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.
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
Field Engineer Johnson & Johnson
Installation,Repairs,Maintenance,Updates of Medical Devices.
Extensive travel. Excellent communication skills,Ability to work independently and build customer loyalty.
The impact of electronic data capture on clinical data managementClin Plus
electronic data capture (EDC)-based clinical trials offer operational and cost-effective approaches for ongoing data entry via the Internet for clinical sites; medical monitoring; monitoring by clinical research associates including initial review. Pharmaceutical, biotechnology, and medical device industry, as well as academia and the government, have all begun to adopt EDC as a new data management tool.
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.
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
Field Engineer Johnson & Johnson
Installation,Repairs,Maintenance,Updates of Medical Devices.
Extensive travel. Excellent communication skills,Ability to work independently and build customer loyalty.
The impact of electronic data capture on clinical data managementClin Plus
electronic data capture (EDC)-based clinical trials offer operational and cost-effective approaches for ongoing data entry via the Internet for clinical sites; medical monitoring; monitoring by clinical research associates including initial review. Pharmaceutical, biotechnology, and medical device industry, as well as academia and the government, have all begun to adopt EDC as a new data management tool.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Leverage Your EDC Solution to Mitigate Risk in Clinical Researchwww.datatrak.com
Every clinical trial is built upon a study protocol - the cornerstone of any trial. A well-defined and written study protocol provides the blueprint for the study, defining its purpose and goals. Studies have become more complex, creating more complicated study design, which can lead to making adherence more challenging for the study team and participants. The potential risk that some aspect of the study could be done incorrectly or not comply is inherent in all studies, but particularly present in complex research.
In order to help mitigate risk, advances in technology and the tools available today provide ways for us to mitigate some of the risk introduced in our clinical trials. While the study protocol is a cornerstone for the clinical trial, electronic data capture (EDC) applications have evolved in the broadest sense into technology solutions that provide us with a variety of tools to help mitigate risk.
We're developing augmented reality software to help clinicians with pre-surgical planning by providing them with patient-specific, high fidelity 3D holograms that have been derived from the same data used to generate conventional CT scans and MRIs.
• EMR System Analyst
• Consulting Sales and clients on various Health IT Product (HERs,EMRs, Patient Portals, Labcorp Client Products). Liaison between Corp IT and Various Vendors. Developing new workflows for each unique physician practice.
• Include onboarding various Hospital HIS system and assist pre/post live support.
• Project Management of clinical office’s EDI implementations.
• Post-live Clinical duties include visiting with Physicians and taking their feedback to Corp IT to help improve Labcorp results.
• Managing various departments within Labcorp to help projects live.
• Responsible for planning, implementing and supporting customers and a variety of EMR vendor applications interface.
• Tests and verifies that EMR solutions are performing according to standards.
• Researches, analyzes, and recommends solutions to potential interface problems.
• Experienced medical professional with evidence of consistently meeting and exceeding established goals related to management, training and education, and client relations
• Skilled in building long-term relationships with all levels of hospital staff and reference laboratories and medical equipment representatives
• Effectively promoted organizational growth and staff development, securing necessary industry- related designations, and increasing overall patient volume
• Self-motivated to ably coordinate daily clinic functions, with excellent interpersonal communications, relationship management and presentation skills
• Participated in over one million HIV tests in the last ten years in different methods, including ELISA, EIA, Oraquick, OraSure and PCR
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Leverage Your EDC Solution to Mitigate Risk in Clinical Researchwww.datatrak.com
Every clinical trial is built upon a study protocol - the cornerstone of any trial. A well-defined and written study protocol provides the blueprint for the study, defining its purpose and goals. Studies have become more complex, creating more complicated study design, which can lead to making adherence more challenging for the study team and participants. The potential risk that some aspect of the study could be done incorrectly or not comply is inherent in all studies, but particularly present in complex research.
In order to help mitigate risk, advances in technology and the tools available today provide ways for us to mitigate some of the risk introduced in our clinical trials. While the study protocol is a cornerstone for the clinical trial, electronic data capture (EDC) applications have evolved in the broadest sense into technology solutions that provide us with a variety of tools to help mitigate risk.
We're developing augmented reality software to help clinicians with pre-surgical planning by providing them with patient-specific, high fidelity 3D holograms that have been derived from the same data used to generate conventional CT scans and MRIs.
• EMR System Analyst
• Consulting Sales and clients on various Health IT Product (HERs,EMRs, Patient Portals, Labcorp Client Products). Liaison between Corp IT and Various Vendors. Developing new workflows for each unique physician practice.
• Include onboarding various Hospital HIS system and assist pre/post live support.
• Project Management of clinical office’s EDI implementations.
• Post-live Clinical duties include visiting with Physicians and taking their feedback to Corp IT to help improve Labcorp results.
• Managing various departments within Labcorp to help projects live.
