Highlights from our discussion with Vis Ayer, Senior Director of Quality at Nevro
In our last blog, we explored why Good Design Controls Are Critical to Avoid FDA Issues. In this second part of our series, Vis Ayer of Nevro shares his experiences on the importance of good design controls. Nevro helps people who are living with chronic pain with an evidence-based pharmacologic neuromodulation platform to treat chronic back and leg pain.
During our recent panel discussion, Vis talked about establishing proper medical device design controls and product development practices. He addressed many issues that occur early in the design process, including managing an outsourced model, design control procedures to help meet compliance, and other common challenges that medical device manufacturers face as they make the shift from manual to electronic systems.
Ann: Thanks, Vis, for joining us today. Let’s start by discussing how design controls have impacted your product development and launch processes.
Vis: It’s great to be here. You know, I realized early on that I had to understand the quality management systems (QMS) of our subcontractors because we outsource all of our design and development activities. Working with a total outsourcing model, your requirements must be thorough and tightly managed. We used to share design documents through emails and FTP sites for review and approval. Internally, we used paper-based change control processes and created design history files (DHFs) using binders. Ensuring the DHF binder was audit-ready was time consuming. With our older paper-based system, it was harder to manage everything. Building, maintaining, and ensuring the paper-based DHF was audit-ready was a huge administrative burden. And, adding international markets and more products only added to our workload.
Now we use an electronic system that streamlines the change control processes and management of DHFs. Our outsource partners have greater access and visibility to different phases, and the requirements, than they did with our older paper-based systems.
Ann: Can you describe your new audit experience?
Vis: Yes. Since we deployed Arena, our audit experience no longer relies on maintaining documents and binders for DHFs. We now share our electronic DHFs with the external auditors and they like the Arena solution. Preparing for an audit is much easier now. We don’t spend a lot of time searching for information anymore. Additionally, our ability to accurately document and perform design controls keeps us compliant with 21 CFR Part 820.30.
Ann: What is the biggest design controls challenge you faced and the impact of using your QMS solution?
Vis: Our product is a Class III active implantable medical device consisting of software, mechanical, and electrical components. We needed to make certain that the integrated system performed as intended. Like many things, planning is critical. At the beginning of our project, we made sure all requirements—including essential performance requirements—were captured. Since we outsourced, we made sure the partner access roles and responsibilities were set up properly in our QMS system. And, all our vendors were qualified and approved per our supplier management process.
Managing the review and change processes with external development partners on a complex product was a huge effort in the past. However, Arena’s product-centric QMS made change control easier. We were able to track, review, and approve revisions using the automated routing process. In addition, Arena helped us manage our DHFs electronically, so the project documents were linked appropriately.
Ann: Keeping in mind your outsourced model, how have you maintained the necessary design controls?
Vis: There is no question that outsourced development and manufacturing adds complexity when trying to maintain regulatory compliance. Our biggest challenge comes from working with our supply chain. We outsource just about everything from development through manufacturing and rely on agile software development. With partners, it’s so important to define who is doing what. Required deliverables must be clearly defined during the design output phase. As you get ready for building units at your contract manufacturer, design verification testing must be done to ensure the units are manufactured using the latest, correct bill of materials (BOM). Having an electronic QMS system built on the product record keeps quality and product teams aligned through the new product introduction process.
Ann: In the past, when you had component issues, did you rely on spreadsheets to find where the component was used?
Vis: Yes, it took a lot of time and there was always the chance we would miss one. Now, our electronic QMS manages the entire product record and BOM. Every component is linked to all assemblies where it is used, making it easier to identify all impacted product lines whenever issues need to be corrected. Searching for where-used assemblies, managing inventory dispositions, and providing supplier access is easy now. Our contract manufacturers are notified of a change to any part and can immediately access the relevant documents within Arena QMS rather than having to pass updated documents via email where it’s easy to lose context of the change. Arena QMS maintains the latest revision by keeping all the related information together in one place.
Ann: We know that risk management is a factor for product development and especially for medical device manufacturers that have to comply with the FDA, ISO, and other regulatory bodies. How does Nevro address risk management?
Vis: Risk management plays a key role in the product development process and throughout the entire product lifecycle: from input, output, verification, and clinical readiness/validation to market release. We use ISO 14971 to identify minimum risk management requirements. We incorporate risk management throughout the design control process. Risk management starts early in the design process, when user needs and design inputs are defined. This early identification of risks helps us manage and deliver successful design verification and validation results.
Ann: As we wrap up, what advice do you have for those looking to create compliant design controls?
Vis: It’s important to understand what you are developing—like user needs, for instance. You need to incorporate risk management activities early in the development process and ensure the user needs are clearly defined during the design input phase. This helps you meet your design output requirements.
The other thing I would recommend is conducting design reviews at the end of each phase. Keep in mind that it’s helpful to conduct multiple design reviews for larger, more complex projects. Be sure to give the project team and the stakeholders enough time, resources, and information to assess the development progress and ensure that critical risks are identified and addressed.
Don’t confuse design verification and validation. Design verification demonstrates the design output meets the design input, whereas the design validation demonstrates the product meets its intended use—user needs.
Finally, you must have a solid and well-controlled change process that provides immediate access to internal and external teams. This speeds the entire development process and avoids quality or compliance issues.
Ann: Those are great tips, Vis. We know that medical device companies must follow good design controls to develop and ship high-quality products to market. And, design controls are not a “nice to have” thing—they are mandated. Establishing and following formal design controls helps companies like yours avoid FDA 483s and warning letters from the FDA.
Ultimately, compliant processes help the medical device manufacturer deliver products that help customers—patients and doctors. And, these processes help avoid quality problems that might harm others, as well as legal or regulatory issues. Stay tuned for our final post in this series as we talk with Organ Recovery System’s Christopher Hill.