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Medical Device Development with Strategic Manufacturing

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Establishing our dedicated Strategic Manufacturing facility equipped with a Cleanroom means Rev.1 Engineering can offer a more comprehensive solution for medical device startups. This state-of-the-art Cleanroom is a significant milestone for us, enabling us to include early-stage manufacturing for validation testing and clinical builds in-house.

The Cleanroom is a crucial component that allows us to produce medical devices with the highest level of precision and quality, meeting the stringent requirements of regulatory bodies such as the FDA. With an on-site Cleanroom we can streamline our processes and eliminate the need to outsource manufacturing while maintaining continuity and reducing costs and turnaround times.

This development marks a significant step forward for Rev.1 Engineering, as we can now provide our clients with a one-stop-shop solution for early-stage development. With this new capability, we can help our clients accelerate their speed to market, saving them valuable time and resources.

With our meticulous protocols and rigorous quality control measures, we ensure that our customers’ medical devices are developed in a controlled environment that meets regulatory requirements and industry best practices.

Class 7 and Class 8 Medical Device Manufacturing Cleanroom

Cleanrooms are specialized environments designed to minimize contamination during the manufacturing or development of sensitive products.

They are classified based on the level of airborne particles per cubic meter of air. Class 7 and Class 8 cleanrooms are two common classifications used in the medical device manufacturing industry.

Class 7 and Class 8 Cleanrooms require stringent environmental controls including:

  • Temperature
  • Humidity
  • Pressure

These environmental controls are met with proper air filtration, HVAC systems, and monitoring to ensure compliance with the relevant ISO standards. This ensures a stable and controlled environment.

Class 7 Cleanroom Specifications

A Class 7 cleanroom or controlled environment requires strict control over airborne particles, with a maximum limit of 352,000 particles per cubic meter of air that are 0.5 micrometers or larger in size.

Class 7 cleanrooms are typically used for the manufacturing or assembly of highly sensitive medical devices, where even minor particles can affect the quality or performance of the product.

In addition to surgical implants, Class 7 cleanrooms are also employed in the production of delicate electronic medical devices, such as high-resolution imaging equipment or precision diagnostic instruments. These devices often contain intricate circuitry or sensitive sensors that necessitate an environment with extremely low levels of airborne contaminants. By operating in a Class 7 cleanroom, we can significantly minimize the risk of particle-induced defects, thereby enhancing the reliability and accuracy of these devices.

Class 8 Cleanroom Specifications

On the other hand, a Class 8 cleanroom allows for a slightly higher level of airborne particles, with a maximum limit of 3,520,000 particles per cubic meter of air that are 0.5 micrometers or larger in size.

Class 8 cleanrooms are often used for processes that involve less sensitive medical devices or components that can tolerate a slightly higher level of airborne contaminants.

For example, Class 8 cleanrooms may be utilized in the production of medical devices such as non-invasive diagnostic equipment, less-complex surgical instruments, and basic medical disposables. These devices still require a certain level of cleanliness, but the manufacturing processes involved are not as sensitive or intricate as those requiring a Class 7 cleanroom. The Class 8 cleanroom ensures that the particles in the environment are maintained at an acceptable level, reducing the risk of contamination during production and assembly.

Both Class 7 and Class 8 cleanrooms play a crucial role in maintaining a controlled and sterile environment for the development or manufacturing of medical devices. Compliance with the stringent requirements of these cleanroom classifications ensures that the quality, safety, and performance of medical devices are upheld, in accordance with regulatory standards and industry best practices.

Cleanrooms as Part of Your Strategic Manufacturing Plan

The development of our Cleanroom with the ability to upgrade from level 8 to level 7 was driven by several key factors. One of the most significant considerations was the recognition that operating a Cleanroom at a lower level can offer significant cost savings, particularly if level 7 is not required for the specific device being developed.

By offering this upgrade flexibility, we can cater to the diverse requirements of various medical devices. Each device has its own unique set of demands and constraints, and our adaptable Cleanroom design ensures that we can accommodate a wide range of development needs.

Optimal conditions are crucial when it comes to the manufacturing and assembly of sensitive medical devices. The Cleanroom environment plays a critical role in maintaining cleanliness, controlling particulate levels, and minimizing the risk of contamination. By allowing for an upgrade from level 8 to level 7, we can ensure that the Cleanroom provides the necessary conditions for sensitive processes, all while remaining mindful of the specific requirements of each device.

Additionally, the ability to upgrade the Cleanroom level offers an added advantage in terms of future scalability and adaptability. As medical device technologies continue to advance, it is essential to have a Cleanroom that can keep pace with evolving industry standards. Our flexible design empowers manufacturers to stay ahead of the curve and seamlessly transition to higher Cleanroom levels if the need arises.

Moreover, by offering a range of Cleanroom levels, we aim to provide our clients with the most cost-effective solution for their specific device development. While some medical devices may require the stringent cleanliness standards of a level 7 Cleanroom, others may be adequately served by the slightly lower level 8.

Our goal is to optimize the Cleanroom configuration to meet the exact needs of each project, striking a balance between cost efficiency and maintaining the highest quality standards.

Rev.1 Engineering’s Advanced Cleanroom Capabilities for Strategic Manufacturing

One of the biggest challenges for medical device startups is successfully navigating the transition from development to large volume manufacturing. To bridge this gap, Rev.1 Engineering is taking advantage of the capabilities of short-run, in-house manufacturing in a controlled environment, providing startups with the flexibility and small-scale manufacturing runs they need to meet regulatory requirements before getting to market.

Our Strategic Manufacturing approach begins at the project planning phase with our Design for Risk Management Throughout the Critical Chain process. By de-risking devices early and often, we can identify potential bottlenecks and establish documented steps to solve them. We also incorporate the development team that designed the device in Design for Manufacture and Manufacturing Transfer, ensuring a seamless transition.

With our expansion into a new 14,000 square foot facility and the conversion of our current 6,000 square foot building into a dedicated, compliant Strategic Manufacturing facility with a 2,000 square foot cleanroom environment, REV.1 Engineering is well-positioned to meet the unmet needs of our development and innovation clients as they move towards commercial launch.

REV.1 Engineering: Partnering with a Strategic Manufacturer

At Rev.1 Engineering, we understand the critical importance of managing risk and planning strategically for the complexities of medical device development. With the integration of a cleanroom into our Strategic Manufacturing process, we have gained the ability to do so at a much higher level.

With our commitment to excellence, innovation, and customer satisfaction, we are the trusted partner for bringing your medical device to life.

Choose Rev.1 Engineering and leverage our advanced strategic manufacturing capabilities to take your medical device development to the next level of precision and success.