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Artificial intelligence (AI) is already transforming the orthopedic device industry. However, experts believe product development professionals have only just begun to tap into the technology’s full potential.
Gokce (Gilly) Yildirim, Founder and CEO of Vent Creativity — a New York City-based med-tech company offering AI-powered auto-segmentation, landmarking and digital surgery planning solutions — is focused on the development of digital twinning to advance the way surgeries are performed.
“Digital twins are simulations of real-world surgery, allowing us to anticipate pitfalls before surgeons enter the operating room,” he said. “We create patient-specific digital models that represent a patient’s bone and soft tissue structure.”
Vent Creativity builds a Principal Density Analysis profile for individual patients. This AI-driven analysis tool helps surgeons and implant manufacturers understand a patient’s unique bone structure and provides a blueprint for personalized implants. “The AI-based system determines optimal implant positions based on bone density and the surrounding soft-tissue envelope,” Yildirim said.
According to Yildirim, AI simulation technologies are integrated into multiple stages of implant design workflows. These tools primarily meet the growing demand for medical image segmentation, which is essential for creating 3D anatomical models and 2D to 3D registrations to determine implant size and position.
Yildirim said AI is increasingly used to study patient populations and inform how implants are made. This represents a significant shift from traditional methods, which rely heavily on cadaver studies.
“The clear solution, which wasn’t possible before, is the generation of thousands of design models instead of just a few, either through data collected in the field or in-silico techniques to generate representative bones for different types of orthopedic surgeries,” Yildirim explained. “This digital twinning will help device manufacturers optimize fit, aspect ratios and fixation features of implants to accommodate various types of patients.”
Yildirim emphasized the need for more complex and comprehensive algorithms to effectively address orthopedic conditions. He believes that AI can identify optimal approaches to improved patient care better than relying solely on surgeons and manufacturers to devise solutions.
“Depending on the available implants and the flexibility of companies to introduce more population-based solutions, AI can determine the best design, size, fit and fixation for individual patients,” Yildirim explained. “This allows surgeons to treat more patients with reduced decision-making burdens, enabling them to focus on tasks that truly add value to the healthcare system.”
Yildirim also anticipates that AI-enabled implant design and surgical planning will foster closer collaboration between engineers and surgeons. “Currently, implants are often designed in isolation and tested on cadavers to obtain surgeon feedback,” he said. “Even the most involved surgeons rarely have the opportunity to actively participate in implant design alongside engineers.”
According to Yildirim, digital twins will eventually feature fully functional joint articulations and accurate representations of soft tissues, arteries and nerves. This advancement will provide surgeons with a more hands-on collaborative role in the device design process, leading to more effective and personalized patient care.
“Imagine an AI-driven platform for which surgeons and engineers can call up thousands of different types of anatomy and introduce an implant design and the patient’s activities of daily living,” Yildirim said. “They could ask AI to modify the implant design based on these criteria and fit it for the specific disease state and patient anatomy to eliminate risks of impingement, fracture or loosening.”
Data-driven Productivity
Bernhard Kappe, CEO and Founder of Orthogonal, has developed frameworks that illustrate the ways AI can enhance the design of orthopedic devices and how it can seamlessly integrate into a company’s product development pipeline. Although the medical device industry is rich in data, Kappe believes it will be years until AI’s judgment capabilities will lead to significant breakthroughs in device design.
Kappe said the medical device space is currently utilizing narrow AI, which performs specific tasks without self-awareness. “It’s about refining algorithms to be more efficient that can then be tested and deployed,” he added. “This approach leverages AI to optimize processes within defined parameters, but it remains task-specific and limited in scope.”
Generative AI is more flexible and capable of drawing broader inferences from vast amounts of data. “It can be used as a general-purpose tool with applications that extend beyond pre-defined tasks, potentially transforming how we approach problem-solving and innovation in medical device design,” Kappe said. “It doesn’t replace a software engineer but it speeds up their work. It’s enhancing the productivity of product developers and can maintain consistency and adherence to best practices, which is crucial in the medical device industry where precision and reliability are paramount.”
As generative AI continues to evolve, the possibilities are vast for its application across the entire product development lifecycle.
“When reviewing our requirements and testing processes, we can leverage large language models to assess whether we have well-formed user needs, well-structured requirements and informed acceptance criteria,” Kappe said. “This approach enhances quality control, helps us identify and manage issues earlier and boosts the productivity of our systems engineers and quality personnel. We are much more productive and produce higher-quality devices with fewer issues.”
He also predicted that generative AI will enable faster and more comprehensive product assessments, noting that similar tools have already significantly enhanced efficiency at Orthogonal.
Ecosystems and the Importance of Data
AI-driven tools are increasingly shaping and enhancing the digital ecosystems that surround medical devices with the goals of improving patient experiences and creating efficiencies for healthcare providers. He highlighted Zimmer Biomet’s mymobility and ZBEdge platforms as prime examples.
“Zimmer Biomet has developed a comprehensive ecosystem that integrates apps, planning tools and data management to create a seamless process,” Kappe said. “ZBEdge gathers data for AI-driven discovery and feeds algorithmic insights back into the system to drive continuous improvements in patient care.”
Kappe also emphasized that AI has the potential to revolutionize entire operating room processes. Real-time data collection and analysis during surgery could yield meaningful insights faster than human effort alone.
Preparing for AI’s expanding role in medical devices requires a fundamental change in perspective, Kappe said. “As software systems and products continue to evolve, the focus should shift from the devices themselves to the entire ecosystems surrounding them,” he added. “Data is just as important, if not more important, than the device itself. Understanding the costs of acquiring and managing that data is crucial.”
Given the significant expense and growing importance of clinical data, Kappe recommended that orthopedic companies hire data economists to develop effective strategies and protect the ownership of the information their devices collect.
“When you’re negotiating device contracts with hospitals, don’t give away the data,” Kappe cautioned. “I’ve seen cases where companies wrote contracts 20 or 30 years ago and now need to pay hospitals to use their own data to improve medical devices. That shouldn’t be the case.”
While some critical data needed for AI applications in medical devices must be uncovered through costly clinical studies and new initiatives, such as filming orthopedic surgeries, Kappe said much of it already exists and can be accessed now.
“You can’t afford to ignore data or hide from it,” he added. “That approach doesn’t work anymore, and it remains one of the biggest barriers to innovation in some companies,” he added.
