Usability Validation Testing of Medical Devices and SoftwareUXPA Boston
The U.S. FDA and international regulatory bodies require usability testing of medical devices, products, software, and systems as part of their overall validation. Manufacturers must demonstrate that all potential use-related hazards have been identified, prioritized, and mitigated. The method for demonstrating this is human factors/usability engineering (HF/UE) validation testing. However, the way we conduct these studies is in many ways different from the way we conduct studies of non-medical products and systems.
This topic is relevant to the Boston UX community given the convergence of consumer and medical devices, as well as the rise of wearable technologies and the apps that interact with them. This presentation will cover the key aspects of HF/UE validation (a.k.a. ‘summative’) testing and what the FDA expects in the final HF/UE summary report.
Importantly, this session will consist of half presentation and half Q&A, with the audience driving the discussion toward current issues, questions, and challenges that are relevant to them.
FDA Guidance on EFS: The Device Evaluation Strategy ChallengesTrimed Media Group
WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.
7 Components to Medical Device Usability Testing SuccessMargee Moore
Despite the publication of various relevant guidance on medical device usability testing and standards for human factors testing confusion regarding best practices still exists. This presentation provides clear language and seven components for planning successful usability testing for medical device development.
The FDA Early Feasibility Study Pilot and the Innovation PathwayTrimed Media Group
WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.
Best Practices for Preparing and Conducting Pre-Submission MeetingsGreenlight Guru
This presentation covers everything you need to know about Q-Subs, how to create the best packet possible, common pitfalls, strategies for conducting pre sub meetings, and observed differences between divisions.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
How to Prepare for and Make the Most Out of your FDA Pre-Submission: Leverage...Greenlight Guru
The FDA Pre-Submission process is one the most effective tools out there to de-risk your 510(k) yet it is often both under-utilized and used improperly.
The Pre-Sub allows for device manufacture to discuss and get feedback directly from FDA on both their product development and regulatory strategy.
When used properly the Pre-Sub process can result in significant time savings to market - however when used improperly or ignored all together, this can easily result in unnecessary delays and wasted money.
This presentation covers:
- What is a Pre-Sub and why it is so important
- How to prepare and get the most out of your Pre-Sub
- The exact Pre-Sub timeline of events
- An example of the contents to include and how to format your Pre-Sub
- What you should do after your Pre-Sub
- A step-by-step case study example of the Pre-Sub process
Watch the presentation with commentary here: https://www.greenlight.guru/webinar/fda-pre-submission-process
Usability Validation Testing of Medical Devices and SoftwareUXPA Boston
The U.S. FDA and international regulatory bodies require usability testing of medical devices, products, software, and systems as part of their overall validation. Manufacturers must demonstrate that all potential use-related hazards have been identified, prioritized, and mitigated. The method for demonstrating this is human factors/usability engineering (HF/UE) validation testing. However, the way we conduct these studies is in many ways different from the way we conduct studies of non-medical products and systems.
This topic is relevant to the Boston UX community given the convergence of consumer and medical devices, as well as the rise of wearable technologies and the apps that interact with them. This presentation will cover the key aspects of HF/UE validation (a.k.a. ‘summative’) testing and what the FDA expects in the final HF/UE summary report.
Importantly, this session will consist of half presentation and half Q&A, with the audience driving the discussion toward current issues, questions, and challenges that are relevant to them.
FDA Guidance on EFS: The Device Evaluation Strategy ChallengesTrimed Media Group
WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.
7 Components to Medical Device Usability Testing SuccessMargee Moore
Despite the publication of various relevant guidance on medical device usability testing and standards for human factors testing confusion regarding best practices still exists. This presentation provides clear language and seven components for planning successful usability testing for medical device development.
The FDA Early Feasibility Study Pilot and the Innovation PathwayTrimed Media Group
WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.
Best Practices for Preparing and Conducting Pre-Submission MeetingsGreenlight Guru
This presentation covers everything you need to know about Q-Subs, how to create the best packet possible, common pitfalls, strategies for conducting pre sub meetings, and observed differences between divisions.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
How to Prepare for and Make the Most Out of your FDA Pre-Submission: Leverage...Greenlight Guru
The FDA Pre-Submission process is one the most effective tools out there to de-risk your 510(k) yet it is often both under-utilized and used improperly.
The Pre-Sub allows for device manufacture to discuss and get feedback directly from FDA on both their product development and regulatory strategy.
When used properly the Pre-Sub process can result in significant time savings to market - however when used improperly or ignored all together, this can easily result in unnecessary delays and wasted money.
This presentation covers:
- What is a Pre-Sub and why it is so important
- How to prepare and get the most out of your Pre-Sub
- The exact Pre-Sub timeline of events
- An example of the contents to include and how to format your Pre-Sub
- What you should do after your Pre-Sub
- A step-by-step case study example of the Pre-Sub process
Watch the presentation with commentary here: https://www.greenlight.guru/webinar/fda-pre-submission-process
User Interface Design for Medical Devices - The Relationship Between Usabilit...UXPA Boston
User Interface Design for Medical Devices - The Relationship Between Usability and Safety
Rich Newman's presentation from the UXPA Boston 2016 conference
FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...Greenlight Guru
One of the newest biocompatibility evaluation tools is extractable and leachable (E&L) testing. A correctly run E&L study, with an accompanying toxicological evaluation, can be used to replace traditional tests like systemic toxicity, genotoxicity, reproductive toxicity, and carcinogenicity. The data gained from these studies can help understand the total risk of your device to an intended population of users; but unlike the traditional animal tests, it comes with separate risks. These tests are not your typical “stamped” tests, where every lab gives a similar quality of results. Because of this, FDA has refined a strict, detailed, list of parameters that should be included in every test. This list is very dynamic and is changing rapidly; the best way to make sure you are performing the correct version of the test is to learn from the most recent FDA feedback on studies.
