From Software as a Medical Device (SaMD), to additive manufacturing and the increasing flexibility of product lifecycle management systems, the medical device development landscape has evolved dynamically in recent decades – placing it increasingly at odds with the FDA’s 1997 design control guidance.
Built on a traditional waterfall framework developed in the 1970s, which dictates a sequential approach that offers minimal iteration or flexibility, the FDA’s guidance has remained unaltered for more than 25 years.
Innovators, designers, and regulators alike grapple with fitting today’s cutting-edge devices into yesterday’s guidelines.
Regulatory updates made in the last few years shine a light on the ageing guidelines. For example, the FDA’s Quality System Regulation (QSR) 21 CFR Part 820 governing medical device design controls remains fundamentally robust. However, the organisation has increasingly emphasised the integration of risk management (ISO 14971), human factors engineering (ISO 62366), and other standards into the design control process. And in 2021 the FDA aligned the QSR with ISO 13485:2016, harmonising these Quality Management System Regulation (QMSR) requirements and streamlining compliance processes internationally.
Additionally, the EU Medical Device Regulation (MDR) significantly changed the EU’s regulatory requirements, emphasising clinical evaluation, post-market surveillance and lifecycle management. Design controls under the MDR require more rigorous documentation and traceability, reflecting the need for continuous monitoring and assessment of device performance and safety.
Squaring the technological advancements and dynamic processes that are driving medtech innovation in 2024 with the inflexible waterfall model is difficult.
Product lifecycle management (PLM) systems can now maintain design control data in live databases rather than on paper or in traditional electronic platforms such as Excel, enabling a dynamic approach that can be updated quickly to reflect changes to design requirements, specifications and the associated risks. But this jars with the inflexibility of FDA guidelines for the design process.
SaMD Also Challenges Traditional Design Control
Software as a Medical Device (SaMD) and other digital medical technologies have been adopted rapidly – another challenge to traditional design control frameworks.
The FDA’s specific guidance for SaMD, emphasising a total product lifecycle approach and risk-based frameworks, is a positive step forward. However, it needs to go much further to accommodate rapid iteration cycles, continuous software updates and cybersecurity considerations, as well as encompassing all types of medical devices.
Additive manufacturing, or 3D printing, is a truly exciting development and will be at the heart of innovation for years to comebut has introduced further complexities in design controls relating to material properties, manufacturing processes and consistency in product performance.
So while new guidance has been issued by regulatory bodies on the use of 3D printing in medical device manufacturing to highlight the need for robust design validation and process controls, the approaches to verification and validation will need to be modified to reflect this new manufacturing method.
The integration of agile and lean methodologies in medical device development requires adapting traditional design controls to ensure regulatory compliance while maintaining flexibility and speed.
Having accessible information which reflects the device design in ‘real time’ can enhance responsiveness to user feedback and regulatory changes.
Bob Cooper, who developed the prominent innovation management process called Stage-Gate, has issued modifications to reflect a more flexible agile development process, incorporating iterative cycles within the individual stages to allow continuous feedback, adaptation and faster response to changes while maintaining structured decision points.
The Product Development and Management Association (PDMA) agrees that waterfall is only suitable for small well-defined projects with requirements that can be fully understood at the start. Large complex projects with frequent requirement changes due to learning cycle and early testing just don’t fit well.
There is no doubt that design control processes have been impacted by the increasing emphasis on post-market surveillance and real-world evidence collection due to the continual monitoring and assessment of the device and its lifecycle. But the iterative improvements and ongoing compliance and safety benefits realised by that surveillance and RWE collection is invaluable, and also helps to feed future innovation.
Medtech design control has been subjected to multifaceted change over the past quarter-century, and this will continue unabated. In fact, FDA approvals reached an all-time high in 2023, according to consulting firm McKinsey, with more approvals for AI and machine-learning-enabled medtech products than ever before. Digital innovations such as neuromodulation and robotics also show a steady increase, which only goes to underline the imperative for change.
New product development (NPD) is more dynamic, iterative and concurrent, which fits uneasily into the current phased process. Design and development documentation are not fixed at the time of launch; they are now fluid and reflect new knowledge from real-world use. And it is fair to say the use of advanced product development tools and practices creates tension between the expectations of QMS and documenting what really occurs in NPD.
The traditional rigid design history file format is no longer suitable for the modern medtech landscape. It’s time to embrace a more dynamic and interconnected approach that leverages the power of technological advancements. The implementation of the FDA’s new Quality Management System Regulation (QMSR) and the adoption of the approach outlined in ISO 13485 are expected to bring about a significant transformation in the industry. With this the terminology “Design History File” (DHF) and “design controls” will gradually become obsolete. It is imperative for companies, especially large ones, to reassess their approach to the stage-gate process, project management methodologies, and design and development tools.
A modern design and development file demands an organic, virtual structure within a PLM software tool. By placing the intended use at the core, with design and device risk requirements branching out, we create a framework that facilitates growth and adaptability. This ensures that all subsequent development activities are directly traceable to these core requirements, promoting a more cohesive and efficient design process.
In short, a new approach is needed to bring an outdated regulatory framework into the 21st century.
About the Author: Archetype is a medtech innovation management consultancy dedicated to helping innovators bring life-changing medical devices to market. It offers a comprehensive suite of services that integrate market approval into every stage of product development. Stuart Grant, Archetype’s founder and principal consultant, has a PhD in medtech innovation, an MSc in project management and a BSc in product design. He is a chartered engineer of the Institute of Mechanical Engineers. In his 25-year career with Johnson & Johnson MedTech, Grant led Depuy Synthes Companies’ response to the new European medical device regulation.
