Human Factors Engineering BOOTCAMP, presentation by Tressa J. Daniels, AAMI Faculty, for mHealth Israel, April 13, 2020. Includes the following:
- Human Factors Engineering in the Product Development Process
- Regulatory Standards regarding Human Factors
- Human Factors Validation Testing
- What leads to failure
- What to do if failure occurs
- Submitting a Human Factors Report to a Regulatory Body
- Human Factors Best Practices
This document discusses design considerations and workarounds related to electronic health record (EHR) systems. It examines human factors like perceptual abilities and visual displays that should be considered in EHR design. Software design elements like the user interface and interoperability are also discussed. Hardware factors such as device type and availability can impact adoption. Workarounds often occur due to barriers in the EHR system, software or hardware. Identifying workarounds can help improve systems by removing barriers to standard workflows and patient care. Organizations should evaluate human, software and hardware factors before selecting an EHR system to reduce issues and save time and money.
2 Studies UX types should know about (Straub UXPA unconference13)Kath Straub
This document summarizes two studies on usability testing. The first study examines how many users are needed to find most usability problems. It analyzes data from a test of 100 users and finds that testing 5 users can find 55-85% of problems, 10 users find 82-94% of problems, and 15 users find 90-97% of problems. The second study compares problems found through usability testing with 30 users versus expert reviews with 14 experts across 6 websites. It finds that only 14% of problems were identified by both users and experts, with users finding more navigation and content problems and experts finding more consistency and standards problems.
This 3-day training event on human factors for medical devices will take place in Dublin, Ireland from October 6-8, 2015. It will provide comprehensive instruction on integrating human factors into the medical device development process to improve usability and streamline regulatory approval. Speakers will include experts from the FDA and industry who will discuss guidance, standards, and the FDA approval process. Attendees will learn methods for requirements analysis, formative testing, validation studies, and reporting to meet FDA expectations. They will also engage in workshops and Q&A sessions to discuss real-world applications and challenges. The goal is to help participants incorporate human factors best practices to bring new devices to market more efficiently.
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.
IUE14 Presentation - Studies UX Pros should know Kath Straub
The document discusses research findings from several studies related to usability testing practices. Some key findings include:
- Reading about nutrition during snack time leads preschoolers to eat more veggies and understand nutrition concepts not explicitly taught.
- Testing 10-12 participants, rather than 5, helps find 94-97% of usability problems on average compared to 55-90%.
- Showing participants multiple designs for comparison elicits more detailed, comparative and negative feedback than single designs.
- Controlled walking tasks provide a better mobile evaluation context than treadmill tests which are not ecologically valid.
The document describes several methods for collecting information during the initial systems analysis stage: observation, examining documents, questionnaires, and interviews. Observation allows analysts to see real work processes and how data flows. Examining documents provides information on what documents are used currently. Questionnaires can gather data from many people but have low response rates. Interviews are the most important technique as they allow analysts to clarify any unclear answers. Collecting information from multiple sources helps analysts understand current systems and user needs.
This document discusses installation, maintenance, and troubleshooting of health IT systems. It addresses support staff structures, including using a tiered approach with specialists. Small practices may need to contract IT services while larger institutions require in-house support teams. When users submit troubleshooting requests, the priorities are triaged and forwarded to specialists. Specialists possess skills in applications, networking, hardware and communicating with vendors. Effective communication is important between internal IT teams and with users.
The goal of this study was to evaluate the usability and user-experience of a new type of standing workstation-system to be used in the context of an Educational Makerspace.
This document discusses design considerations and workarounds related to electronic health record (EHR) systems. It examines human factors like perceptual abilities and visual displays that should be considered in EHR design. Software design elements like the user interface and interoperability are also discussed. Hardware factors such as device type and availability can impact adoption. Workarounds often occur due to barriers in the EHR system, software or hardware. Identifying workarounds can help improve systems by removing barriers to standard workflows and patient care. Organizations should evaluate human, software and hardware factors before selecting an EHR system to reduce issues and save time and money.
2 Studies UX types should know about (Straub UXPA unconference13)Kath Straub
This document summarizes two studies on usability testing. The first study examines how many users are needed to find most usability problems. It analyzes data from a test of 100 users and finds that testing 5 users can find 55-85% of problems, 10 users find 82-94% of problems, and 15 users find 90-97% of problems. The second study compares problems found through usability testing with 30 users versus expert reviews with 14 experts across 6 websites. It finds that only 14% of problems were identified by both users and experts, with users finding more navigation and content problems and experts finding more consistency and standards problems.
This 3-day training event on human factors for medical devices will take place in Dublin, Ireland from October 6-8, 2015. It will provide comprehensive instruction on integrating human factors into the medical device development process to improve usability and streamline regulatory approval. Speakers will include experts from the FDA and industry who will discuss guidance, standards, and the FDA approval process. Attendees will learn methods for requirements analysis, formative testing, validation studies, and reporting to meet FDA expectations. They will also engage in workshops and Q&A sessions to discuss real-world applications and challenges. The goal is to help participants incorporate human factors best practices to bring new devices to market more efficiently.
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.
IUE14 Presentation - Studies UX Pros should know Kath Straub
The document discusses research findings from several studies related to usability testing practices. Some key findings include:
- Reading about nutrition during snack time leads preschoolers to eat more veggies and understand nutrition concepts not explicitly taught.
- Testing 10-12 participants, rather than 5, helps find 94-97% of usability problems on average compared to 55-90%.
- Showing participants multiple designs for comparison elicits more detailed, comparative and negative feedback than single designs.
- Controlled walking tasks provide a better mobile evaluation context than treadmill tests which are not ecologically valid.
The document describes several methods for collecting information during the initial systems analysis stage: observation, examining documents, questionnaires, and interviews. Observation allows analysts to see real work processes and how data flows. Examining documents provides information on what documents are used currently. Questionnaires can gather data from many people but have low response rates. Interviews are the most important technique as they allow analysts to clarify any unclear answers. Collecting information from multiple sources helps analysts understand current systems and user needs.
This document discusses installation, maintenance, and troubleshooting of health IT systems. It addresses support staff structures, including using a tiered approach with specialists. Small practices may need to contract IT services while larger institutions require in-house support teams. When users submit troubleshooting requests, the priorities are triaged and forwarded to specialists. Specialists possess skills in applications, networking, hardware and communicating with vendors. Effective communication is important between internal IT teams and with users.
The goal of this study was to evaluate the usability and user-experience of a new type of standing workstation-system to be used in the context of an Educational Makerspace.
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.
Integrating Human Factors Engineering into the Product Development Lifecycle_...BasemAbdo4
The document discusses integrating human factors into medical device product development lifecycles. It describes how usability engineering aims to reduce use errors and enhance safety. Key points include:
- Usability engineering applies knowledge of human behavior and characteristics to design safe, effective medical device user interfaces.
- International and FDA regulations increasingly require usability validation due to many adverse events stemming from use errors.
- Throughout development, usability methods like task analysis, user research, and formative/summative testing should inform design to prevent errors.
- The level of usability work depends on each project's risks but is especially important for new interfaces or known problem areas.
The document discusses environmentally sound technologies (ESTs) and the process for assessing and selecting them in Oman. It defines ESTs as technologies that are less polluting and more environmentally friendly than conventional options. It outlines Oman's regulatory requirements for selecting best available technologies and demonstrating an internationally recognized EST assessment. The assessment process involves gathering information on proposed and alternative technologies, evaluating them based on environmental and other impacts, consulting stakeholders, and making recommendations. The goal is to select options that minimize environmental degradation and risks to human health and welfare.