TAKEAWAY ITEMS:
• Understand recent FDA feedback and dissect what FDA is asking/looking for
• Learn how to address these concerns and develop a protocol to make sure you don’t receive similar questions
• Recognize how FDA is using the new ISO 10993-18 and where they deviate from that standard
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Regulatory Challenges to Successful Global Clinical StudiesMichael Swit
A review of key issues that can make or break the success of a clinical study conducted outside the United States, with an emphasis on site, GCP issues, challenges that vary nationally, and enforcement concerns.
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca MosesLevi Shapiro
Presentation by Rebecca Moses, Human Factors for MedTech Ergonomics and Usability, for the mHealth Israel community: Human Factors for MedTech Ergonomics and Usability
Extraordinary design considerations e bacon 2011 08-05Elizabeth Bacon
This presentation was delivered at Device Design Day 2011 by Elizabeth Bacon of Devise. The talk was recorded, so if you're interested in seeing that please contact liz(dot)devise(at)gmail(dot)com for a link.
Anthony Presentation at DIA Chicago Oct 2008AKTaylor
The requirements of the clinical trial databases provision in the FDA
Amendments Act apply to academic and independent investigators
as well as to industry conducted clinical trials. This session will
highlight the challenges faced by academic and independent investigators
and best practices in registering clinical trials and establishing
procedures for reporting study results to ClinicalTrials.gov.
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
User Interface Design for Medical Devices - The Relationship Between Usabilit...UXPA Boston
User Interface Design for Medical Devices - The Relationship Between Usability and Safety
Rich Newman's presentation from the UXPA Boston 2016 conference
FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...Greenlight Guru
One of the newest biocompatibility evaluation tools is extractable and leachable (E&L) testing. A correctly run E&L study, with an accompanying toxicological evaluation, can be used to replace traditional tests like systemic toxicity, genotoxicity, reproductive toxicity, and carcinogenicity. The data gained from these studies can help understand the total risk of your device to an intended population of users; but unlike the traditional animal tests, it comes with separate risks. These tests are not your typical “stamped” tests, where every lab gives a similar quality of results. Because of this, FDA has refined a strict, detailed, list of parameters that should be included in every test. This list is very dynamic and is changing rapidly; the best way to make sure you are performing the correct version of the test is to learn from the most recent FDA feedback on studies.
TAKEAWAY ITEMS:
• Understand recent FDA feedback and dissect what FDA is asking/looking for
• Learn how to address these concerns and develop a protocol to make sure you don’t receive similar questions
• Recognize how FDA is using the new ISO 10993-18 and where they deviate from that standard
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Regulatory Challenges to Successful Global Clinical StudiesMichael Swit
A review of key issues that can make or break the success of a clinical study conducted outside the United States, with an emphasis on site, GCP issues, challenges that vary nationally, and enforcement concerns.
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca MosesLevi Shapiro
Presentation by Rebecca Moses, Human Factors for MedTech Ergonomics and Usability, for the mHealth Israel community: Human Factors for MedTech Ergonomics and Usability
Extraordinary design considerations e bacon 2011 08-05Elizabeth Bacon
This presentation was delivered at Device Design Day 2011 by Elizabeth Bacon of Devise. The talk was recorded, so if you're interested in seeing that please contact liz(dot)devise(at)gmail(dot)com for a link.
Anthony Presentation at DIA Chicago Oct 2008AKTaylor
The requirements of the clinical trial databases provision in the FDA
Amendments Act apply to academic and independent investigators
as well as to industry conducted clinical trials. This session will
highlight the challenges faced by academic and independent investigators
and best practices in registering clinical trials and establishing
procedures for reporting study results to ClinicalTrials.gov.
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Designing an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy CuevaMad*Pow
At the Health 2.0 Fall conference, Mad*Pow's Co-Founder and CXO, Amy Cueva shared her insights on Designing an Ecosystem of care, addressing unmet needs in healthcare.
Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...Mad*Pow
SVP - Creative Director, Buck Beaudoin; Chief Design Officer, Michael Hawley; and Chief Creative Officer, Will Powley share their secrets on how Mad*Pow has succesfully built a unique company culture which inspires employee creativity.
Check out the Webinar: http://vimeo.com/46813861
Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...Mad*Pow
The map, the diagram and the timeline are an integral part of our interactive design vocabulary. As we confront our next User Experience and Interactive Design assignments, where can we turn for inspiration? What are the information design principles and techniques that great maps and diagrams share? Where did these principles come from? Experience Design Director, Paul Kahn tells all!
Check out the full presentation on Vimeo: bit.ly/OjVsgG
In this talk, Susan discusses several techniques that she has used to evaluate the usefulness and desirability of interfaces. The best techniques to evaluate usefulness involve open-ended interview questions regarding current processes and pain points, followed by a usability evaluation of the interface and then a reflective interview discussing the benefits and drawbacks of that solution to their personal situation.
