This methodology is particularly interesting for start-ups due to the type of solution they usually have, innovative ideas but with high technical and economic uncertainties. Its use is recommended in cases where the requirements are expected to remain stable throughout development . This allows planning during the initial development phase both in terms of time and cost. In addition, the deliverables generated at each step ensure an efficient flow of information between phases. This, together with its clear and well-defined structure, makes it an easy methodology to control and manage the project.
This work highlights that the high number of applicable standards requires a methodology that eases compliance in an efficient and orderly way. It also shows that the current methods are not suitable for the sector’s needs nor do they help the nature of start-up companies. Although it is a methodology that can offer many advantages, it is not yet a commonly used method, and there are some gaps or concepts that are still to be defined and evolved. It is challenging to implement in start-up companies without experience in design and development methodologies such as Stage-Gate. This year, a name was given to the cost overruns and quality deficiencies that were being suffered in different software developments .
3. Lean Startup Methodology
During this development, phases 2 and 3 of the methodology have been applied. Phase 1 was not executed because the client already had a preliminary prototype with which the feasibility of the development was validated. On the one hand, usability tests have been carried out on dependent and older people living in an assisted living facility. On the other hand, environmental, electrical safety, and clinical trials, among others, are still pending. Those tests that must be performed in official institutions are still pending. Following phase 2 of the proposed methodology, the functional development of the device is carried out incrementally and iteratively.
- This methodology emerged to create successful companies using continuous improvement.
- It is worth noting that when defining these requirements, special consideration is given to the requirements that a methodology must meet to enable a start-up company to successfully develop a medical device.
- That is, it is envisaged that starting from a preliminary creative idea, it will end up in an embedded medical product.
- It is expected to provide effective uncertainty management and cost control during all design and development phases.
- The development team consists of several professionals who are involved in the development of the product.
This aims to provide a starting point for the definition of a new methodology for designing and developing embedded medical devices. It is worth noting that when defining these requirements, special consideration is given to the requirements that a methodology must meet to enable a start-up company to successfully develop a medical device. Therefore, as its main contribution, this article presents a methodology that outlines the steps to design and develop embedded medical devices. As it is a methodology for start-ups, the aforementioned methodology aims to minimise financial investment during high-risk technological phases. In addition, it encourages the evaluation of the device by the client or product manager in the early stages of development.
This is a device for professional use, which is regulated by the European IVDR regulations as class B and IEC as class B. The client, a consolidated company, has a technical department with embedded software and hardware development capabilities, but due to a lack of available resources, it has decided to outsource this activity. Phases 1 and 2 of the proposed methodology have been fully implemented in this development.
7. Methodology Contributions
It should offer a sampling of the key aspects of the problem and provide a solution that is simple enough to understand and implement easily. To guide the iteration process, a project control list is created that contains a record of all tasks that need to be performed. It includes items such as new features to be implemented and areas of redesign of the existing solution. The control list is constantly being revised as a result of the analysis phase. During this period, the United States Air Force and NASA worked together to develop the X-15 hypersonic aircraft, using a largely iterative design process throughout.
However, some Agile approaches to scheduling, such as Kanban do away with iterations in this later sense, but retain the other aspects of multiple repetitions and planned rework. The device has been tested to verify the reliability of the measurement results. Firstly, the temperature sensor’s accuracy has been determined by temperature tests in a climatic chamber. Regarding the SpO2 measurement, a signal-to-noise ratio measurement was performed by placing the device on the charging station. This dock is designed to block external light artefacts and reflect the signal from the LEDs.
Moreover, it does not fit projects that require a high degree of predictability and fully defined planning. Therefore, Agile methodologies were developed to address the huge amount of bureaucracy that traditional methods have to deal with. Agile methodologies are not documentation or development-planning oriented.
As the medical device regulation specifies, each step of the design and development processes must be planned and documented; there are a lot of plans and records among the documentation defined within this methodology. On the one hand, Scrum brings the approach of working in well-defined and planned teams to deliver continuous value to end-users. On the other hand, Kanban focuses on process efficiency by ensuring ongoing process improvement. Thanks to these features, Scrumban saves time, helps to manage large projects efficiently, helps the whole team to have the same vision, provides fairness among team members and helps to reduce staff stress. On the other hand, this framework is still evolving, and not all the best practices are clearly defined. It also makes project management difficult as long as the whole team is making decisions.
An iterative model is proposed to allow the client to assess the suitability of the approach at the end of each iteration. The Agile framework of the proposed model for phase 2 is presented in Figure 12. Agile and Lean Startup methodologies aim to satisfy clients through iterative and incremental processes.
This methodology proposes generating a set of deliverables for each iteration of the method. These deliverables will serve to assess the progress of the development and clarify technical uncertainties. Typically, a team has between five and 15 members, including the Product Owner, the Scrum Master and the development team .
Finally, the validation of this methodology has been carried out through the presentation of use cases in which its application has been successful. The wearable solution involves vital signs monitoring platform in the form of a smart wristband, which can collect relevant https://www.globalcloudteam.com/ data about the user’s health. Still, most of them are not developed to comply with medical device regulations, so the data they provide cannot be considered reliable. This development aims to provide a wristband that offers reliable diagnosis and accurate results.
After the implementation, the defined verification plans must be executed, first the Development Verification Tests, then the Functional Tests, and finally the Transference Tests. Although the main objective of this phase is not to ensure compliance with the medical regulations, the proposed model and the generated deliverables are defined to be fully compliant after the execution of phase 3. Gates are the checkpoints at which a decision is made on whether to continue with the execution of the next phase or stage. These decisions are based on the inputs available at each moment and are made according to different metrics that help evaluate the development’s status.
Once the URS has been updated, the validation plan should be generated; this plan will cover the validation of all the defined URS. Tests related to clinical evaluation and research or performance evaluation and performance studies are considered at this stage. Likewise, any testing that applies to the product according to the IEC family of standards or others must be performed in accredited entities. Other hybridisations are based on combining Agile and State-Gate methodologies .
The decisions that can be taken at each gate are Go (go ahead), Kill (do not go ahead), Hold (project in pause), and Recycle (go ahead with changes) . Lean Startup is a product design methodology that focuses on customer needs. This method was born as an evolution of the Lean Manufacturing methodology. The origins of Lean go back to 1890, when Sakichi Toyoda, a textile entrepreneur, created several patents for machines that helped automate the work of operators. Kiichiro Toyoda developed this philosophy by focusing on the collaborative work of machines and humans to add value to production without generating waste. Agile development methodologies have several concepts that constitute their core.