The document discusses environmentally sound technologies (ESTs) and their assessment and approval process. It defines ESTs as technologies that are better for the environment than conventional technologies by avoiding waste and pollution. It also outlines two types of ESTs - "hard" technologies like equipment and "soft" technologies like processes. The document then discusses why ESTs are important and describes the Environmental Technology Assessment (EnTA) process used to select ESTs, which involves gathering information on proposed and alternative technologies, analyzing situations and regulations, consulting stakeholders, and identifying impacts. The goal of EnTA is to justify the use of environmentally sound technologies.
This document outlines principles for improving patient safety through systems thinking and reliable design. It describes how human errors often stem from systemic issues rather than individual mistakes. Two case examples are presented where patients experienced harm due to miscommunications or lack of safeguards. The document discusses how reliability science focuses on anticipating and containing errors within complex systems. Checklists, standardized processes, and other tools can help reduce risks. Organizational culture and human factors also significantly impact safety. Continuous improvement models like PDCA and Lean are effective approaches to redesigning systems and workflows to prevent future harm.
The document discusses various methods for evaluating the usability of interfaces and software systems. It describes the goals of evaluation as assessing functionality, interface effects, and identifying specific problems. Both analytical and empirical testing methods are covered. Analytical methods include heuristic evaluation, consistency inspection, and cognitive walkthrough. Empirical methods involve observation/monitoring of users and experimentation. Key aspects discussed for evaluation include iterative testing, formative vs. summative approaches, and the DECIDE framework.
Many businesses seek ‘ergonomically’ designed products to improve their safety efforts. However, the selection of ergonomic products for work can be a frustrating and potentially costly process if they fail to live up to expectations upon implementation.
This presentation aims to shed light on the differences between good design and ergonomic design, a distinction that is important for safety outcomes. Ergonomic design principles are discussed to highlight some important distinctions that can de-mystify some misnomers that exist associated with products claimed to be ergonomically designed. Examples of redesign projects are shared to highlight how matters relating to context and individual differences influence the user experience and ultimate successful adoption of the product.
This webinar provides an overview of key frameworks for identifying barriers and enablers to implementation, with a focus on the Theoretical Domains Framework (TDF). The TDF synthesizes 128 constructs from 33 theories of behavior change into 12 domains to understand factors influencing healthcare professionals' behaviors. The webinar uses a case study of improving physician hand hygiene to demonstrate how the TDF can be applied to identify potential barriers within domains like Knowledge, Skills, Social Influences, and Environmental Context & Resources.
11 - Evaluating Framework in Interaction Design_new.pptxZahirahZairul2
The document discusses evaluation frameworks in interaction design. It introduces key concepts like prototypes, evaluation paradigms, and techniques. Low and high fidelity prototyping are described. Evaluation paradigms include quick and dirty evaluations, usability testing, field studies, and predictive evaluation. Common techniques involve observing, asking, and testing users. The DECIDE framework is presented as a process for planning evaluations by determining goals, exploring questions, choosing techniques, and addressing practical and ethical concerns. Pilot studies are recommended to test evaluation plans.
Demystifying the FDA's Human Factors GuidanceGreenlight Guru
The document provides an overview of the FDA's human factors guidance for medical device design. It discusses identifying device users and use environments, conducting formative usability testing during design, and validation usability testing on the final design. The goals are to demonstrate a device can be used safely and effectively by intended users. Post-market surveillance is also important to monitor for usability issues after a device is released. The three main steps in the human factors design process are identifying users and tasks, formative usability testing, and validation usability testing.
The document discusses testing without formal requirements. It notes that testers often complain about a lack of adequate requirements, but still rely on requirements to base their tests. Even without defined requirements, testers can ask questions about the system, anticipate common risks, involve users in acceptance testing, and perform random testing. The document provides suggestions for growing a "system function tree" to understand and describe a system without formal requirements in order to develop a test strategy, approach, and cases. It emphasizes that testing can still be done effectively even without traditional requirements.
How User Experience Design and Human Factors Engineering can Accelerate Produ...Greenlight Guru
This document discusses how human factors engineering and user experience design can accelerate medical product development. It recommends implementing these practices early in development to avoid costly changes later. Following standards like IEC 62366 involves user research, usability testing, and risk analysis to identify and address usability issues. This helps ensure medical devices are safe, effective and easy to use as intended.
User experience & design user centered analysisPreeti Chopra
UCA is a multistage process which allows designers to analyze and foresee how user is going to use the product. UCA employs proven and objective data-gathering and analysis techniques to develop a clear understanding of who the users are and how they will approach a website or application.
Looking at some of the check lists and evaluation guidance for those making choices about assistive technologies suitable for certain tasks in the light of user needs.
The document discusses the importance of usability engineering and designing for usability from the beginning. It provides definitions of usability and outlines the key steps in the usability engineering process, including concept planning, understanding needs, requirements analysis, and design/development. Throughout each step, it emphasizes applying best practices like user research, prototyping, and usability testing to prevent usability problems and ensure products are easy to use.
This document discusses strategies for implementing health information technology (HIT) systems. It compares "big bang" implementations, where a system is launched system-wide at once, to "staggered" or phased implementations. While big bang implementations have faster rollout, they carry higher risk. Staggered implementations have lower risk but slower return on investment. The document also emphasizes the importance of user training and long-term support during and after implementation to ensure success. Contextual factors like organizational culture and individual user needs must also be considered in planning. Nested implementation teams and designated super-users or internal consultants can help provide support.
Begins during the communication activity and continues into the modeling activity
Builds a bridge from the system requirements into software design and construction
The document discusses sociotechnical systems and people-process-technology interactions in health informatics. It covers topics like unintended consequences of health IT, change management of health IT projects, user involvement in design, and foundations of user interface design. Key aspects of successful health IT implementations discussed include communication, workflow changes, training, and addressing change resistance.
Systems Engineering and Requirements Management in Medical Device Product Dev...UBMCanon
Systems engineering is an interdisciplinary approach that focuses on defining customer needs, documenting requirements, and enabling the realization of successful systems. It considers both business and technical needs across the entire life cycle from concept to disposal. Requirements management is the foundation of systems engineering. Organizations can improve processes and reduce risks through structured approaches like the Systems Engineering V-Model and maturity models like CMMI that provide standard processes and best practices. Verification and validation are used to ensure a system meets its requirements through methods like testing, analysis and demonstration.
Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
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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.
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The document discusses integrating human factors into medical device product development lifecycles. It describes how usability engineering aims to reduce use errors and enhance safety. Key points include:
- Usability engineering applies knowledge of human behavior and characteristics to design safe, effective medical device user interfaces.
- International and FDA regulations increasingly require usability validation due to many adverse events stemming from use errors.
- Throughout development, usability methods like task analysis, user research, and formative/summative testing should inform design to prevent errors.
- The level of usability work depends on each project's risks but is especially important for new interfaces or known problem areas.
The document discusses environmentally sound technologies (ESTs) and the process for assessing and selecting them in Oman. It defines ESTs as technologies that are less polluting and more environmentally friendly than conventional options. It outlines Oman's regulatory requirements for selecting best available technologies and demonstrating an internationally recognized EST assessment. The assessment process involves gathering information on proposed and alternative technologies, evaluating them based on environmental and other impacts, consulting stakeholders, and making recommendations. The goal is to select options that minimize environmental degradation and risks to human health and welfare.