Hands on collaboration has become a dominant approach to designing new solutions whether they be for products, services, environments, etc. But bringing people who have different perspectives of a topic, ways of expressing themselves, and levels of comfort in working together can be tricky. Taking the time to think through why, how, and when to best bring people together and intentionally design your design workshops helps to ensure that at the end of your event you walk away with the information and answers you need.
Working Better Together: Characteristics of Productive, Creative Organization...Mad*Pow
At WebVisions Chicago, Mad*Pow's Experience Design Director, Adam Connor gives a presentation on the common characteristics of productive and creative organizations based on observing a wide variety of organizations and team structures over his career as a designer.
Presentation at the Service Design Global Conference, Paris, Oct. 30, 2012. Service Design in three Mad*Pow UX projects: Aetna, WasteManagement and Healthrageous!
Preference and Desirability Testing: Measuring Emotional Response to Guide De...Paul Doncaster
(From UPA 2011-Atlanta) Usability practitioners have a variety of methods and techniques to inform interaction design and identify usability problems. However, these tools are not as effective at evaluating the visceral and emotional response generated by visual design and aesthetics. This presentation will discuss why studying visual design is important, review considerations for preference and desirability testing and present two alternative approaches to user studies of visual designs in the form of case studies.
R&D Directions Webcast June Final[1]cmowen0206
Review a webcast presentation from experts from Vince and Associates Clinical Research, MidLands IRB, and Kendle for three presentations that delve into various aspects of clinical trial patient recruitment, from the perspectives of two prominent CROs and an AAHRPP-accredited independent review board. The presentations for this webinar are:
Phase I Patient Population Trials: Feasibility, Recruitment and Long-term Confinement
Speaker: Dr. Bradley Vince, D.O., Vince and Associates Clinical Research
Beyond Paper: Using Data-Driven Expertise to Enhance Patient Recruitment
Speaker: Jeffrey M. Zucker, Senior Director and Global Head, Patient Recruitment, Kendle
IRB Considerations in Proof-of-Concept Trials
Speaker: Kathy Chase, Pharm.D., IRB chair, MidLands IRB; Director, Provider Services, Cardinal Health - Pharmacy Solutions
R&D Directions Webcast June Final[1]cmowen0206
Review webcast presentation from MidLands IRB, Vince and Associates Clinical Research, and Kendle for three presentations that delve into various aspects of clinical trial patient recruitment, from the perspectives of two prominent CROs and an AAHRPP-accredited independent review board. The presentations for this webinar are:
IRB Considerations in Proof-of-Concept Trials
Speaker: Kathy Chase, Pharm.D., IRB chair, MidLands IRB; Director, Provider Services, Cardinal Health - Pharmacy Solutions
Phase I Patient Population Trials: Feasibility, Recruitment and Long-term Confinement
Speaker: Dr. Bradley Vince, D.O., Vince and Associates Clinical Research
Beyond Paper: Using Data-Driven Expertise to Enhance Patient Recruitment
Speaker: Jeffrey M. Zucker, Senior Director and Global Head, Patient Recruitment, Kendle
Conducting a Summative Study of EHR Usability: Case StudyUXPA Boston
At least year’s conference, a group of us explored the complexity involved with evaluating the usability of Electronic Health Records: The wide range of user profiles and characteristics, a seemingly infinite number of tasks, and challenges in obtaining realistic data while respecting HIPAA regulations. In December, the Usability team at athenahealth conducted a summative usability study of [product]. In this Case Study, the Kris will discuss how the team navigated the challenges of summative EHR evaluation to conduct this study. Topics include task selection, recruiting, metric selection, logistics, and lessons learned.
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
Elizabeth Mansfield, PhD, discusses the FDA’s approach to regulation
of in vitro diagnostic tests.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
Demystifying the FDA's Human Factors GuidanceGreenlight Guru
In 2016, the FDA finalized its human factors guidance for medical devices.
This guidance document cleared up some of the uncertainty about how manufacturers should implement human factors into their product development process.
However, due to the wide diversity of medical devices manufactured today (auto-injector vs. infusion pump vs. robotic surgical system etc.), manufacturers often struggle to understand how the guidelines apply to their own specific device(s).
This webinar will break down FDA’s human factors guidance into a list of actionable steps.
Specifically, you will learn:
-An understanding of usability testing and its role within the field of human factors
-How to improve overall product design and speed to market by implementing human factors into design controls
-Strategies to pass a human factors validation test on the first attempt
-The importance of including in their human factors strategy all of the tasks impacted by the device use (device setup, instructions for use, cleaning, disposal, etc.)
-The first step a manufacturer should take after receiving a deficiency letter that mentions a lack of human factors
-The future of post-market usability surveillance
Watch the presentation here: https://www.greenlight.guru/webinar/human-factors-fda
Challenges of Summative Usability Testing in a Community Hospital Environment...David Schlossman MD
Findings of a summative scenario based ehr usability testing protocol and challenges of conducting the research in a private practice community hospital environment.
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?CTSI at UCSF
Presentation by Laurie Herraiz, RD, CCRP in May 2012 at CHR sponsored workshop on UCSF Campus. Topics include, basics of regulatory and recruitment, iMedrRIS application instructions, waivers of consent/authorization for recruitment purposes, examples of approved recruitment materials, and common challenges to recruitment.
