11.11.15
Leveraging “big data.” Improving device cybersecurity. Incorporating patient preference in policymaking.
Those are just a few of the goals the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has set for itself in 2016, as outlined in a nine-page document released in October. The dossier lists the agency’s 10 major priorities for 2016—goals intended to foster regulatory science development, standards, and methodologies used to study the safety, effectiveness, performance, and quality of medical devices.
According to the report, CDRH will focus on 10 priority areas in 2016:
“…Harvesting and analyzing information from data warehouses may aid the regulatory process by streamlining scientific review and identifying potential emerging post-market issues earlier in the process. Therefore, it is important to develop appropriate informatics capabilities and information technology/software tools to collect, store and analyze Big Data relevant to enhancing safety, performance, and/or quality of medical devices,” the report states.
In light of recent threats to public health, the CDRH is making safety a priority, vowing to develop a comprehensive approach on device reprocessing techniques, taking into account such factors as device design and disinfection methodologies. “To minimize patient harm from inadequately reprocessed devices and to enhance the safety, effectiveness, performance, and/or quality of these devices, it is critical to develop a comprehensive approach to address the effectiveness of reprocessing techniques,” the report states. “Approaches should encompass the areas of device design; human factors; reprocessing instructions; reprocessing methodologies; validation methods for reprocessing, including cleaning and high-level disinfection; validated markers of successful reprocessing; and surveillance of reprocessed devices in healthcare facilities.”
On growing cybersecurity concerns, the agency contends that research is needed to “enhance performance and security of medical devices and interoperability, and to understand the impact of software modifications on device performance.”
According to the report, the CDRH wants to develop human factors research tools and apply engineering principles into device design and usability, which are areas associated with many device recalls and adverse events.
In addition, the agency is looking to reduce dependence on animal testing by using alternative tools like chemical characterization, computational, or in-silico modeling to test the biological risk/biocompatibility of device materials. Likewise, CDRH bigwigs maintain that alternative tools are needed to determine the ways in which new materials and technologies such as surface coatings, materials corrosion and additive manufacturing impact device quality, performance and safety.
“There is a gap in the availability of tools and methodologies to assess the impact of various materials and material types on the quality, performance and safety of medical devices, particularly when trying to predict long-term clinical outcomes. There is a need to improve the non-clinical assessment of physicochemical and mechanical performance of devices,” the report notes.
The Regulatory Science Subcommittee (RSS) of the CDRH Center Science Council, created in 2013, developed the priorities and needs assessments based on collections made by the RSS across all CDRH offices, according to a report from the Regulatory Affairs Professionals Society. The process of crafting the list of priorities is meant to be participatory from all stakeholders, in support of a better regulatory science environment.
“We envision that our external stakeholders can use these priorities to better target their regulatory science resources as well complement these activities. In addition, we believe that collaboratively we can work to maximize the impact of regulatory science research investments,” CDRH states in its report.
Those are just a few of the goals the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has set for itself in 2016, as outlined in a nine-page document released in October. The dossier lists the agency’s 10 major priorities for 2016—goals intended to foster regulatory science development, standards, and methodologies used to study the safety, effectiveness, performance, and quality of medical devices.
According to the report, CDRH will focus on 10 priority areas in 2016:
- Leveraging “big data” for regulatory decision making;
- Leveraging evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision-making;
- Improving the quality and effectiveness of reprocessing reusable medical devices;
- Developing computational modeling technologies to support regulatory decision-making;
- Enhancing the performance of digital health and medical device cybersecurity;
- Incorporating human factors engineering principles into medical device design;
- Modernizing biocompatibility/biological risk evaluation of medical device materials;
- Advancing methods to predict clinical performance of medical devices and their materials;
- Advancing the use of patient-reported outcome measures in regulatory decision-making; and
- Collecting and using patient experience/preference in regulatory decision-making.
“…Harvesting and analyzing information from data warehouses may aid the regulatory process by streamlining scientific review and identifying potential emerging post-market issues earlier in the process. Therefore, it is important to develop appropriate informatics capabilities and information technology/software tools to collect, store and analyze Big Data relevant to enhancing safety, performance, and/or quality of medical devices,” the report states.
In light of recent threats to public health, the CDRH is making safety a priority, vowing to develop a comprehensive approach on device reprocessing techniques, taking into account such factors as device design and disinfection methodologies. “To minimize patient harm from inadequately reprocessed devices and to enhance the safety, effectiveness, performance, and/or quality of these devices, it is critical to develop a comprehensive approach to address the effectiveness of reprocessing techniques,” the report states. “Approaches should encompass the areas of device design; human factors; reprocessing instructions; reprocessing methodologies; validation methods for reprocessing, including cleaning and high-level disinfection; validated markers of successful reprocessing; and surveillance of reprocessed devices in healthcare facilities.”
On growing cybersecurity concerns, the agency contends that research is needed to “enhance performance and security of medical devices and interoperability, and to understand the impact of software modifications on device performance.”
According to the report, the CDRH wants to develop human factors research tools and apply engineering principles into device design and usability, which are areas associated with many device recalls and adverse events.
In addition, the agency is looking to reduce dependence on animal testing by using alternative tools like chemical characterization, computational, or in-silico modeling to test the biological risk/biocompatibility of device materials. Likewise, CDRH bigwigs maintain that alternative tools are needed to determine the ways in which new materials and technologies such as surface coatings, materials corrosion and additive manufacturing impact device quality, performance and safety.
“There is a gap in the availability of tools and methodologies to assess the impact of various materials and material types on the quality, performance and safety of medical devices, particularly when trying to predict long-term clinical outcomes. There is a need to improve the non-clinical assessment of physicochemical and mechanical performance of devices,” the report notes.
The Regulatory Science Subcommittee (RSS) of the CDRH Center Science Council, created in 2013, developed the priorities and needs assessments based on collections made by the RSS across all CDRH offices, according to a report from the Regulatory Affairs Professionals Society. The process of crafting the list of priorities is meant to be participatory from all stakeholders, in support of a better regulatory science environment.
“We envision that our external stakeholders can use these priorities to better target their regulatory science resources as well complement these activities. In addition, we believe that collaboratively we can work to maximize the impact of regulatory science research investments,” CDRH states in its report.