The document discusses environmentally sound technologies (ESTs) and their assessment and approval process. It defines ESTs as technologies that are better for the environment than conventional technologies by avoiding waste and pollution. It also outlines two types of ESTs - "hard" technologies like equipment and "soft" technologies like processes. The document then discusses why ESTs are important and describes the Environmental Technology Assessment (EnTA) process used to select ESTs, which involves gathering information on proposed and alternative technologies, analyzing situations and regulations, consulting stakeholders, and identifying impacts. The goal of EnTA is to justify the use of environmentally sound technologies.
This document outlines principles for improving patient safety through systems thinking and reliable design. It describes how human errors often stem from systemic issues rather than individual mistakes. Two case examples are presented where patients experienced harm due to miscommunications or lack of safeguards. The document discusses how reliability science focuses on anticipating and containing errors within complex systems. Checklists, standardized processes, and other tools can help reduce risks. Organizational culture and human factors also significantly impact safety. Continuous improvement models like PDCA and Lean are effective approaches to redesigning systems and workflows to prevent future harm.
The document discusses various methods for evaluating the usability of interfaces and software systems. It describes the goals of evaluation as assessing functionality, interface effects, and identifying specific problems. Both analytical and empirical testing methods are covered. Analytical methods include heuristic evaluation, consistency inspection, and cognitive walkthrough. Empirical methods involve observation/monitoring of users and experimentation. Key aspects discussed for evaluation include iterative testing, formative vs. summative approaches, and the DECIDE framework.
Many businesses seek ‘ergonomically’ designed products to improve their safety efforts. However, the selection of ergonomic products for work can be a frustrating and potentially costly process if they fail to live up to expectations upon implementation.
This presentation aims to shed light on the differences between good design and ergonomic design, a distinction that is important for safety outcomes. Ergonomic design principles are discussed to highlight some important distinctions that can de-mystify some misnomers that exist associated with products claimed to be ergonomically designed. Examples of redesign projects are shared to highlight how matters relating to context and individual differences influence the user experience and ultimate successful adoption of the product.
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The document discusses testing without formal requirements. It notes that testers often complain about a lack of adequate requirements, but still rely on requirements to base their tests. Even without defined requirements, testers can ask questions about the system, anticipate common risks, involve users in acceptance testing, and perform random testing. The document provides suggestions for growing a "system function tree" to understand and describe a system without formal requirements in order to develop a test strategy, approach, and cases. It emphasizes that testing can still be done effectively even without traditional requirements.
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UCA is a multistage process which allows designers to analyze and foresee how user is going to use the product. UCA employs proven and objective data-gathering and analysis techniques to develop a clear understanding of who the users are and how they will approach a website or application.
Looking at some of the check lists and evaluation guidance for those making choices about assistive technologies suitable for certain tasks in the light of user needs.
The document discusses the importance of usability engineering and designing for usability from the beginning. It provides definitions of usability and outlines the key steps in the usability engineering process, including concept planning, understanding needs, requirements analysis, and design/development. Throughout each step, it emphasizes applying best practices like user research, prototyping, and usability testing to prevent usability problems and ensure products are easy to use.
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harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
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3. Private Biotech Financing Market Update
4. Key Advice For Healthcare Companies
Current State of Play; Healthcare has Underperformed the Broader Market Over the Last Twelve Months; Signal-to-Noise is Getting Worse; Healthcare IPO Activity has Decreased Significantly Since 20–21 Pandemic Levels; Biotech Financing Activity Has Remained Robust in 2024; Biotech M&A Market Remains Incredibly Active; Biotech M&A Market Remains Incredibly Active; Big Pharma Upcoming Patent Expirations; Since November 2023 Oncology has accounted for over half of all M&A; Oncology, Autoimmune / I&I, and CV & Metabolic Remain the Top Areas in M&A; Small Molecule Beats Out All Other Modalities in M&A Despite IRA Concerns; Value of Big Pharma Acquisitions by Therapeutic Area in Q1 2024; Private Financing Market Update; 2024 Private Placement Activity On Track to Approach, If Not Exceed, 2020 Levels; Oncology, Particularly Solid Tumor, Continues to Attract VC Investors; Despite the IRA, Small Molecules Continue to Attract VC Dollars; Preclinical-Stage Companies Make Up Almost Half of Private Placements in 2023; Valuations by Development Stage – 2023; Typical Biotech Investors Remained Active in Q1 2024; 23 $100M+ Deals were Raised in Q1 2024; Biotech Fundraising Momentum Continued into 2024; Key Advice For Israeli Healthcare Companies; Although Israel has Strong Presence on US Public Markets, There is Room to Grow; Telling Your Story Effectively; Interacting with Investors to Build Long-term Credibility; Seven Simple Rules for Pitch Decks;
Version Bravo- The Springboard for Navy SEAL entrepreneurship, cohort 003Levi Shapiro
Description of the Version Bravo intensive entrepreneurial launch program for 7 Israeli and 7 US former Navy SEALs. Details about each startup concept, the CEOs, the sector, etc.
Radical Life Extension_Dr. Leon Peshkin_Dec 2023Levi Shapiro
Presentation for mHealth Israel by Dr. Leon Peshkin, Harvard Medical School, exploring research into Embryology and Longevity, emphasizing Germline and protein aggregates. Includes current overview, anti aging through history, Lifespan Expansion, ALEC: Animal Life Expectancy in Controls, Scalable Platform in Pharmacobiology, Embryos Cleanse Protein Aggregates, Lysosomal switch triggers proteostasis renewal, Xenopus, Rejuvenation Roadmap, Citizen Science Approach to Aging, Xenopus: Maternal Dowry Molecules, Human Disease Modeling
Israel’s Life Science Hub 2023 English Abstract.pdfLevi Shapiro
The war between Israel and Hamas brings its own set of business
challenges. Challenges that may impact how we communicate with
partners and investors abroad. We should portray the life science sector as resilient and adaptable, even in times of crisis. This document is a a messaging outline for Israel's Life Science Hub despite the war with Hamas. Four key points to emphasize:
1) Global activity (resilience and agility)
2) Continuity of care and preventive medicine
3) World leading clinical trials industry
4) Dynamic scientific, research and entrepreneurial ecosystems
Gil Bashe FINN Partners: The Future of Digital Health – Nose Dive or Transfor...Levi Shapiro
The Future of Digital Health – Nose Dive or Transformation, by Gil Bashe, Dec 4th, 2023 at the mHealth Israel conference. Digital Health Innovation Ecosystem Investment Trends. Data & Methodology. Digital Health Taxonomy. Key Insights for Digital Health Innovation in H1 2023. Global Digital Health Funding Across Regions. Funding in North America. Shifting Focus in North America Digital Health Funding. Investment Focus for Digital Health Venture Funding. Ventures are turning to partnerships for proof points, scale and funding. 2022 new partnerships. North America digital health investor participation. Most active partners in North America. North America Ecosystem Development. Venture distribution by stage. Funding distribution. Comparison to 2022 Funding. Noteworthy deals, noteworthy exits.
Urgent Request and Call for Action for Ensuring Safety and Inclusivity at MITLevi Shapiro
We, 465 MIT Alumni, Staff, and Students, are writing to express our deep concern, fear, and disappointment regarding the recent protest that took place Thursday afternoon, in front of the MIT Stratton Student Center. While we fully support the principles of free
speech and the right to peaceful assembly, it is essential that we also prioritize the safety and well-being of all members of the MIT
community.
