Ups

Risk management in the medical devices' development field is currently focused on technical risks, comprising product, usability, and development process risks, ...

The last fold proposes having a smart periodic review process of the register since as described in the results of [Figure 10](#f0010), the expansion of the risk register can make the periodic review a complex mission for start-ups. Though this framework proposes four early stages of MDD, it does not require adhering to the exact stages as this was not in the scope of the conducted research, while the identification of risk types to be covered by MDD start-ups was the upmost research’s interest. [Figure 11](#f0011) has been derived from the ISO 31000 and 14971 RM processes, which demand a risk identification through risk treatment process and accompanied with monitoring and commitment as represented in [Figure 1](#f0001), while reflecting this study’s recommendations and specifically the identification of non-technical risks. None of them, however, were built based on the performance of the RM process among MDD start-ups and considered the several risk types that should be covered to reduce risk encounter and increase the chances of the MDD project success among start-ups who may have little development and RM experience. This risk context scoping should be studied and identified by MDD start-ups at the RM earliest stages in order to identify what are the risk types that are applicable to their scope of work. The results in this question showed that FMEA is the mostly utilized risk identification method by most participants and that the range of risk types addressed by the start-up is not influenced by the utilized identification approach. The stage-gate process demands the involvement of the right constituencies of the MDD process, referred to as functional groups, such as marketing, legal, research and development to orchestrate the execution of the process, which may influence the risk identification process, without detailing the risk areas to be addressed. The obtained literature has allowed to generate a list of open-ended generic questions to review the application of RM stages and identify the risk spectrum being addressed by start-ups in the domain. [7](#cit0007) Similarly, the study by Gray and Larson [6](#cit0006) proposes that a risk breakdown structure should be adopted, commonly known as a hierarchical depiction of the identified project risks followed with a risk study towards each of the work breakdown structure (WBS) of a project to identify as many risks as possible, to reduce the probability of a risk being missed. It brings broad description of the various activities and decisions associated with the development of medical devices, from early-concept selection to post-market surveillance, with a list of proposed RM models, such as the models established by ISO 14971 and the FDA which do not dwell into risk types and represent instead a high-level RM process like the one presented by ISO 31000, that can be embedded into the MDD process. Start-ups in the domain of MDD seek compliance to regulations, such as the European Union’s MDD directives and regulations as well as the FDA requirements in the United States, in addition to international standards which are a compliance tool and not all of them are mandatory as in the case of directives or regulations, such as ISO, in order for their aspired products to be sold in the respective markets. which confirms that this standard also conveys a high-level process that does not consider the nature or class of the developed product and does not identify the various risk types or categories that shall be covered.