Development Handbook for Medical Devices

In the fast-paced world of medical device development, ensuring a quick and efficient process is crucial. One company, Gerresheimer Medical Systems, with over 25 years of experience in project management for medical devices, is making waves by bringing customer products to market swiftly and with high quality.

The key to their success lies in their unique approach to the medical device development process. The process begins with a comprehensive planning phase, where the engineering team captures system requirements from end-users, operators, buyers, regulatory agencies, manufacturers, and others. Every micro-step in this stage aligns with the input requirements gathered from the planning process.

RBC, a partner of Gerresheimer Medical Systems, plays a significant role in this process. They involve manufacturing during design and development to ensure the system is manufacturable. This proactive approach helps to avoid potential pitfalls down the line.

The partner's engineers leverage a proprietary Fast2MarketSM Development process to speed along the project timeline. They continue improving the product's form, fit, and function based on the planning brief, ensuring the device is not only functional but also aesthetically pleasing and user-friendly.

Outsourcing the entire medical device product development process to a single vendor like RBC is essential for gathering market feedback, improving product features, and returning the devices to market quickly for profitable results. This approach allows for a streamlined process, reducing the potential for errors and delays.

The medical device development process is experiencing a substantial increase in outsourcing due to its complexity and potential for error. This outsourcing trend is reflected in the industry's spending on quality control. The medical device industry spends 12-18% of total revenue on quality control, totaling up to $26 billion a year.

Validation, an external process that ensures the product meets the needs of the clients, and Verification, an internal process that ensures a design outcome matches the specification or regulation defined in the design input, are critical steps in the process. These steps help to ensure the final product is not only functional but also complies with stringent regulatory compliance mandates, such as ISO 13485.

Prototyping in the medical device development process tests feasibility, functionality, scalability, and creates images and mock-ups for investor presentations and marketing purposes. Design transfer delivers the medical device design team's vision to manufacturing, further streamlining the process.

Finally, RBC handles post-launch service and post-market evaluation as part of the medical device design process and manufacturing partnership. A validated and properly implemented medical device product development process can help avoid, mitigate, or eliminate potential pitfalls, ensuring the success of the product in the market.

In conclusion, Gerresheimer Medical Systems' unique approach to medical device development, in partnership with RBC, is revolutionising the industry. By streamlining the process, reducing errors, and ensuring regulatory compliance, they are bringing innovative medical devices to market quickly and efficiently.