10 FDA Answers on ‘Driving a Culture of Quality for Devicemakers’

By Daniel R. Matlis, President, Axendia

Last month, I had the privilege to moderate a discussion with Capt. Sean Boyd, deputy director for regulatory affairs in CDRH’s Office of Compliance, and Francisco (Cisco) Vicenty, acting program manager of Case for Quality in CDRH’s Office of Compliance.

During the webinar hosted by FDAnews, we discussed topics including:

• The Case for Quality – Why does it matter?
• Are we playing regulatory whack-a-mole?
• How is the role of FDA evolving to encourage a culture of quality for device makers?
• Have “Compliance First” regulatory approaches slowed innovation?
• Who benefits from a focus on quality?
• Are there appropriate substitutes for routine FDA inspections or pre-approval inspections?
• What are the quality outcomes metrics FDA will collect and monitor?
• How will FDA operate as we shift from documents to data/metrics as a result of using quality tools?

In addition, Capt. Boyd and Mr. Vicenty addressed the following audience questions:

Q1: How is the CfQ program different than Quality by Design?

A2: Quality by Design (QbD) is the systematic approach used in the pharmaceutical space for development that focuses on risk management and predefined objectives for product and process control. QbD is more analogous to Design Controls in Quality System Regulation. Case for Quality is an effort to work together with a community of stakeholders to incentivize performance and product quality. This collaboration will allow for faster and better data to drive purchasing decisions and FDA activity.

Q2: How will you measure the success of this program?

A2: This initiative is focused on moving past the compliance base-line and incentivizing manufacturers who produce high quality medical devices through transparency and working to bring these high-performing products to the hands of users faster. One of the efforts of this program has identified seven key outcome measures that will be used to monitor the performance of the products. This program shifts the focus from compliance to continuous improvement. These measures and metrics will become the gauge for success as the program evolves.

Q3: Eliminating device makers from routine inspections, is there a proposal for how long that would last? Such as permanent while CfQs are provided?

A3: This is part of the proposal being developed. FDA is pursuing options for how this would work. First, we want to clarify that the goal isn’t about removing the routine inspection. FDA recognizes that any inspection can be a disruption and we want to adjust for that. We want to be able to leverage data and results to assure that the systems are working through less disruptive means. It moves to better and faster information in place of the routine inspection. CfQ is the title of the larger initiative. There will be a capability appraisal and then submission of the data will be used to monitor. The need for any additional audits or appraisals will be variable based on the capability of the facility and the data shared. As the program matures, an evidentiary appraisal to [Capability Maturity Model Integration] maturity levels will be possible, these then occur every 3 years.

Q4: You suggested “access to data which we haven’t had before….could be uncomfortable…” What type of data do you think would help you better understand the firm’s state?

A4: This is still in development, but there are several KPIs that a manufacturer uses now internally to assess the health of the system. No one is the gold standard, it really is about which is best for your organization. There may be key trends or results that the Agency would care about. These are the ones we would like to have visibility into. Yes, these could be uncomfortable, which is why we are working through a third party to collect and anonymize the data at first. Part of the effort is very dependent on transparency. We understand this needs training and context. Additionally, it means that we need to engage on the trend and how a manufacturer responds, not on how the single instance in time looks. This will be a learning period for all those involved and we are looking to establish principles for how that will be governed.

Q5: Do you think that FDA will actively encourage medtech companies to implement fully electronic DHRs to give full visibility to traceability of production history and quality?

As medical device manufacturing becomes more complex, with more use of electronic components and automation, the practice of validation and verification become directly opposed to manufacturers’ goals of fast changes to processes or operations. What are your thoughts on if this difficult task is inhibiting manufacturers from becoming fully ‘smart’ in the context of the Internet of Things and Industry 4.0 concepts?

A5: FDA will not actively prescribe that a manufacturer needs to implement specific systems. That is driven by the needs and capability of the manufacturer, but we can actively acknowledge the benefits these systems bring, the improved product quality, the improved analysis, and the improved responsiveness. That brings a manufacturer into much higher organizational levels and quality performance. We are prepared to actively encourage that performance. This could have an effect of encouraging implementation and adoption of better systems. FDA can then actively work to clear the path implementation.

Q6: You mentioned possibly needing more information from companies. Are there pieces of information you already clearly believe you need? Does it come from current EQMS, or are there new capabilities needed?

Are regulators from Europe or elsewhere in the world involved in CfQ-type conversations also?

A6: This data is available in various systems that now exist. We don’t have a defined set of data that we need, what we as an agency are working to establish is a defined set of assurances that we need and are working with manufacturers to establish the metrics and data that provide that assurance. As the data evolves and we learn, new capabilities may become apparent, but that will be driven by the whole ecosystem, not FDA.

Currently, this is an FDA regulatory effort and other regulators are not involved yet. A key tenet of Case for Quality is about not creating new regulation, but using data and real world evidence, to be smarter and more efficient in how the regulations that exist are fulfilled.

Q7: Is there a consideration of the interaction of CfQ with global initiatives, such as MDSAP?

A7: Yes, we are engaged with the MDSAP teams to leverage their output as a way to establish a baseline compliance. The elements on assessing capability and performance beyond the baseline are outside the scope of current regulatory models.

Q8: Is the CfQ for a specific product to be submitted for approval or the company as a whole?

A8: CfQ is looking to assess an organization’s capability as a whole. The assessment and maturity model can be applied down to the device, project, or organizational unit. We are looking to incentivize a focus on quality performance, a manufacturer can decide how they want to tackle their internal efforts, but the real value is when the whole company is part of the process. That is where we ultimately want to be as a community. It is not an immediate switch that is turned on and we want to be flexible to that.

Q9: Is this something that industry software providers can partner with CfQ program? For example, MES and PLM providers specific to medical devices?

A9: Yes, one of the key points to this effort is that everyone has a role to play in delivering improved patient outcomes. We have been engaged with industry software providers and they have been an asset in our learning. There is a need for everyone’s expertise in this effort and we welcome any involvement.

Q10: Is this initiative being implemented through the 21st Century Cures Act?

A10: No, this initiative was started in 2011 as a result of Jeffrey Shuren, CDRH director, challenging the entire medical device ecosystem to find a better way. If we are all focused on the goal of improving patient outcomes and delivering high-quality product, then we can find a win-win-win model that can deliver that result. We believe the 21st Century Cures Act provides more opportunities to do that.

See the recorded webinar here: http://axendia.com/wp/fda-discusses-driving-a-culture-of-change-for-devicemakers-webinar/.