- Review new regulatory standards and requirements for combination products, packaging, IFUs, and adverse event reporting in Japan
- Understand the role of HCPs in Japan and their impact on combination product design and development
- Adapt to cultural and linguistic differences in product design and labeling
As healthcare solutions increasingly feature AI, this brings new challenges to usability research. AI outputs can have a broad range of quality and noticeably “weird” errors – so how can you confidently assess risks and validate products? AI also significantly changes user workflows, making it more important to ensure working on the right problems.
- Plan a good workflow fit when user workflows are changing
- Develop and validate automatic metrics required for AI model optimization based on user feedback
- Increase your skill set to include data wrangling and quantitative analysis skills
- Utilize HF in formative studies to narrow down multiple device options
- Evaluate user needs and requirements in early stages
- Recognize how patient characteristics can impact device function in unexpected ways
Old-fashioned methods for reconstituting lyophilized drug products placed a heavy burden on lay users, who often struggled to mix and inject them properly. Dual-chambered devices can take some of these challenges away, but introduce new ones – so how can you strike the best balance in your designs?
- Review market progress of dual-chambered syringes and auto-injectors
- Outline the new challenges of dual-chambered devices
- Adapt device design around drug formulations that users must be allowed to self-administer
Single-use endoscopy products must integrate input from both users, use environment, and the user interface. When designing a single-use product with associated software component, aimed for use by surgical team members, teams must prioritize a thorough hazard analysis.
- Recap the HF and system architecture of a single-use endoscopy device
- Evaluate the impact of single-use vs reusable devices
- Trace development through actual and simulated study environments
How would you feel walking into a room of 12-15 people all eager to watch you potentially fumble through using a tool you’ve never seen before? As researchers responsible for organizing such studies, we need to be able to lead without authority when planning user studies and set clear boundaries for attendees. This can be harder to do when starting in a new role or early in one’s career before gaining confidence to ensure that even business leaders know their place when attending usability testing.
- Understanding potential impact and biases induced by attendees
- Setting boundaries with project teams
- Considerations for space and facility planning for research
It is too easy to get into a mental frame of conducting research when what you really need to do is hold conversations. Treating test users like a performance for you to view will yield far worse results than understanding their mental models and motivations – and this will require convincing them that you are on their side, not judging them.
- Frame their involvement as helping you with a project, not assessing their abilities
- Position yourself as a “safe” outside opinion with whom they can share confidential critiques
- Modify your approach as needed to gather feedback about internal tools
Typically, user research does not require root cause analysis of how use errors are detected and analyzed for risk and root cause. With no specific guidance from regulators, companies can approach user research in highly different manners.
- Adapt best practice around your scope and creative style
- Debate the number of formative tests you should perform, and how you know when to stop
- Acknowledge why some companies may actually want to avoid best practice recommendations on root cause analysis
- Recognize the value of designers partnering closely with HF teams
- Focus on UX tools that designers leverage
- Analyze similarities and differences of the two teams
Recruitment for a full Human Factors summative study is especially difficult when working in the realm of rare disease. Is there a better, more structured way to approach recruitment that can yield better results and ease the stress of a human factors summative study?
- Work with internal resources to start creating a panel of interested patients
- Build a surrogate justification that can overcome FDA scrutiny
- Collaborate with vendors to help ease the burden of recruitment
Integration of technologies into regular everyday work systems benefits from human factors considerations. Medical devices are not always designed around the complex, messy and unpredictable situations in which they are used. Using direct observations of clinical work, systems analysis approaches, human factors integration frameworks, and incident reports, you can continue to bridge the gap between “work as imagined” and “work as done” for device design and implementation.
It can still be difficult to get upper management to understand the value of HFE/UI, and this can be an obstacle to funding key projects. It is crucial to prepare for 1-on-1 advocacy and to spread a grassroots personal management understanding of your work so other teams know how and when to approach you.
- Assess how frequently your own projects don't get funded due to what are perceived as higher priorities
- Confront head-on the reputational challenges you face in a field that lacks clear meanings and metrics and that may be seen as less important than systems, safety, or software
- Home in on the value proposition
- Show ROI Rate of Return for investments in HFE/UE with mini-business cases
What are the best strategies for building and advocating for diverse, cross-functional teams? By learning to harness the full potential of HFE, you can bring your team and organization to new levels of success.
- Convey the benefits of in-house usability research
- Cultivate cross-functional teams with diverse expertise and interest in HFE
- Recruit from varied backgrounds and experience to enrich team capabilities and testing outcomes
- Utilize insights from psychology and education to streamline user training and enhance usability
IFUs are required to carry so much safety information that they may be more intimidating than educational. Users often rely more on previous experience, on instructions from HCPs or other promotional support resources, or even social media. These can be more digestible – but have different risk and regulatory considerations.
- Highlight success rates of instructional materials, including risk mitigations and user adherence of the UI experience.
- Review conflicting feedback from health authorities on whether quick reference guides and QR codes are acceptable – and how this varies across markets and regions.
- Keep user preferences and capabilities in mind throughout IFU design
Comparative use guidelines for generics can cause confusion for your team, as they were written with a biostatistics perspective that focuses on clinical trial design, not HF studies. Each sector lacks understanding of the other, and this can get in the way of proper comparative analysis and leveraging data.
The User Interface Design Description is a critical document within the Design Control process, yet it has historically been challenging to read and navigate. The key question is: how can we transform the UIDD into a more effective, user-friendly tool that serves as a valuable resource for all stakeholders, particularly the HFE team?
- Simplify the UIDD: Streamline the document's structure and present workflows in a clear, intuitive manner, making it easier for all stakeholders to understand and utilize.
- Collaborate with HFE early: Engage the HFE team in early discussions to walk through the system workflows, enabling the identification and mitigation of potential risks at the outset of the project.
- Evolve the UIDD over time: Continuously refine and update the UIDD as the project progresses, ensuring that it accurately reflects the evolving design and remains a relevant tool for decision-making and risk management.
