By Sean Fenske, Editor-in-Chief
 
In recent years, many medical device manufacturers have faced a number of challenges with regard to their supply chains and service provider partners. As a result, they are looking at ways in which to safeguard these aspects of the business to avoid future concerns as well as ease excessive logistics costs. As companies alter their supply chain strategies, in some cases, they move work from one supplier to another.
 
When a project is transferred from one service provider to another, it provides an opportunity to revisit design specifications. Ensuring clear and definitive details on vital aspects of a design can help smooth this transition. Determining where tolerances should be specifically set and where they aren’t as important is another factor to clarify.
 
Fortunately, Command Medical Products LLC has extensive experience with these types of reviews and can facilitate the transition of new projects to help minimize potential issues and delays down the road. To explain how this materializes in a real-world situation, Miguel Ballesteros, engineering manager, and Tanya Sima, director of supply chain, responded to a series of questions about how Command handles this potentially problematic process.
 
Sean Fenske: What specifically do you mean by specification alignment within product design?
 
Miguel Ballesteros: Specification alignment refers to ensuring the dimensions and quality criteria of raw materials support and align with the finished product’s requirements. When contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs) are awarded new business, they often need to transfer established products into their facilities. These products typically come with pre-defined bills of materials, specified sub-tier suppliers, and detailed specification packages. These packages include raw material specifications, multi-level finished product specifications, and associated quality criteria.
 
At Command Medical, we have a formal process that begins with a comprehensive desktop review of all specification inputs. Frequently, we discover inconsistencies or missing details in the documentation. If these issues are not addressed before creating production tools, initiating validation, or finalizing internal work instructions, they can lead to delayed launches, additional non-recurring engineering (NRE) costs, or rejected lots, resulting in customer dissatisfaction. We mitigate these challenges by conducting these checks early in the onboarding process and incorporating necessary adjustments into the product drawings package.
 
Fenske: What are the most common misalignment issues you find?
 
Ballesteros: The most frequent inconsistencies include tolerance stack-up on interfacing parts, unclear inspection methods, and variable particulate criteria.
 
Fenske: Can you elaborate more on the impact of these alignment issues?
 
Ballesteros: We work with complex tube sets and assembled devices that integrate various injection-molded components, needles, and nozzles. Each component has specified dimensions with designated tolerances. If tolerance stack-up between interfacing parts is not properly reviewed, it can lead to fit issues, where parts either do not fit together, or worse, may fit initially but come apart later in production or in the field. Legacy products can also face mold wear issues, leading to tolerance deviations beyond acceptable limits.
 
Another concern is the inspection method and critical-to-quality (CTQ) details specified on raw material component drawings. Sometimes, specifications lack CTQ criteria crucial for downstream functionality. Inadequate communication of these details can create failure points. The accuracy and consistency of measurement tools used during inspections—whether incoming, in-process, or final—can also contribute to misalignment. Early discussions to align specifications and capture necessary knowledge are vital to prevent future production issues.
 
Tanya Sima: From a supply chain perspective, we must reconcile raw material suppliers’ process capabilities with the device specifications. Identified gaps from our reviews may necessitate tighter control of tolerances, improved particulate controls, and additional dimensional inspection points. If components are off-the-shelf items, negotiating these requirements can be complex and may increase costs. My goal is to ensure we meet customer needs while focusing on cost control, which sometimes involves candid discussions about raw material specifications and the true design requirements versus ideal requests.
 
Fenske: You mentioned variable particulate criteria as one of the top three common issues in specification misalignment. Can you please expand on this issue?
 
Sima: Particulate criteria are critical when aligning raw material specifications with finished device requirements. Each raw material has a specification to ensure it meets physical requirements and is compatible with our cleanroom conditions. However, many off-the-shelf components, particularly injection-molded parts and films, may not meet the desired particulate levels specified for our customers’ finished products. This is especially true for life science/biomedical products, which have more stringent particulate requirements compared to typical disposable medical devices.
 
Fenske: Can you provide an example?
 
Sima: For instance, if a specific film is required for fabricating an RF-welded bag, the film might meet the supplier’s particulate specification but not the finished bag’s criteria, which could call for no loose particulate. This discrepancy means the raw material could be out of specification for the finished device. Understanding this gap allows the CMO to work with the supplier to tighten measures at the raw material production level. If that’s not feasible, a secondary in-house process may be necessary to clean the film before conversion to ensure the end product meets the particulate-free specification.
 
For reference, the TAPPI chart, which outlines acceptable particulate levels in materials, can be useful in this context. You can find more information on the TAPPI chart here.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Ballesteros: My additional recommendations to OEMs would include:
 

• Ensure technical teams, including engineering and quality, collaborate to analyze all details down to the raw material level. This includes articulating CTQ requirements beyond immediate dimensions, inspection tools, cleanroom packaging, and particulate levels. Omitting these details often leads to issues later on.
• Avoid over-specifying criteria on parts where it’s unnecessary, as this can add unnecessary costs.
• Verify that designated raw material suppliers can meet the required criteria before approving them for your bill of materials.
• Expect gaps during technology transfers and work closely with your CMO to document details on specifications and drawings, ensuring both parties understand what is required and feasible.