DAY TWO | WEDNESDAY, OCTOBER 23
8:00 REGISTRATION & WELCOME COFFEE
8:25 CHAIRPERSON’S OPENING REMARKS
Cindy McDermott, Vice President, Strategic Development, XIMEDICA
8:30 FIRESIDE CHAT: FDA PERSPECTIVES ON MEDICAL DEVICE HUMAN FACTORS REGULATION
With the mandate of ensuring medical products are safe and effective for use, regardless of the use scenario, the Agency is increasingly focused on human factors and usability testing to validate that new and existing medical products are designed and commercialized in a user friendly, lowrisk manner. Increasingly sophisticated technology including the adoption of robotic aides in surgery, machine learning in imaging equipment and mobile applications which assist in monitoring health all pose new and unique risks which must be assessed and mitigated under the careful eye of the FDA. In an open discussion with Agency staff, participants will have the opportunity to pre-submit questions regarding agency expectations for dossiers, methods for engaging the Agency in meaningful feedback surrounding studies as well as risk assessment of critical tasks, and ensuring FDA feedback is integrated into future study design & protocols.
INTERVIEWER: Eric Claude, MPR ASSOCIATES INC.
Rita Lin, Human Factors Reviewer, FDA
Mary Brooks, Medical Device Reviewer, FDA
9:15 INTEGRATING HUMAN FACTORS WITH DESIGN CONTROLS TO ADDRESS REGULATORY NEEDS AND IMPROVE DEVICE SAFETY
As the need for conducting human factors engineering activities during medical device design and development becomes more widely known, the question of how these activities should be included as part of the overall process remains. Incorporating a human factors engineering focus into existing design controls helps programs properly plan for such work. In addition, it provides crucial visibility to the myriad stakeholders within an organization. Adherence to this process ensures that human factors inputs and evaluations are conducted at the appropriate times, which results in safer and more effective device designs. Beyond improving a product’s design, it helps satisfy regulatory agencies’ requirements for applying human factors engineering during the development of medical devices.
Merrick Kossack, Research Director, EMERGO BY UL
10:00 COFFEE & NETWORKING BREAK
10:30 PANEL DISCUSSION: HUMAN FACTORS AND USER EXPERIENCE FOR INNOVATIVE, DISRUPTIVE TECHNOLOGIES
Current guidelines, best practices and regulatory standards apply to a broad range of existing medical devices, but rapid and constant technological breakthroughs continue to advance the device industry into unknown territory. Unprecedented developments in AI and machine learning, robotic surgical tools and systems, and nanotechnology continue to redefine the limits and functions of human factors in medical devices, and vigilant forecasting of trends will prepare human factors teams to utilize the full breadth of future innovations.
Annie Lutz, IMPROVITA
Elaine McCann, GE HEALTHCARE
Aadel Al-Jadda, AURIS HEALTH, INC.
Jerome Canady, US MEDICAL INNOVATIONS, LLC
11:15 RECRUITING AGAINST THE ODDS: EFFECTIVELY SOURCING PARTICIPANTS FROM DIFFICULT DEMOGRAPHICS
Some recruits can be found by utilizing a typical market research recruiter database, but there are a plethora of instances when this search method fails to yield the target enrollment goals. With the rise in orphan drugs, personalized medicine, and the consumerization of medical devices, the need to recruit participants from specific, rare, and difficult-to-access demographics is set to become even more commonplace. By employing creative strategies that include leveraging social media to supplement traditional recruiting methods and working alongside hospitals and patient advocacy groups, human factors professionals can vastly improve the outcomes of recruiting hard-to-find participants.
- Drawing from first-hand experiences in challenging recruiting scenarios
- Formative Evaluation and Risk Analysis results as rationales for merging groups
- Identifying group size and quantity requirements for Formative Studies
- Preserving patient population numbers before reaching a Summative Study
Talia Serrecchia, Human Research & Regulatory Affairs Lead, XIMEDICA
12:00 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS
1:00 ALIGNMENT OF HUMAN FACTORS TESTING WITH IEC-62366 TO ANALYZE, SPECIFY, DEVELOP & EVALUATE USABILITY
As medical device human factors and usability testing becomes increasingly relevant on a global scale, executives look to international standards harmonized with FDA regulation for a comprehensive guide to ensuring tests meet the needs of various regulators. Long considered the gold standard in Europe, IEC 62336-1: 2015 provides guidance on evaluating use risk in correct and normal uses and when applied, and aligns with FDA guidance to ensure robust regulatory compliance.
- Utilizing FDA guidance to interpret IEC 62366-1
- Practical implementation of 62366-1 in usability tests
- Focus on User Interfaces of Unknown Provenance
- Insights into the application of IEC 62366-2
Daniel Mabini, Usability Lead, GE HEALTHCARE
1:45 TAILORING USABILITY FOR PATIENTS IN HOME ENVIRONMENTS
Patients and caregivers utilize a diversity of medical devices outside of medical contexts to manage personal health outcomes. The design of medical devices to be used by patients and caregivers in the home is significantly different than designing a product for use by doctors and nurses in clinical environments. Patients and caregivers often possess different mental processes, levels of health literacy, and physical capabilities than clinicians; these differences must be fully understood and accounted for when designing systems for home users. A user-centered design process can mitigate risk and ensure device effectiveness, all while maximizing ease of use.
- Understanding the mental processes of users
- Fully designing the whole solution
- Unboxing process
- Clear and intuitive IFU
- Sound and sensory cues
- Creating design principles that guide decision making
- Anticipating situational stress and reducing patient anxiety
Stephen Nelson, Principal Scientist, User Experience & Human Factors Design, MEDTRONIC
Yoko Sen, Founder, SEN SOUND
2:30 COFFEE & NETWORKING BREAK
2:45 INTERNATIONAL SPOTLIGHT: ENHANCED USABILITY & RISK MITIGATION REQUIREMENTS IN THE EU MDR
Building on the Medical Device Directive (MDD) of 2010, the Medical Device Regulation (2017) which comes into effect in May 2020 increases the focus on risk reduction and patient safety, requiring greater testing of usability in the intended user environment and with a particular focus on user knowledge and training. While the regulation goes into great detail surrounding types of users which must be considered, many manufacturers are concerned with nebulous user group thresholds as well as documentation considered sufficient.
- Notified body interpretation of usability
- Reduce risks related to ergonomic factors
- Environment in which device is intended
- Technical knowledge of users & environment
Renee Walker, Lead Auditor, Medical Health Services, TÜV SÜD AMERICA
3:30 MASTERCLASS: EFFECTIVE MEASUREMENT OF USABILITY IN DEVICE HUMAN FACTORS TESTING
Utilizing an advanced blend of heuristics and research methods, human factors executives are able to gather insightful measures into device use, providing data to support usability as well as feedback on potential design changes to propel future product iteration. Comprehensive measurement of test subjects includes a range of markers, including success vs. failure rates, volume of errors, and time spent on tasks, as well as monitoring of physiological signs indicating cognitive pressure faced by test subjects. In addition to metrics used during usability studies, effective human factors and usability executives will also integrate post-study discussion, gaining even deeper insights into the cognition and perception of test subjects.
Corbin Clawson, Director of Engineering, LONGEVITI NEURO SOLUTIONS
4:15 CLOSING REMARKS AND CONFERENCE CONCLUSION