During the protest, a particular slogan was prominently displayed and chanted, which has raised significant concerns. The slogan
"From the [Jordan] river to the [Mediterranean] sea, Palestine will be free!" has been a source of contention due to its potential
implications and the real safety risks it poses to Jewish and Israeli students on campus [See video footage attached]. This slogan
has been time and again associated with calls for the destruction of the State of Israel and has been used in contexts that
promote violence, which raises legitimate concerns about the safety and security of our Jewish and Israeli students and staff.
Furthermore, we would like to draw your attention to recent events that demonstrate the potential dangers associated with this
slogan. During the 2023 Israel-Hamas war, British Home Secretary Suella Braverman proposed criminalizing the use of the slogan
in certain contexts, recognizing the potential harm it can cause. Additionally, on October 11, ‘23, Vienna police banned a
demonstration, citing the inclusion of the phrase "from the river to the sea" in invitations, as it was seen as a portrayal of a violation
of Article 2 of the European Convention on Human Rights.
In addition to the use of these derogatory messages, several attendees of the event used hateful wordings and messages towards
Jewish and Israeli bystanders. In one case, a perpetrator aggressively held their bicycles as intended to harm a Jewish MIT student,
stating that “[your] ancestors did not die in the Holocaust so they could kill Palestinians” [See video footage attached]. In another
incident, protesters chanted “one solution, intifada revolution”. In the context of the on-going Israeli-Palestinian conflict, the word
"Intifada" means the armed and violent Palestinian insurrection targeting Israelis, including civilians, which resulted in the killing of
thousands of Israelis in the last few decades.
On Oct. 22nd, a statement by MIT CAA (Coalition Against Apartheid) came to our attention. In this document, MIT CCA states that
they "hold the Israeli regime responsible for all unfolding violence". They later call the October 7th terror attack a "response to
the settler colonial regime", and continue justifying it throughout the document.
In this matter, MIT CAA is justifying the heinous and barbaric crimes committed on Oct 7th. Furthermore, these statements have the
potential to fuel acts of aggression
Overview of the Israeli exhibitors at the 2023 HLTH conference in Las Vegas. Exhibitors included 6Degrees, AppScent, Belong.Life, Datos, Expecting, IntraPosition, Kahun Medical, Kemtai, Maverick, Neteera, QuantaIX, Respiration Scan, Nerivio, Xoltar.
40% of Israeli technology investment is devoted to Life Science. Within that domain, the largest sector is Medical Devices and Digital Health (over 65 percent of companies). In the medical device arena, Israeli scientists and engineers have integrated advanced technologies in electronics, communications and electro-optics to develop world-class innovations in Digital Imaging, Medical Lasers, Telemedicine, Early Diagnostics,
Smart Surgical Equipment and more. Over 600 medical device exporters engaged in a variety of medical application
such as Cardiovascular and Peripheral Vascular, Neurology and Degenerative Diseases, Preparedness and Emergency
Medicine, Intensive Care, Women Health, Orthopedics and Sport Medicine, Gastrointestinal, Infection Control, Ophthalmology, Pain and Wound Management, Oral and Dental Care, Dermatology and Aesthetics
Baptist Health- Engineering the Future of HealthcareLevi Shapiro
Presentation by Mark Coticchia, Chief Innovation Officer, Baptist Health, for mHealth Israel community, September, 2023. Baptist Health has internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences.
A not-for-profit organization supported by philanthropy and committed to its faith-based charitable mission of medical excellence, Recognized by Fortune as one of the 100 Best Companies to Work For in America and by Ethisphere as one of the World’s Most Ethical Companies.Innovation is paramount to health system’s performance and reputation.
Becker’s 2019 Advisory Board survey revealed innovation and technology ranked as the top priority among healthcare finance professionals - up from eighth in 2018. 90% healthcare/life science leaders agree that the pandemic will fundamentally change the way they do business, requiring new products, services, processes, and business models (McKinsey: Innovation Through Crisis Survey). Innovation has been proven to help health systems in many ways. A capability and culture of innovation accomplish numerous goals:
Innovation capability and culture improve the care and work environment. They enhance the reputation through recognition for discoveries made at and through Baptist Health. They aid in the recruitment and retention of top talent. And they help systems harness money that otherwise would be leaving the system – licensing revenues and investment returns and corporate research support and donor revenues. Successful Programs - Common Underpinnings. Innovation as a strategic, institutional priority
Program built on institutional assets and centers of excellence
Experienced, professional team
Technology development and sourcing, Dedicated, long term support. Doing healthcare innovation well at a large enterprise takes a highly specialized team and skill set. Collectively, they need to have deep knowledge of healthcare regulation, medical procedures, patient safety, business development, transactions, business law, innovation markets, entrepreneurship, venture capital, commercialization, tech transfer, organizational change management, and much more. Programs- services, technology management, corporate co-creation, global medical service lines and facilities; Focus on market opportunity vs. technology; Select & concentrate on winners; Operate as a business; Proactive in new company formation; Progress, milestones, preliminary results; Building New Innovation Pathways; Improving Treatment for Cancer Patients; Predicting & Preventing Heart Attacks; Improving Outcomes in Cardiac Care; Enhancing a Culture of Innovation at Baptist Health & South Florida; Cleerly, TriVentures, COTA; Innovation is paramount to health system’s performance and reputation.
Baptist Health has established an innovation function predicated on best practices and tailored to its assets and the opportunities extending from Miami’s economic growth
YEDA Techn Transfer at Weizmann Institute- Discord and Challenges in Academic...Levi Shapiro
Presentation by Yael Klionsky, YEDA, for the mHealth Israel community in September, 2023. Title: Challenges in Academic Technology Transfer. Examples-
Transplantation Immunology and Immunometabolism. Efranat Pharma was developing an anticancer immunotherapy treatment based on a natural plasma protein molecule. From target discovery to clinical validation. Clinical-stage drug discovery and development company utilizing a broadly applicable, predictive
computational discovery platforms to identify novel drug targets and new biological pathways and develop
therapeutics in the field of cancer immunotherapy. To allow SOCIETY to benefit from discoveries made at the academic institution. To enable SCIENTISTS to transfer their new technologies to the market. To create an additional source of INCOME for the INSTITUTE so that more independent research can be conducted. Three important elements that make an idea patentable:
1) The invention must be new: the same idea can’t have been
published before in any form; 2) There must be some inventive step of ‘non-obviousness’.
