In order to deliver quality medical devices that meet customer demands, manufacturers need to have a Requirements Management (RM) process in place. RM is the practice of understanding and documenting the needs and wants of the customer, as well as any other stakeholders, in a way that allows development teams to build something that meets those needs. In this blog post, we will discuss some of the top 5 Requirements Management tools for medical device organizations available on the market today.
What is Requirement Management?
The medical device industry is a place where you can not afford any mistakes. All the medical equipment must be super-efficient and of the highest quality. This makes the development process for medical devices more stressful. But if everything is kept on track from the very beginning, things would become a lot easier. Hence, the first place to start with is managing your requirements.
Now, what exactly is requirements management?
According to Ian Sommerville, “Requirements management is the process of managing changing requirements during the requirements engineering process and system development.”
In other words, requirement management is collecting, analyzing, refining, and prioritizing all the products or requirements, in the development phase.
The major purpose of requirement management is to ensure clear, concise, and error-free requirements to the engineering team so that they can make sure to detect errors in the system and potentially reduce the project cost as well as risk.
Importance of Requirements Management
In Medical Devices, as we have already discussed, the medical device industry is a very critical one. Requirements management becomes even more important in such cases. If any mistake or error occurs in the development process of a medical device, it could result in serious consequences or even death.
Hence, it is essential to have a requirements management system for developing any kind of medical equipment.
A requirements management system will help you to keep track of all your requirements and make sure that they are up to date. It will also ensure efficient communication between different stakeholders involved in the project so that everyone is on the same page.
The major benefits of implementing these tools include:
- Greater effectiveness in project management and adding accuracy to the project controlling.
- Increasing and maintaining traceability on all levels
- Increased efficient re-use and product-line management
- Higher ability to create baselines
- Improved knowledge of project scope to the stakeholders.
Challenges in the Medical Device Industry
- Enforcing Regulatory Compliance – Stringent laws, traceability, and safety are among the most important concerns for a medical device producer. Manufacturers confront difficulties in obtaining government support in the form of tax and financial assistance, subsidized research, and development due to country-specific compliance and regulatory criteria like IEC 62304, ISO 14971, FDA 21 CFR Part 11 and 820.
- Customer Satisfaction – To minimize product recalls and consumer dissatisfaction, product quality is critical. The medical device manufacturing sector, which is regulated by the FDA, keeps a thorough log of all data to keep up with changing legislation. Businesses may use best-in-class software to track devices by batch number, lot number, or serial number to standardize operations and reduce product recalls.
- Ineffective Business Processes – Managing all of a company’s products, operations, and resources is difficult. A medical device manufacturing firm must have cutting-edge technology that can be used to automate cross-functional processes, share data securely, and access files and papers from anywhere using mobile devices. By employing software that breaks down silos and supports activities such as warehouse management, production, purchasing, quality control, shipping, and other fundamental tasks, organizations will make better decisions faster.
5 Best Requirements Management Tools for Medical Device Organizations
Visure Requirements ALM Platform – Visure is a highly trusted requirements management tool in the medical device industry. The company integrates through the whole ALM processes including risk management, issue and defect tracking, traceability management, change management, and various other areas like quality analysis, requirements versioning, and powerful reporting.
Pros:
- Standards – Visure ensures streamlining the requirements keeping in mind to maintain compliance with various standards like IEC 62304, FDA 21 CFR Part 820, and Part 11, ISO 14971 in a cost-effective manner. These standards are dynamically traced throughout all the stages of development.
- Traceability – Visure also helps you in maintaining full traceability between your system and all the software requirements, risks, tests, and other artifacts. Furthermore, Visure assists you in generating full traceability reports as well.
- Multi-tier Collaboration – Visure supports XML-based standards, like ReqIF and XRI, that help you in exchanging requirements between various different customers and suppliers.
- Security – Visure ensures proper security of information and requirements. The tool does this through its rigorous access policy where only certain people can access the artifacts even at the elementary level.
- Quality Analysis – Visure’s Quality Analyzer allows you to perform semantic analysis of the requirements to identify the quality of the requirements. Therefore, if the requirements are low quality, the tool will automatically flag them with ambiguity or inconsistencies.
- Free Trial – Visure offers a free 30-day trial that can be downloaded from the website itself. Other details about pricing and demo can be found on Visure’s website.
