Why are requirements important?
Requirements are important for providing an understanding of what needs to be accomplished. They help ensure that needs and expectations of stakeholders are fulfilled and they provide a basis for measuring progress and success. Clear, well-defined requirements reduce unnecessary work, improve quality and ensure delivery on time and within budget.
This is important in all organizations that have to adhere to complex expectations no matter where the expectations come from (legislation, standards, customers, sub contractors, etc.).
What are requirements?
Requirements are statements that specify what the end result of a project should be or what it should do. They describe the features, functionality, performance, constraints, usability, security, safety, compliance and other characteristics of an end result.
Top sources of requirements:
- Business: Business stakeholders, such as managers or executives, provide requirements that align with the strategic objectives of the organization. Like need to increase productivity or cut down costs.
- Market & Customers: Market requirements describe the needs and expectations of the target market that are typically derived through market research. They ensure the system meets the needs of its intended users and is competitive in the marketplace. When there are direct customers for a system they provide input on the features and functionality they would like to have.
- Regulations and standards: Requirements may be derived from laws, regulations, industry standards, or other external sources that a system or product must comply with. These requirements are often extremely important to fulfil as non-compliance may mean that the end result can not be used. These requirements address things like functional safety, cyber security, environmental issues, etc.
- Knowledge: Requirements may also arise from prior projects experience, from subject matter experts and other sources of specific knowledge.
Requirements really are everywhere
In this age of increasing data, autonomous systems, artificial intelligence, climate change etc. requirements are becoming more and more important in all industries. The regulatory bodies are doing their best to ensure safety, security, environmental aspects, sustainability and fairness. This means an increasing amount of global regulation and standards like GDPR, NIS 2, MDR, Machine Directive, IED and many more.
Complex requirements and the need for structured requirements management is not an industry specific thing anymore. All industries are affected by the ongoing trends and would benefit from better processes to capture, document, analyse and validate their requirements.
Efficient Requirements Management
Managing requirements effectively becomes increasingly challenging as products and systems grow in complexity, consisting of hundreds or thousands of requirements. To streamline the requirements management process and accelerate product development, businesses must employ strategies that address this complexity while ensuring clarity and prioritization.
Read our article about ‘Efficient Requirements Management’ to discover the strategies you should have in place to effectively handle the large volume of requirements, achieve a faster time-to-market, and gain a competitive advantage in the market!
Requirements Management in Medtech Industry
In order to succeed in the medtech industry, it is required to work systematically with requirements management. Specifying requirements, or design inputs, and traceability between requirements and other design artefacts are demanded by regulations. Systematic and digitalized approach helps enormously in saving work effort securing compliance.
