Transition from Design for Prototypes to Design for Manufacturing

Transitioning from a design for prototypes to a robust design suitable for manufacturing processes is a crucial step in the device development process.  Effective Design for Manufacturing (DFM) of complex catheters can significantly improve manufacturing efficiency, quality, and product performance while decreasing costs and time-to-market. 

How to Apply Design for Manufacturing to Complex Catheters

  1. Identify Manufacturing Processes:  Review the assembly processes for the prototype and identify any inefficiencies, risks for errors, and other opportunities for improvement.  Determine the ideal, tried-and-true manufacturing processes to produce the catheter, whenever possible.  The processes to be changed will depend on the current prototype assembly methods and manufacturing needs; however, common changes include 3D printing to injection molding; adhesive bonding to welding or mechanical locking; material selection for process compatibility, availability, or cost; and manual assembly to automated assembly methods.
  2. DFM Planning:  Develop a plan to transition to the more robust manufacturing processes including timelines, budgets, resources, and key performance indicators.  Prioritize the DFM changes that would otherwise require design verification testing to be repeated, e.g. material selection before automated assembly with robots.  Also consider the low hanging fruit, i.e. the impactful changes that are relatively easy and low risk to implement.
  3. First Articles:  Produce first articles of the device using the DFM changes selected.  These first articles can help you evaluate the effectiveness of the DFM or fix any issues.
  4. Design Verification.  Once the new DFM has been implemented with the materials and processes that will be used for the commercial product, conduct design verification testing to confirm that the updated DFM meets all performance requirements.
  5. Process Validations:  Provide comprehensive training to ensure that employees are fully prepared to operate and maintain the equipment and processes, implement quality control measures, and validate the processes. Consistently manufacturing a high-quality design is essential to the success of any new medical device.
  6. Monitor performance:  After the manufacturing processes are implemented, monitor performance to ensure that you maintain design for manufacturing best practices.  Continuously evaluate and refine the manufacturing process (and product design, if necessary) to streamline performance.

If your medical device design or manufacturing process is more complex, or if you’re producing a large volume of the device, you’ll want to begin the design for manufacturing process as soon as possible.  Changes to design become much more costly as development progresses and product quantities increase, and any repeat of design verification testing (necessary with most material and process changes) can be expensive and delay time-to-market.

That said, confidence in the product viability in the market is critical before investing heavily in equipment, tooling, and process development.  Strategically evaluating the product and how it’s made at every stage of the process will smooth out the transition to manufacturing the device. An expert partner can help you navigate this process, creating medical device designs ideally suited for your state of development, including manufacturing, and making their own production facilities and capabilities available to you.

Looking for a partner to bring your new medical device to life? Contact Medical Murray to get started.

By Tanner Hargens