Quality Managers | Moving from the Back Seat to the Driver's Seat in Medical Device Development

Written by Eric Sugalski

In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations, quality managers primarily focus on identifying and adhering to consensus standards, routing documentation for design reviews, conducting non-conforming material reporting, auditing suppliers, and the like. As a result, their time is often spent reacting to the work of others, leading to the perception of quality managers as the "police" within organizations. In these cases, quality managers are often pointing out when teams are going the wrong way.

However, it is crucial to recognize that quality management has the potential to play a much more proactive and leadership-oriented role in medical device development. While compliance is undoubtedly important, quality managers can also provide guidance and support to teams, helping them understand the right way to go. By shifting the mode from reacting after-the-fact to proactively leading and guiding the development process, quality managers can drive widespread improvements, enhance efficiency, and avoid many of the issues are discovered during reactive quality management activities. Below are some of the specific ways that quality managers can lead proactively:

Driving the Right Process

Beyond ensuring compliance, quality managers can guide teams in understanding the right way to proceed. Often, technical, regulatory, clinical, and commercial teams are misaligned on the development process. When quality managers react to these misalignments, it often comes too late, and teams end up in a costly and time-consuming redo loop. A better approach is for quality managers to help teams understand the development process up-front and throughout the development process. Process flowcharts can be a simple yet highly effective tool used by quality managers when communicated regularly. Proactive quality managers should be helping teams understand, "here's where we are now" and "here's what we need to do next." 

Usage of process flowcharts seems like a simple concept, but it never ceases to amaze me how experts with decades of medical device experience often have very different views on the "right way" to conduct development. Organizations need to prevent individual team members from going rogue, and doing it their way. The company needs to instead develop its own development process. Then, lock it in. Publish it. Train to it. Overcommunicate it. By getting teams on board with the company's development process, not only will a regulatory-compliant approach be achieved, but efficiency will also be streamlined, and the occurrence of redo loops will be significantly reduced.

Defining the Right Requirements

Another crucial aspect where quality managers can provide guidance is in helping teams converge on the right requirements. Often, the "right requirements" stem from following the right process. For example, some technical teams may be inclined to skip steps like collecting user feedback and instead make assumptions about the use case and user needs. This approach can lead to flawed assumptions and, ultimately, the need for a redo loop, which is often enforced by reactive quality teams. However, if quality drives the right process, activities such as user inquiry and formative human factors studies can trigger the identification of user needs. Once user needs are established, the appropriate design inputs can be linked to them. The same applies to consistent application of risk management early and often during the development process.

Furthermore, drafting requirements is a highly subjective task. Two highly experienced medical device developers will often have very different methodologies for drafting design requirements. In this regard, quality managers need to assist teams in landing on a consistent way of writing requirements for their organization. This can be achieved through training, in-process team collaborations, and design reviews. By establishing a consistent approach to drafting requirements, teams can ensure that the captured requirements accurately meet the clinical, regulatory, commercial, manufacturing, and technical needs.

Creating Team Alignment

In addition to driving process and defining requirements, quality managers also play a crucial role in aligning teams. This alignment extends beyond just the technical aspects and encompasses other business functions as well.

One critical area requiring team alignment is concept down selection. Quality managers can guide teams in defining the right criteria for selecting concepts, taking into account not only technical aspects but also considerations from other business functions such as clinical, regulatory, manufacturing, and commercial. In this regard, quality can serve as the hub that ensures all functions have their needs adequately represented and prioritized. Quality managers can also assist in objectively scoring concepts against these criteria and filtering out concepts through the definition of user needs and design inputs. Furthermore, quality managers can help modify or augment design requirements based on the concept that is selected.

Another area where team alignment is essential is in risk management. Quality managers can provide guidance on how to identify hazards, conduct risk analyses, and complete severity and frequency scoring. In medical device development, risk management is typically evaluated through a clinical lens. While that is most critical, the concepts of risk management can also apply to general business needs. The risk management approach can help teams make better decisions about intellectual property, unit costs, timeline risks, supply chain risks, and much more. One may argue that these perspectives are far outside the domain of quality. Be that as it may, proactive quality managers can leverage these same skills to help multi-disciplinary teams navigate these complex matters that need group input and holistic decisions. And also bear in-mind that if a product doesn't reach patients due to business factors, the lack of a safe and effective solution presents a patient risk that could be argued to fall under the domain of quality.

Overall, team alignment is a critical aspect of quality management, encompassing various areas such as concept down selection and risk management. By aligning teams across different business functions and guiding them in the right direction, quality managers can contribute to the successful development of medical devices.

Moving into the Driver's Seat

In conclusion, quality managers need to transition from a passive role to a more proactive one, taking on the responsibilities of driving the right process, defining the right requirements, and keeping multi-disciplinary teams aligned throughout the development of medical devices. They need to move from the back seat into the driver's seat, maintaining their critical regulatory compliance role but taking a more hands-on approach.

In many ways, quality managers need to operate like project managers, providing leadership, hands-on instruction, and in-process reviews instead of waiting for formal stage gates. In smaller organizations, it may even make sense for quality managers and project managers to be one and the same, as many of their roles and responsibilities overlap. However, if these roles are merged, it is crucial for the merged quality manager and project manager to prioritize product quality and patient safety above project timelines or budgets -- a prioritization that company management needs to acknowledge and agree. Ultimately, the goal is to have quality managers take a more proactive and leadership-driven approach, resulting in successful medical device developments while ensuring regulatory compliance and patient safety.

At Archimedic, our project leaders take on the dual role of project managers and quality managers. We understand the importance of being proactive in defining and driving the development process, establishing clear requirements, and aligning team members throughout the project. If you are in need of proactive quality and project management for your organization, we would be delighted to hear from you. Our team is ready to assist you taking your medical device to its fullest potential while helping you achieve your business goals. Contact us today to discuss how we can support your journey towards success.