturer can test various elements of the design and conduct virtual experiments.
Here's where software greatly assists, as it can automatically generate necessary documentation for regulatory compliance.
2. Boost Productivity
The medical device development process is known for its lengthy timeline. On average, it takes many years to create a new product from the idea. That's why it's vital to utilize all available resources and be as productive as possible to finish a specific project.
For instance, to start working on a new product, the company needs to complete several steps, such as concept validation and design verification. The software can help to speed up the process.
How does it work? Let's take a look.
Product Concept Validation
At this point, the manufacturer can use an integrated development environment (IDE) to develop new product concepts faster.
The IDE links all design applications and simplifies creating a complete documentation package for new products.
Design Verification
For this stage, the manufacturer uses computer-aided design (CAD) tools to create a detailed 3D model of the device.
CAD tools simplify the design process and help to save a substantial amount of time.
Testing
The manufacturer can track the production process and adhere to all regulatory requirements with a quality management program.
The program makes the testing phase easier and allows maintaining product quality.
Manufacturing
A manufacturing execution system (MES) helps automate the process, maintain product traceability, and properly document all activities. The system allows analyzing the efficiency of production and tracking workflows.
The manufacturer can simplify the medical device development process with the appropriate software within reach. From design to manufacturing and operation, software technology can sit on top of the production and testing stages, automate tasks to boost productivity, and decrease manufacturing time.
3. Improve Communication
Various experts are involved in the process in the medical device development section. Engineers, designers, regulatory specialists, and more have their contributions to the device's safety, features, and performance, which makes communication critical.
It's crucial to establish clear, efficient communication channels throughout the operation. The medical device development team must collaborate, share ideas and concepts, and get on the same page. It's convenient for everyone to update the information in this shared space.
Such information includes device design, testing reports, and other crucial details.
Implementing software tools, such as cloud communication and constant data transfer, create a central hub that makes it easy for everyone to convey. Expert team members can discuss the project at any day and work together on one platform.
There's a better chance for accelerated medical device development with this approach.
Minimize Errors
Trials and errors are part of the medical device development process. Unfortunately, they also lead to device failures and faulty products.
To make the process better-performing and more explicit, manufacturers may implement innovative software to minimize errors in every step of the process.
While most manufacturers may rely on virtual prototyping tools, they can also simulate and test the device design before it's manufactured.
Virtual prototyping helps to catch critical errors early on and test the equipment under real-life conditions. Thus, better chances to optimize the design and check if critical components function correctly.
Conclusion
In the medical device development section, software tools can be an excellent method to stay organized from design through production stages. That's why investing in software technology is vital for the medical device development process. It creates a solid foundation for the company's future and ensures that every product is manufactured with accuracy and precision.
Clara Davis is a researcher and blogger with an extensive background in the medical devices industry. She studied engineering and medical business administration, which helped her analyze complex problems and present practical solutions.
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