Christopher Delporte, Editorial Director05.14.14
As consumers, we’re used to providing feedback about everyday products and services. How did you like your stay at XYZ hotel? Would you take a minute to fill out a brief survey about your new smartphone app? If you don’t ask, you don’t get. Sounds simple enough, right? Such information is critical for new product development or iterative improvements to an existing product or
service, and providing that kind of feedback is commonplace.
But what about with medical devices? Hmm… can’t remember the last survey you filled out? Well, it’s because you probably haven’t. But that may change soon enough.
In late April, the U.S. Food and Drug Administration (FDA) awarded a contract worth approximately $500,000 to the Medical Device Innovation Consortium (MDIC) to conduct research to better understand patient preferences and how to integrate them into the development of medical devices.
Minneapolis, Minn.-based MDIC is a non-profit organization formed in 2012 to enhance regulatory science around medical devices. The group claims it’s the first public-private partnership created with the sole objective of advancing medical device regulatory science in an effort to improve product safety and performance while at the same time reducing cost and time to market. The consortium functions in what it terms a “pre-competitive medical device space,” providing a forum for collaboration to leverage resources and share information.
Industry and the FDA have been trying to find scientifically valid ways to reliably assess patient views on the potential benefits and risks of devices. Developers, regulators and patient groups see the value in weighing device benefits and risks from the patient perspective, but there aren’t any guidelines on how to collect and use this data.
“The comparison of benefits and risks that is critical to the regulatory process should include the perspective of patients, since they’re the ones taking the risks of a medical intervention to achieve clinical benefits,” said Bill Murray, president and CEO of MDIC.
MDIC’s Patient-Centered Benefit-Risk Project, funded by the contract, will bring together patient advocates, industry representatives, FDA staff and academics to find “measureable ways to bring patient perspective into such benefit-risk determinations through the use of robust assessment tools,” according to MDIC.
The one-year project has three goals. Researchers want to create: a catalog of methods for assessing patient preferences about medical devices; a framework for incorporating that information into device development and benefit-risk assessments; and an agenda for further research. The results, which are expected during the first half of next year, will be posted on the MDIC website.
In 2012, the FDA’s Center for Medical Devices and Radiological Health (CDRH) issued guidance for manufacturers on how it makes benefit-risk determinations during the pre-market process. The agency emphasized that “patient tolerance of risk and perspective on benefits” is important. While FDA’s guidance discusses the importance of the patient perspective in certain regulatory decisions, it does not outline how such information should be collected or used. For example, what types of patient preferences should be measured? How and when should this information be provided to inform regulatory authorities?
MDIC formed a steering committee of member organization representatives, patient advocates, the FDA and other experts to work on the project. The FDA contract will help support its work, enabling the committee to catalogue methods of assessing patient preferences and develop a framework to help guide the use of the data.
The FDA recently has made a push to bring patients into the loop. The agency has revamped its website to make patient input about medical devices—not just about reporting errors—easier. In September last year, the FDA convened a two-day workshop (an agency first) titled “The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Process.” MDIC’s Murray was a speaker during the event. The gathering was a move to involve patients, caregivers, healthcare providers, researchers and industry to discuss ways to incorporate patient preferences in the evaluation of the risks and benefits of the medical devices.
“In trying to incorporate patient preferences into our regulatory decisions, it’s important to know how to accurately and reliably measure their preferences for treating and diagnosing their conditions,” according to a blog by Michelle McMurry-Heath, M.D., Ph.D., CDRH associate director for science. “So, we’re also trying to advance the tools and methods that could be used to do so.”
It will be interesting to see where this move to chart quantifiable patient preference information on a broader scale will lead the FDA and the industry. Of course, human factors data is always of interest to medical device companies and critical to device submissions. But now, in addition to the risk-benefit considerations, in-depth data about what patients actually like (or more importantly don’t), also could chart new territory for changes in design, marketing and even manufacturing practices.
