Assessing your full drug pipeline with the Perception-Cognition-Action method can help highlight areas where formulation teams have unrealistic expectations of user group capabilities (i.e. reconstituting drug products on their own). The necessary analysis can help you spot trigger points where fuller involvement from your HFE team is required.
- Learn from cases where formulation teams did not understand why IFUs were needed
- Transmit good design processes from packaging to the products themselves
- Create “Stop/Go” points based on how all patient groups are impacted perceptually and how they receive information
Usability testing for pediatric users is especially difficult: patients can’t talk, can’t swallow certain formulations, and are more impacted by certain textures. When the actual device users are more likely to be caregivers, parents, and hospital staff, what are the extra complications you must bear in mind?
- Differentiate between use errors by caregivers and those by children
- Analyze a large-scale study evaluating pediatric challenges
- Gain clarity on what HCPs and caregivers prefer when working with this patient pool
With the increase in demand for personalized patient therapies through digital health solution apps, digital accessibility design standards for patients with disabilities can be critical to drug dosage, adherence, verification, and information. With the Web Content Accessibility Guidelines (WCAG) design standards for Information & Communication Technologies (ICT) – inclusive of digital health solutions and software as a medical device, explore the WHY, the WHAT, and the HOW for digital accessibility.
- WHY: patients and disease state disabilities
- WHAT: trends in digital health solutions
- HOW: digital accessibility design standards
Preclinical human factors validation studies have rapidly proliferated – but if a clinical trial is a truly controlled environment, will the manner of device use be proper for evaluating usability? Is it the right thing to do to hold a human factors study before Phase III – and if so, how should you proceed without clear guidelines?
- Evaluate whether you can use commercial IFUs for clinical studies or need to create separate ones
- Map the steps necessary for testing devices meant for home use
- Visualize the differences that regulators may expect from clinical to commercial stages
The design of the user interface is everything, and when done poorly it is the antagonist in all human factors dossier regulatory submissions. In 1996, a CDRH working group published “Do it by Design: An Introduction to Human Factors in Medical Devices,” which promoted the concept of user-centered design and served as a primer for the impact of design upon safe and effective use of medical devices. This session provides a historical view to present revisions of human factors design standards while providing best practices for optimizing the design of any user interface.
- Review ergonomic design principles – where to find them and how to use them
- Grasp why simply reporting use errors is not enough to make meaningful changes in the design of the user interface
- Recap where we have been and what’s to come next in the revised ANSI/AAMI HE 75
The risk level of each task is determined in the original hazard analysis from the quality team, and then trickles down into other levels of analysis. By keeping your hazard analysis and risk assessment based on every step, you can determine what risks users truly face.
- Quantify the severity of harm to users if tasks are done inaccurately
- Ensure your team explores every task regardless of severity
- Follow the most recent regulatory guidelines
On top of desk-based activities like task and risk analysis, formative usability studies are a helpful tool to uncover potential use errors associated with product use. How these use errors are analyzed and added to use-related risk documentation requires careful consideration of what was observed and associated root causes.
- Recognize different ways in which non-SME R&D team members might respond to formative study learnings that are more familiar to HF SMEs
- Appropriately define acceptance criteria during testing to ensure your formative usability studies are generating meaningful results
- Differentiate between participant feedback that is based on the participant's experience rather than speculation
- Review new and historic regulatory guidelines
- Compare and contrast to U.S. and other markets
- Fine-tune your approach for Chinese regulatory authorities
Generic drug-device combination products (DDCPs) seeking FDA clearance through the Abbreviated New Drug Application (ANDA) pathway must demonstrate user interface design changes do not impact interchangeability of the product with the reference listed drug. Human factors methods for assessment of DDCP interchangeability require use-related-risk based methods capable of tying specific design changes to potential harm. Key takeaways will share how to:
- Manage challenges associated with the comparative use human factors draft guidance for an ANDA submission
- Implement methods for assessing whether design differences qualify as “minor” vs “other”
- Establish elements necessary for an ANDA submission justifying whether (or not) a CUHF study is required
The range of applications and realistic uses for AI within medical devices has made a quantum leap in just the past two years. It has now reached the point where there are far more tools to use than there are data libraries to rely on – so you must take care to avoid “GIGO”.
- Tally the full slate of commercial, free, and open source medical device tools available
- Differentiate between tools that are already robust and those needing further investment
- Persuade teams and management of the risk of finding yourselves at competitive disadvantage
You don’t need to go through an IRB for every single study you do – but for those where it is necessary, it is a relationship you cannot afford to have go sour. Especially with tests involving pediatric users or their caregivers, novel devices will need special approval, and you will have to maintain a positive working relationship all throughout the process.
- Start with a clear vision of whether your device and/or user groups will require IRB approval
- Stay on the same page with your vendors regarding their IRB relationships and involvement thresholds
- Track the level of IRB involvement across different patient age cohorts or investigational drug vs placebo
How can you move beyond collecting data for data’s sake into finding value? Employing the best tools makes data processing and analysis more efficient, and generates new insights you can leverage for everything from requirement setting to regulatory justifications for design decisions.
- Understand how and when to augment traditional observational techniques
- Discuss fit-for-purpose tools that can improve your study workflow
- Focus on instrumentation and advanced analytics to offload post-processing requirements
With the lengthy amount of critical tasks your validation tests must cover, if users begin performing tasks not assigned or within the workflow they can add extra use errors that force you to provide extra documentation. What are the best ways to monitor and maintain order during trials so users don’t feel like you’re shutting them down?
- Figure out how to moderate accordingly and adjust trials on the fly
- Maintain a “poker face” and avoid seeming judgmental
- Learn to indicate a need for a different approach that can trigger self-correction
Users are embarrassed if they make mistakes – more so if they are medical professionals. HCPs may be generally averse to trying something new and looking like amateurs, especially with an audience watching them. At the same time, the careerist motive and drive to be seen as an innovator can be useful for recruiting and motivating them.
- Accept and work around the reality of HCP user egos
- Give HCP users a more positive mental image than one involving error or failure
- Highlight opportunities to be among the first to ever use a particular approach
Even if advances in medical device design bring better outcomes and overall improved quality of life, if medical professionals are not willing to accept it, it will become nothing more than a distraction. Revolutionizing engagement also requires understanding and prioritizing the equipping, education, empowerment, and event-based support for patients. What new training and habits of mind do your teams need to accomplish this?
- Build winning strategies for HCPs to adapt their current therapy workflow with integration of new elements
- Grasp the priorities and problems of chronic disease patients whose therapeutic adherence can run up against comorbidities and complications
- Track successes and failures of new device engagement across multiple areas of medicine
