Infrastructure, Patients and Quality are FDA CDRHs priorities

This week FDA released their CDRH 2016-2017 Strategic Priorities.  The top three priorities are no surprise to anyone that has been listening to Dr. Jeff Shuren's FDA CDRH vision.  The priorities are highly interdependent; like a three legged stool.


  • Establish a National Evaluation System for medical devices;
  • Partner with patients; and
  • Promote a culture of quality and organizational excellence.


With the focus on surveillance for the past several years and the UDI requirements underway, FDA CDRH has already been spearheading the effort to create an infrastructure that can detect medical device performance and drive technologies to be of highest performance.  One of the core reasons premarket applications have such a high demand for data, is that it is very challenging to monitor device performance in 'real world'.  Imagine if the 'real world' can be easily monitored and tracked.  Innovators can target their initial release on a specific patient population, collect the specific data and get to market faster.  Then incrementally they can learn from the data and adjust the Indication of Use; ideally expanding the Indication of Use.  This strategic priority is really a next step to the 'Rebalancing of the Pre and Post market data requirements'.  

The second priority is directly on patients. With the national focus on patient-centric healthcare, it is fitting that CDRH is taking the work they have done this past decade, to completely embrace patients' voice.  From adding a patient representative to the review panels, to expanding the mission to both protect and promote health, incremental steps have been taken to brining the patients' voice into the process.  In the most recent years the Patient Centered Benefit-Risk Assessment (PCBR) was add as a tool by which to assess Benefit/Risk of a device. Devices' meeting patients' needs sounds great, and I think most device companies get in the business for that reason.  It is the cost of R&D and regulations that challenge companies'.  After all there are less than 4,000 medical device companies in the USA.  If we want more patient-centric devices, then there needs to be an easier way to obtain approval and expand Indication of Use.  There-in lies the interdependency with the National Evaluation System.

Quality is that word that everyone agrees to the desire and need. But defining Quality, in a way that applies to all device types, is like pinning Jell-O to the wall; hard to define without missing something because, to err is human.  Quality is not just great people with a great idea.  That may speak to our passion for quality.  As well, we can set up all the metrics and processes we want, the checklists to monitor, management review meetings for oversight, and even have all the transparency up and down an organization.  But that will not be enough.  Quality is more in line with curiosity.  It is when we stop asking ourselves 'what if' and 'why', is when we stop having quality.  If anything, the engine to Quality is like the 5 year old in all of us.  When was the last time you spent time with a 5 year old in the "why?" conversation?  It is the endless, mind numbing, warp speed tenacity to be curious, which leads to quality.  And just as it is hard to be in the, 5 year old "why?" conversation, for any length of time, so is quality hard to attain and maintain.  For devices to be meeting patients' needs, with the cost of doing business controlled, and approvals efficient, organizations need to have corporate cultures where asking questions and raising concerns is valued.

  • -- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™