Patient Safety in Design and Development of 3D-Printed Medical Devices: The Crucial Role of Surgeons and Scientific Rigor

Introduction:

Welcome to the second installment of our series on the regulation and safety of 3D-printed individualized medical devices. In our previous article, we explored the foundational pre-market phase and emphasized the critical steps needed to ensure patient safety. In this article, we will delve deeper into the design and development phase, where the concept of a medical device is transformed into a tangible product. This phase is where it all begins, according to MDR 2017/745, and it demands meticulous planning, scientific rigor, and the invaluable input of experienced surgeons.

Designing a medical device is far more than just an exercise in engineering. It’s a complex process that requires a deep understanding of biology, patient-specific needs, and surgical practices. The overarching principle guiding this process should always be patient safety. This means that patients are not to be treated as test subjects; instead, the design and development process should be rooted in scientific evidence and clinical experience.

The Foundation: Scientific Resources and Predicate Devices

When embarking on the design of a new 3D-printed medical device, the first step is to gather all the relevant scientific literature. This body of research provides the foundation upon which a safe and effective device can be built. The use of scientific resources ensures that the design is based on proven concepts rather than untested ideas.

One of the most effective strategies in this phase is to consider the use of predicate devices—those that are already on the market and have established performance data. By identifying a predicate device, manufacturers can anchor their design in a framework that has already been validated through regulatory approval and clinical use. This approach not only accelerates the development process but also significantly enhances patient safety by leveraging existing knowledge.

However, the process is not as simple as reverse engineering a device that’s already on the market. While it might be tempting to believe that creating a new device is merely about tweaking an existing design, this mindset overlooks the complexities of biology and patient-specific factors. Reverse engineering alone cannot account for the myriad variables at play in the human body, which is why scientific rigor and clinical input are indispensable.

The Role of Surgeons: The Most Critical Stakeholders

When it comes to designing medical devices, the most valuable insights often come from those who have the most experience in dealing with complications and patient outcomes—surgeons. Surgeons, especially those who have a long and varied clinical history, are key stakeholders in the design process. Their experience in the operating room provides a wealth of practical knowledge that is critical for developing safe and effective medical devices.

In the world of individualized medical devices, the role of the surgeon cannot be overstated. The design of these devices is 5% engineering, 25% patient-specific biology, and 70% surgical expertise. Therefore, the stakeholder with the most impact on the success of a medical device is the surgeon, followed closely by the patient. The ability to design, while important, is almost secondary to the experience and insights provided by the surgical community.

At Boneeasy , we recognize the importance of surgeon input in the design process. Over the past eight years, we have gathered data from nearly 4,000 medical devices and have consistently involved surgeons in every stage of development. This collaborative approach ensures that our designs are not the product of a single person's vision but are instead the collective experience of a large community of surgeons.

Design Is More Than Just Engineering: Understanding the Bigger Picture

One of the common misconceptions in the design of 3D-printed medical devices is that it’s primarily an engineering challenge. Some may think that the key to success lies in creating intricate lattice structures, hollow designs, or thin layers that push the boundaries of what is technically possible. However, this view is narrow and overlooks the broader context in which these devices will be used.

The true challenge in designing medical devices lies not in the engineering itself but in understanding how these designs will interact with human biology and how they will be used in surgical procedures. Biology remains a vast and largely unexplored frontier, with many unknowns that science has yet to fully decode. The best designs are those that integrate engineering with a deep understanding of biology and surgery, creating a product that is not only innovative but also practical and safe for patient use.

The real innovation often comes from understanding the biological and surgical implications of a device, rather than from pushing the limits of engineering. For this reason, the design process should always be informed by extensive consultations with surgeons who can provide insights based on their experiences with similar devices and procedures.

Boneeasy’s Approach: Empowering Surgeons Through Collaborative Design

At Boneeasy , we take a unique approach to the design of individualized medical devices by empowering surgeons to be at the center of the design process. We believe that the best designs are those that are informed by the practical knowledge of surgeons who have a deep understanding of patient outcomes. Our role is to gather data, facilitate the design process, and ensure that the devices we produce meet the highest standards of safety and effectiveness.

To achieve this, we are constantly developing software tools that allow surgeons to take an active role in the design of medical devices. These tools provide surgeons with the ability to customize devices based on their clinical experience, while we handle the manufacturing process, ensuring that all devices are produced according to Good Manufacturing Practices (GMP).

The collaborative approach we employ ensures that the devices we produce are not just the result of engineering creativity but are also grounded in the realities of clinical practice. By involving surgeons in the design process, we can ensure that the devices we create are tailored to the needs of patients and are backed by the collective wisdom of the surgical community.

A Dynamic Process: Continuous Improvement and Feedback

Designing a medical device is not a one-time event but a dynamic process that continues even after the device is registered and approved. As new data and feedback from clinical use become available, it is crucial to revisit the design phase to make necessary adjustments and improvements. This iterative process is essential for ensuring that the device remains safe and effective throughout its lifecycle.

At Boneeasy, we have built a robust feedback loop that allows us to continuously gather input from surgeons and other stakeholders. This feedback is invaluable for identifying potential improvements and for ensuring that our devices evolve in response to real-world clinical experiences. While we cannot change the design every time someone has a new idea, we are committed to making evidence-based adjustments that enhance patient safety and device performance.

The design of a medical device should never be the product of a single person's idea. It should be the result of a collaborative effort that incorporates the knowledge and experience of as many stakeholders as possible. By maintaining a focus on patient safety and continuous improvement, we can ensure that the devices we produce are not only innovative but also reliable and effective.

Conclusion: The Art and Science of Medical Device Design

In conclusion, the design and development of 3D-printed individualized medical devices is a complex process that requires a careful balance of engineering, biology, and surgical expertise. Patient safety must always be the guiding principle, and this can only be achieved through a rigorous, collaborative approach that involves scientific research, surgeon input, and continuous feedback.

As we move forward in this series, we will explore the next stages of device development, including market surveillance and post-market evaluation. By staying focused on patient safety and leveraging the collective experience of the medical community, we can continue to push the boundaries of what is possible with 3D-printed medical devices, while ensuring that these innovations translate into better outcomes for patients.