This can be hard to define and depends on the context; 3) The disclosure in a patent must be sufficient for a skilled
person to reproduce the invention with only routine effort; Technology Transfer Company - modus operandi; OUR PURPOSE- To provoke transformative scientific breakthroughs that will shape the future of humanity; SCIENTIFIC STAFF- 300 Principal investigators, >2,000 Research students and PhDs; 5 FACULTIES – BASIC SCIENCE, Biology, Physics, Biochemistry, Math/CS
Chemistry; Generated IP- 57% in Life Science & Biotech; Among the Highest
Income per Researcher
Worldwide; 1959 (First TTO outside the US); Today- More applications per PI than in most Ivy league universities; Copaxone- >$30B
ANNUAL SALES BASED ON Weizmann IP; 20 new licenses per year and 10 new companies per annum; www.yedarnd.com
HADASIT: Tech Transfer and More in Life ScienceLevi Shapiro
Overview of activities in Life Science of Hadasit, the technology transfer arm of Hadassah Hospital in Jerusalem. Includes details about Jerusalem Biodesign program; spinouts like Brainwatch; details about tech transfer (the Secret Engine Behind Israel’s Success); relationship and examples of TTOs enabling Israel's greatest success stories; contrasting of Adademia (Scientific driven research, Creation of new knowledge, Publication, Sharing of Material, Social responsibilities) and Industry (Applied research & specific objectives, Develop new products, Product development, Secrecy and patent protection, Organization responsibilities); Development gap between initial inventions and product development; the Art of translation (from academic research to medical companies); Tech transfer transforms cutting-edge research into marketable healthcare technologies; LICENSING TO EXISTING COMPANIES; SPINNING OFF STARTUPS; CO-DEVELOPMENT OF JOINT IP; Technology Transfer Offices from Academia/Research Hospitals – to Industry; Overview of Hadassah and Hadasit (TECHNOLOGY TRANSFER COMPANY AND INNOVATION ENGINE OF HADASSAH UNIVERSITY HOSPITALS); Examples of “HADASSAH MADE” PRODUCTS IN THE GLOBAL MARKET; RECENT TECH TRANSFER SUCCESS; Example- Lineage Exclusive Worldwide Collaboration with Genentech Opregen® RPE Cell Therapy for the Treatment of Ocular Disorders; HADASIT PILLARS-
NURTURING INTERNAL INNOVATION, Tech Transfer, EXTERNAL INNOVATION. External- SERVICES & COLLABORATIONS WITH COMPANIES, BIOHOUSE FOR STARTUPS, DIGITAL HEALTH ACCELERATOR); Internal Innovation- NURTURING INTERNAL INNOVATION, HADASSAH SEED FUND, JERUSALEM BIODESIGN PROGRAM; TYPES OF RELATIONS WITH EXTERNAL COMPANIES- CONSULTING, SAB, CLINICAL TRIALS, R&D SERVICES, DATA LICENCE, ALPHA/BETA SITE, PILOTS, DESIGN PARTNERSHIPS.
Presenting to Investors & the Media.pdfLevi Shapiro
Presenting to Investors and the Media, lecture by Drew Levinson, LifeSci Communications to mHealth Israel. Three sections: Making a good presentation, Handling
interviews with reporters and Answers that resonate. PRESENTING TO INVESTORS AND THE MEDIA- Compelling delivery, Commanding a room, • Lasting Impact. A good presentation includes Information, Motivation and Excitement. Never put them to sleep. Audience impact includes content, credibility and delivery. Decisions are made leading to potential partnerships, winning business, so much more than a deck, your business, your brand, you. How to captivate begins with storytelling and conversation. More than features- benefits, humanize, positive impact. Don't complicate your message with jargon. Feel the passion- contagious, vision, determination. Know your audience- who are they, what do they know about you, how much do they know, interests, concerns. Articulate your vision- see it, feel it, believe in it. Take them on your journey- compelling narrative, make it personal, why are you doing this, inspiration. Your team- experienced, knowledgeable, aligned, execute. Risks and challenges- recognize, address, plan to mitigate. Test drive your room. What does it look like? Where is the podium? Where will I be standing? Where will you be sitting? Feel comfortable. Three parts to attention. The beginning- attention, interest, what's in it for them, entusiasm, preview. The middle- core, insights, challenges, solutions, relatable. The ending- summary, reinforce, messages, benefits, call to action, keep the momentum going. How to answer questions. The Four R's: repeat, reinforce, refer, remember. Talking to reporters- necessity; Good interview can enhance reputation; Bad interview can tarnish reputation; Preparation is vital. Shapes public opinion: Elevates your brand; Establishes authority; Showcases your business; A bridge; Reputation; Trust; Visibility. Know the reporter. Audience; What have they written; Previous stories; Questions asked. Concise- clear, succinct, engaging. Make it relatable: Stories; Anecdotes; Experiences; Examples; Metaphors; Connect. Honesty and transparency. It is okay not to know every answer. You don’t have to answer every question. Control the narrative. What not to do when talking to reporters. Come up with another way to say no comment. What to wear- solid colors, blues and grays, nothing distracting. Expertise, passion, vision, lasting impression, connections. High stakes, high rewards. Preparation; Know your audience; Deliver with confidence; Enthusiasm; Authenticity. Begin the journey. Engage in dialogue; Build relationships; Inspire trust and confidence; Valued; Enlightened; Motivated and excited.
Nissan Elimelech, Founder, Augmedics: How I Built the World's First XR Surgic...Levi Shapiro
Presentation by Nissan Elimelech, Founder, Augmedics: How I Built the World's First XR Surgical Navigation Company and What's Next for XR. Covers the company founding across multiple milestones and key success factors.
Beyeonics CEO, Ron Schneider, Advances in Medical XRLevi Shapiro
Overview by Beyeonics CEO, Ron Schneider, about the company. Beyeonics One is the first ophthalmic exoscope with an augmented reality surgical headset. It is a high-definition, fully digital imaging platform enabling surgeons to see a magnified, three-dimensional (3D) image of the surgical field. The small footprint, the fast setup, automation, and zero turnover time between procedures all contribute to the efficiency operating rooms strive for. Over 3000 cases to date. Unconstrained Movement. Unconstrained workflow. Data connectivity. Designed for continuous innovation.
XRHealth is revolutionizing healthcare, bringing patient care into the Metaverse. Includes a description of the TeleHealth Platform. Lessons Learned – Building the clinical Metaverse. Last mile delivery
Building a product in the Metaverse is easy – getting people to use it is hard. Virtual Care can’t be based only on XR. HMDs bring friction – Charging, Guardian, Safety, Passwords etc. Expanding virtually in a brick & mortar payer environment. Once you cross the chasm – adherence/ satisfaction/retention goes ballistic. Patient Outcomes-
Patients report significant improvement in symptoms following treatment. Adherence - patients follow Home Exercise Plans as prescribed. 92.2% with XRHealth vs 50% with regular treatment. Patient satisfaction - 85 NPS vs 38 NPS in healthcare
93.3% patient retention -complete treatment cycle as prescribed. XRHealth Luna AI Reduces Hot Flashes and Improves Psychological Well-Being in Women with Breast and Ovarian Cancer: A Pilot Study. Virtual reality immersion compared to monitored anesthesia care for hand surgery: A randomized controlled trial. Lessons Learned – Autism Spectrum Disorder. The future of the Mediverse.
Digital Health in US Health Systems.pptxLevi Shapiro
April, 2023 presentation by Gil Bashe, Global Chair, Health Practice, FINN Partners. Insights and analytics, in collaboration with Galen Growth, tracking Digital Health collaboration, adoption, integration, and best practices across the leading US Health Systems. There is a section about focus areas for digital health in health systems and hospitals. The most active health systems are partnering more in diagnosis and have a higher share of digital tools for research. Comprehensive breakout of digital health activities at the Top 10 players: Mayo, Mount Sinai, Cleveland Clinic, Sloan Kettering, Massachusetts General, Northwell, Cedars Sinai, Brigham & Women's, InterMountain. Global breakout of health systems with digital health partnerships at scale. Geographical breakout of digital health partner headquarters (by region). Strong preference for B2B business model. 1/3 of digital health partnerships with Early Stage venture companies. Emphasis is on strong clinical evidence. Portfolio size allows greater diversity. Cluster distribution depends on therapeutic area. Digital health analytics breakout including alpha score, venture similarity score, venture valuation, team signal, partnership signal, evidence signal.
Course Syllabus (Digital Rosh): The Future of Digital Medicine- Biology, Gene...Levi Shapiro
Syllabus for the Future of Digital Medicine course, 2023- Biology, Genetics, Technology and BioInformatics. Includes lectures from Noam Shomron, Michal Rosen-Zvi, Eyal Zimlichman, Gila Tolub, Dana Bar-On, Yesha Sivan, Vladi Dvoryis, Varda Shalev, Avi Schroeder, Christian Tidano, Eyal Toledano.
