Scaling Patient-Specific Implants: Why Now Is the Time to Break the Workflow
For years, personalized medicine has been the goal in healthcare—delivering care tailored to each individual patient. But in orthopedics, one of the most impactful areas for personalization, true patient-specific solutions are still the exception, not the rule.
So what’s the holdup?
Daniel Crawford, Founder and CSO at Axial3D, believes the answer lies not in the absence of technology, but in how it’s being used. In a recent interview, Crawford breaks down the bottlenecks in traditional workflows, the tools that can change the game, and how scalable, patient-specific implants are finally within reach.
The Power Shift: Patients Are Driving Change
Orthopedics has made huge strides in implant design—stronger materials, better osteointegration, and advanced coatings. But we’re reaching the limits of what can be achieved with off-the-shelf solutions. The next leap forward? Customizing those innovations to fit each patient.
“The most powerful driving force is the patient,” Crawford says. “Personalized care leads to better outcomes. It reduces surgery time, lowers the risk of complications, and increases implant longevity.” And as clinical evidence builds, the case for custom becomes harder to ignore.
Add in the rise of advanced computing and machine learning, and what used to be time-consuming, resource-heavy work can now be automated at scale. Cloud computing has democratized access to high-performance tools, leveling the playing field for companies of all sizes.
What’s Slowing Us Down?
One of the biggest challenges is scale. Take knee replacements—over 800,000 are performed in the U.S. every year. Traditional workflows simply can’t keep up with that volume. The linear approach—image acquisition, segmentation, CAD modeling, design approval, manufacturing—requires hands-on engineering at every step. It’s slow, expensive, and hard to scale.
Crawford argues that the only way forward is to break the process apart and inject automation wherever possible.
“We need to move away from manual, sequential tasks and toward AI-assisted, parallel workflows,” he explains. “Let software handle the repetitive parts so engineers can focus on quality control and complex cases.”
Reimagining the Workflow: What It Looks Like
Here’s what a modern, scalable patient-specific workflow could look like:
- Cloud-first imaging access: Instead of relying on CDs or manual file transfers, imaging data is securely accessed through cloud infrastructure, enabling faster and more compliant workflows.
- AI-assisted segmentation: Rather than spending hours segmenting scans by hand, AI tools can complete the task in minutes. Engineers validate the output instead of starting from scratch.
- Automated design: With machine learning and generative AI, surgical guides and implants can be designed automatically with consistency and precision, reducing human error and production time.
- Pay-as-you-go scalability: Cloud infrastructure also eliminates the need for expensive on-site hardware. Companies can spin up powerful computing environments as needed, without massive upfront investment.
At Axial3D, all software is usage-based. “It’s not just about the tech—it’s a new business model,” Crawford says. “We’re making innovation scalable and accessible.”
Data Management: The Unsung Hero of Patient-Specific Surgery
Getting the workflow right also means having solid data practices in place. That starts with protocols for imaging—especially for repeatable procedures like joint replacements. But even when imaging protocols vary, tools like Axial3D’s validation system can automatically flag missing data or poor-quality scans, so issues are caught early.
Traceability is another must. “Every imaging file gets a unique identifier, linking it to the patient and their surgical plan,” Crawford says. “That’s how we maintain organization, security, and compliance from start to finish.”
Cloud-based systems also make it easier to comply with regional data regulations, keeping data stored and processed in the right jurisdictions.
Common Pitfalls—and How to Avoid Them
What do companies often overlook when they start building patient-specific solutions?
- Regulatory frameworks: Patient-specific devices require different quality and regulatory pathways than off-the-shelf solutions. Crawford advises having a robust QMS from the outset.
- Surgeon experience: Tools should allow surgeons to review and adjust plans asynchronously—not via clunky phone calls or outdated video conferencing.
- Data sovereignty: Transferring data across regions can create legal headaches. Using cloud platforms with localized processing is key to staying compliant.
The Future: From Niche to Normal
According to Crawford, the shift is already happening—and fast. In the next three to five years, most high-volume orthopedic procedures will include some element of personalization, whether it’s a surgical plan, guide, or fully custom implant.
For medical device companies, that means adapting to a hybrid world—where hardware meets scalable, software-driven workflows.
“The ones who make that leap now will be the leaders of this next generation,” Crawford says.
Thank you to Orthopedic Design & Technology for publishing this Q&A on how we’re enabling patient-specific implants at scale.
We’re proud to be working at the intersection of AI, automation, and cloud computing to help bring personalized orthopedic solutions to more patients than ever before.
