mb privitera - Academia.edu (original) (raw)
Papers by mb privitera
The medical device industry requires multi-disciplinary collaboration between researchers and phy... more The medical device industry requires multi-disciplinary collaboration between researchers and physicians (Freudenthal et al. 2011). In responding to the challenges associated with medical device development, Ogrodnick (2013) proposed a collaborative model in which design teams have a/synchronous access to a repository of information regarding the progress of the development of a medical device. This research investigates the nature of interactions between manufacturers and physicians throughout the process of medical device development to facilitate more effective practice. A literature review explored the history of medical devices; design and development processes; overall approaches to design and case studies involving healthcare practitioners coupled with collaborative processes. From this detailed review, three gaps in knowledge were identified: industrial design practice in medical device development is not well described; the models and frameworks of user involvement were un...
Data analysis actually starts in the field when the research team selects where to aim the camera... more Data analysis actually starts in the field when the research team selects where to aim the camera/s and decides what notes are important enough to write down. However, further analysis, post-observation, provides the ability to collate design insights across all data collected and takes a deeper look into the field experiences. The task of analyzing data and providing meaningful conclusion can seem like a daunting task due to the tremendous amount of data collected. This is especially true for large studies or studies with multiple facets. The reality of qualitative research for the purposes of design is that not all of the information collected is actually useful. Analysis skills are necessary to discriminate the valuable information from the noise. Some of the data will be potentially collected for another use while some information may be discarded. For example, say the research team headed out to the operating room (OR) for what was to be a target procedure only to find out that the surgeon changes the devices they use mid-procedure but they have permission to observe and video. If time permits, why not observe and learn. Watching users complete tasks and understand who they are is part of the inquiry and while the data collected is not in the target, the team can gain the flow of the organization and begin the relationship with the study participant. Certainly some of the data collected might fit to be analyzed while the rest can possibly be ignored and stored for another project. At the heart, the process of data analysis includes deciding which pieces of collected information are important in regard to the goals of the study and which pieces are not.
The medical device industry requires multi-disciplinary collaboration between researchers and phy... more The medical device industry requires multi-disciplinary collaboration between researchers and physicians (Freudenthal et al. 2011). In responding to the challenges associated with medical device development, Ogrodnick (2013) proposed a collaborative model in which design teams have a/synchronous access to a repository of information regarding the progress of the development of a medical device. This research investigates the nature of interactions between manufacturers and physicians throughout the process of medical device development to facilitate more effective practice. A literature review explored the history of medical devices; design and development processes; overall approaches to design and case studies involving healthcare practitioners coupled with collaborative processes. From this detailed review, three gaps in knowledge were identified: industrial design practice in medical device development is not well described; the models and frameworks of user involvement were unverified; user involvement was based on formal agency requirements. Empirical studies were undertaken to identify the state of the art in medical device development and opinions of physician users. These studies were conducted to identify the practices, opinions and influences for collaborative medical device design. The industry study consisted of a multiple case study research design and was used to elicit the practices of 18 major medical device manufacturers. Industry participants were selected on the basis of meeting specific criteria in location, size, type of device manufactured and use of industrial design. Interviews with practicing physicians were conducted to gain insights. The responses from the participants were analyzed using NVivo software, card sorting and data visualization to identify routes to more effective engagement in collaboration during medical device design. The findings indicated that there were seven issues ideas priorities for collaborative practice. These included: user integration throughout the development process; the negotiation/ownership of intellectual property; the knowledge of impact to device design; consistent communication between device developers and physician users; timeliness and efficiencies of interactions; the identification/connection of partners; and meeting legal requirements of healthcare laws. These issues were translated into design requirements and six potential tools for cMDD. Using a Pugh matrix, each concept was evaluated against the developed requirements. As a result, the comprehensive computer application concept, which addressed the maximum number of issues, was selected and further developed for the purposes of validation. The navigation and graphic design was completed and a video, which justified the purpose and explained the software, was produced. To evaluate the concept, seven reviewers consisting of both industry representatives and physicians, whom had no previous knowledge of the research project, evaluated the video with positive responses, further potential uses for the software and suggested improvements. This research concludes that within the current regulated process of development there was flexibility in the application of design control during the conceptual phase and that the majority of developers followed a user driven approach to design. Industrial design was responsible for aesthetic design but limited in impact due to a lack of training in clinical science. Physician users are involved however lack knowledge of development process requirements and their impact. Further that there are barriers to collaboration that prevent consistent and valued interactions. Finally, the research resulted in a confirmed app-based tool that would support the promotion of cMDD.