The Business of Genomic Testing by James CrawfordKnome_Inc
View this webinar at: http://www.knome.com/webinar-business-of-genomic-testing. This presentation discusses the findings of a College of American Pathologists survey of “early adopters” of NGS recently published in "Genetics in Medicine". The study objective was to identify the reasons for health systems to bring next-generation sequencing into their clinical laboratories and to understand the process by which such decisions were made. A standardized open-ended interview was conducted with the laboratory medical directors and/or department of pathology chairs of 13 different academic institutions in 10 different states.
Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...Mad*Pow
Characteristics like race, ethnicity, gender, and disability status can have a significant impact on how we experience the world, and how the world experiences us. In UX research, diversity is the first thing to vanish from the recruit when the going gets tough; Megan will talk about what we miss when that happens, and what researchers can do about it in their own practice. This presentation will demonstrate why a diverse recruit is imperative for a strong user research study, provide examples of what we miss when the recruit is homogeneous, and offering tactics for addressing the issue.
Presented by Megan Campos, Experience Research Director, Mad*Pow
Watch the presentation at https://youtu.be/E41q8Nx67Do
Webinar: Intro to Strategic Foresight & Futures ThinkingMad*Pow
Presented by Mad*Pow Experience Strategist, Liz Possee Corthell.
When the future is uncertain, how can organizations design and innovate boldly but responsibly? Futures thinking is an approach to strategic design that considers what is likely to change and what is likely to stay the same in the future, as a means to be more reflective in strategic planning. Considered by some to be more of an art, and by others to be a science, futures thinking gives us a framework to talk about our current world, and how the world may look in the future.
To quote futurist Dr. Sohail Inayatullah, “With futures thinking, we use the future to change the present. “
In this webinar, you’ll learn that futures thinking is not an effort to predict the future, but rather a means to illuminate unexpected implications of present-day issues that empower individuals and organizations to actively design desirable futures. The emphasis isn’t on what will happen, but on what could happen, given various observed drivers.
It’s a way of gaining new perspectives and context for present-day decisions, as well as for navigating the dilemma at the heart of all strategic thinking: the future can’t be predicted, yet we have to make choices based on what is to come.
This presentation will include a few tools you can start using right away, as well as a few activities to get us thinking about the future.
Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...Mad*Pow
Love it or hate it, people spend most of their lives working. Those working hours include behaviors, tasks, and, interactions that all add up to… experiences… and how well the employee experience is designed can have far reaching impacts on the delivery of products and services to customers. As the world embraces human centered design and focuses more and more on the importance of thoughtfully designed customer experiences, we must not lose sight of the other humans in our experience ecosystem, (not just the ones paying for a product or service). Employee experience is more than just physical environments and HR benefits – it’s about understanding the unique needs of people who mediate the experiences of others, whether through direct interaction with customers or behind the scenes roles with downstream effects. Thankfully, the very tools that help us design and deliver exceptional experiences for customers also help us understand and support the employees within an organization.
Join this webinar to learn more about service design, and how grounding your customer engagement strategies in service design methods can provide uniquely powerful aids to improve employee experience– retaining talent, scaling operational efficiencies, and ultimately empowering your employees to deliver better customer experiences in turn.
Presented by Jen Briselli, Mad*Pow SVP Experience Strategy & Service Design
Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...Mad*Pow
We live in an age where most of the pressing health issues we face as a society can be linked directly or indirectly to underlying social and behavioral determinants. These two issues present not only significant challenges to healthcare providers but also to payers seeking cost-effective ways to manage population health and provide value. Supporting people in living healthier lifestyles is, therefore, a fundamental concern for both affected and at-risk populations as well as for healthcare payers, providers, caregivers, and governments.
But how do we best support people in adopting and sustaining health promoting and protective behaviors, and reducing or avoiding health-risk behaviors over the course of a lifetime? The answer, lies of course, in the ever-maturing science of behavior change. The past decade has materialized a renaissance of theory-and-evidence-to-practice approaches that focus not only on identifying ‘what works’ when it comes changing behavior for a given problem, population, and context but also on how these techniques can be used to deploy interventions through any channel to change behavior and achieve meaningful outcomes.
This webinar will present an overview of the essential components of modern, applied behavioral science, and a process model for the design, implementation, and evaluation of effective behavior change interventions.
Communication Strategies to Keep Employees Engaged and Informed During a Chronic Crisis
View the webinar here: https://youtu.be/2frLDn5C_zs
As the new normal continues to evolve, companies are being challenged daily to keep employees engaged and informed while supporting their business operations. Throughout the pandemic, employees have demonstrated their adaptability in the face of remote working, unanticipated childcare needs, furloughs, and isolation. Many employers are realizing that effective employee communication is the key.
Join Mad*Pow Founder and Chief Experience Officer Amy Heymans and Beth Clauss, President, Small Potatoes Communications, to learn how they have helped clients engage their employees, strengthen their company culture and create a unified and informed employee community. The webinar will cover how organizations can create an employee communications strategy that helps employees weather the unique circumstances of a long-term, ongoing crisis, while navigating the treacherous waters of promoting productivity and profits during a pandemic.
Design More Innovative Solutions with a Holistic Understanding of the Chronic...Mad*Pow
Hosted by Jen Briselli, SVP of Experience Strategy and Service Design, Mad*Pow and Priyama Barua, Director of Experience Strategy, Mad*Pow.
Through years of work across the health care ecosystem, Mad*Pow has developed The Chronic Health Experience Map. This artifact represents a human-centered architecture of the health ecosystem for someone managing a chronic condition. It illustrates common health related events so designers and innovators can build empathy for the health seeker’s experiences at different points on their journey and design more meaningful solutions that build value and improve health outcomes.
