Biomedical Automation Benefits Development and Approval

• Medical device testing systems simplifies validation by providing repeatable measurements
• Medical device manufacturing can benefit from automated processing, to improve consistency and avoid injuries
• Biomedical automation reduces project risk during development and validation

Companies have two areas where automation can create significant advantages for an organization. Test methods and manufacturing processes begin as manual operations to obtain proof of concept. However, to improve development, it can be an advantage to automate these items early in the process for medical devices. What are the benefits of biomedical automation? Is it acceptable to automate after product launch?

Detecting requirement compliance depends on medical device testing. Manual methods are prone to errors and risk allowing medical devices to slip into the hands of users. Developing automated test methods can ensure the design and manufacturing processes meet expectations while avoiding the risk of repetitive use injuries. It will also provide method consistency to increase the detectability. As designs become more complex to treat more challenging therapies, the value of medical device test method development becomes more critical to project performance. Using these automated systems during design verification and process development provides the confidence for use during full-scale production.

Also, the medical device manufacturing process itself can benefit from the consistency provided in biomedical automation. Many processes can achieve a higher process capability compared to manual methods. This can reduce the need for manual inspection techniques, which are prone to error, as discussed above. This approach to producing medical devices can also speed the development process and increase throughput during full-scale manufacturing.

Using a combination of medical device manufacturing process and test method solutions, a company can gain an essential edge during development and production with biomedical automation. Providing this test method and process automation during development will accelerate design verification and process qualification at the project phase’s end. These stages are often on the critical path and the final steps to submit a new product to the FDA. Using medical device testing and medical device manufacturing automation provides faster and more reliable results. Increasing the likelihood of acceptance from internal and external sources. Enabling both internal an external schedule benefits can bring a new medical device to the market even sooner, which provides an essential competitive advantage for the organization the pursues this path.