SCIE90011 - User Requirements Specifications (URS)

Explicate the definition of a User Requirements Specification (URS) and differentiate it from technical design specifications.
Identify and categorize the primary classifications of user requirements.
Formulate user requirements that adhere to standards of clarity, measurability, and verifiability.
Apply structural and prioritization frameworks to manage user requirements.
Recognize the function of the URS as the primary driver for subsequent design decisions and validation studies.

Core Definition: A URS is a structured, formal description of what users require from a system or product. It details the necessary tasks the system must perform and the level of quality/performance required.
Characteristics of a URS:
- User-Centred: Framed from the perspective of the individual or group interacting with the product.
- Technology-Agnostic: Focused on the "what" rather than the "how." It does not specify particular engineering solutions or scientific implementations.
- Verifiable: Stated in a manner that allows for objective testing to confirm if the requirement has been met.
Perspective Comparison:
- User Requirements (URS): Defines "what" the product must do and "how well" it must do it from the user perspective.
- Design/Technical Specifications: Defines "how" the product will be built from an engineering or scientific perspective.
Product Layer Context:
- Core Product (Benefit)
- Generic Product
- Expected Product
- Augmented Product
- Potential Product

Stakeholder Alignment: Acts as a bridge to align diverse groups, including users, developers, regulatory bodies, and management.
Risk Mitigation: Reduces the likelihood of developing "technically clever" solutions that fail because they are unusable or clinically irrelevant.
Contract for Testing:
- Verification: Provides the baseline to determine: "Does the product meet each individual requirement?"
- Validation: Provides the baseline to determine: "Does the product fulfill its intended use in a real-world context?"
Translation: URS translates abstract needs and concepts into explicit expectations that govern the design and validation phases.

Functional: Explicitly states what the product must do.
Performance: Specifies how well the product must perform (e.g., speed, accuracy).
Usability & Human Factors: Focuses on how people interact with the product, including user interface and ease of use.
Quality & Reliability: Addresses the robustness, consistency, and dependability of the product.
Regulatory, Safety & Compliance: Covers legal mandates and safety constraints (e.g., TGA, FDA regulations).
Interoperability & Supportability: Deals with system integration, maintenance requirements, and the product lifecycle.
Constraints: High-level resource limitations or environmental conditions.

The Problem Space: As a project moves from a Defined Problem to an Idea/Concept and finally to a URS, there is a marked increase in specificity through four stages: Identify, Define, Validate, and Understand.
Criteria for a "Good" Requirement:
- Clear: Understood identically by all stakeholders.
- Measurable / Verifiable: Testable to ensure satisfaction.
- Relevant: Directly coupled to user needs and the intended use case.
- Solution-Agnostic: Concentrates on needs, not implementation methods.
Comparative Examples of Requirement Formulation:
- Speed:
  - Poor: "The test must be fast."
  - Better: "Time from sample insertion to result must be $\le 30 \text{ minutes}$ in $95\%$ of standard tests."
- User-Friendliness:
  - Poor: "The system should be user-friendly."
  - Better: "A new lab technician with basic lab experience must be able to perform a standard test safely after $\le 2 \text{ hours}$ of training, and complete the test within $10 \text{ minutes}$ in $90\%$ of cases."

Iterative Cycles: In fields like Synthetic Biology, the URS feeds into the iterative Design-Build-Test-Learn (DBTL) cycle (Waldby et al. 2018).
Verification and Validation: The URS serves as the benchmark for verifying the design and validating the final product. Revisions to the URS may occur after testing cycles.

F – Functionality: Features, capabilities, and interfaces.
U – Usability: Human factors, ease of learning, and ease of use.
R – Reliability: Failure rates, availability, and robustness.
P – Performance: Speed, capacity, accuracy, and responsiveness.
S – Supportability: Maintainability, interoperability, configurability, and installation.

Basic (Must-be) Requirements: Features taken for granted; their presence does not increase satisfaction, but their absence causes strong dissatisfaction.
Performance Requirements: Satisfaction is directly proportional to how well these requirements are fulfilled.
Exciters / Delighters: Unexpected features that significantly increase user satisfaction.

M – Must Have: Essential for safety, basic functionality, and regulatory compliance.
S – Should Have: Important features that are not mandatory for the initial version.
C – Could Have: "Nice to have" features to be considered if resources permit.
W – Won’t Have (for now): Explicitly excluded from the scope of the initial release.

Direct Users: Requirements derived from clinicians, lab staff, process engineers, patients, and operators.
Third-Party Influencers: Requirements that users are legally or professionally bound to respect:
- Regulators: Therapeutic Goods Administration (TGA), European Medicines Agency (EMA), Food and Drug Administration (FDA), Office of the Gene Technology Regulator (OGTR), and biosafety committees.
- Standards Bodies: International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and various pharmacopeias.
- Institutional Policies: Hospital protocols or university-specific biosafety rules.
- Certifiers and Labellers: Eco-labels and CE marking.
- Payers and Procurement: Health insurers and hospital purchasing departments.
Impact on Product and Process:
- The Product Appearance/Behavior: Influenced by TGA, FDA, and ethics committees.
- Design and Manufacturing Methods: Shaped by Good Manufacturing Practice (GMP), ISO 9001, and eco-labels.
Conclusion on Adoption: A complete URS must reflect both user needs and third-party constraints; a product will not be adopted if it is non-compliant or impossible to manufacture within existing regulatory frameworks.