In our previous columns, we described six concepts for the successful development of complex medical devices. In this article, we review those concepts and describe the final concept: Aligning quality system procedures to support and embrace these best practices.

CONCEPT 7: Quality Systems for Managing Complexity

What kind of quality system is needed at a medical device company embracing the concepts we have described in our previous columns? Fundamentally, the design control procedures and other parts of the quality system should not undermine or conflict with best practices for managing the development of complex medical devices. There are many ways to comply with design control regulations, and companies should define their design control procedures to align with their product development process and not the other way around.

Further, the design control procedures should provide a robust, scalable framework to organize large projects with large product teams and coordinate the work of multiple sub-teams. The procedures should support multiple design iterations during development, such as in the Micro Projects concept described previously. Also, the procedures should be designed to efficiently manage multiple upgrades after product launch. Quality system procedures that are poorly designed or simply mismatched to the company’s needs will impede every product team.

In the case of the Eagle Project, the quality system procedures exacerbated the problems of the project. The design control procedures were based on a linear development sequence (waterfall approach). The product team was expected to start by fully defining and approving product requirements for the new medical device, then implementing those requirements in hardware and software. The next step involved bringing all those parts together in a single integration milestone (followed by verification and validation (V&V) testing and transfer to manufacturing). 

This very sequential approach forced the team to define the product with insufficient knowledge of user needs and technical limitations; it had no support for iterations to optimize the design and supply chain, and it pushed defects into the late phases of development, where they are the most expensive to fix. The design reviews at the end of each phase focused on completion of documents while ignoring project risks, which allowed those risks to continue unaddressed until they became obvious during system integration and the beginning of V&V testing. Since it had largely skipped over crucial Phase Zero activities, the team started Phase 1 with many big project risks. When the Eagle Project team “finished” Phase 1 of its design controls on schedule, it gave the company a false impression that the project was progressing well. In reality, the team had produced some formal documents based on partial knowledge, misconceptions, and wishful thinking.

Quality system procedures for the development of complex medical devices should emphasize project risk reduction first (i.e., rapid learning), then implementation second. The procedures should support rapid design iterations by allowing design input, design output, design verification, and design validation work all within a single phase. Change control should be lightweight early in development, when the impact is minimal, increasing to full production-level control late in development (i.e., staged change management). The procedures should be flexible enough to scale up with the size of the project and enable the coordination of work of multiple cross-functional teams distributed across different companies. Finally, management of product upgrades, small and large, should be integrated into the procedures so there is no ambiguity about how to manage future changes to the product (i.e., re-entrant design controls). 

Quality system procedures must be designed for the needs of large-scale projects and complex products, but product teams also need appropriate software tools to manage the product data and development processes. For example, managing a few dozen requirements for a simple medical device is straightforward in a document, but a device with hundreds or thousands of requirements needs specialized software tools for efficient development.

Review of Concepts

We began this series on managing the development of complex medical devices by describing what makes these projects different from the development of non-complex medical devices and why that requires a different approach. We have presented this different approach as a set of concepts within the Design Viewpoint column. The first three concepts are crucial for Phase Zero work, while the remaining concepts are applicable throughout development.

CONCEPT 1: Understanding the Customer’s Job (July/August 2024)
Brainstorm questions in Phase Zero with a team to understand customer needs, define product strategy, and select customers for visits. Conduct customer site visits in Phase Zero using a skilled team, seeking insights and refining questions for informed product development.

CONCEPT 2: De-Risking Technology (September 2024)
During Phase Zero, advanced development groups aid in exploring and refining new technology, assessing intellectual property, and defining remaining technical risks before starting product development.

CONCEPT 3: Defining the Product Strategy (October 2024)
An explicit definition of the Product Strategy at the end of Phase Zero ensures development starts in the right direction. Product strategy is analogous to a business plan presented to investors. It includes a market assessment, the regulatory strategy (and whether or not a clinical study will be needed), a product launch strategy, and a description of project risks.

CONCEPT 4: Building the Right Product Team (March 2025)
A successful product development team requires core-team leadership, cross-functional expertise, autonomy based on product needs, and strong leadership skills for complex projects. It’s also important to determine how best to structure a large, diverse, distributed project workforce.

CONCEPT 5: Team Truly Understands (April 2025)
Achieving a shared understanding within the project team is not merely a best practice but the cornerstone of successful project execution. Product development can lose significant time and opportunities for better outcomes when the team isn’t aligned.

CONCEPT 6: Micro Projects and Learning Cycles (May 2025)
Micro Projects involve breaking down product development into smaller, measurable phases (two to eight weeks) to detect issues early, focus work on the biggest unknowns/risks, and get feedback from stakeholders. Managing development as a series of Micro Projects emphasizes rapid prototyping, learning from failures, subsystem integration, and customer feedback.

Conclusion

The challenges in developing complex medical devices are fundamentally a human problem, where leadership and good management are key. The structure of the organization into Product Teams and Core Teams, with good systems leadership, means even very large, distributed teams can function effectively. Fully utilizing the time before product development begins (i.e., Phase Zero on Steroids) is crucial to set the team in the right direction and maximize their chances of success. We discussed how the concepts of keeping the team focused on the customer’s job, operating with trust and collaboration, and using small teams in Micro Projects maximize the value of the development work and identify and resolve problems early. Customer and market check-ins keep the team aligned and aware of the target goals throughout development. We believe these concepts will benefit the development of any innovative new medical device, but are essential for meeting the challenges of developing complex medical devices.

In our next column, we will discuss some methods and tactics to help product teams tackle these challenges.

MORE FROM THESE AUTHORS: Power of Small in Developing Complex Medical Devices

Russ Singleton, principal consultant with Russ Singleton Consulting LLC, is based in California. He has extensive experience in VP R&D, general management, and C-suite roles in the semiconductor equipment and medtech sectors. He holds a Ph.D. and M.S. in electrical engineering from the University of Illinois and a bachelor of engineering from the Pratt Institute.

Aaron Joseph, principal consultant with Sunstone Pilot, is a biomedical engineer based in Waltham, Mass. With over 20 years of experience across a broad range of medical devices, from surgical robotics to medical imaging to IOT and SaMD products, he helps clients efficiently tackle risk management and design controls for new product development.