Event Sponsors
Featured Speakers
Aditya Jagannathan
former Clinical & Human Factors Program Leader
BD
Ajit D’Souza
Director, Combination Product Development and Manufacturing
KINIKSA
Alexis Chernosky
Senior Scientist
ALCON
Carli Bartnik
Human Factors Engineer II
MEDTRONIC
Ed Israelski
Technical Advisor, Human Factors
ABBVIE
Evan Edwards
Co-Founder and Executive Advisor
KALEO
Hanniebey Wiyor
Human Factors Regulatory Reviewer, CDRH
FDA (Pending Approval)
Jonathan Amaya-Hodges
Associate Director, Regulatory Affairs CMC, Combination Products and Medical Devices
BIOGEN
Joseph Purpura
Associate Vice President, Medical Device Safety
ALLERGAN
Khaudeja Bano
Executive Medical Director, Head of Combination Product Safety
AMGEN
Mary Pat Cottengim
Principal Usability Engineer, Medical Devices
BAUSCH & LOMB
Omar Vakharia
Director, Human Factors, User Experience Design
BD
Tiffany McIntire
Senior Human Factors Engineer
ROCHE
Valerie Schiebel
Senior Human Factors Design Engineer
MEDTRONIC
Event Schedule
ALL TIMES ARE IN EST
The amount of training decay allowed in your study should be representative of what a user would experience in the real world. But with complex devices or users who travel long distances for training, they may not interact with the device for days or even weeks afterwards. How can you simulate prolonged delays, and how rigorous is your rationale for the amount of training decay you select?
- Gain ground in simulating overnight training decay
- Uncover regulatory preferences during presubmission interactions
- Balance realism with the logistical needs of usability studies
Whereas graphical user interfaces and vision-oriented products are easily tested remotely, other device aspects are far more challenging. New approaches in augmented reality, virtual reality, and puppet testing can all be achieved in the short term and can bridge COVID’s gaps.
- Review data collection through virtual reality and other new methods
- Establish a visual brand language that fits with product iconography and workflow
- Fuse the expertise of research groups and designers
FDA favors use-related risk analysis, which has key differences from traditional FMEA methods. In particular, FDA does not accept probability estimates of risk – yet at the same time, their guidance directs you to reduce the likelihood of use error. It will be more worthwhile for your engineering teams to include all critical tasks and high severity tasks, not just their probability, but making that change in presentation will require careful forethought.
- Review the usefulness of fault trees and sensitivity analysis
- Lead your engineering colleagues into a new understanding of measuring risk
- Deal with new risk constraints in the way FDA prefers
International notifying bodies may not want the same thing as FDA; how can you create similar documentation designed to support different submission deliverables by region? It may be possible to find the right balance when creating a single set of deliverables supporting filings in both US, EU, and elsewhere, but there are significant opportunities for errors.
- Analyze real use cases for streamlined usability final documentation
- Weigh whether reports must be compartmentalized according to region
- Understand the pros and cons of both approaches
Home-use devices pose a variety of challenges to users, from adhesive issues to lighting issues to understanding IFUs. Many at-home users represent vulnerable patient populations dealing with severe or chronic health challenges, and in those cases the safety features associated with hospital or clinic use will necessarily be absent. How can you best compensate for this?
- Account for the patient monitoring and emergency signals that are lost in home-use settings
- Ensure design teams grasp the vulnerability of patients using at-home devices related to chemotherapy, severe mobility challenges, and other challenges
- Build in alternatives to a site-based safety net to improve your device’s safety profile
If your device has critical attributes that risk causing serious injury if used improperly at the point of care, you must ramp up your level of testing to validate design outputs. The degree of realism you aim for will have a tremendous influence on testing costs – how can you determine which details are essential to keep?
- Learn from simulation techniques used in other sectors such as energy, military, and aviation
- Evaluate the pros and cons of renting vs recreating surgical theaters
- Control costs by limiting the expansiveness of your scenario and the biological features of surgical mannequins
Across the digital landscape, cloud connectivity, and surgical robotics, subsystems performing different task across different products must be able to accurately assess risk. What are the best use-related risk analyses for large systems design, and how can they be best set up to communicate risk across different methods of documentation?
- Visualize systems for products that have multiple user touchpoints across discrete subsystem components
- Deploy use-related risk analysis to track how breakdowns in one system will effect another
- Recognize the reality of working across companies
- Trace convoluted error pathways across multiple linkages
ALL TIMES ARE IN EST
Wearable device design can be particularly challenging, as you need to strike a delicate balance on the strength of the adhesive patch and the size that a patient can tolerate. Making the best approach from a patient perspective requires quickly and coherently reaching consensus among HF engineers, process engineers, design engineers, and other stakeholders.
- Understand the constraints facing all of your design team members
- Differentiate between UI challenges and physical device durability and access challenges
- Explore team-based approaches to improved software usability
Building a usability study around information and preferences from KOLs can be misleading, as it may not reflect the practices of the majority of field medical staff. By acknowledging that each user group is distinct, you can better set your teams up for success.
- Understand what internal stakeholders are hoping to gain
- Map out the most efficient ways to design the key tasks in your studies
- Clarify when you need specialized technical experts and when you don’t
There has been a recent surge in new trainees focusing on UX design – but while this can be quite useful at targeting customer emotions and purchasing preference, it may also hinder a traditional usability testing effort. The skills to mitigate user risk do not perfectly overlap with what your marketing colleagues prefer. Who gets the project manager’s ear, and where is the money more likely to be spent?
- Acknowledge the generational shift newly prioritizing UX as a desired job skill
- Remain focused on legal obligations even as the traditional usability expertise pool shrinks
- Weigh the best approach to balance safety and ease-of-use
Despite growing overall awareness of the importance of applying human factors to medical device and combination product design, there are still internal challenges regarding management acceptance. Engineering and HF teams struggle to convince management to invest earlier in the development process or to spend the extra time and money to complete another design validation study. This discussion provides insights and recommendations on how to overcome these hurdles and become an internal champion at your company.
- Discuss the challenges HF and engineering teams face when presenting to management
- Recognize why management struggles to make HFE and UE a priority
- Review key reasons for investing in HFE and UE outside of just design controls
- Provide recommendations and resources to support in effecting change internally
Your device design team covers multiple backgrounds, and it can be a challenge to guide diverse viewpoints into a common solution that meets HF requirements and creates a pleasant user experience. Managing and focusing the input from so many disciplines requires a careful, diplomatic approach.
- Review leadership techniques that help in uncovering mistakes while avoiding blame
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Refocus the input from engineering, marketing, and clinical research colleagues to emphasize HF outcomes
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Build a close rapport with your lead engineers and clinical specialists
At-home delivery devices, such as on-body injectors, should help people take control of their healthcare and thus need to prioritize ease and comfort. This can prove to be challenging if the therapeutic regimen requires delivering large volumes subcutaneously. How can you achieve both design goals?
- Analyze both the device’s ability to deliver and the human body’s ability to receive large dose volumes subcutaneously
- Focus on the risks of discomfort, pain, inflammation or rapid excretion
- Track the steps in successful increases of drug volume
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