The Manufacturing Triangle is Still Critical During COVID-19

The COVID-19 pandemic is an extremely challenging situation. Faced with this global crisis, it has been amazing to see how people and companies around the world have responded, through many different approaches. The span across industries, from medical, repair and logistics, to engineering, 3D Printing and manufacturing, have all really shown the benefit of communication, leadership and teamwork. On the engineering and manufacturing side, there has been a focus on building personal protection equipment (PPE), either from scratch or retrofitting full face snorkeling masks with adaptors to accept N95 filter cartridges. Ventilators (Minimum Viable Product versions) have been a main focus as well, to help address the expected peak influx of patients who will need help breathing.

During this sprint to find solutions, it is critical to remember the first principles in manufacturing. We always start with the Manufacturing Triangle: Cost, Quality and Schedule. In the case of COVID-19, cost is (for once) not the primary driving factor due to the importance of finding critical solutions quickly and financial support of very generous donors. Schedule and Quality are where we need to focus.  

Schedule:

• Engineering Development Time: This is how long it takes to create a working prototype, CAD and a BOM. This engineering effort is in turn driven by the specifications of the device. Simpler is faster, but too simple of a device may lack key components and render the device ineffective. In the “fog of war”, it’s often difficult to separate the signal from the noise and figure out what the MVP specs actually are. In these cases, often the best approach is to slow down to speed up. It is helpful to create a list of key questions that will impact the architecture of the device and get answers before diving into the design.
• Component Lead-Time and Availability: This has always been an issue in manufacturing, and is even more important now that supply chains are strained. During the engineering phase, work hand-in-hand with your sourcing team to confirm the parts you are designing are available in the required quantities, and understand how long it will take to ship them to where you are performing final assembly.
• Manufacturing Readiness: In addition to being designed for manufacturing and assembly, assembling and testing a product in high volume will likely require a Contract Manufacturer. Make sure your factory is operational, and understand their current capabilities. This exploration can be done in parallel with the engineering effort.
• FDA Approval: Determine if this approval is required, and put together a plan for submission. If possible, work with an experienced advisor who can guide you through the process.

Quality:

• Test Specification: It is critical to have a spec that describes the performance requirements of the device. This spec should be created before engineering begins. In the case of more complicated medical equipment, such as Ventilators, it can be difficult to find the detailed specs. We encourage all companies working on solutions for COVID-19 to open source their specs citing the reference sources so that other teams can access the data and there is a common set of acceptance criteria.
• Separate Test Team: In parallel with the engineering team, it’s helpful to set up a Quality team to create the detailed QC Plans, develop, build and validate test fixtures, and provide feedback to the Engineering team.
• Documentation: Due to the schedule pressure and concern of part shortages, the engineering and quality processes can become chaotic. It’s critical to keep track of design decisions, version control, Bills of Materials, etc. If a product will be submitted to the FDA, this document will become even more important.

We are energized to see so many people from all disciplines dive in and use their skills to help others during this challenging time. It’s an opportunity for us to come together and solve a critical global problem.

Feel free to reach out if you have any questions or suggestions: [email protected]