In the practice of medical device registration, there is a common belief that the parallel launch of technical testing, toxicology, and clinical trials can significantly reduce the timeframes. Formally, this logic seems reasonable. However, in practice, it only works under one condition: if the entire registration process is manageable and transparent at every stage.
A client approached Equilibrium after the registration process had already begun. At the time of the approach, they only had technical specifications and a technical testing protocol in hand. Despite payment for the work, the remaining documents were not provided. The consulting company that had previously accompanied the project stopped responding, and it became impossible to obtain confirmation of the actual completion of toxicological and clinical studies.
As a result, the client found themselves in a situation where registration was formally launched, but control over the process was completely lost. Registration ceased to be manageable at the work organization stage. All registration payments were accepted by the consulting company rather than directed directly to the laboratories. This excluded the traceability of work performance and deprived the client of the ability to monitor the progress of testing. Without direct contracts with laboratories, it was impossible to confirm which studies had actually been conducted, in what volume, and with what results.
«The parallel launch of stages is not an error in itself. The lack of manageability is what becomes the error. If a client does not have direct contracts with laboratories, stage-by-stage submission of results, and transparent payments, registration quickly gets out of control», noted Vladislav Klimov, Executive Director of Equilibrium.
Analysis of the situation showed that key mistakes were made at the project’s start. The counterparty was chosen without sufficient verification, the contractual model did not provide for staging, and work results were not transferred to the client as they were completed. The absence of direct contracts with laboratories deprived the project of basic transparency and made it impossible to manage timelines and work quality.
After assessing the project’s status, it was decided to essentially start work anew. The old technical specifications were deemed unsuitable and issued in a new edition. Technical testing protocols required adjustments, and some tests had to be repeated. Attempting to preserve previously completed stages in their original form would only increase regulatory risks and costs.
«In such situations, it is important to honestly assess which works can truly be used further and which cannot. Attempting to preserve everything that has already been done almost always leads to additional costs and regulatory risks», noted Vladislav Klimov.
As a result of working with Equilibrium, the project gained a clear structure. Staged contracts were implemented, full traceability of work was ensured, and testing payments began to be made directly to the laboratories. The client began receiving results at each stage and understanding the real registration status. The project returned to a manageable state and was brought to obtaining a registration certificate.
Concluding the case study, Vladislav Klimov emphasized: «The main lesson for manufacturers is to carefully choose a counterparty and control the process. It is necessary to request all documents for completed work, conclude testing contracts directly with laboratories, and fix the staging of implementation. Without this, registration ceases to be manageable, regardless of budget and timeline».
