13 Tips for Successful Medical Device Product Development

Here are 13 tips to consider prior to your product development endeavors:

• Document and utilize a defined product development process. The process should define project phases, major deliverables, and key milestones.
• User needs and intended use(s) should be the basis for medical device product development.
• Develop a product development project plan.
• Identify a core, cross-functional project team.
• Design Input Requirements must be thorough, comprehensive, and objective.
• Use product risk management activities (i.e. hazard analysis, FMECA, FTA) as tools to improve device safety and efficacy.
• Ensure the manufacturing processes for the product have been designed for repeatability and reproducibility.
• Pre-define acceptance criteria for design verification and design validation activities.
• Involve actual end-users throughout the product development process–especially during design validation.
• Follow Design Control regulations and requirements defined per FDA QSR 820.30 and ISO 13485:2003.
• Maintain Design Control and project documentation.
• Conduct timely phase reviews and design reviews to evaluate product development process and make decisions about the device design.
• Realize that product development is a business process.

Creo Quality, LLC can help you implement this tips and with your medical device product development needs.