In this Webinar, the co-creators of this map will share insights from the research that led to this map’s creation, and discuss examples of how they’ve successfully used it in work with healthcare clients, along with tips and tricks for using it in your own organization.
The map is free to download at https://bit.ly/3gta94n. Print it, or paste the downloaded file into a Mural or Miro board to facilitate remote collaboration during an ideation session.
Accessibility for Design & Content hosted by VP, Content Strategy, Marli Mesibov & Director, Experience Design, James Christie
Mad*Pow is offering a two hour accessibility workshop for people who design digital products and services. Through a mix of presentations and participatory activities attendees will learn and practice the skills needed to ensure digital sites and services meet the needs of a real-world diverse audience.
Design and content teams have nearly universally embraced user experience, which is wonderful news for their audiences! Unfortunately, too many still lack the knowledge or ability to create accessible, inclusive designs. That means the final experiences are great for some people, but not all.
Standards and guidelines exist, but they can be complicated and long winded. Join us to move past the legalese. You will participate in activities that give you tools to improve your UX work.
This workshop is valuable for any UX designer, content strategist, product manager, or anyone else with an impact on design decision making.
By the end of the workshop, participants will
Understand the various levels of accessibility
Gain a working knowledge of the legal and regulatory frameworks that define and enforce digital accessibility
Practice how to identify and categorize accessibility problems — so you can fix them
Plan and prepare accessible design and content, before it gets to your users.
FXD attendees kicked off their experience at a half-day Leadership Forum, 12:30pm -4:30pm on October 24, 2019. This forum was comprised of a diverse, creative, thoughtful group of thinkers and leaders from across the financial ecosystem and they were engaged an intimate and inspiring conversation.
During the forum, Mad*Pow’s Chief Design Officer, Michael Hawley hosted structured networking and workshop-type activities designed to identify and answer key challenges of the financial services industry. By coming together in structured dialog and sharing ideas from a leadership perspective, attendees created opportunities to learn from each other and help us lead our organizations to deliver better experiences. The forum was rich with opportunities for attendees to grow their networks and build new relationships with other leaders in finance.
Specific topics for discussions were driven by the participants in the forum, so they were as relevant as possible. The structure of the event will allowed us to build toward collective insight and inspiration:
“Meet Your Peers” – Facilitated networking and identification of challenges to designing to great experiences in finance
“Solving Challenges” - Idea sharing and relevant experiences, process, and organizational approaches to key challenges
“Imagining the Future” – Learning and finding inspiration from others by collaboratively constructing stories and future experience ideas.
Engaging with People Through Multiple Touchpoints, Channels, and Technologies.
New technologies, device types, and evolving patient expectations place a large burden on service offerings from health organizations. New technologies can be disruptive, but they can also be disrupting, especially if organizations don’t have a strategy on how to deal with the evolving landscape. Virtual reality pain management? Passive low-band telemetry data? Health monitoring? We will discuss approaches that health organizations can take to manage the ever evolving technology landscape and shifting patient dynamic from hospital care to home care.
Facilitator: Jonathan Podolsky, VP Experience Strategy, Mad*Pow
Human-Centered Design and Innovation in Health Organizations.
There is increasing acknowledgement and movement toward human-centered design and design thinking for innovation, service design, and product development. However, evolving and transforming toward these practices in well-established and highly regulated health organizations is a challenge. Organizations have explored Innovation Centers, re-organizing around products and service lines, aligning with functional domains, and expanding design thinking through training. Attendees will share their experiences as we collectively look at how health organizations can evolve to get the most impact from their design transformation efforts.
Facilitator: Adam Connor, VP Design Transformation, Mad*Pow.
Designing for Health Behavior Change.
Beyond use of digital tools and services, health organizations are increasingly considering how they can help people make positive change in their lives. Additionally, there are potential business benefits to changing behaviors to align with the organization's objectives. But designing for behavior change is challenging and has long-term outcome goals that may not be aligned with short-term business incentives for health organizations. Issues of trust and ethics also come into play. With these complex factors in mind, this discussion will explore the strategic options for health organizations to consider related to changing behavior.
Facilitator: Dr. Amy Bucher, Behavior Change Design Director, Mad*Pow.
Aline Holzwarth is an applied behavioral scientist, primarily focusing on digital health research and scientifically informed product design. She is Head of Behavioral Science at Pattern Health, a healthcare technology company that makes it easy to create personalized care plans (patterns) for patients, leveraging behavioral science to help patients stick to these patterns. She also co-founded the Behavior Shop, a behavioral science advisory company, and holds an appointment as Principal of the Center for Advanced Hindsight at Duke University, an applied behavioral science lab that helps people be happier, healthier and wealthier, at home and abroad.
Vanessa is the research director for IFTF's Future 50 Partnership, a network of future-smart organizations that support strategic foresight research into the urgent futures that will shape the next decade across the business, social and civic spheres. Her research and foresight work delivers and scales real-world impact with a focus on health and healthcare, equity and technology.
Prior to Institute for the Future, Vanessa worked in a variety of roles at the intersection of inclusive design, innovation and health, advancing product and business strategy for technology that advances health equity and programs and strategies that foster entrepreneurship among underrepresented populations.
