The FDA and other global regulatory agencies require all medical devices to be manufactured using a design control process. A design control process ensures that the medical device is developed and documented under a controlled process. The design control process is a regulatory requirement that benefits the manufacturer when employed correctly by ensuring all functional area inputs are captured: from intellectual property protections, product design requirements, manufacturing needs, usability inputs, and regulatory considerations.
DeviceLab has developed a comprehensive design control process that meets FDA design control requirements, 21 CFR 820 and global regulatory requirements, ISO 13485 and ISO 14971. The DeviceLab design control process consists of six critical tracks to design and develop a medical device:
- Intellectual Property Support Track
- Product Design Track
- Risk Management/ Design Control Track
- Manufacturing Track
- Human Factors Track
- Compliance and Regulatory Support Track
Intellectual Property Support Track
Early in research and development, manufacturers should begin to consider if there are any Intellectual Property (IP) risks or potential patent opportunities. IP risks are existing patents that might be similar to the technology being developed by the engineers. If there are patent opportunities, manufacturers will want to start the patent application as soon as possible to ensure the technology is protected.
Product Design Track
Product design refers to the group of engineers and scientists involved in researching the customer’s needs, developing the solution, designing prototypes, and testing the product. This group of people can be large and takes the product from ideation to a finished medical device. As part of the design a list of product requirements is documented and eventually the design is validated against that list of product requirements as the design validation. The product design track in an organization needs to maintain good documentation of the design and development of the product, as required by FDA regulation.
Risk Management and Design Controls Track
The product design track is responsible for developing the medical device but the work isn’t completed unless it is properly documented. The risk management and design controls track ensures all necessary tasks are completed and documented appropriately, as required by FDA and global regulatory agencies. This track works very closely with the product design track to ensure risk assessments are completed at the appropriate stages in development and that risks are properly mitigated. Once a product is marketed, this track continues to support the device by monitoring customer feedback and complaints.
The manufacturing track is the part of the organization that takes the final prototype of a medical device and upscales the manufacturing of the device. This track is responsible for ensuring the final device has a reproducible design and can be efficiently manufactured. The manufacturing track works closely with external suppliers and develops the full supply chain for the medical device.
Human Factors and Usability Track
Devices are only useful if a customer is able to efficiently use the device. The Human Factors and Usability Track are responsible for design requirements for the device to ensure the product can be used by customers and develop customer loyalty. Human Factors and Usability might inform how the product needs to be packaged, warnings, directions, and training needed for the customer’s success with the product. FDA requires some medical devices to be formally studied for human factors and usability success.
Compliance and Regulatory Support Track
Typically the final finished medical device and all of the testing will be submitted to FDA as part of a 510(k) or to other global regulatory agencies. To prepare for this submission, the compliance and regulatory support tracks will design a regulatory strategy that defines all regulatory requirements and the timelines to receive regulatory approval.
DeviceLab is here to support your medical device in all tracks of medical device development, from product ideation through regulatory approvals. Contact DeviceLab today to schedule an initial consultation.