"We Are the Only Medical Center in Israel Manufacturing Implants Within Its Own Walls"

CT and MRI scans of a patient with a bone tumor appear on screens at the Levin Center for Surgical Innovation and 3D Printing at Ichilov Medical Center. Within minutes, the images are transformed into a 3D model rotating before the eyes of surgeons, engineers, and medical designers. Together, they define precise resection margins, evaluate how much bone must be removed, and determine how the resulting defect will be reconstructed.

Layer by layer, the model evolves into a detailed surgical plan. Just a few rooms away, a custom-made titanium implant is manufactured, sterilized, and prepared for direct use in the operating room.

This is no longer merely the use of a 3D model for visualization, nor the ordering of a standard implant from an external supplier. Celebrating its tenth anniversary, the Levin Center demonstrates how a medical institution can take full ownership of the entire process—from medical imaging and surgical planning through engineering, manufacturing, quality control, and ultimately implantation of a personalized solution into the human body.

Pushing Innovation to the Clinical Edge
The Levin Center enters its second decade in a vastly different landscape from the one it faced at its inception.

"We were pioneers," says Dr. Solomon Dadia, orthopedic oncology specialist and founder and director of the center. "For the first four to five years, we had virtually no competition in medical 3D printing. Today, naturally, everyone wants to operate in the worlds of 3D printing, augmented reality, robotics, and personalized surgery".

The center's first decade was defined by breakthrough innovation. The second begins with an equally ambitious objective: transforming surgical innovation from a collection of exceptional capabilities into a comprehensive, regulated, and productive methodology that connects surgeons, engineers, materials scientists, regulators, and patients awaiting solutions that simply do not exist off the shelf.

The challenge is no longer proving that the technology works. The challenge is bringing it all the way to its clinical endpoint—from imaging and planning to manufacturing implants that remain inside the patient's body for years to come.

A major milestone marking this new era was the center's recent achievement of an international ISO certification for surgical planning and the production of customized medical devices and implants. The certification places the Levin Center alongside some of the world's most advanced medical device manufacturers—while remaining part of a public hospital in Israel.

"This is a certification that major global medical technology companies aspire to achieve," says Dr. Dadia. "We accomplished it here without investors, without going public, without becoming a corporation—not even as a company".

Beyond Planning: Manufacturing the Entire Surgical Solution
When surgeons elsewhere describe performing a procedure using 3D planning, they are telling the truth, explains Dr. Dadia. However, external partners often perform much of the engineering and manufacturing work behind the scenes.

"At the Levin Center, when we say we designed, manufactured, and implanted a titanium implant following the removal of a femoral tumor, every stage of that process happened in-house," he says. "From image acquisition and digital processing to modeling, CAD design, surgical planning, device manufacturing, and implant production—everything is done here within the hospital".

The critical distinction lies in implant manufacturing itself.
A printed anatomical model is a valuable planning tool. A patient-specific surgical guide, also produced through 3D printing, significantly improves surgical precision. But manufacturing an implant that enters the body permanently requires an entirely different level of responsibility: validated materials, controlled engineering design, biomechanical performance testing, biological compatibility, sterilization protocols, documentation, verification, validation, and rigorous quality control.

"This is where the line is drawn," says Dr. Dadia. "Today, we are the only medical center in Israel manufacturing implants within its own walls."
For him, this is also the point where surgical innovation must meet the same standards demanded of the global medical device industry rather than relying solely on clinical experience or surgical creativity.

"Absolutely," he says, "That is the difference between printing a medical model and operating a true medical manufacturing system. The certification requires us to demonstrate that every step—from file transfer and material selection to sterilization—is controlled, documented, and reproducible. We have taken entire regulatory frameworks from Europe and the United States and embedded them into a hospital environment. This is not simply a hospital with a 3D printer in a corner room. It is innovation transformed into medicine".

The Quality Seal
The road to certification began long before the official approval.
As early as 2018, during the center's second year of operation, Dr. Dadia initiated a professional committee through Israel's Ministry of Health aimed at establishing standards for medical 3D printing within hospitals.

