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Is Your Design Ready? Manufacturing Readiness Checklist

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There is a world of difference between making ten units versus 100,000 units/month. The ability to bring a product from design to production efficiently and effectively is crucial for companies striving to remain competitive. This blog post explores the importance of manufacturing readiness and highlights key strategies to achieve it. 

Is Your Design Ready? 

Determining the readiness of a product design for production involves several key considerations. Here is our checklist to evaluate to assess the readiness of your product design: 

Video transcript available at https://www.fusiondesigninc.com/blog/2020/2/17/where-does-design-begin

Design and Specifications 

  • Is your product specification (MRD and PRD) complete and up-to-date?  

  • Has the design been built, tested, updated and tested again.  

  • Does the design and the functional testing meet the design requirements set forth in the PRD? 

  • Are all part drawings and schematics complete and ready for production? 

  • Is the bill of materials (BOM) complete and fully costed? 

  • Do all of the OTS parts have multiple sources? If not, should they? 

  • Are standard components specifications available for all off-the-shelf parts? 

  • Are any of the OTS parts near end of life? 

  • Are the custom parts designed for the optimal manufacturing process? 

  • Are specifications and drawings available for all custom parts? 

  • Has proper tolerancing been done for both the manufacturing process and the assembly process to follow? 

  • Have all parts been assigned part numbers? 

  • Does an approved-vendor list exist and does your design leverage it properly? 

  • What regulatory and safety requirements do you need to meet? Do the OTS parts meet regulatory requirements on their own? Does the overall assembly comply.  

  • Have safety, compliance, and packaging tests been performed and passed? 

Is Your Process Ready? 

Along with product documentation, many processes need to be transferred to manufacturing to ramp up production. These usually include manufacturing and inspection instructions, training material, testing procedures, fixtures, and “known” good units to validate testing. Out-of-date process documentation and missing training records are the most common problems when transferring products.  

Testing 

  • For projected volumes, do you need manual, semi-automated or fully automated testing? Does your manufacturing partner have the right equipment and ability? 

  • Do you have proven testing procedures?  

  • Does your test time align with your manufacturing task time? Will single testers do the job or do you need parallel systems? 

  • How many known good reference product samples are needed?  

  • What regulatory and safety requirements do you need to meet? Has your product been tested and approved? 

Assembly process 

  • How many devices will be produced and according to what schedule? 

  • Are complete assembly procedures available? 

  • Are assembly fixtures required? If so, what are they and how many are needed to meet build rates? 

  • Are there any design modifications required for efficient manufacturing? 

  • Is there an onsite champion who will own and manage your assembly process? 

  • What materials and components need incoming inspection procedures and processes? 

  • Can low volume assembly be done locally and moved to lower cost locations later? This allows the scaling for a mature process vs a new less mature one.  

Processes may need to be reviewed when scaling from small quantities to very large quantities. As the production volume increases, rethinking jigs, hand tools, and fixtures becomes necessary to ensure efficiency and maintain quality standards. In Automation Friendly Design, Fusion has tips for optimizing the design for production efficiency.  

Manufacturing readiness encompasses a range of factors, including detailed and comprehensive design, process optimization, supply chain management, quality assurance, and capacity planning. See our Manufacturing Transfer Guide.

Conclusion 

Manufacturing readiness encompasses a range of factors, including process optimization, supply chain management, quality assurance, and capacity planning. It involves evaluating and addressing various aspects of the manufacturing process to ensure a smooth transition from product development to full-scale production. Achieving manufacturing readiness is vital to minimize risks, avoid costly delays, optimize operational efficiency, and deliver high-quality products consistently. 

Related Content 

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Design for Manufacturing Pro Tip: Improved Assembly Processes

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For improved assembly processes, our designs often include integrated 3D-printed support elements (handles) that get snapped (or cut) off after the assembly is complete. It's like giving a tiny gear a big handle to hold onto until it's in place. After assembly, you snap off the handle or alignment feature, and the gear remains in place.

Integrating 3D-printed support elements or handles can be a helpful strategy to facilitate the assembly process and ensure that components are correctly aligned. By providing a larger handle or alignment feature, it becomes easier to manipulate and position smaller or intricate parts during assembly.

Once the assembly is complete, these support elements can be snapped or cut off without affecting the functionality or structural integrity of the final product.

By incorporating these support elements into the design, you can improve the overall assembly experience, reduce the risk of misalignment or damage during assembly, and potentially save time and effort in the production process. This approach to leverages the benefits of 3D printing technology for enhanced assembly processes.

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May 2023 - Good News in Digital Health

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There’s finally some good news for an industry rocked by hospital bankruptcies, health insurance companies like Bright Health collapsing, and serious questions about the viability of digital therapeutics after the Pear Therapeutics bankruptcy.

Digital health encompasses medical devices that leverage electronic and software technology to provide healthcare solutions. This includes a wide range of technologies such as mobile health applications, wearable devices, telemedicine platforms, electronic health records, and more.

According to CBInsights, Q1’23 is the first quarter since 2021 where digital health funding hasn’t dropped quarter-over-quarter, either in total funding or number of deals. That might not sound like much, but it’s better than the venture economy as a whole where funding fell 13% QoQ. 

Image source: CBInsights