Design and Development of Software Model for Therapeutic Medical Devices

Abstract

Healthcare equipment include a vast range of goods, from basic equipment to complex software systems. Incorporating software into such equipment is difficult since it requires market permission and approval from regional regulatory organizations. As a consequence, medical enterprises must oversee both the creation of these equipment and compliance with regulatory norms and standards. While regulatory organizations do not specify a particular model, they do need careful consideration. Plan-driven techniques, on the other hand, tend to stifle software development and shifts, while agile techniques are frequently criticized for insufficient preparation and paperwork. The goal of our investigations is to offer an adequate process framework for developing health care devices while taking regulatory constraints into account. We first introduced the Improved Agile the V-Model (EAV) after conducting a thorough examination of the previous research and McHugh's suggested framework. This model combines plan-driven and agile methodologies. We then linked the suggested solution with the MDEVSPICE architecture to verify that it meets the IEC62304 standard. Finally, we assessed the suggested model using an actual case study utilizing a wave therapy device for medicine. The EAV strategy flexibility for both waterfall and agile processes makes it easier to incorporate novel demands into medical equipment, and the suggested systems design methodology helps in software and hardware interaction. Connecting the EAV paradigm to the MDEVSPICE infrastructure indicates total compliance with requirements. In addition, the proposed approach was statistically tested and effectively executed in our particular study. We assessed equipment usage along with effectiveness indicators, and most questions had a trust level of P<0.05. The suggested design meets regulatory requirements and has already been used effectively in the production of a wave therapy equipment. However, its usefulness for smaller and simple medical goods need to be confirmed, which can be evaluated via the model.