is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, November 17th, 2011. For more details or to register, please visit our site at www.fxconferences.com
FDA's expectations are changing. Medical manufacturers are required by FDA and other global regulatory bodies to prove that human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user(s), how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews guidance documents issued by FDA regarding its human factors initiative. The speaker also presents several examples of a human factors engineering project, including templates that have been designed to assist in the process of usability testing in the medical industry.
Showing posts with label human factors. Show all posts
Showing posts with label human factors. Show all posts
Friday, November 4, 2011
Wednesday, July 20, 2011
Conducting Formative and Summative Usability Studies for Medical Devices
is being presented by Adam R. Shames, Director, Human Factors Research, with Design Science Consulting, Inc. and airs on Wednesday, August 24th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA expects it, your customers need it, and if you do it right, usability testing will all but guarantee that your product is a success. Done wrong, your product will never see its commercial launch.
Drawing on several real-life case studies, this audio conference presents attendees with a roadmap for conducting formative usability studies that lead to a successful summative study. Our speaker reviews the relevant standards such as IEC 62366, HE 75, and the FDA draft guidance entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 22, 2011). The presentation provides insight on what device manufacturers need to do – and what not to do – to assure that their product passes its user-interface design validation, and demonstrate to the FDA that they have developed a safe and effective medical device.
The FDA expects it, your customers need it, and if you do it right, usability testing will all but guarantee that your product is a success. Done wrong, your product will never see its commercial launch.
Drawing on several real-life case studies, this audio conference presents attendees with a roadmap for conducting formative usability studies that lead to a successful summative study. Our speaker reviews the relevant standards such as IEC 62366, HE 75, and the FDA draft guidance entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 22, 2011). The presentation provides insight on what device manufacturers need to do – and what not to do – to assure that their product passes its user-interface design validation, and demonstrate to the FDA that they have developed a safe and effective medical device.
Tuesday, June 7, 2011
Medical Market Research Best Practices: Not Just for the Marketing Department
is being presented by Maria Shepherd and airs on Thursday, June 30th, 2011. For more details on this event, or to register please visit our site at www.fxconferences.com
The medical device industry is complex and unique. Medical market research is utilized by a number of other departments in medical device companies, beyond the marketing department. FDA expects regulatory departments to provide market sizing data in submissions. The quality department needs usability research (a sister science to market research in form, but not function) for Human Factors Engineering usability testing mandates by FDA. R&D departments use Voice of the Customer, a tool that relies heavily on solid market research principles to obtain and analyze customer feedback on new product design.
This audio conference reviews basic principles and best practices for finding the market data and clinician (or patient/stakeholder) input that you need to meet the data collection objectives your function requires. The speaker will discuss these techniques and present several examples of market sizing data for regulatory submissions and human factors usability testing tools and best practices. Market research techniques for Voice of the Customer will also be covered in this audio conference, and will review identifying, profiling, screening and recruiting respondents for VOC research. An overview of best practices in interviewing and discussion guide development for the VOC qualitative in-depth component will be reviewed as well as developing, administering and analyzing online surveys for the quantitative component.
The medical device industry is complex and unique. Medical market research is utilized by a number of other departments in medical device companies, beyond the marketing department. FDA expects regulatory departments to provide market sizing data in submissions. The quality department needs usability research (a sister science to market research in form, but not function) for Human Factors Engineering usability testing mandates by FDA. R&D departments use Voice of the Customer, a tool that relies heavily on solid market research principles to obtain and analyze customer feedback on new product design.
This audio conference reviews basic principles and best practices for finding the market data and clinician (or patient/stakeholder) input that you need to meet the data collection objectives your function requires. The speaker will discuss these techniques and present several examples of market sizing data for regulatory submissions and human factors usability testing tools and best practices. Market research techniques for Voice of the Customer will also be covered in this audio conference, and will review identifying, profiling, screening and recruiting respondents for VOC research. An overview of best practices in interviewing and discussion guide development for the VOC qualitative in-depth component will be reviewed as well as developing, administering and analyzing online surveys for the quantitative component.
Wednesday, December 15, 2010
Advanced Human Factors Engineering
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Tuesday, January 25th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
FDA's expectations are changing. Medical manufacturers are required by FDA and other global regulatory bodies to prove that human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user(s), how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews guidance documents issued by FDA regarding its human factors initiative. The speaker also presents several examples of a human factors engineering project, including templates that have been designed to assist in the process of usability testing in the medical industry.
FDA's expectations are changing. Medical manufacturers are required by FDA and other global regulatory bodies to prove that human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user(s), how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews guidance documents issued by FDA regarding its human factors initiative. The speaker also presents several examples of a human factors engineering project, including templates that have been designed to assist in the process of usability testing in the medical industry.
Wednesday, November 17, 2010
HFE 101 – Essentials of Human Factors Engineering
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, December 16th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation is designed for those new to the integration of human factors research into product design, or those who want a basic overview of FDA requirements in this area. This presentation reviews several guidance documents issued by FDA regarding its human factors initiative, and the speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation is designed for those new to the integration of human factors research into product design, or those who want a basic overview of FDA requirements in this area. This presentation reviews several guidance documents issued by FDA regarding its human factors initiative, and the speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Friday, August 20, 2010
Human Factors Requirements and Usability Testing for Medical Devices
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, September 16th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews several guidance documents issued by FDA regarding its human factors initiative. The speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews several guidance documents issued by FDA regarding its human factors initiative. The speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Wednesday, February 3, 2010
Considering Human Factors in Designing Medical Device Trials
Increasingly, FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design. Evaluating the human interface in the user environment produces critical data for pre-market applications to FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.
In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.
Considering Human Factors in Designing Medical Device Trials was presented by Annette Valles-Sukkar, Senior Manager, Clinical Operations, with Pleiad Devices and aired on 2009-05-07. For more details or to download this event, please visit our site at www.fxconferences.com
In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.
Considering Human Factors in Designing Medical Device Trials was presented by Annette Valles-Sukkar, Senior Manager, Clinical Operations, with Pleiad Devices and aired on 2009-05-07. For more details or to download this event, please visit our site at www.fxconferences.com
Friday, November 20, 2009
Friday special - save 75% on "Considering Human Factors in Designing Medical Device Trials"
Increasingly, FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design.
Evaluating the human interface in the user environment produces critical data for pre-market applications to FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.
In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.
But hurry! If you purchase Considering Human Factors in Designing Medical Device Trials by November 26, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
Evaluating the human interface in the user environment produces critical data for pre-market applications to FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.
In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.
But hurry! If you purchase Considering Human Factors in Designing Medical Device Trials by November 26, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
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