Great question Samiha!

In my opinion, when transferring design control and standards to any contract manufacturer, especially in medical device production, companies must consider several critical issues or limitations to ensure compliance and quality. First, quality control consistency is critical. Contract manufacturers may not have the same standards as the company. Having clear, mutually agreed upon criteria along with regular audits is extremely important. Ensuring regulatory compliance is also important, particularly regarding ISO13485 which we've learned about, and often necessitates training and/or certification checks. Protecting intellectual property also requires strict confidentiality agreements to protect proprietary designs and ideas. Addressing these factors and more allows firms to maintain their product quality and regulatory adherence, protecting them from potential audit findings.

There are many issues and limitations involved with using contract manufacturers. Someone has already brought up ensuring good and consistent QC. Whether you rely on their internal QC or your QC to ensure product quality is also a very important decision that needs to be made. However, just as important if not more is ensuring that the contract manufacturer has a solid quality assurance system as well. If their QA is not up to your standards it may result in huge issues for your device, and will probably result in lower efficiency and therefore higher costs in the manufacturing of your device. Most importantly however, is poor QA systems may result in your device getting into regulatory trouble, which will not only harm customers but also destroy the trust that people have not only in your device but your company as a whole. Additionally, if you are not handling the shipping, distribution and long-term storage of your device, and that is also being handled by the contract manufactures, that whole process also needs to be under a good QA system as well, which will need to be audited by your company to ensure standards. 

When transferring design controls to a contract manufacturer, it is critical to maintain traceability and design intent throughout the production process. Even if contract manufacturers have strong QC & QA systems, there can still be gaps if communication/documentation is not tightly managed. For example, if the internal R&D updates a usability specification but the contract manufacturer proceeds with an outdated drawing, the device could still pass their internal quality checks while diverging from the validated design intent. Thus, this could create compliance issues and potentially pose patient-safety risks — without obvious red flags.  

There is also the challenge of process validation/risk management continuity, as the process must be traceable to the device's risk analysis/design file. 

Ultimately, I wonder how companies rectify the balance between oversight and flexibility. How involved does the original design organization remain once manufacturing begins? And does this change for Class I vs. II vs. III devices?

I liked the point regarding maintaining consistent QC and QA in transferring design control. I also agree that there is great importance in maintaining traceability and documentation. Something that no one else has mentioned, however, is how the intent of the design sometimes gets lost during transfer. The FDA and ISO standards ensure that documentation is complete through the DMR, DHR, and risk files. Nevertheless, they do not really make sure that the reasoning behind the documents is communicated fully. A manufacturer might get final specifications but not the information for why a certain finish was chosen or why a certain tolerance was picked, especially if those decisions came from clinical feedback. Without this proper communication, the manufacturer can change something and unintentionally make a huge negative impact without even realizing it. 

Dr. Simon showed how design controls are a feedback system as opposed to just being a documentation requirement. In other words, it helps prevent small issues with the design from becoming larger safety or usability problems in the future. He did this by emphasizing how design controls are a feedback system, as every input is connected to an output that loops through verification and validation. However, by making this loop go across two organizations, it can break. Ensuring the “why” and specific rationale behind certain choices is imperative. To fix this, I think we can implement context-based transfer tools. This would include digital annotations within systems or having a joint design examination before starting the manufacturing. This would ensure that nothing gets “lost in translation.” 

I also believe a small human-factors validation should be included, even with proper communication of information, since any changes made to a design could lead to a different feel for the human using the device, even if the device still meets specifications. This step would ensure that the device meets the user's needs. 

Do you think the FDA or ISO make companies show tangible proof of the intent behind design when transfers are made? Would this make the process too complicated and slow down production? What are other tools or methods that could be implemented to make everything go faster and smoother?

Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer must be completed so that the manufacturing stage can start. To prevent any issues or limitations, a contract review should be conducted to establish if the contract manufacturer is capable of meeting the requirements that the OEM has. These requirements range from technical capabilities to quality standards and deadlines. A quality plan is developed to guide the device through process validation and manufacturing, establishing clear standards for all produced parts. Good communication between the OEM and the CM can resolve discrepancies before the design transfer, as well as agree on a criterion by which deliverables are passed or rejected.