She is a frequent speaker and has been recognized as a 2018 Aspen Ideas Festival Spotlight Health Scholar, 40 Under 40 Tech Diversity Silicon Valley, 2016 New Leaders Council San Francisco Fellow, 200 Black Women in Tech to Follow on Twitter and as a 2016 TEDMED Research Scholar. Vanessa earned her BA in psychology from Yale University and her MPH in global health from Columbia University
Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...Mad*Pow
How Kaiser Permanente is using human centered design to help members understand and improve their emotional health
In this session you will learn:
One
We will share key insights from our journey to stand up an ecosystem for emotional health and wellness with digital therapeutics in multiple care settings and ‘self-serve’ access to these tools and resources on our patient facing portal.
Two
We will also share our learnings on the application of human centered design to mental health, our preliminary data and insights on the development of a digital therapeutic formulary for emotional health and wellness and key takeaways we have so far on what it takes to integrate these tools across clinical pathways.
Three
Understand how human centered methods map to health literacy
You could be a professional graphic designer and still make mistakes. There is always the possibility of human error. On the other hand if you’re not a designer, the chances of making some common graphic design mistakes are even higher. Because you don’t know what you don’t know. That’s where this blog comes in. To make your job easier and help you create better designs, we have put together a list of common graphic design mistakes that you need to avoid.
Transforming Brand Perception and Boosting Profitabilityaaryangarg12
In today's digital era, the dynamics of brand perception, consumer behavior, and profitability have been profoundly reshaped by the synergy of branding, social media, and website design. This research paper investigates the transformative power of these elements in influencing how individuals perceive brands and products and how this transformation can be harnessed to drive sales and profitability for businesses.
Through an exploration of brand psychology and consumer behavior, this study sheds light on the intricate ways in which effective branding strategies, strategic social media engagement, and user-centric website design contribute to altering consumers' perceptions. We delve into the principles that underlie successful brand transformations, examining how visual identity, messaging, and storytelling can captivate and resonate with target audiences.
Methodologically, this research employs a comprehensive approach, combining qualitative and quantitative analyses. Real-world case studies illustrate the impact of branding, social media campaigns, and website redesigns on consumer perception, sales figures, and profitability. We assess the various metrics, including brand awareness, customer engagement, conversion rates, and revenue growth, to measure the effectiveness of these strategies.
The results underscore the pivotal role of cohesive branding, social media influence, and website usability in shaping positive brand perceptions, influencing consumer decisions, and ultimately bolstering sales and profitability. This paper provides actionable insights and strategic recommendations for businesses seeking to leverage branding, social media, and website design as potent tools to enhance their market position and financial success.
Expert Accessory Dwelling Unit (ADU) Drafting ServicesResDraft
Whether you’re looking to create a guest house, a rental unit, or a private retreat, our experienced team will design a space that complements your existing home and maximizes your investment. We provide personalized, comprehensive expert accessory dwelling unit (ADU)drafting solutions tailored to your needs, ensuring a seamless process from concept to completion.
White wonder, Work developed by Eva TschoppMansi Shah
White Wonder by Eva Tschopp
A tale about our culture around the use of fertilizers and pesticides visiting small farms around Ahmedabad in Matar and Shilaj.
Usability Testing Medical Devices - UPA International 2012.-Chris Hass and Dan Berlin
1. UPA 2012
Usability Testing Medical Devices Las Vegas, NV
Dan Berlin Chris Hass
Experience Research Director SVP of Experience Design
@banderlin @chrishass
dberlin@madpow.net chass@madpow.net
2. Usability activities are NOT clinical Trials
Generally the process will be less stringent:
• More loosely defined, faster
• Will likely involve a relatively small number of people per activity
• Initial studies stress simulation, with no medicinal agents or clinical
impact.
• Dovetail with interaction design, visual design, and marketing activities
Usability
Tes,ng
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Devices
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3. It’s going to feel like a clinical trial
• Extremely detailed “Usability Specification” documents
• “Usability Validation” (Risk assessment and amelioration)
• “Usability engineering file” / “Design Efficiency File”
• Know Federal and International regulations:
• FDA Quality System Regulation
• HE: 75 2009
• ISO/IEC 62366:2007
• Knowledge of (and inspiration for)
emerging standards
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Devices
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4. Medical Device Manufacturers may be unfamiliar
with your practices and lack of regulations
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Devices
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5. Safeguarding participants may be more challenging
• Your safety protocols must be exacting, fully defined,
piloted, and effective
• Even simulated product use may put participants at risk
• Target audiences may be physically or cognitively
vulnerable
• Activity environments may be unusual
• Work with client and medical care specialists
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Devices
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6. Reporting responsibilities, guidelines, formats, and
requirements will be more complex
• Reporting guidelines, formats, and requirements will likely
be extensive and complex
• Industry reporting standards (CIF)
• Specialized reporting formats
• Raw data may be reviewed again and again and again. . .
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Tes,ng
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Devices
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7. Research locales may be more challenging
Device use environments may be:
• Unfamiliar
• Sterile
• Stressful
• Germ-laden
• Emotionally distressing
• Gross
• Secure
• Rarely observable
• Complex
• or otherwise unusual to non-medical personnel
• (And fainting can be a factor!)
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8. Client Relationship
Source: http://robot6.comicbookresources.com/2010/07/take-a-look-at-the-avengers-assemble-painting-by-alex-ross/
• A robust set of client team members is essential –
as is knowing their roles:
– Legal
– Medical advisor
– Safety advisor
– Compliance
– Adverse Event Specialist
– Physician is helpful, but not enough
– The usual suspects
• Clients may ask for proof of insurance
– But too much insurance could be a bad thing
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9. FDA Relationship
Source: http://news.petpardons.com/fda-denies-rumors-over-
possible-discovery-of-chicken-jerky-toxin/
• If the study is for FDA approval – learn about
the client’s relationship with the FDA:
– What are the relevant regulations?