• Responsible for planning, implementing and supporting customers and a variety of EMR vendor applications interface.
• Tests and verifies that EMR solutions are performing according to standards.
• Researches, analyzes, and recommends solutions to potential interface problems.
• Experienced medical professional with evidence of consistently meeting and exceeding established goals related to management, training and education, and client relations
• Skilled in building long-term relationships with all levels of hospital staff and reference laboratories and medical equipment representatives
• Effectively promoted organizational growth and staff development, securing necessary industry- related designations, and increasing overall patient volume
• Self-motivated to ably coordinate daily clinic functions, with excellent interpersonal communications, relationship management and presentation skills
• Participated in over one million HIV tests in the last ten years in different methods, including ELISA, EIA, Oraquick, OraSure and PCR
How User Experience Design and Human Factors Engineering can Accelerate Produ...Greenlight Guru
A growing number of medtech companies are embracing User Experience (UX) Design and Human Factors Engineering (HFE) — not just to meet FDA regulations, but also to create more intuitive, more usable, and holistically better products. These practices required to promote safety and efficacy also provide an opportunity for your company to quickly deliver products that are more innovative, which can be a key differentiator in the competitive medical device market.
This session will answer the questions: what is Human Factors Engineering and why is it important? We’ll also cover:
• Human Factors guidance and regulations
• Human Factors Engineering process overview
• Differences between regulatory usability and UX
• How to use UX to feed regulatory development
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.
Here is our corporate profile, you will find information about all our solutions for vaccines clinical trials and also patient's programs. We have a variety of mobile and web apps that have been developed to enhance and improve your results in any clinical trial or patient care system.
1. CHRISTA (AARON) MEYER
222 Forkner Drive #20 706-766-1106
Decatur, GA 30030 cmeyer10513@gmail.com
EDUCATION
Georgia Institute of Technology, Atlanta, GA
Bachelor of Science in Biomedical Engineering, December 2010
EMPLOYMENT
SGS North America Suwanee, GA 1/2014 - Present
Project Engineer
• Perform product certification evaluations of medical devices to US, Canadian, and other International Standard versions of IEC
60601-1, Medical Electrical Equipment- Part 1: General requirements for Basic Safety and Essential Performance
• Evaluate Risk Management Procedure and product specific assessments in accordance with ISO 14971 and IEC 60601-1
• Evaluate PEMS documentation (Programmable Electrical Medical Systems) to IEC 60324 in accordance with IEC 60601-1
• Perform evaluations of particular and collateral standards for device specific applications. Examples include home healthcare,
electrocardiographs, high frequency surgical equipment, ultrasonic medical diagnostic and monitoring equipment, and medical
non-laser light sources
• Responsible for providing communication of project status between the client, management and sales staff throughout the
evaluation, testing and certification process
Guided Therapeutics, Inc Norcross, GA 4/2011 – 10/2013
R&D Engineer (R&D Department)
• Worked on development of spectroscopy based diagnostic device for Barrett's Esophagus
• Assisted with development of interstitial fluid harvesting device
• Assisted with the clinical feasibility study with exposure to Informed Consent and Case Report Forms
• Responsibilities have included writing test procedures, troubleshooting circuit design, preparing the Bill of Materials and
ordering for the Alpha phase
R&D Engineer (Engineering Department)
• Assisted with verification and validation testing of LuViva, a cervical cancer spectroscopy based diagnostic device
• Primary author and coauthor on many software test procedures and requirements documents
• Assisted with the administration of the secure document library
Center for Assistive Technology and Environmental Access Atlanta, GA 1/2009 - 12/2010
Student Research Assistant
• Initial project was to create a modified gaming controller with larger buttons to allow persons with disabilities that inhibit fine
motor control to participate in game play. Two modified gaming systems are in use at Children's Healthcare of Atlanta that
allowed disabled persons to participate in game play.
• Current project is on a study of pressure ulcer prevention. Testing of the pressure mapping system proved that sensors were
malfunctioning; this development led to an opportunity to research and design a new pressure mat.
• Characterized and developed a calibration protocol for a set of sensors that measure blood flow in buttock tissue.
• Assisted with various other research projects when pressure mapping was necessary.
PROFESSIONAL SKILLS
Computer: Proficient in Microsoft Office, Solidworks, and Google Sketch-up. Experienced with Matlab, LabView, Altium Designer,
and Photoshop, with some exposure to MPLAB. Exposure to automated testing (Ranorex), and creating Batch Files.
Languages: Experience with Spanish writing and reading.
Other: Experience with soldering.
EXTRACURRICULAR ACTIVITIES
Junior League of Dekalb County, 2015-2016 Tour of Kitchens Chair and Mary Gay House Endowment Fund Committee Member
Furkids, Volunteer and Adoption Team Member
Alpha Phi Atlanta Alumnae Chapter, Member
