Medical Device transition from design into manufacturing is typically broken into the following Phases:
Phase 0 Product Definition & POC (Proof of Concept)
Phase 1 Design & Development
Phase 2 Design Transfer
Phase 3 Manufacturing
Expert Tips for a Seamless Medical Device “Design Transfer” to Manufacturing (Phase 2)
Successfully launching a medical device requires careful attention across all phases of development. One critical phase is the Design Transfer phase to manufacturing, a step that often defines whether a product is ready for mass production. In medical device development, the Design Transfer to the factory floor involves numerous complexities, from documentation to supplier management and process validation. Here, we’ll walk you through key strategies to ensure a smooth transfer to manufacturing.
Phase Two: The Bridge Between Design and Manufacturing
In the medical device development lifecycle, Phase Two—Design Transfer to Manufacturing—is pivotal. Before you even reach this stage, Phase One (Design and Development) must be completed with precision. If any elements are overlooked or corners cut during design, it can create significant challenges during transfer. For example, if the manufacturing technology or production volumes were not fully considered, costly delays and rework are almost inevitable.
The earlier you incorporate manufacturing considerations into the design & development phase, the easier the transition will be. Here are some key strategies to facilitate this process:
Build a Solid Foundation in the Design Phase
A well-coordinated design & development phase ensures a seamless handoff to manufacturing. Engage a manufacturing engineer early in the process to collaborate with your design team. By doing so, they will understand the product from the ground up, reducing the risk of errors or overlooked details during the manufacturing process. Having them involved early also helps with resource planning, understanding shelf space needs, and managing additional manufacturing resources.
Documentation plays a significant role in this phase as well. Keeping your Device Master Record (DMR) up-to-date with all design iterations, drawing updates, and minor revisions will streamline the transfer. Conduct iterative reviews to ensure you are not rushing into major changes that could complicate production.
Streamline Assembly and Testing Documentation
Clear and detailed documentation is key to reducing errors in the manufacturing phase. Assembly and test procedures should be meticulously recorded, ideally with step-by-step instructions and photographs to illustrate the process. This ensures consistent builds, whether they are prototype units or large-scale production runs.
When creating your work instructions, document real-time builds instead of trying to recall steps after the fact. This prevents miscommunication and helps streamline the manufacturing process. Additionally, consider using a Medical Device Transfer to Manufacturing Checklist to ensure all steps are covered, reducing repetitive tasks and ensuring alignment across multiple teams (software, mechanical, electrical, etc.).
Agility in Design Transfer
Even with the most rigorous planning, flexibility is crucial during the transfer. Don’t rush to finalize the DMR. Use minor revisions and iterative changes to validate the build process before committing to major updates. Taking time to validate these smaller changes will help avoid complications down the road, speeding up the overall timeline and reducing the risk of delays.
Supplier and Supply Chain Considerations
A well-established supply chain is essential for successful medical device manufacturing. Before moving to the next phase, confirm that your suppliers can handle production volumes, packaging, and certification requirements, such as the Certificate of Conformity (CoC). The supply chain should be scalable and capable of supporting the entire lifecycle of the product.
Choosing the right suppliers for high-volume production is critical. During development, you might work with suppliers who offer rapid prototyping but lack the capacity for full-scale manufacturing. Ensure that your selected vendors can deliver parts in the needed volumes without compromising quality or timelines. Evaluate suppliers early on based on their ability to meet your quality plan, particularly for critical parts that affect the safety and efficacy of your device.
Additionally, forecast your production needs ahead of time and engage suppliers during the design phase. Early involvement can prevent delays caused by supply shortages or logistical challenges. Prototype molds for injection molding can also be a cost-effective solution, especially if the total market for the device is relatively small.
Localization and Compliance
Medical devices must meet various regulatory and localization requirements depending on their intended market. Ensure you have all necessary compliance documentation before placing orders for transfer materials. Localization issues such as translations for labels or power cord specifications, can delay your project if not addressed early.
Packaging is another crucial element that should not be rushed. Poor packaging design can lead to increased shipping costs or, worse, product damage during transit. Plan for compliance and packaging needs during the transfer phase to avoid last-minute headaches.
Quality Assurance and End-User Considerations
Conducting comprehensive Quality Control (QC) testing before your device goes to market is essential. Once the device is released, be prepared for field servicing, ensuring that your product can be quickly located and retrieved if issues arise. Traceability is key, especially for identifying units that might need troubleshooting or repair.
Understanding real-world use cases and anticipating end-user challenges will help reduce product failures in the field. Make sure your team has a clear plan for how the device will be serviced and what steps need to be taken if it breaks down. Avoid sending R&D engineers into the field—this is a job best suited for trained service engineers.
Manufacturing Optimization and Training
Manufacturing optimization directly impacts product margins. Focus on streamlining processes that have the most significant impact on time and cost. For example, high-touch-time tasks should be identified and automated wherever possible.
Involving manufacturing teams early in the design and development phase of your medical device can also uncover potential assembly challenges. Their insights will help designers make informed decisions that improve manufacturability, reduce errors, and increase production speed. Train and certify your manufacturing personnel to ensure consistency and quality across all units produced.
Conclusion
Transferring a medical device from design and development to manufacturing is a complex, but manageable process with the right strategies. By engaging manufacturing experts early, maintaining robust documentation, and building a scalable supply chain, you can ensure a smooth transition. Keep the focus on quality, compliance, and adaptability, and you’ll set the stage for a successful product launch.
For more insights into medical device development, explore our blogs on Phase Zero Product Definition and PoC and Phase One Design and Development.
On the picture Camiel, Stefano and Milos with over 50 years of work experience together, as 1 team, in Creanova (dressed for entering clean assembly space, not the clean room)