– Who is the client’s liaison to the FDA?
– What is the client’s relationship with the FDA?
– Has the client met with the FDA?
– Have they received comments from the FDA?
– Does the client understand usability testing?
– Are we allowed to talk to the FDA?
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10. Working with an IRB
• IRB = Institutional Review Board Source: http://www.bioedge.org/index.php/bioethics/bioethics_article/
who_is_watching_the_irb_watchdogs_asks_nature
• For FDA approval, typically work with an independent IRB
• Their job: to ensure that research conducted on human subjects is carried
out correctly and humanely
• Not as scary as you may think
– We are NOT evaluating medical efficacy or safety
– But we DO have to be conscientious
• Have your ducks in a row and it will be a smooth process
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11. Working with an IRB
• Adds about $2000-$5000 to the cost of the study
Source: http://www.bioedge.org/index.php/bioethics/bioethics_article/
who_is_watching_the_irb_watchdogs_asks_nature
• Adds a day or two to the project for dealing with
the IRB
• Be cognizant of any non-disclosure agreements
• Prior to the study, signature pages should be
signed-off, circulated, and returned in a timely
manner
• Everyone on the team will take this very
seriously!
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12. IRB Documents - Forms
Source: http://blog.pennysaverusa.com/tag/tax-tips/
• Indemnification Agreement: So the IRB doesn’t get sued
• Financial Disclosure: The researchers don’t have conflicts of interest
• Investigator Statement: The researcher code of conduct
• Satellite Site Application: May be needed if the study involves multiple
locations
• Shipping & Invoice: Where documents are sent
• Study Application: Detailed information about the study
• Curriculum Vitae for all researchers
• Other forms that your IRB requires
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13. IRB Documents – Study and Device Info
• Recruitment Screener: Be very precise Source: http://healthcareit.etisbew.com/
• Recruitment Flyer: To hang in doctor’s office to aid with recruiting
• Moderator’s Guide: A second guide may be needed if there are child
participants
• Consent and asset forms: For adults and children, respectively
• Safety Concerns: Outline potential risks
• Device Background: Detailed explanation of the device including
indication and new features
• Device Instructions for Use: If they are also included in the study
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14. IRB Documents – Validation Plan
• A detailed explanation of how the study will
validate that the device is usable
– If you’re used to winging it, you can’t do that
here
– Lay out every question and how it will be
interpreted
– Lay out a rationale for every metric
– Break down the pieces of the tasks and what
will be observed
– A detailed explanation of how the will be
analyzed and presented
• Quantitative measures (asked and observed)
– Rating scales
– Yes/No observations
Source:
hDp://www.vnet5.org/pub/approach/uva.html
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15. Chart
Color
Quantitative Measures
%
of
chart
that
is
red
%
of
chart
that
is
black
• Rating Scales
– Asked – Observed
• Ease of use • Usability
• Instructions for • Help needed
Use clarity • Number of
• Design errors
• Ergonomics
• Yes/No observations
– Did the participant do this, that, AND the other thing?
Ra,ng
No
Help
Needed
LiDle
Difficulty
Some
Help
Much
Help
Task
Failure
Explana,on
Completed
with
no
help
1-‐2
small
errors
3-‐5
errors
Moderator
gets
involved
Failure
Small
errors:
Doesn't
press
the
green
buDon
Doesn't
remove
cap
properly
Etc.
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16. Recruiting
• Give your recruiter a heads up LONG before the
study starts
– And start recruiting early
• Make a flyer to be hung in doctor’s offices and
distributed electronically which includes:
– The purpose of the study
– Why they would want to participate
– Compensation Source: http://www.toptenz.net/top-10-wwii-propaganda-posters.php
– Recruiter contact information
• During the project, any screener changes need to be
re-approved by the IRB
• Many institutions can’t “promote” a study that is
under their auspices
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17. Sample Flyer
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18. Recruiting
• Don’t be shy – makes friends with local hospitals
and clinics
– Nurses and admins are the gateway
– Have the sanitized IRB approval in-hand
• Find groups that can be a gateway to your desired
audience
Source: http://www.toptenz.net/top-10-wwii-propaganda-posters.php
– Healthcare institutions
– Local and national support groups
– Federal agencies
– Community support groups
– Craigslist & Social Media
• Plan for surprises – like extensions to the timeline
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19. Working with Children
• From a legal standpoint, a child is someone under 18
years old
Source: http://evilstaring.com/2011/06/08/amazingly-evil-child-3/
• Children cannot consent to participate in the study,
they can only assent
– An assent form explains the details of the study, in the
first person
• You will treat a 17 year old different than an 8 year old
– Be cognizant of the protocol to ensure you are
consistent in your data capture
• The parent conundrum: should they participate?
– At what point does it become co-discovery and is that Source: http://cautionmagnet.blogspot.com/2011/05/confused-kids.html
okay?
