Designing medical devices is a complex and challenging process. Ultimately, the resulting device has the potential to greatly impact the health and safety of the patient. You should consider a wide variety of different factors during the design process if you want to create the best possible product. These helpful tips for designing medical devices will help you craft high-quality instruments that operate safely.
Consider Overmolding Sensitive Components
Overmolding refers to a process that involves molding one or multiple items inside of another material to form a single, seamless part. Typically, the overmolded material fully covers the item. There are several benefits of overmolding medical devices, such as increased part strength, improved sanitation, and better protection for fragile components.
Overmolding electronic parts into a medical device can also help reduce the risk of intellectual property theft. If such benefits appeal to your application, think about using a manufacturing method such as reaction injection molding for your device. This will allow you to implement overmolding in your production.
Seek Out Consumer Feedback
This is another helpful tip for designing medical devices. User feedback is incredibly valuable when designing any products—including medical devices. Upon completing a prototype for your medical device, seek feedback from potential consumers to learn about what they think of the product.
Their insight can be invaluable when it comes to identifying any design mistakes that you and your team overlooked. You can incorporate their feedback and make any necessary improvements to the design before moving onto the next stage of development.
Conduct a Design Failure Mode and Effect Analysis
When designing medical devices, you should always keep safety as a top priority. To ensure your device is safe to use, conduct a design failure mode and effect analysis (DFMEA). DFMEA describes a set of systematic activities you implement to identify and evaluate the outcome of potential system, products, or process failures. Since medical device failures and malfunctions could impact the health and safety of a patient, running a DFMEA should be an essential step in the design process of a medical device.