Since it is known that going back to a previous phase during the review meetings can be really expensive and counterproductive, I was wondering about the amount of error and deviance from the expectations that must occur for something like that to happen. Of course, I recognise that this depends on each product and case but was wondering whether there is some consensus on that.
I feel as though going back to a previous phase is not counterproductive as long as the issue(s) are resolved, or a better proposition is put forth. It could cost financially, however for the progression of the project and to continue to the next phase, it is important to ensure that previous steps are not left unfinished. There is no numerical value of how much error or deviance would occur from the expectations to have counterproductivity. I believe that the severity of the issue from the previous phase determines how quickly it can be resolved and pushed along, which would impact the timeline and financial side of the project. Having mistakes is not bad, as long as it does not shake up the projects trajectory too much.
There would have to be something fundamentally wrong with the project in order to go back to a previous phase. The design review process is set up to guide the project forward. Certain requirements must be met to move on to the next phase. A common phase for the project to hit setbacks would be V&V. If the project is consistently failing V&V test, the project might get kicked back to development to work on the issue.
Once a product is in post-release phase, it may also go back to previous phases. For example, if a product is receiving complaints in the market, a new design project may be initiated to fix these issues. Sometimes all of the design phases are completed again,
Going back to a previous phase in project development is often costly and time-consuming, but in some cases, it is necessary to ensure compliance, functionality, and safety (especially in highly regulated industries like medical devices). While there isn’t a strict numerical threshold that dictates when a project must revert to an earlier phase, the severity of the issue, regulatory requirements, and risk assessment outcomes typically drive such decisions.
One common trigger for returning to a previous phase is repeated failures in Verification and Validation testing. If a medical device consistently fails during verification due to design flaws, it may need to go back to the development phase for redesign. Similarly, if validation testing reveals that the product does not meet user needs, modifications may be required before commercialization.
Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) add complexity to this issue. If an external manufacturer or testing facility fails to meet regulatory standards, companies may need to re-audit their processes, delaying production. Regular supplier audits and stringent quality control checkpoints can help mitigate this risk.
This topic is explored in Simulation 3, as a problem with cytotoxicity will force a return to the verification phase. This is costly and generally avoided unless absolutely necessary. Thus, such a step is warranted only when critical errors or significant deviations are identified—typically those that impact safety, regulatory compliance, core functionality, or user requirements. In this case, cytotoxicity spurred the return to verification. Minor issues are usually logged for resolution in the current or future phases. The decision often hinges on risk assessment: if the potential consequences of proceeding without correction outweigh the cost and delay of backtracking, then reverting is justified.
While there's no universal metric defining the exact degree of deviation warranting a rollback, the overarching principle is that any deviation posing a risk to safety, efficacy, or compliance is taken seriously. Implementing robust design controls and risk management practices, as outlined in standards like ISO 14971, helps in proactively identifying and mitigating such risks, thereby reducing the likelihood of significant deviations that could necessitate reverting to earlier development phases.
Patient Safety Concerns: Any discovery of potential risks that could compromise patient safety necessitates a thorough reassessment, potentially leading to a rollback. The FDA emphasizes that design changes impacting safety require stringent control and documentation.
Regulatory Compliance Issues: Identifying non-compliance with regulatory standards during verification or validation phases may require revisiting earlier design stages to ensure adherence to necessary guidelines. The FDA's Design Control Guidance underscores the importance of addressing such discrepancies promptly.
Manufacturability or Stability Issues: Breakdown of the medical device during usage.
As mentioned by FDA "When conducting risk analysis, firms are expected to identify possible hazards associated with the design in both normal and fault conditions. The risks associated with those hazards, including those resulting from user error, should then be calculated in both normal and fault conditions. If any risk is deemed unacceptable, it should be reduced to acceptable levels by the appropriate means, for example by redesign or warnings".
An important part of risk analysis is ensuring that changes made to eliminate or minimize hazards do not introduce new hazards.
Common tools used by firms to conduct risk analyses include Fault Tree Analysis (FTA), and Failure Modes and Effects Analysis (FMEA).
One should not be hesitant to go back to the previous phase if it compromises the safety of the patients.