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20. Working with Children
• Put the child at ease:
– Explain the lab (to a point)
– Ask if s/he would like a break Source: http://lovefunnypictures.com/funny-pic-bush_funny_face.php
– Give reminders that s/he is doing a great job in the study
– Structure the study so that it isn’t drudgery
– Don’t make them remember rating scales
– Not all children like to be spoken to like a child
• Be extra vigilant for signs that the participant is telling you want you
want to hear
– As well as signs of fatigue and confusion
• You don’t need to be their friend, but don’t scare them away
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21. Moderator’s Guide
• Be precise with a tightly written protocol Source: http://tips.tntdental.com/?tag=website-navigation
• Must be well-defined in advance and piloted
– No changes to the protocol without revisiting the IRB, the client, the FDA
approval minutes, etc.
• Clients may be used to clinical trials and view usability methods as “thin”
– We’re not running a clinical trials, but that’s no excuse for not adequately
preparing
• Adhere to the protocol!
– Any changes require IRB approval
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22. Moderator’s Guide
• The moderator’s guide should capture: Source: http://tips.tntdental.com/?tag=website-navigation
– The tasks
– Steps in the tasks
– What should be observed
– The questions to be asked of the participants
– Observer rating scales
• Basically, a shortened version of the Validation Plan
• Be precise in the metrics and methods
– They cannot vary
– Data reporting requirements will be significant
– Gaps in the reporting will be very visible
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23. Notes Grid
• We are using “micro-tasks” and want to
capture precise information
• The notes grid should facilitate the analysis
Source: http://beta.armagetronad.net/design/tron.html
yet be easy to use
– Every step and question on its own row
– Have clear study sections (introduction, etc.)
– Grey out areas that can be ignored
• Team note taking: moderator concentrates on
certain items, note taker does the rest
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24. Notes Grid
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25. Lab Preparation
• Capture the participants from two
different angles
– A close-up view of the device interaction
(over-the-shoulder)
– Straight-on to capture the entire field
• Have all device supplies at the ready
– Alcohol wipes, extra needles, batteries, Source: http://www.ebaumsworld.com/pictures/view/218095/
etc.
– You’ll use more supplies than you expect
• Get a first aid kit and nitrile gloves
– Have a first aid plan and practice
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26. Participant Safety
• As with any usability, participant comfort and safety is the
top priority Source: http://en.wikipedia.org/wiki/File:Sign_first_aid.svg
• Must be mindful of participants with health conditions
– Will they need accessibility accommodations?
– Will they have an aide/caretaker?
– How will the condition affect their participation?
• What you can do to ensure participant comfort and safety:
– Have a robust first aid kit (and possibly medical personnel)
– Provide water, juice, sugary, and non-sugary snacks
– Ensure they know that they will be working with a placebo
– Accessible food
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27. Participant Safety
• Warn participants of safety hazards while using the device, if it’s
part of the protocol Source: http://en.wikipedia.org/wiki/File:Sign_first_aid.svg
• Have a plan of action if someone is injured
• Establish a path of notification if a participant is injured
– Reporting may have many phases: reporting it internally, then to the
client, to the FDA, and the IRB
• Educate yourself about the condition
• Ensure the protocol does not exacerbate a disease or condition
• Be vigilant about fatigue, confusion, disorientation, dehydration, &
stress
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28. Adverse Effects
• An adverse effect (AE) event is when a participant
tells you about a side effect or other experience
while using a device or drug
• This is critical information for the client and must
be reported, typically immediately
Source: http://www.cartoonstock.com/directory/d/Din.asp
• Some clients may require you to go through AE
training
• Before the study begins, determine to whom AEs
are reported When in doubt,
report!
• AEs can be complex to identify, but are VERY
important
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29. Adverse Effects
• In the course of a usability study for a medication website, a participant
mentions that she stopped taking the drug. She explains that the blister
packs and pills sometimes arrived crushed.
• While testing an infusion pump, the participant mentions that the tube
always falls out of his previously used pump, which is the client’s
product.
• During a study, a participant mentions that her arms started to itch when
she stopped taking the client’s medication.
• A male participant mentions that his wife got pregnant two weeks after
he started taking the client’s medication, even though she used the birth
control pill.
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30. Analysis
• The setup from the validation plan, moderator’s
guide, and notes grid should make analysis easy
Source: http://www.webseoanalytics.com/blog/how-to-conduct-market-
research-competitor-analysis/
• Dealing with gaps in the data can be tricky
– Did the question get asked?
– Was the behavior observed?
– Do we have to go back to the recordings?
• Make sure you HAVE the recordings!
• Rely on quantitative measures
– What percentage of participants passed the task?
– What ease of use ratings did participants give?
– How many participants committed the most
common errors?
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31. Analysis
• Remember to think on a micro-task scale – every little
step of using the device should be observed
– It’s difficult to watch and report on every step of a
complex interaction and document it precisely, Source: http://www.webseoanalytics.com/blog/how-to-conduct-market-
research-competitor-analysis/
especially live
– Tallying needs to be specific, yet practical
• Be mindful of capturing and organizing the important
qualitative data
– This can be especially tough when dealing with many
participants
– Summarize qualitative data directly after the session –
don’t wait
• Know what you’re reporting – there may be data to
help marketing
• Sometimes the goal of these studies is to identify
marketing claims, which can raise concerns
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32. Thank You!
• Conducting a usability study for a medical
device is similar to a typical study, except
with much stricter protocols Questions/Comments?
• Your safety and the safety & comfort of the Dan Berlin
participants are paramount dberlin@madpow.net
@banderlin
• Use quantitative measures and report
percentages of participants that did or Chris Hass
didn’t perform an action chass@madpow.net
@chrishass
• It’s all about proper planning!
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