We’re Underestimating the Damage Extreme Weather Does to Rooftop Solar PanelsGrid Freedom Inc.
Grid Freedom is the best solar leads company based in New Jersey that provides Exclusive solar appointments of qualified solar appointments for guaranteed solar appointments for the best way to get solar leads throughout the nation. Grid Freedom is a solar lead provider, that connects exclusive pre-set appointments with pre-screened homeowners who are ready for solar company leads. The solar lead generators company was founded to provide solar appointment leads contractors with better solar sales leads-buying high-quality exclusive solar leads experience that gives pre-set solar appointments great ROI.
Company Profile of Tempcon - Chiller Manufacturer In Indiasoumotempcon
This is the company profile of Tempcon - chiller manufacturer in India. Tempcon manufactures water cooled and air cooled chillers and industrial AC. The company has been in the business since 1983.
website: https://www.tempcon.co.in/
The Future of Wearable Technology in Healthcare: Innovations and Trends to WatchbluetroyvictorVinay
As wearable technology continues to shape multiple facets of our lives, its potential in healthcare is becoming increasingly apparent. With the rapid advancement of technology, the integration of wearables into healthcare systems worldwide is accelerating. In this evolving field, we delve into the latest innovations and trends that are transforming healthcare.
"IOS 18 CONTROL CENTRE REVAMP STREAMLINED IPHONE SHUTDOWN MADE EASIER"Emmanuel Onwumere
In iOS 18, Apple has introduced a significant revamp to the Control Centre, making it more intuitive and user-friendly. One of the standout features is a quicker and more accessible way to shut down your iPhone. This enhancement aims to streamline the user experience, allowing for faster access to essential functions. Discover how iOS 18's redesigned Control Centre can simplify your daily interactions with your iPhone, bringing convenience right at your fingertips.
2. Disclaimer
The opinions expressed in this presentation and on the following slides are solely
those of the presenter and do not represent those of Teleflex Inc. or AAMI.
Presentations are intended for educational purposes only and do not replace
independent professional judgement. Teleflex Inc. and AAMI do not endorse or
approve, and assumes no responsibility for the content, accuracy or completeness
of information presented.
3. Agenda
• Introduction (5 minutes)
• Human Factors Engineering in the Product Development Process (15 minutes)
• Regulatory Standards and Expectations regarding Human Factors (20 minutes)
• Human Factors Validation Testing (20 minutes)
• What leads to failure (5 minutes)
• What to do if failure occurs (5 minutes)
• Submitting a Human Factors Report to a Regulatory Body (5 minutes)
• Human Factors Best Practices (5 minutes)
• Concluding Remarks (5 minutes)
4. Definition
“The scientific discipline concerning understanding of interactions among humans and other
elements of a system, and applying theory, principles, data, and other methods to design of user
interfaces in order to optimize human well-being and overall system performance.”*
*As defined by the Human Factors and Ergonomics Society
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5. Human
Factors
Engineers
Research Research user and product problems
Study Study workflows
Observe Observe environments of use
Define Define product and user needs
Run
Moderate usability testing to verify
solutions meet user expectations
Ensure
Ensure safety and effectiveness are
designed into the product
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8. The Primary
Objective
Identification and control of user
interface design problems or flaws that
could lead to…
• Harm to user or patients
• Compromised medical care
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9. Human Factors in Product Development Process:
Activities & Deliverables
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10. Human Factors
Skillsets &
Activities
• Formative Research - Identifying user’s needs and
wants
• Ethnographic research
• Usability Inspection & Heuristic Evaluations
• Formative Usability Testing
• Tasks Analysis
• Interaction Design
• Workflows, wire frames
• Online, mobile, embedded graphic design
• Industrial Design
• Product Color, shape and form
• Physical interface design
• Ergonomic design
• Human Factors Validation - Testing and
validating safety and efficiency
• HF/UE Documentation
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12. In the beginning: HF Focus is on Research
CONTEXTUAL
INQUIRY
BEHAVIORAL
OBSERVATION
JOB
SHADOWING
SITE VISITS
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13. In the middle: HF Focus is on Design
Feedback
Prototypes
Low fidelity: Paper
High fidelity: Clickable screens or foam
core mockups
Formative
Evaluations
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14. Feedback gathered
on all product UI
• IFU
• Packaging
• Labeling
• Hardware
• Software
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16. At the end: HF Validates Production Units
Sample Size: 15 users per user
group
Final production equivalent
product
All aspects of the UI
Focus on critical tasks
Relies on uFMEA or Hazards Analysis
If design changes are needed
after validation – those
changes must be validated
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17. Documentation
created during
the PDP
• HF/UE Project Plan
• Exploratory Research Plan
• Exploratory Research Report
• Use Specification
• Task Analysis
• uFMEA
• User Interface Specification
• Formative Usability Test Plan (per test)
• Formative Usability Test Report (per test)
• Human Factors Validation Test Plan
• Human Factors Validation Test Report
• HF/UE Project Report
• HF/UE File
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20. US and OUS The IEC report provides
guidance on how to implement
a usability engineering process.
It contains requirements for
safety and human factors.
By following the IEC, AAMI and
FDA guidelines the likelihood
of a successful PMA and/or
510k submission increases
greatly.
Code of Federal
Regulations, Part 820 Title
21.
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23. Initiate Use
Specification
• Use specification is refined over time starting with
Intended use.
• Level of detail is increased through user research
• A Use specification might contain the following:
• Identify user groups which are going to be
approached for interviews
• Identify use environment which is going to be
inspected
• Identify medical indications which are needed to be
further explored
• These elements aid in identifying the known and
foreseeable hazards and hazardous situations related to
the user interface.
• Understanding these elements is necessary to develop an
adequate usability evaluation plan
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24. Methodologies
for
development of
Use Spec
• Contextual Inquiry and Observation
• Researcher observes users while performing User Tasks in intended use
environment and discusses the details with the user
• Interviews and Surveys
• Location agnostic discussion with users as to knowledge, perception and
opinions as they relate to the medical device and its use. This can be
stand-alone or supplement the above-mentioned observation
• Expert reviews
• An expert might cite strengths and weaknesses of a device or heuristic
analysis might be performed where a number of experts independently
identify and prioritize improvements
• Advisory Panel reviews
• 6-12 members who collaborate with the design team on design options.