Cons:
- If you’re currently working on a very short-term project with no cross-project impact, they you might be better off getting a lightweight tool like Jira.
- If you are currently working on an IT project with no criticality, perhaps this is not the tool you will be looking for.
IBM DOORS – IBM DOORS is another great requirements management tool in today’s market. The best thing IBM offers is great compatibility with other tools in the field. IBM offers flexible solutions suitable for large-scale enterprises along with a high-level granularity and configurability.
Pros:
- Standards – IBM supports easy compliance with various medical device standards like IEC 62304, 21 CFR Part 820 Part 11, and ISO 13485.
- Easy Operations – IBM allows you to easily create baselines, track versioning when detailed requirements are involved, and interlink the change requests directly to the initial documents.
- Collaboration – IBM also helps in boosting the collaboration among the team by managing the code, planning sprints, running standups, and tracking work in order to reduce rework.
Cons:
- The interface of DOORS is quite outdated and dull.
- Importing images, pdfs, and text files in IBM can be a pain sometimes.
- IBM does not offer integration outside the IBM technology ecosystem making it difficult to adapt to other tools.
- IBM is also too expensive for small or medium organizations.
CodeBeamer – CodeBeamer is a tailor-made ALM tool by Intland Software for advanced products and software development. This tool comes up with pre-configured templates and compliance for Agile and DevOps-oriented organizations.
Pros:
- Standards – CodeBeamer brings quality by adhering to various standards like ISO 13485, IEC 82304-1, ISO 14971, IEC 60812, IEC 62304, and more.
- Flexible – CodeBeamer is known to be quite flexible and a highly configurable tool. This tool supports quality analysis, audits, and reviews and further helps in generating custom-configurable QMS reports.
- Supporting System – The supporting system from CodeBeamer is highly appreciated in the market. The reporting system is quite strong and keeps you up-to-date with the latest project progress.
- Traceability and Documentation – CodeBeamer is quite liked for the traceability it provides between all the requirements and other artifacts. The documentation assistance the tool provides is also quite liked in the market.
Cons:
- The tools seem to lack traceability among low-level requirements and source code.
- The user interface of the tools is also quite confusing and does not look really nice.
- It is also said that while the tool is suitable for IT-oriented organizations, the same can not be said for other types of organizations.
Jama Software – Jama is a leading application for application lifecycle management that provides a great platform for risk and test management. Jama assists you in building complex products and systems by improving cycle times and hence, enhancing the quality.
Pros:
- Standards – Jama complies with various ISO, IEC, FDA, and EU standards for quality and risk management, lifecycle management, and other regulatory requirements.
- Interface – Jama offers a quite modern and intuitive interface along with features like live traceability and an effective notification system. This enhances efficiency, and alignment, and mitigates the risks.
- Easy Integration – Jama can be easily integrated with other tools like Jira and Azure DevOps. It also supports various development methodologies like Agile.
Cons:
- For beginners, Jama can take some time to get used to.
- For the users who do not possess licenses, Jama limits the number of users and some other features as well.
- The import and export feature is also not quite convenient in Jama.
Modern Requirements – Modern Requirements is a cloud-based requirement management tool that integrates with Azure DevOps, TFS, and VSTS. It offers strong traceability to project managers throughout each stage of the process. Modern Requirements works for various industries like healthcare, banking, and technology.
Pros:
- Standards – Modern Requirements performs formal reviews to enhance the input and integrates the comets from reviewers on a regular basis. It helps your organization achieve full compliance with the 21 CFR Part 11.
- Documentation – Documentation of Modern Requirements is another one of the most liked features. Modern Requirements allows you to build live requirements documents that will update along with your requirements. The review management helps you build online review reports from within your project.
- Strong Traceability – Modern Requirements allows you to create horizontal traceability matrices that help you review your traceability within a few seconds. It also uses an intersectional matrix to ensure easy viewing, managing, and changing things between various artifacts of the project.
Cons:
- There is no free version for Modern Requirements available.
- The security for the third-party plugins is also not so good.
Conclusion
Requirements management is a task that sounds quite easy but many organizations fail due to a lack of proper requirements management. The medical device is an industry that does not have any place for faults and defects. Hence, an appropriate requirements management tool is very essential. It will help you centralize your requirements and work on them in a better way. It will also enhance your team as well as cost-efficiency. Therefore, it is important to choose a tool that would suit your needs the best.