Full text release has been delayed at the author's request until November 3, 2013. Degree MS... more Full text release has been delayed at the author's request until November 3, 2013. Degree MS, University of Cincinnati, Engineering and Applied Science: Biomedical Engineering, 2010. Abstract The lack of a cognitive and haptic interface for catheter medical devices ...
2019 Design of Medical Devices Conference, Apr 15, 2019
Laparoscopic surgery offers multiple clinical advantages over open surgical procedures. The rise ... more Laparoscopic surgery offers multiple clinical advantages over open surgical procedures. The rise in adoption of laparoscopic surgery brings with it unique human factors challenges for surgeons and device developers. The design of laparoscopic surgical tools requires specialized human factors analysis and ergonomic considerations to overcome these challenges. Often, this necessary ergonomic design refinement is a secondary effort after proof-of-concept engineering prototypes demonstrate technological feasibility. In this paper, the evaluation and redesign of an engineering proof-of-concept multimodal hand tool, is presented. The baseline design, a three-in-one laparoscopic hand tool for liver resection, merged three distinct devices into one integrated solution for dissection, vessel sealing, and tissue cautery. The work described herein evolves the initial prototype using a multifaceted human factors analysis and design process. This included the use of operating room and laboratory contextual inquiry, simulated use studies, anthropometric underlays, an iterative design process, and expert reviews. The revised design reduced ulnar deviation based on directed hand position via design, provided dual grip options, added over-molded interaction points, incorporated end-effector rotation, and implemented a new handle and controls layout based on anthropometric underlays. The outcome reinforces the notion that human factors and industrial design principles are required elements of a successful user centered design process.
Most current sit-to-stand devices are electrically powered. These devices, typically chairs, are ... more Most current sit-to-stand devices are electrically powered. These devices, typically chairs, are for home use and are not portable. Yet there is a great need for a device that can be used anywhere. This paper proposes a novel portable device, named the QuickStand. Its working principle is based on a spring which provides partial support. When sitting down, this spring stores energy, which becomes available in getting up. A lock avoids undesired release of spring energy. The device is adjustable to subjects and chairs, making it very versatile. A prototype was manufactured. Technical evaluation showed the ability to provide around 150 N of support force over the whole range of motion. The device was successfully tested on a subject with a full body muscle disorder.
The medical device industry requires multi-disciplinary collaboration between researchers and phy... more The medical device industry requires multi-disciplinary collaboration between researchers and physicians (Freudenthal et al. 2011). In responding to the challenges associated with medical device development, Ogrodnick (2013) proposed a collaborative model in which design teams have a/synchronous access to a repository of information regarding the progress of the development of a medical device. This research investigates the nature of interactions between manufacturers and physicians throughout the process of medical device development to facilitate more effective practice. A literature review explored the history of medical devices; design and development processes; overall approaches to design and case studies involving healthcare practitioners coupled with collaborative processes. From this detailed review, three gaps in knowledge were identified: industrial design practice in medical device development is not well described; the models and frameworks of user involvement were un...
Data analysis actually starts in the field when the research team selects where to aim the camera... more Data analysis actually starts in the field when the research team selects where to aim the camera/s and decides what notes are important enough to write down. However, further analysis, post-observation, provides the ability to collate design insights across all data collected and takes a deeper look into the field experiences. The task of analyzing data and providing meaningful conclusion can seem like a daunting task due to the tremendous amount of data collected. This is especially true for large studies or studies with multiple facets. The reality of qualitative research for the purposes of design is that not all of the information collected is actually useful. Analysis skills are necessary to discriminate the valuable information from the noise. Some of the data will be potentially collected for another use while some information may be discarded. For example, say the research team headed out to the operating room (OR) for what was to be a target procedure only to find out that the surgeon changes the devices they use mid-procedure but they have permission to observe and video. If time permits, why not observe and learn. Watching users complete tasks and understand who they are is part of the inquiry and while the data collected is not in the target, the team can gain the flow of the organization and begin the relationship with the study participant. Certainly some of the data collected might fit to be analyzed while the rest can possibly be ignored and stored for another project. At the heart, the process of data analysis includes deciding which pieces of collected information are important in regard to the goals of the study and which pieces are not.
The medical device industry requires multi-disciplinary collaboration between researchers and phy... more The medical device industry requires multi-disciplinary collaboration between researchers and physicians (Freudenthal et al. 2011). In responding to the challenges associated with medical device development, Ogrodnick (2013) proposed a collaborative model in which design teams have a/synchronous access to a repository of information regarding the progress of the development of a medical device. This research investigates the nature of interactions between manufacturers and physicians throughout the process of medical device development to facilitate more effective practice. A literature review explored the history of medical devices; design and development processes; overall approaches to design and case studies involving healthcare practitioners coupled with collaborative processes. From this detailed review, three gaps in knowledge were identified: industrial design practice in medical device development is not well described; the models and frameworks of user involvement were unverified; user involvement was based on formal agency requirements. Empirical studies were undertaken to identify the state of the art in medical device development and opinions of physician users. These studies were conducted to identify the practices, opinions and influences for collaborative medical device design. The industry study consisted of a multiple case study research design and was used to elicit the practices of 18 major medical device manufacturers. Industry participants were selected on the basis of meeting specific criteria in location, size, type of device manufactured and use of industrial design. Interviews with practicing physicians were conducted to gain insights. The responses from the participants were analyzed using NVivo software, card sorting and data visualization to identify routes to more effective engagement in collaboration during medical device design. The findings indicated that there were seven issues ideas priorities for collaborative practice. These included: user integration throughout the development process; the negotiation/ownership of intellectual property; the knowledge of impact to device design; consistent communication between device developers and physician users; timeliness and efficiencies of interactions; the identification/connection of partners; and meeting legal requirements of healthcare laws. These issues were translated into design requirements and six potential tools for cMDD. Using a Pugh matrix, each concept was evaluated against the developed requirements. As a result, the comprehensive computer application concept, which addressed the maximum number of issues, was selected and further developed for the purposes of validation. The navigation and graphic design was completed and a video, which justified the purpose and explained the software, was produced. To evaluate the concept, seven reviewers consisting of both industry representatives and physicians, whom had no previous knowledge of the research project, evaluated the video with positive responses, further potential uses for the software and suggested improvements. This research concludes that within the current regulated process of development there was flexibility in the application of design control during the conceptual phase and that the majority of developers followed a user driven approach to design. Industrial design was responsible for aesthetic design but limited in impact due to a lack of training in clinical science. Physician users are involved however lack knowledge of development process requirements and their impact. Further that there are barriers to collaboration that prevent consistent and valued interactions. Finally, the research resulted in a confirmed app-based tool that would support the promotion of cMDD.
Full text release has been delayed at the author's request until November 3, 2013. Degree MS... more Full text release has been delayed at the author's request until November 3, 2013. Degree MS, University of Cincinnati, Engineering and Applied Science: Biomedical Engineering, 2010. Abstract The lack of a cognitive and haptic interface for catheter medical devices ...
2019 Design of Medical Devices Conference, Apr 15, 2019
Laparoscopic surgery offers multiple clinical advantages over open surgical procedures. The rise ... more Laparoscopic surgery offers multiple clinical advantages over open surgical procedures. The rise in adoption of laparoscopic surgery brings with it unique human factors challenges for surgeons and device developers. The design of laparoscopic surgical tools requires specialized human factors analysis and ergonomic considerations to overcome these challenges. Often, this necessary ergonomic design refinement is a secondary effort after proof-of-concept engineering prototypes demonstrate technological feasibility. In this paper, the evaluation and redesign of an engineering proof-of-concept multimodal hand tool, is presented. The baseline design, a three-in-one laparoscopic hand tool for liver resection, merged three distinct devices into one integrated solution for dissection, vessel sealing, and tissue cautery. The work described herein evolves the initial prototype using a multifaceted human factors analysis and design process. This included the use of operating room and laboratory contextual inquiry, simulated use studies, anthropometric underlays, an iterative design process, and expert reviews. The revised design reduced ulnar deviation based on directed hand position via design, provided dual grip options, added over-molded interaction points, incorporated end-effector rotation, and implemented a new handle and controls layout based on anthropometric underlays. The outcome reinforces the notion that human factors and industrial design principles are required elements of a successful user centered design process.
Most current sit-to-stand devices are electrically powered. These devices, typically chairs, are ... more Most current sit-to-stand devices are electrically powered. These devices, typically chairs, are for home use and are not portable. Yet there is a great need for a device that can be used anywhere. This paper proposes a novel portable device, named the QuickStand. Its working principle is based on a spring which provides partial support. When sitting down, this spring stores energy, which becomes available in getting up. A lock avoids undesired release of spring energy. The device is adjustable to subjects and chairs, making it very versatile. A prototype was manufactured. Technical evaluation showed the ability to provide around 150 N of support force over the whole range of motion. The device was successfully tested on a subject with a full body muscle disorder.