Human Factors is the scienti ic discipline concerned with the understanding of interactions among humans and other elements

of a system in order to optimise human well-being and overall system performance. In this de inition, the "system" represents the physical, cognitive and organisational aspects of human interaction. Human Factors Engineering (HFE) can contribute to performance improvement, risk reduction and safety by considering the needs, abilities and limitations of the people involved in the use of those systems. Regulatory bodies have reassessed the importance of HFE relating to device success, risk and safety. Of the worlds leading medical device providers, over 30% have experienced device recalls due to human factors problems in recent years. The FDA believes that failure to use a product successfully is a source of risk for any product that provides medical treatment. At Design Partners we combine human factors engineering expertise with industrial design creativity and engineering excellence to deliver user centred designs that surpasses user expectations. While the regulatory perspective is design optimisation for safety and risk reduction, Design Partners believe that HFE is also a strategic product development tool that delivers competitive advantage by ensuring user needs are met while hidden needs are uncovered and addressed. The HFE process can also reduce development cost and time to market. HFE addresses regulatory requirements but is also a means of optimisation leading to competitive advantage and product development cost containment.

Discovery

Concept

Concept Development

Design Detail

Pilot Build 2

Pilot Build 1

Integrating Human Factors Engineering into the Design Process

21 CFR 820.3 Section C Design Inputs

21 CFR 820.3 Section D Design Outputs

21 CFR 820.3 Section E Design Review

Design Freeze

21 CFR 820.3 Section F Design Veri ication

21 CFR 820.3 Section G Design Validation

Tool

Design Veri ication

Design Validation

DHF

Product requirements document De ined project brief Marketing perspective Identify engineering standards Patient perspective
Design Process Human Factors Engineering (HFE)

Series of concept proposals Rationale for concepts Foam models / rigs Digital media assets Schematic drawings

Mechanical & technical development Design development mapped to HFE 3D iles for engineering feasibility Mechanical rigs Physical and GUI iterative prototyping

Mechanical & technical veri ication Design aligned to HFE requirements Production speci ication control drawings High idelity prototypes GUI prototype (near inal)

Tooled or Preproduction Components Batch Production Parts Re ined Speci ication Final GUI Full Function Preproduction Prototype

FDA/CE
Identify critical tasks Identify HFE standards De ine user populations De ine use environment Understand system Competitive analysis HFE usability test plan Essential & critical usability de ined Task analysis Risk matrix related to tasks Design development guidelines Heuristic - expert review Tests on working prototypes Updated risk matrix and tasks Aggregate & prioritise for risk reduction Usability design criteria is set Guidelines for design re inement Usability validation test plan Usability tests on working prototype Representative users / actual users Risks identi ied, addressed & tested Simulated use conditions Evidence to support design freeze Con irm HFE validation test plan Usability tests on pilot builds Test participants & rationale (actual users) Tasks for testing & rationale Subjective assessment Test results in table form Statement of mitigations HFE report annex to DHF

Preliminary Analysis

Usability Inspection

Usability Testing

Trial Usability Validation

Usability Validation

HFE Report

Formative
Establish foundational elements of usability, user population and typical use environments. Identify critical tasks. Understand needs, abilities and limitations of typical user populations in the context of a system and use environment.

Formative
Usability exploration and analysis carried out using patient and caregiver perspectives, product requirement document and project goals. These activities are explorative, designed to inform product development decisions early in the process.

Formative
Phase informs design iteration. Evaluate and document usability design development. Tests are performed using physical assets generated during design development such as paper and virtual prototypes as well as rigs and physical prototypes. Document HFE failures addressed and tested.

Formative Conclusion
The conclusion of formative usability testing. Usability testing is carried out with formal performance acceptance criteria as a trial run to validation testing. At this stage explorative testing is complete. Testing con irms the project is ready for design freeze and sets the project up for validation testing.

Summative
Primary evidence to the FDA to support the conclusion that the inal embodiment of the design is optimal. Having fully explored and provided proof that use, users and use environments were fully understood and considered. Validation testing should be comprehensive in scope and focused on task priority.

Human Factors

Design Process

HFE report recording process, methods and rational informing usability design decisions during product development. Report addresses regulatory perspective on usability safety and optimisation.

designpartners.com

Iterative process of design re inement and testing