Such an advisory panel might be leveraged continuously throughout the
design process
• Competitive/Predicate Device Usability Testing
• Performing base-line usability testing to identify strengths and weaknesses
of existing products
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25. Identify
Intended
Users
• Example Primary Users:
• Patients
• Physicians
• Nurses
• Technicians
• Therapists
• Pharmacists
• Emergency Response
Personnel
• Example Non-Primary
Users:
• Assemblers
• Installers
• Trainers
• Transporters
• Engineers
• Repair Personnel
• Recyclers
• Sterile Processors
• Admin Personnel
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26. Develop User
Profiles
• Common characteristics of Users
• Examples include:
• Occupation
• Demographics
• Knowledge and Skills (education, experience
level, language, literacy)
• Limitations (vision, hearing, cognitive,
impairments)
• Performance Shaping Factors (learning style,
preferences, tendencies)
• Work responsibilities (Tasks pertinent to medical
device)
• It may be helpful to develop a “Persona” or a
fictitious user who represents a user profile
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27. Define User
Groups
• Where users share characteristics, users can be
grouped to inform usability
• Examples include:
• Age: Child (>2 yrs to 12 yrs), adolescent (>12
yrs to 21 yrs), Adult (>21 yrs)
• Occupation: Physician, Nurse, Therapist,
Technician, Patient, Installer
• Prior experience using similar medical
devices: New user (none), inexperienced (<6
mo), experienced user (>6 mo)
• Level of training
• Education
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28. Anticipate
Environment
of Use
• Characteristics of the anticipated use
environment should be defined to inform
usability. Examples include:
• Physical environment (gloves, eye protection,
heavy clothing)
• Lighting
• Noise level
• Professional interactions and responsibilities
• Additional equipment present
• Furnishings
• Climate
• Distractions
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30. Finalize Use
Specification
• IEC 62366-1 requires the following:
• Intended Medical Indication
• Intended Patient Population
• Intended Part of the Body or Type of Tissue
Interacted With
• Intended User Profiles
• Intended Use Environment
• Operating Principle
• The following are not required but are
recommended:
• User Tasks (Use Cases, User Stories)
• User needs derived from User Tasks
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31. User
Interface
Specification
• The User Interface Specification consists of:
• The Use Specification
• The known or foreseeable Use Errors
• The selected Hazard-Related Use Scenarios
• The User Interface Specification should be developed
ahead of the User Interface, but then evolve with the
ensuing design
• User interface requirements should be developed to
encompass Instructions for Use and other
Accompanying Documentation
• IEC 62366-1 requires that the manufacturer
determine whether Accompanying Documentation or
Training are required for safe use of the medical
device
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32. Iterative
Formative
Usability
Testing
• IEC Recommends 2 to 3 Formative evaluations to be conducted at a
minimum. They further note that multiple small-scale evaluations can
be more productive than fewer larger scale evaluations.
• Formative Evaluations can vary in formality and methodology but
should begin to resemble the planned Validation as it approaches.
• Both Formative and Summative Evaluations typically involve one or
more Usability Tests.
• IEC 62366-1 requires that the Usability Test Protocol include the
following:
• Participants in the Usability Test to be representative of each
intended User Group
• Test environment and other use conditions, to be representative
of the Intended Use Environment
• The Accompanying Documentation to be provided during the
Usability Test, if any
• The Training to be provided during the Usability Test, if any, and
the minimum elapsed time between training and the beginning of
the Usability Test
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34. Design
Validation
Defined
Validation is the process of making sure that you
have objective evidence that user needs and
intended uses are met. It is usually done by tests,
inspections, and in some cases analysis. However,
the target of the validation is to make sure
the user needs are met in a medical device that
consistently provides the intended medical benefit
in actual-use conditions.
https://www.asme.org/topics-resources/content/validation-verification-for-medical-devices
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35. Design
Verification
Defined
• According to the FDA, design verification is “confirmation
by examination and provision of objective evidence that
specified requirements have been fulfilled.”
• Keep in mind that while it will involve testing, there are
other acceptable verification activities.
• They can include tests, inspections, and analyses (for
more on this, check out FDA Design Control Guidance
• While Validation looks at User Needs, Verification looks
at Product Requirements & Design Specs.
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36. Design
Validation
Guidance
• CFR 820.30
• Design validation. Each manufacturer shall establish and maintain
procedures for validating the device design. Design validation shall be
performed under defined operating conditions on initial production
units, lots, or batches, or their equivalents. Design validation shall
ensure that devices conform to defined user needs and intended uses
and shall include testing of production units under actual or simulated
use conditions. Design validation shall include software validation and
risk analysis, where appropriate. The results of the design validation,
including identification of the design, method(s), the date, and the
individual(s) performing the validation, shall be documented in the DHF.
• The FDA Design Controls Guidance
• VALIDATION METHODS. Many medical devices do not require clinical trials.
• However, all devices require clinical evaluation and should be tested in
the actual or simulated use environment as a part of validation. This
testing should involve devices which are manufactured using the same
methods and procedures expected to be used for ongoing production.
While testing is always a part of validation, additional validation
methods are often used in conjunction with testing, including analysis
and inspection methods, compilation of relevant scientific literature,
provision of historical evidence that similar designs and/or materials are
clinically safe, and full clinical investigations or clinical trials.
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37. Human
factors
Validation
Defined
• Human Factors Validation is a type of Design
Validation
• Demonstrates that devices can be used by the
intended users, under expected use conditions,
without serious use errors or problems.
• Test participants represent the intended (actual)
users of the device.
• All critical tasks are performed during the test.
• The device user interface represents the final
design (production equivalent).
• The test conditions are sufficiently realistic to
represent actual conditions of use.
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38. IEC Guidance Clause 5.9
• The MANUFACTURER shall perform a SUMMATIVE EVALUATION of each
HAZARD-RELATED USE SCENARIO on the final or production equivalent
USER INTERFACE.
• The data from the SUMMATIVE EVALUATION shall be analyzed to
identify the potential consequences of all USE ERRORS that occurred. If
the consequences can be linked to a HAZARDOUS SITUATION, the root
cause of each USE ERROR shall be determined.
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39. FDA Guidance section 3.7
• Testing conducted at the end of the device development process to
assess user interactions with a device user interface to identify use
errors that would or could result in serious harm to the patient or user.
• Human factors validation testing is also used to assess the effectiveness
of risk management measures.
• Human factors validation testing represents one portion of design
validation.
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40. Simulated HFVT
Simulated-use should be
sufficiently realistic so that
the results of the testing are
generalizable to actual use.
It is not acceptable to use of
the “think aloud” technique.
Mirrors participant’s real-life
interaction with labeling.
Testing carried out with final
finished combination
product. (can contain
placebo)
Simulation methods can vary
(e.g., manikin, injection
pads, placebo, etc.)
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41. Test Participants
Represent the population of
intended users.
Minimum number of
participants is 15 for each
distinct user population; (e.g.
pediatric, adult, healthcare
providers and lay users)
For FDA
Reside in the United States
Exceptions to this are considered on a
case-by-case basis.
Does not include your
employees.
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42. Task & Use
Scenarios
• Tasks that logically occur in sequence >
Use Scenarios
• Organize to represent a natural workflow.
• Prior to testing, define user performance
that represents success for each task.
Not just a percentage of completion!
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43. Select
Hazard-
Related Use
Scenarios
• Choose tasks based on severity
• Critical tasks that have a low frequency of occurrence require careful
consideration and should be included in the testing.
• the manufacturer must determine which Hazard-Related Use
Scenarios shall be evaluated
• The purpose of this determination is to ensure that the Validation
includes all Use Scenarios needed to demonstrate Safety related to
the User Interface of the Medical Device
• IEC 62366-1 provides the following three options:
• Include all Hazard-Related Use Scenarios
• Include a subset of Hazard-Related Use Scenarios based on
Severity of Harm
• Include a subset of Hazard-Related Use Scenarios based on
Severity of Harm and circumstances specific to device and
Manufacturer
• HF Validation must also show that Users are able to accomplish the
intended purpose of the Medical Device as described in the Use
Specification
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44. Instructions
for Use
• The labeling must represent the final designs.
• Validation test can indirectly assess the IFU,
but only in the context of use.
• Stating that you mitigated the risks by
“modifying the IFU” is not acceptable, unless
you provide additional test data
demonstrating that the modified elements
were effective in reducing the risks to
acceptable levels
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45. IFU
Knowledge
Tasks • Assess comprehension
• Read-then-do
• Read-then- paraphrase
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46. Participant
Training
• Should approximate the training that actual
users would receive.
