5 Steps for Smooth Transition to Manufacturing


In an increasingly challenging market, the process of medical device design and manufacturing can have many inherent challenges. One of the key make-or-break phases of taking a product from concept to commercialization is the degree of success in transitioning an instrument from development and design to production. Here are five tips for success.Close_up_engineering-sm.png

In an article in Medical Device and Diagnostic Industry (MDDI) magazine, KMC Systems' Frank Pawlowski, systems engineer director, and Bill St. Onge, director of manufacturing, have weighed in on their tips for a smooth transition to market for medical device development.  
 
Their top five tips for transitioning from design to manufacturing are:
 
1. Plan for the Transition Early
Make all final changes to the medical device design before the transition to manufacturing begins.  This will save additional costs and avoid time delays.  According to the online article, that Frank Pawlowski and Bill St. Onge contributed to for the Medical Device and Diagnostic Industry publication, planning for transition must begin in the product development stage, well before the software and system verification and validation efforts have been completed. The timing is critical because manufacturability, testability, and serviceability must be considered during the design phase
 
 2. Assemble Cross-Functional Teams
Create cross-functional teams, composed of mechanical, electrical, software, systems, manufacturing, and quality engineers to smooth the transition from medical device design to manufacturing.  Combining their proven expertise and wide knowledge base enables a holistic approach for manufacturing and regulatory compliance. During each phase of development, the team minimizes obstacles and adheres to FDA regulations, bringing the product quicker to market.
 
3. Implement Staged Reviews
Implement checkpoints throughout the product design and development process to ensure everything is on track and there are no hidden obstacles. Per the article, Frank and Bill suggest 3 checkpoints: 
 
Critical Design Review: A critical design review should occur at the completion of the product prototype phase and prior to the release of documentation for the procurement of pilot material. This review must assess product design to ensure that the hardware and software meet system requirements prior to pilot production.
 
Pilot Production Readiness Review: A pilot production readiness review can help determine whether a product can begin its transition to manufacturing. This review verifies that all appropriate design and program activities are satisfactorily completed and that the program team is prepared to build pilot production units. It ensures that the system design meets all applicable specifications and customer requirements and is mature enough for pilot production units to be built by operations. During the review, team members record findings, deficiencies, and technical issues. They compile an action items list and identify the individuals responsible for resolving them.
 
Manufacturing Readiness Review (MRR): A final MRR is conducted after pilot production units are built and design validation is complete. This review verifies that the product is ready for full-scale manufacturing. A designated review leader should identify and request personnel from appropriate departments and functions to act as reviewers. Ideally, a review team includes representatives from engineering, operations, strategic sourcing, and quality assurance. The review verifies that all appropriate design, validation, and manufacturing preparations are complete and the program is adequately prepared to move to the production phase.  To review KMC's indepth Manufacturing Readiness Review, click here.Download KMC's Manufacturing Readiness Review Checklist
 
4. Train the Manufacturing Team
Transfering the knowledge behind the medical device design from the engineering development team to the production team is a critical step to take. Utilizing a computer-aided design (CAD) or manufacturing execution system (MES) that provides simple text and picture-based instructions provides greater assurance of quality and workmanship and faster time to market.
 
5. Maintain Morale During and After Transition
Communicate daily to keep all team members up to date on production goals. Gather employee feedback on each stage of the medcal device design, development and manufacturing. Keep a large progress board, and update it at the completion of each project or subassembly. This communication increases team spirit which in turn, contributes to a more efficient manufacturing process.
 
Follow these 5 steps to achieve a smoother transition from medical device design to manufacturing.  Reap the benefits of getting products to market quicker while staying within budget. 
 
If you would like to speak with KMC to discuss the design, development and manufacturing of your next medical device, contact us today.

Topics: medical device design and manufacturing