The charging and serial communication port is also located on the back of the wristband. Another possible hybridisation is the combination of Design Thinking, Lean Startup and Agile [64]. Each of the methodologies is optimal in different processes, so when combined, they can increase the value of the methodology [65]. Measurements are automatically taken regularly with minimal patient intervention, making it as simple as possible. Patients place their right hand on the device when prompted by the wearable to perform the electrocardiogram. The collected data are stored in the internal memory and can be downloaded through USB using the charging platform or through Bluetooth communication.

Unlike phase 2, an Agile, Iterative and Incremental model is not considered. This will ease product certification by regulatory bodies since the reference standards suggest the development of medical devices following the traditional V-model. Compared to the V-model presented in phase 2, the only difference is that the transference stage becomes a validation stage. During this phase, the development feasibility document will be generated. The purpose of this document is to create enough information to decide whether the development is feasible. This document should assist in evaluating technical, economic and market feasibility.

Iterative development is a software development approach that breaks the process of developing a large application into smaller parts. Each part, called “iteration”, represents the whole development process and contains planning, design, development, and testing steps. Unlike the Waterfall model, the iterative process adds features one-by-one, providing a working product at the end of each iteration, and increases functionality from cycle to cycle. In 2021, Tekniker obtained the ISO certification for the design and development of medical devices. For this, phase 3 of this methodology has been fully implemented throughout the design and development procedures of embedded electronic products carried out in the Electronics and Communications Unit. In this phase, it is proposed to follow a V-model similar to the one presented in phase 2.

Introduction to the special issue on reconfigurable cyber-physical and embedded system design

A first phase of feasibility verification of the measurement principle was carried out, which is followed by the development of the functionality and, finally, the consolidation process. During this last phase, the client actively participated in the validation of the device, assuming almost all of its execution as its own. This development is on the market in Europe and the United States, and no problems have been identified with applying the proposed methodology. Thanks to this use case, the methodology is validated not only for the integral design of new medical products. It is also used to evolve or extend the functionality of devices already on the market. Furthermore, even though this methodology aims to address European regulatory needs, following the proposed methodology, this device has been approved by the FDA.

embedded iterative development model

The Product Owner is in charge of optimising and maximising the product’s value. Likewise, it is in charge of the Product Backlog and is the link between the team and its stakeholders. The Product Owner must identify and clearly define the objectives in each sprint. The Scrum Master is responsible for ensuring the Scrum is carried out correctly.

Project Planning

Overall, the Iterative model is an important methodology for software development today. It provides a flexible, collaborative, and adaptive framework for managing complex projects and delivering high-quality software. By emphasizing incremental progress and continuous feedback, this approach allows developers to respond quickly to changing requirements and customer feedback, ensuring that the final product meets the needs of its users. Subsequently, the high-level design and detailed hardware (HDS) and software (SDS) design are performed. This is followed by implementing the added functionality, both software and hardware.

The first reference to the Design Thinking methodology dates back to 1969. Herbert Alexander Simon, Nobel Prize winner, mentioned this concept in his book The Sciences of the Artificial [54]. It was not until 2008 that Tim Brown defined the methodology as it is known today. This approach was published in an article entitled “Design Thinking” in the Harvard Business Review [55].

That is, it is envisaged that starting from a preliminary creative idea, it will end up in an embedded medical product. During the initial phases of such projects, there is a high level of uncertainty in both the feasibility of the concept and the specifications, which usually decreases as the technical development progresses. Therefore, this methodology seeks to minimise the investment made during the phases of maximum uncertainty.

embedded iterative development model

The documentation generated in this phase will be the initial version of the final product documentation. Although the documentation effort is minimised, it should be generated as the development progresses. However, all the information will be consolidated, and the final product documentation will be generated in phase 3.

This hybridisation offers new features that can make new product development much more efficient. On the one hand, Stage-Gate provides a vision for the selection of ideas or projects to be developed. On the other hand, Agile is more project management-oriented, offering techniques and tools for adaptive, time and cost-optimised development [61]. Crystal is a framework family for agile development focused on people and their interactions. This methodology was defined in 1991 by Alistair Cockburn, creator of the Agile Manifesto. This methodology pursues individual improvement to achieve the overall improvement of the team.

This methodology is an advantageous alternative for medical product development where the overall requirements are clear. It is also suitable when there is a lot of technical uncertainty or the technical team is not highly qualified. While the term iterative and incremental development got started in the software industry, many hardware and embedded software development efforts are using iterative and incremental techniques. The third stage of the methodology aims to consolidate the development and turn it into a medical product. To this end, the deliverables generated during phase 2 are used as input.

embedded iterative development model

The Iterative model is based on the iteration of several Waterfall cycles. However, this model does not require having all the specifications of the system to start with the development [27]. The model execution starts with the creation of an initial version of the system. Then, it is evaluated, and further iterations are performed to improve and add functionality to the system. To this end, this standard defines the characteristics that a quality management system must fulfil to ensure that these products are reliable and of high quality. Today, the Iterative model is widely used in software development and is seen as an effective way to manage complex projects that involve multiple stakeholders, changing requirements, and evolving technologies.

iterative development definition

The use of a product design methodology can help to address the regulatory and technical requirements involved in the development of these devices effectively. Therefore, this section reviews existing methodologies for product design. Hybrid methodologies that combine different methodologies are also discussed. For each of the reviewed methodologies, their suitability or difficulty in being implemented for the development of healthcare products is detailed.

Its clear structure, easy management and the possibility to control deviations make it an ideal methodology for inexperienced teams. On the other hand, being a linear and sequential methodology makes it not very flexible to changes that may arise during the development process [17]. A simple change implies re-executing all the phases, resulting in a very costly process.

The final output of the project renewed at the end of the Software Development Life Cycle (SDLC) process. The idea of iterative development predates Agile – by at least a decade or two. The electronics are divided into two connected PCBs; one is used for the sensing stage, and the other is used for the control stage. Both PCBs are held in the lower case, while the battery is in the upper case.

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