What is design control?
The design control process outlines a clear roadmap to medical device design and implementation. This process is outlined by the FDA and is implemented in the medical device industry. It begins with outlining design inputs. Each input consists of a requirement and a corresponding specification. Together, these design inputs guide decision making throughout the design process. Using design control sets a developing device up for success so that it has the highest chance of meeting all requirements. It also protects the device from future design changes that could negatively affect the design output.
Current Requirements for the PG-Detect POC Device
- The analyzer shall be capable of controlling temperature of a reaction chamber.
- The analyzer shall detect the presence of a specified genetic material.
- The analyzer will have a test time that aligns with point of care devices, from patient sample insertion to test completion.
- The analyzer must be within the standard dimensions of handheld and portable devices.
- The analyzer shall be powered through non-infrastructural means.
- Any component of the analyzer that comes in contact with genetic material must be capable of being discarded or disinfected without loss of color or functionality.
- The analyzer shall be capable of storing data and must inform user when maximum capacity has been reached.
- The analyzer shall be capable of transmitting data.
- The analyzer shall be durable under a wide range of environmental conditions.
- The device will comply with standard safety and regulatory requirements.
- The analyzer will provide user with ability to enter and run specific metrics.
- The analyzer shall offer user direction for how to conduct a test.
- The prototype must cost less than $500 and device retail cost must support sale in economically disadvantaged areas.
- Patient information stored on the device must be protected.
- The device shall not create or contribute to an environmental burden.