is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Tuesday, January 17th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The medical device industry faces a unique challenge; R&D professionals develop products but rarely get a chance to use them, while quality departments lack the data to translate customer needs and marketing specifications into technical requirements and metrics. To compound the issue, FDA will soon have its final HFE Guidance in place, and all device products and companies will have to comply.
Voice of the Customer (VOC) allows device manufacturers to immerse product design teams in the customer’s culture and environment, and this audio conference presentation looks at how to use the VOC process to collect and analyze customer data and integrate it into the design process. Attendees learn how to develop market surveys and other tools to assess the needs of customers, and how to define and categorize customer issues with products. Our speaker discusses the relationship between VOC and HFE principles, and shares critical techniques for new product and product improvement initiatives.
Showing posts with label Maria Shepherd. Show all posts
Showing posts with label Maria Shepherd. Show all posts
Wednesday, January 4, 2012
Friday, November 4, 2011
Advanced Human Factors Engineering
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.
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.
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.
Subscribe to:
Posts (Atom)