How will medical device companies use this information? It might be too early to tell. But when the time comes, just ask.
Christopher Delporte
Editorial Director
cdelporte@rodmanmedia.com
service, and providing that kind of feedback is commonplace.
But what about with medical devices? Hmm… can’t remember the last survey you filled out? Well, it’s because you probably haven’t. But that may change soon enough.
In late April, the U.S. Food and Drug Administration (FDA) awarded a contract worth approximately $500,000 to the Medical Device Innovation Consortium (MDIC) to conduct research to better understand patient preferences and how to integrate them into the development of medical devices.
Minneapolis, Minn.-based MDIC is a non-profit organization formed in 2012 to enhance regulatory science around medical devices. The group claims it’s the first public-private partnership created with the sole objective of advancing medical device regulatory science in an effort to improve product safety and performance while at the same time reducing cost and time to market. The consortium functions in what it terms a “pre-competitive medical device space,” providing a forum for collaboration to leverage resources and share information.
Industry and the FDA have been trying to find scientifically valid ways to reliably assess patient views on the potential benefits and risks of devices. Developers, regulators and patient groups see the value in weighing device benefits and risks from the patient perspective, but there aren’t any guidelines on how to collect and use this data.
“The comparison of benefits and risks that is critical to the regulatory process should include the perspective of patients, since they’re the ones taking the risks of a medical intervention to achieve clinical benefits,” said Bill Murray, president and CEO of MDIC.
MDIC’s Patient-Centered Benefit-Risk Project, funded by the contract, will bring together patient advocates, industry representatives, FDA staff and academics to find “measureable ways to bring patient perspective into such benefit-risk determinations through the use of robust assessment tools,” according to MDIC.
The one-year project has three goals. Researchers want to create: a catalog of methods for assessing patient preferences about medical devices; a framework for incorporating that information into device development and benefit-risk assessments; and an agenda for further research. The results, which are expected during the first half of next year, will be posted on the MDIC website.
In 2012, the FDA’s Center for Medical Devices and Radiological Health (CDRH) issued guidance for manufacturers on how it makes benefit-risk determinations during the pre-market process. The agency emphasized that “patient tolerance of risk and perspective on benefits” is important. While FDA’s guidance discusses the importance of the patient perspective in certain regulatory decisions, it does not outline how such information should be collected or used. For example, what types of patient preferences should be measured? How and when should this information be provided to inform regulatory authorities?
MDIC formed a steering committee of member organization representatives, patient advocates, the FDA and other experts to work on the project. The FDA contract will help support its work, enabling the committee to catalogue methods of assessing patient preferences and develop a framework to help guide the use of the data.
The FDA recently has made a push to bring patients into the loop. The agency has revamped its website to make patient input about medical devices—not just about reporting errors—easier. In September last year, the FDA convened a two-day workshop (an agency first) titled “The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Process.” MDIC’s Murray was a speaker during the event. The gathering was a move to involve patients, caregivers, healthcare providers, researchers and industry to discuss ways to incorporate patient preferences in the evaluation of the risks and benefits of the medical devices.
“In trying to incorporate patient preferences into our regulatory decisions, it’s important to know how to accurately and reliably measure their preferences for treating and diagnosing their conditions,” according to a blog by Michelle McMurry-Heath, M.D., Ph.D., CDRH associate director for science. “So, we’re also trying to advance the tools and methods that could be used to do so.”
It will be interesting to see where this move to chart quantifiable patient preference information on a broader scale will lead the FDA and the industry. Of course, human factors data is always of interest to medical device companies and critical to device submissions. But now, in addition to the risk-benefit considerations, in-depth data about what patients actually like (or more importantly don’t), also could chart new territory for changes in design, marketing and even manufacturing practices.
How will medical device companies use this information? It might be too early to tell. But when the time comes, just ask.
Christopher Delporte
Editorial Director
cdelporte@rodmanmedia.com