• Minimum 1-hour training decay must follow
training
• Longer time may be appropriate if potential
source of use-related risk.
• Stating that you mitigated the risks by
“providing additional training” is not acceptable
unless you provide additional data that
demonstrates that it would be effective in
reducing the risks to acceptable levels.
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47. Objective
Data
Collection
• Observational data - observations of
participants’ performance of all the critical
use
• Knowledge task data - comprehension of
interface components
• DFU, quick start guide, labeling on the device
itself, and training.
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48. Subjective
Data
Collection
• Post Session Interview data from Participants
• Their feedback considering the overall
device focused on each critical task or use
scenario.
• Their identification of any use difficulties,
confusions or errors that were
experienced during the test.
• Their assessment of root cause for any
observed or participant reported use
difficulties, confusions or errors
• Do not use Likert scale ratings
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49. Actual Use
Testing • Definition: Use of final finished product in a
real (not simulated) environment of use.
• It is rare that actual-use testing is determined
to be necessary to ensure safe use of the
proposed device.
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51. Why we do Human Factors Validation Tests
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52. REGULATION
• FDA HF Device Guidance:
• “CDRH recommends that manufacturers
consider human factors testing for medical
devices as a part of a robust design control
subsystem.
• CDRH believes that for those devices where an
analysis of risk indicates that users performing
tasks incorrectly or failing to perform tasks could
result in serious harm, manufacturers should
submit human factors data in premarket
submissions (i.e., PMA, 510(k)).”
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53. We should
Responsible for
safe and effective
products
Controls risk
Reduces support
calls
Reduces
complaints
Reduces recalls
Competitive
advantage
Brand loyalty
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54. What is the difference between a Usability
Test & a Human Factors Validation Test?
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55. Formative
Methods
• Analytical
► Task Analysis
► Heuristic Evaluations
► Expert Reviews
• Empirical
► Interviews & Focus Groups
► Contextual Inquiry
► Formative Studies (Cognitive
Walkthroughs, & Usability Testing)
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56. Goals of Formative Evaluations
COLLECT
FEEDBACK
UNDERSTAND
PAIN POINTS
UPDATE DESIGN ITERATIVE
TEST/EVALUATION
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57. Formative vs.
HF Validation
• Formative – expect to iterate on the design to “form” it
• Formative studies can be relatively short and conducted
with a small number of representative users.
• Conducted early in the design cycle, as few as 8-10
participants can reveal 90 percent of existing design
flaws in the UI that can be modified to eliminate errors
and use problems.
• As the UI design matures, formative studies may be
employed as trial run tests before conducting the final
validation test, which saves significant time and cost by
preventing the need to repeat the validation study due
to residual problems in the interface or the study
methodology itself.
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58. Formative vs.
HF Validation
(cont.)
• Validation – prove safe and effective use
• is not meant to be an exploratory effort seeking inputs on
design features but should serve as a ‘final’ demonstration of
use safety for the device. Therefore, participants are not
interrupted with questions or corrected in their performance.
• Participants engage in use scenarios chosen to represent
sequences of typical interaction with the device. These
scenarios should cover all tasks that have been categorized as
containing high risk in the use risk analysis.
• Training and device familiarization should be provided and
represent realistic conditions. This could be done by conducting
a training session prior to testing with an appropriate
intervening interval to represent potential memory and learning
decay.
• Device instructions for use should be available to the
participant, but with no requirement to read the instructions
prior to performing the use scenarios, unless the participant
chooses to do so on their own.
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59. Formative vs.
HF Validation
(cont.)
• Validation – prove safe and effective use
• User performance on each scenario task (or step) should be
observed and categorized with respect to failure, success, and
success with difficulties such as hesitation, self correcting of
actions, and potential confusion. These instances, along with
failures, should be noted for further post-test analysis.
• Should include a post-test dialogue with the study team in order
to determine the root cause of any failures and difficulties
including both specific questions about unexpected or incorrect
actions, or general questions about task difficulty during the
test.
• Results of the validation test should support an overall
conclusion regarding use safety for the device. This conclusion
should not be based on meeting pre-defined quantitative goals
(i.e. 95 per cent success rate across tasks and participants), but
on whether there is a remaining pattern of use-related
problems that are directly attributable to the UI or
accompanying documentation (labelling and instructions, etc.).
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61. Where is
HFVT within
the Process
• End
• Production Equivalent System
► Training (IFU, ILT, Computer Based)
► Product
► Labels/Labeling
► Hardware
► Software
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62. What Leads to Failure
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63. Use Error
• A situation where device use
was different than intended,
but not due to malfunction
of the device
• Frequently, use errors are
due to poorly designed
devices
• Well-designed medical
devices eliminate or
minimize the possibility of a
user using a device
incorrectly
Easy to use correctly = fewer
medical use errors = safer
device
https://www.fda.gov/medical-devices/human-factors-and-
medical-devices/postmarket-information-device-surveillance-and-
reporting-processes
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64. Common
Mistakes
• Testing an incomplete sample size (fewer than
15 users per user group)
• Lack of evidence or due diligence of developing
an appropriate HF protocol
• Not relying on your use related risk analysis to
drive test scenarios
• Lack of consideration of KUE’s for a predicate
product
• Inability to prove an effective mitigation
• Preparing to make it a formative test if
validation fails
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65. Reasons for validation
Failure
• Failure to conduct formative evaluations
• Validating untested final product and
study design
• Failure to focus on strong mitigations
• Red flags identified before study
initiation
• Timeline priority affecting decisions
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66. Responding to
Validation Failure
• Pause the study
• Redesign your protocol
• Repeat validation
• Convert validation to formative
• Identify opportunities for improvement
• Initiate redesign
• Assess study results
• Determine the validation failures
• Initiate redesign
• Focused validation
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68. Making
Design
Changes
after HFVT
• Considerations for Design Changes after HF
Validation
• ► Clinical study reveals design flaws
• ► Post-market surveillance
• ► Respond to post-market use-related
safety reports, complaints or problems
• ► Meet needs of an expanded indication
or user population
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69. Making
Design
Changes
after HFVT
• Conduct updated use-related risk analysis
• ► Does the design change alter the user
interface in any way (e.g., audible, tactile,
color recognition, user instructions, etc.)?
• ► Does the design change alter an existing
critical task or add a new critical task?
• ► Does the design change alter the
expected users or their knowledge base?
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71. Submitting
an HFVT
Report
Submissions to FDA pre-market approval
process generally require validation test
results
Typical Manufacturer Deficiencies
-Not using the preliminary use risk
analysis to justify testing protocols
-Reporting just the success rates
without making the overall use-safety
case
-Reporting preference results
-Failure to include the right user
groups
-Attributing test result failures to
human error without further
justification
-Failure to test the IFU when indication
it is a risk control
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73. Best Practices
Early research:
•Ethnography
•Customer confirmation
•Build user needs based on data
Iterative formative testing
during design and
development – with all
intended user groups
Ensure a minimum of 15
users per distinct user
group
Your employees should
not serve as test
participants
Be sure to test mitigations
that map to IFU
comprehension
Clearly list critical tasks
and the mitigation you
are testing – linked to a
user need
Clearly define
performance
success/failure
(acceptance criteria)
Clearly describe how you
will identify root cause(s)
of use errors, difficulties,
and close calls
If design changes are
made to any part of a
user facing portion of the
product you must do a
focused validation test
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74. Thank You!
Tressa J. Daniels
tressadaniels@gmail.com
https://www.linkedin.com/in/tressadaniels/
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