Presentation
MDD10 - Expanding the Role of Human Factors in Pharma
DescriptionThe release of the 2011 draft guidance on applying human factors to medical devices prompted many established medical device developers to begin forming previously non-existent internal human factors teams to conduct and facilitate the work required by the Food and Drug Administration (FDA). Over the past decade plus, teams have developed skills and adapted to best industry practices. Although the regulatory landscape continues to change and nuanced regulatory expectations emerge, the scope of human factors work for medical devices and combination products is largely established.
Because human factors engineering is still newer to healthcare than many other disciplines, large companies may misunderstand and/or underutilize the skills of human factors engineers. As skilled human factors professionals can provide value far beyond meeting the regulatory requirements to get products on the market, it behooves industry to consider the broader scale on which these employees can provide value. Though this may not be realistic for startups or smaller device developers, large companies with a subsequently larger scale of varying work, particularly in the pharmaceutical space, have rich opportunities to engage with their human factors teams in different ways to take advantage of their specialized expertise. This may include patient-centered research before devices are incorporated with a drug, assessment of low-risk digital technologies, and even improvement of internal documentation, training materials, and processes.
The human factors team at Genentech, a biotechnology and pharmaceutical company with almost 14 thousand employees in the United States, has undertaken efforts over the past several years to expand our reach across the organization to provide human factors input outside of the traditional regulatory activities. This presentation will discuss how this was achieved and give examples of the impact of these internal collaborations. Examples include the following:
Working with an internal team to redesign a product complaints shipper instructional sheet to help patients properly return malfunctioning devices. A text- and jargon-heavy instructional sheet was modified to a simpler, visually-based double-sided insert.
Conducting heuristic evaluations for vision evaluation tools that included a clinician-facing website and patient-facing app. Based on the results, the team made interface updates to improve visibility and saliency of important information for the target patient population, reduce potential confusion about certain interface functionality, and facilitate correct task completion.
Assessing low-risk devices for implementation in a clinical trial to aid in downselection. Efforts include user testing and heuristic evaluation, and ultimately development of fit-for-purpose instructional and training materials for both clinical staff and clinical trial enrollees.
Examination of the gowning procedure in a drug manufacturing facility to identify process and workflow improvements. Work is ongoing as of this submission.
Building the right connections to do this work, particularly in a large company, can seem overwhelming. However, identifying the right communication channels and demonstrating the value of even simple human factors activities for our patients, users, and internal stakeholders can lead to success. By hearing how one team is striving towards a more holistic approach of incorporating human factors into drug and device development, others may be inspired to seek out similar opportunities to encourage a more user-focused and patient-centric mindset across disciplines.
Because human factors engineering is still newer to healthcare than many other disciplines, large companies may misunderstand and/or underutilize the skills of human factors engineers. As skilled human factors professionals can provide value far beyond meeting the regulatory requirements to get products on the market, it behooves industry to consider the broader scale on which these employees can provide value. Though this may not be realistic for startups or smaller device developers, large companies with a subsequently larger scale of varying work, particularly in the pharmaceutical space, have rich opportunities to engage with their human factors teams in different ways to take advantage of their specialized expertise. This may include patient-centered research before devices are incorporated with a drug, assessment of low-risk digital technologies, and even improvement of internal documentation, training materials, and processes.
The human factors team at Genentech, a biotechnology and pharmaceutical company with almost 14 thousand employees in the United States, has undertaken efforts over the past several years to expand our reach across the organization to provide human factors input outside of the traditional regulatory activities. This presentation will discuss how this was achieved and give examples of the impact of these internal collaborations. Examples include the following:
Working with an internal team to redesign a product complaints shipper instructional sheet to help patients properly return malfunctioning devices. A text- and jargon-heavy instructional sheet was modified to a simpler, visually-based double-sided insert.
Conducting heuristic evaluations for vision evaluation tools that included a clinician-facing website and patient-facing app. Based on the results, the team made interface updates to improve visibility and saliency of important information for the target patient population, reduce potential confusion about certain interface functionality, and facilitate correct task completion.
Assessing low-risk devices for implementation in a clinical trial to aid in downselection. Efforts include user testing and heuristic evaluation, and ultimately development of fit-for-purpose instructional and training materials for both clinical staff and clinical trial enrollees.
Examination of the gowning procedure in a drug manufacturing facility to identify process and workflow improvements. Work is ongoing as of this submission.
Building the right connections to do this work, particularly in a large company, can seem overwhelming. However, identifying the right communication channels and demonstrating the value of even simple human factors activities for our patients, users, and internal stakeholders can lead to success. By hearing how one team is striving towards a more holistic approach of incorporating human factors into drug and device development, others may be inspired to seek out similar opportunities to encourage a more user-focused and patient-centric mindset across disciplines.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives