July 18-19 2012 Planning Meeting
to prepare for Spring 2013 Workshop
on “Medical Device Innovation Using Cyber Physical Systems”
Julian M. Goldman, Chair, Massachusetts General Hospital
This planning meeting is intended to develop the agenda and speakers for a full workshop on Medical Device Innovation that the NSF Cyber Physical Systems (CPS) program will sponsor in Spring 2013. The planning meeting is bringing together invited experts from the clinical and technology domains who, respectively, will define healthcare challenges that can benefit from advanced CPS-enabled technologies, and will describe the kinds of emerging technologies that might be applied in new domains such as health care.
NSF plans to hold a workshop in Spring 2013 to bring together academic, clinical, and industry experts in technologies and processes to identify and explore new manifestations of cyber physical systems (CPS) in design methods and platforms that would encourage radical innovation in next generation diagnostic and therapeutic devices and their control, integration, and manufacturing. Opportunities for CPS-enabled innovation in medical device technology include, as examples, new actuation modalities such as optical, ultrasound and thermal; coordinated interoperation of autonomous and adaptive devices; new methods for device placement and drug delivery; new therapeutic interventions; new concepts for managing and operating medical physical systems using computation and control, miniaturized implantable smart sensing and actuating platforms, energy harvesting, body area networks, programmable materials, and new fabrication approaches such as 3D printing.
The goal of this workshop is to find safer, more effective, more capable, and more reliable solutions than with current approaches, and to consider solutions that will cross the kinds of domains indicated in the topic area examples below. By bringing together cutting-edge technologists with visionary clinicians and biomedical engineers, we hope to stimulate new perspectives and different ways of thinking that generate excitement and foster opportunities for collaboration. The workshop is expected to develop a report by NITRD NCO that guides future science applications for CPS research technology.
This pre-workshop planning meeting will ensure the success of the full workshop. The goal of the planning meeting, which convenes July 18-19 2012, is to develop a program for the full workshop that will enable it to meet its key objectives: (1) educating the CPS community about over-the-horizon (next 5-20 years) medical technology needs and opportunities, and educating the medical device development community about emerging CPS technologies and capabilities; (2) encouraging investigators to think about CPS at the medical device design stage rather than as an afterthought; (3) envisioning how new CPS technology could influence new medical device capabilities and open up new device opportunities; and (4) providing FDA perspective on the pathway to integrate CPS technology and methods into medical technology to make devices more reliable and safe.
The planning meeting participants will work with the following list of topics to organize sessions and content for the full workshop:
- What new medical technology opportunities could change the ways we deliver medical care?
- New biomedical technologies, devices, and concepts needed to make a difference
- Current devices that could be improved (e.g. infusion pumps, pacemakers, ventilators, surgical or medical care robots)
- Improved patient safety through data fusion, clinical decision support, and device control enabled by device integration: medical device interoperability
- Distributed devices
- Core technologies that can be broadly applied
- What kinds of engineering and technologies are needed for future devices? What is different in biologically engineered systems?
- Energy scavengers and micro-powered devices
- Micro-sized systems on a chip
- Mixed fluid-sensor-actuator devices
- Translational opportunities
- Programmable biology
- New ways of containing diagnostic entities
- Models of system components (sensors, actuators, computational)
- Systems, batteries, packaging, electromagnetic interference
- Physiological models for heat transfer, miniaturization of ultrasound, artificial pancreas, device design and verification, etc.
- Use of simulation (models) to assist in product development and validation
- Behavioral attributes of device models
- What development pipeline / development processes are applicable or need to be developed?
- What attributes will these processes produce to support safety and effectiveness?
- How do we assure safety of innovative medical device systems?
- What is the role of a regulated environment in innovation?
- What regulatory strategies need to be undertaken to address the regulatory landscape for innovation?
- How can we architect systems upfront (e.g. with sensors, etc.) to facilitate collection of performance information to enable pre-market validation (e.g. for clinical trials)?
- What are the risks/challenges, especially control issues, that arise from connectivity and networking of devices? How can we explicitly define hazards and mitigation, so as to enable safe systems of integrated medical devices?
- How can modeling and control problems be addressed in such a way as to instill confidence in design and processes?
- How do we educate physical systems scientists in cyber physical systems concepts and practices?
- How do we frame medical device innovation, education, etc. for the future?
Recent meetings on related work:
The proposed workshop will build on a body of work that has been sponsored by NSF CPS over the past eight years, including a series of workshops focused on embedded software and systems in medical devices and on the safe integration of medical device systems to enable device interoperability.
- June 2-3 2005 – High Confidence Medical Device Software & Systems (HCMDSS) Workshop sponsored by NSF in Philadelphia, PA
- June 6-7 2005 – Medical Device Plug-and-Play (MD PnP) Interoperability Workshop sponsored by DoD / TATRC in Boston, MA
- June 25-27 2007 – Joint Workshop on High Confidence Medical Device Software & Systems (HCMDSS) and Medical Device PnP Interoperability sponsored by NSF and DoD / TATRC in Boston, MA
- April 9 2009 – 2nd Joint Workshop on High Confidence Medical Device Software & Systems (HCMDSS) and Medical Device PnP Interoperability sponsored by NSF in San Francisco, CA
- April 11 2011 – 3rd Joint High Confidence Medical Device Software & Systems (HCMDSS) and Medical Device PnP Interoperability Workshop sponsored by NSF in Chicago, IL
Meeting Details
The Planning Meeting will take place on July 18-19, at the NSF in Arlington, Virginia. The meeting is being planned for approximately 45 non-federal participants, plus 10 federal participants. The Program/Steering Committee identified potential participants – academic and clinical, and one from industry – who have been invited to represent expertise in key domains and broad perspectives on the role that technology can play in health care. The Planning Meeting conference grant will reimburse travel expenses (airfare and accommodations) for all invited non-federal participants.
The Planning Meeting will include both plenary sessions and breakout sessions on major topic areas of interest for the full workshop. The first morning we plan to have a series of Clinical Challenge presentations that characterize the challenges of domains such as cardiovascular, neurology, etc. that could be addressed by technology, and a series of presentations on New CPS-Enabled Technologies that may offer solutions in these domains. The afternoon will consist of breakout discussions of major topic areas that could be fruitful for the Full Workshop, and report-back to the entire group. The morning of Day 2 will include several speakers on topics / core technologies related to the breakout discussions, followed by more breakouts and a subsequent discussion to achieve the goal of this Planning Meeting: to finalize the proposed agenda and speakers for the Full Workshop.
July 18-19 2012 Planning Meeting
to prepare for Spring 2013 Workshop
on “Medical Device Innovation Using Cyber Physical Systems”
Julian M. Goldman, Chair, Massachusetts General Hospital
This planning meeting is intended to develop the agenda and speakers for a full workshop on Medical Device Innovation that the NSF Cyber Physical Systems (CPS) program will sponsor in Spring 2013. The planning meeting is bringing together invited experts from the clinical and technology domains who, respectively, will define healthcare challenges that can benefit from advanced CPS-enabled technologies, and will describe the kinds of emerging technologies that might be applied in new domains such as health care.
NSF plans to hold a workshop in Spring 2013 to bring together academic, clinical, and industry experts in technologies and processes to identify and explore new manifestations of cyber physical systems (CPS) in design methods and platforms that would encourage radical innovation in next generation diagnostic and therapeutic devices and their control, integration, and manufacturing. Opportunities for CPS-enabled innovation in medical device technology include, as examples, new actuation modalities such as optical, ultrasound and thermal; coordinated interoperation of autonomous and adaptive devices; new methods for device placement and drug delivery; new therapeutic interventions; new concepts for managing and operating medical physical systems using computation and control, miniaturized implantable smart sensing and actuating platforms, energy harvesting, body area networks, programmable materials, and new fabrication approaches such as 3D printing.
The goal of this workshop is to find safer, more effective, more capable, and more reliable solutions than with current approaches, and to consider solutions that will cross the kinds of domains indicated in the topic area examples below. By bringing together cutting-edge technologists with visionary clinicians and biomedical engineers, we hope to stimulate new perspectives and different ways of thinking that generate excitement and foster opportunities for collaboration. The workshop is expected to develop a report by NITRD NCO that guides future science applications for CPS research technology.
This pre-workshop planning meeting will ensure the success of the full workshop. The goal of the planning meeting, which convenes July 18-19 2012, is to develop a program for the full workshop that will enable it to meet its key objectives: (1) educating the CPS community about over-the-horizon (next 5-20 years) medical technology needs and opportunities, and educating the medical device development community about emerging CPS technologies and capabilities; (2) encouraging investigators to think about CPS at the medical device design stage rather than as an afterthought; (3) envisioning how new CPS technology could influence new medical device capabilities and open up new device opportunities; and (4) providing FDA perspective on the pathway to integrate CPS technology and methods into medical technology to make devices more reliable and safe.
The planning meeting participants will work with the following list of topics to organize sessions and content for the full workshop:
- What new medical technology opportunities could change the ways we deliver medical care?
- New biomedical technologies, devices, and concepts needed to make a difference
- Current devices that could be improved (e.g. infusion pumps, pacemakers, ventilators, surgical or medical care robots)
- Improved patient safety through data fusion, clinical decision support, and device control enabled by device integration: medical device interoperability
- Distributed devices
- Core technologies that can be broadly applied
- What kinds of engineering and technologies are needed for future devices? What is different in biologically engineered systems?
- Energy scavengers and micro-powered devices
- Micro-sized systems on a chip
- Mixed fluid-sensor-actuator devices
- Translational opportunities
- Programmable biology
- New ways of containing diagnostic entities
- Models of system components (sensors, actuators, computational)
- Systems, batteries, packaging, electromagnetic interference
- Physiological models for heat transfer, miniaturization of ultrasound, artificial pancreas, device design and verification, etc.
- Use of simulation (models) to assist in product development and validation
- Behavioral attributes of device models
- What development pipeline / development processes are applicable or need to be developed?
- What attributes will these processes produce to support safety and effectiveness?
- How do we assure safety of innovative medical device systems?
- What is the role of a regulated environment in innovation?
- What regulatory strategies need to be undertaken to address the regulatory landscape for innovation?
- How can we architect systems upfront (e.g. with sensors, etc.) to facilitate collection of performance information to enable pre-market validation (e.g. for clinical trials)?
- What are the risks/challenges, especially control issues, that arise from connectivity and networking of devices? How can we explicitly define hazards and mitigation, so as to enable safe systems of integrated medical devices?
- How can modeling and control problems be addressed in such a way as to instill confidence in design and processes?
- How do we educate physical systems scientists in cyber physical systems concepts and practices?
- How do we frame medical device innovation, education, etc. for the future?
Recent meetings on related work:
The proposed workshop will build on a body of work that has been sponsored by NSF CPS over the past eight years, including a series of workshops focused on embedded software and systems in medical devices and on the safe integration of medical device systems to enable device interoperability.
- June 2-3 2005 – High Confidence Medical Device Software & Systems (HCMDSS) Workshop sponsored by NSF in Philadelphia, PA
- June 6-7 2005 – Medical Device Plug-and-Play (MD PnP) Interoperability Workshop sponsored by DoD / TATRC in Boston, MA
- June 25-27 2007 – Joint Workshop on High Confidence Medical Device Software & Systems (HCMDSS) and Medical Device PnP Interoperability sponsored by NSF and DoD / TATRC in Boston, MA
- April 9 2009 – 2nd Joint Workshop on High Confidence Medical Device Software & Systems (HCMDSS) and Medical Device PnP Interoperability sponsored by NSF in San Francisco, CA
- April 11 2011 – 3rd Joint High Confidence Medical Device Software & Systems (HCMDSS) and Medical Device PnP Interoperability Workshop sponsored by NSF in Chicago, IL
Meeting Details
The Planning Meeting will take place on July 18-19, at the NSF in Arlington, Virginia. The meeting is being planned for approximately 45 non-federal participants, plus 10 federal participants. The Program/Steering Committee identified potential participants – academic and clinical, and one from industry – who have been invited to represent expertise in key domains and broad perspectives on the role that technology can play in health care. The Planning Meeting conference grant will reimburse travel expenses (airfare and accommodations) for all invited non-federal participants.
The Planning Meeting will include both plenary sessions and breakout sessions on major topic areas of interest for the full workshop. The first morning we plan to have a series of Clinical Challenge presentations that characterize the challenges of domains such as cardiovascular, neurology, etc. that could be addressed by technology, and a series of presentations on New CPS-Enabled Technologies that may offer solutions in these domains. The afternoon will consist of breakout discussions of major topic areas that could be fruitful for the Full Workshop, and report-back to the entire group. The morning of Day 2 will include several speakers on topics / core technologies related to the breakout discussions, followed by more breakouts and a subsequent discussion to achieve the goal of this Planning Meeting: to finalize the proposed agenda and speakers for the Full Workshop.