The goal of this publication is to help you in the setup of your medical software development environment. The earlier you start with good practices application the more value and time you will gain from it.
Targeted audience
The information gathered in this publication should be particularly useful for:
- Head of Software Development Team,
- Software Project Managers,
- DevOps team,
- Software developers.
Introduction
For introduction content, refer to the Part 1 previously published.
Good practices
Refer to the Part 1, 2, 3 and 4 previously published.
Issues & Tasks management system
To ensure completeness of your project and efficient development you will need to define multiple tasks and assign them to members of your team. It is important to make the distinction between project management tasks (for example: organize risk analysis session, write down user manual, …) and development tasks (for example: add a text field to display patient name). Both of those types of tasks might benefit directly from task management software, but it is especially true for development tasks where the number of tasks increases quickly and where the level of details of the task (or sub-task) shall be important to ensure alignment between expectations and deliverable content.
To ensure efficient collaborative development, you will quickly need tools to ensure task management and follow-up. A list of tasks within an Excel document or any similar document will quickly show its limitation. This document will require giving editing rights to multiple users to update frequently the task list and the tasks status. This quickly increases the risk of having unexpected edition and loss of information and will limit the additional features you benefit from, as for example: notification when a task changes status.
Commonly used task management platforms include but are not limited to:
- Jira,
- GitLab,
- Azure DevOps,
- Polarion.
For those reasons, Debiotech highly recommends you to:
- Setup a task management tool. No need for fancy brand new solution. Simple task management platform already provides a significant set of features that will increase the productivity of your team.
- Select a tool that allows:
- To create a task and to divide it into sub-tasks.
- To group task into sprints, features or targeted release versions.
- To define different task status. For example: Opened, assigned, on-going, under review, closed and abandoned.
- To define different task priority levels (for example: High, medium and low), expected delivery date and effective delivery date. No to be used as a support to blame anyone but to be able to continuously improve your planning skills.
- To block task deleting. Use “Abandoned” status instead to keep track of what was thought as necessary or useful at some points.
- To define who has the rights to assign task to someone else. The rules there should depend on the way you want to work. It is sometimes useful to limit task assignment only to the software development project manager. Within other teams, you might want each of your developer to be able to assign tasks to other developers even if the software development project manager might want to change this assignment later.
- To generate reports at various times to have an overview of your task management activities within a given period.
- To assign tasks to given software releases.
- Ideally select a tool that can integrate with a code repository management platform to allow you to have automatic links between code commits and tasks.
- Ensure your team updates the status of their tasks systematically and immediately and not once a day or even worst once a week. Nothing worst to have not fully updated tasks status.
- Congratulates your team on major task or task group achievements!
Finally, a last point that can be useful is to integrate your task management platform with your technical documentation management platform to make links between specifications or use cases and tasks and software versions.
This might allow you to have a complete traceability between your specifications and test cases and your software versions. However, this is not mandatory and might create more execution challenges than solve any real problem. Debiotech do not recommend trying to develop such solution unless you really perceive a need there.
Systems for technical documentation writing
A critically important activity for software and especially for medical software development is technical documentation writing. Medical device regulations impose multiple requirements on the content and structure of such documentation. The way to structure such documentation, the items characteristics and the different tools helping you in such writing will be the subject of a specific publication by Debiotech.
Applicable regulatory landscape
This publication does not aim at answering completely to a specific standard or regulation but provide recommendations on multiple aspects that should be established early on in your development to ensure the efficiency of your team. However, it covers directly or indirectly multiple requirements from following standards and regulations:
- Europe: MDR
- US: CFR Title 21 Part 820,
- International: ISO 13485, IEC 62304, UL-2900-1/2
Authors
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Rémi Charrier Business Development Director r.charrier@debiotech.com |
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João Budzinski |
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Laurent Colloud Software Project Manager l.colloud@debiotech.com |
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Gilles Forconi |
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Next steps
Debiotech is glad to have the opportunity to share its knowledge with innovative companies from the MedTech industry. Your feedbacks on this publication are welcome and will be used to update it or to create new publications on topics you care about.
Continue your education on medical device development by:
- Accessing Debiotech historic publications: https://www.debiotech.com/news-grid/
- Following Debiotech on LinkedIn to be notified on new publications: https://www.linkedin.com/company/debiotech-sa
- Contacting us to ask a question or request personalized support: contact@debiotech.com
Debiotech would be proud to be your partner and support you with:
- Medical device design & development services:
- Software: Digital Health, Firmware, Embedded, SaMD
- Electronics: Design, Verification and Validation
- Mechanics: Design for micro-fabrication & fluidics systems
- Supply chain development and optimization
- Support in medical innovation management:
- Market analysis and segmentation
- IP management
- Business plan consolidation
- Partnership development
