The success of wearable medical devicesIn the highly regulated world of medical devices, the transition from prototype to full-scale production can be complex and filled with potential challenges. This process, known as design transfer, is critical for ensuring that products meet regulatory standards, quality controls, and production capabilities. Justin Rice, Director of Program Management at BioIntellisense, provides insights into how they have successfully navigated this process with their flagship device, the BioButton.
Understanding the Design Transfer Process:
For BioIntellisense, the design transfer process is built around compliance with 21 CFR Part 820, a set of quality management regulations specific to medical devices. As Justin explains, this process begins with user needs and ends with verification and validation. It’s not just about handing over a design to a contract manufacturer (CM), but about ensuring that all relevant documentation, specifications, and regulatory requirements are met.
The BioButton is a remote monitoring device used for both acute and at-home care, tracking vital signs like heart rate and respiratory rate. Bringing a device like this to market requires careful planning, including selecting the right CMs that have the capacity to meet both short-term and long-term production goals.
Common Watchouts in the Process:
One of the biggest challenges Justin highlights is labeling. While often overlooked, labeling issues can lead to production delays if not addressed early on. Additionally, maintaining control over subcomponent quality and visibility into the supply chain is vital. Small changes in third-party components can have significant downstream effects on the final product.
Ensuring a smooth design transfer involves robust documentation and collaboration with CMs to validate that their manufacturing capabilities align with the product’s needs. BioIntellisense works closely with their CMs, providing detailed technical specifications, inspection procedures, and verification data to ensure product consistency.
Strong Partnerships with CMs:
Another key point Justin emphasizes is the importance of building strong relationships with contract manufacturers. At BioIntellisense, they engage CMs early in the process, allowing for design feedback and adjustments that can improve manufacturability and cut costs. They also use second sourcing to avoid sole reliance on a single supplier, which can be crucial in managing supply chain risks.
Conclusion:
The success of BioIntellisense’s BioButton is a testament to the importance of a well-executed design transfer process. From ensuring regulatory compliance to building strong partnerships with CMs, Justin’s approach highlights the need for meticulous planning and collaboration to bring a medical device from concept to market.