"The technology was advancing faster than regulation," he recalls. "That was exactly why we chose to operate as though the regulations already existed".

The team meticulously evaluated data transfers between software platforms, verified model accuracy, assessed material suitability for surgical applications, determined how long materials could safely remain in the body, and established appropriate sterilization protocols.

"No one required us to do this," says Dr. Dadia. "But we cannot place materials inside the human body without a structured and transparent process. We brought in external regulatory experts, invested heavily in testing and validation, because that is the right way to practice medicine. The certification is the result of that commitment".

The ISO certification currently covers two materials central to the center's clinical activity: polymers and titanium.

PEEK-based polymers are primarily used for cranial, maxillofacial, and skull reconstructions. Since the outbreak of the Iron Swords War, Ichilov has treated soldiers requiring customized cranial implants following life-saving surgeries, with the Levin Center manufacturing those implants on-site.

Titanium implants are used in femoral and tibial reconstruction following oncologic tumor resections and severe trauma cases involving crushed bones, nonunions, or failed prior surgical interventions.

Designing the Next Generation of Implants
The next frontier extends beyond manufacturing and into material science itself.

"We are currently evaluating carbon-based materials, silicone, ceramics, and biodegradable materials that can gradually be replaced by biological tissue," says Dr. Dadia, "The regulatory infrastructure is already in place. The material is the variable".

Looking further ahead, he envisions hybrid implants that provide both structural support and biological regeneration.

"When we print a titanium implant today, it doesn't have to be a solid block of metal," he explains. "We can design lattice structures with internal spaces that allow surrounding bone to grow into the implant through a process called osseointegration. In the future, those spaces may also contain advanced biological components, including stem cells capable of differentiating into bone tissue".

Such technology remains experimental, but progress is already underway.

"We hold patents and have conducted preclinical studies in rats, rabbits, and sheep, examining how bone integrates into implants over time", he says, "This work is being carried out in collaboration with Reichman University, Tel Aviv University, and Ben-Gurion University".
The ultimate challenge remains creating biological bone tissue capable of bearing substantial loads.

"Today we can generate biological bone tissue, even from a patient's own stem cells," says Dr. Dadia, "The problem is that it is still too soft. If a surgeon must replace ten centimeters of femur or tibia, the patient ultimately needs to stand and walk on that reconstruction. The solution must be both biological and mechanically strong".

From Implants to Intelligent Operating Rooms
Beyond implants and materials, Dr. Dadia believes the next revolution will take place in mixed and augmented reality.

Unlike 3D printing, however, progress in this field remains dependent on rapidly evolving hardware and software ecosystems.
"To make augmented reality truly useful in surgery, hospitals must build their own infrastructure rather than waiting for technology companies to decide the future", he says.

Over the coming months, Ichilov will establish a dedicated Mixed Reality Center staffed by engineers and content specialists. Working alongside rehabilitation departments, the hospital's simulation center, and the Sagol Brain Institute, the initiative aims to support surgery, rehabilitation, pain management, simulation training, and neuroscience research.
Yet perhaps the most ambitious project involves integrating information inside the operating room itself.

Today's operating rooms are crowded with robots, cameras, imaging systems, anesthesia monitors, and digital displays. The challenge is that these systems often operate independently, forcing surgeons to divide their attention among multiple information sources.

"Our next major project is data integration in the operating room," says Dr. Dadia, "Surgeons currently monitor video feeds, fluoroscopy, vital signs, anesthesia data, equipment positioning, and team activity simultaneously. Our goal is to unify all of that information into a single, clear layer of data".

The vision is not centered on a specific device, but on transforming vast amounts of medical information into an intuitive language that supports surgeons in real time.

"I don't know exactly what the interface will look like .It may be through smart glasses, holographic projections, or technologies that do not yet exist. What matters is that the right information reaches the surgeon at the right moment and helps them make better decisions under uncertainty".

"That has been our mission throughout the first decade," he concludes, "And it will continue to define the next one as well."

In collaboration with Ichilov Medical Center and the Levin Center for Surgical Innovation and 3D Printing