Israeli startup CustoMED has gotten $6 million to make patient-specific orthopedic devices a reality using AI. The seed round took in capital from the Israel Innovation Authority, Varana Capital, Flag Capital, Longevity Venture Partners, and an orthopedics firm. Similar to other existing preoperative planning tools that let you create customized implants, CustoMED hopes to be a tool for surgeons, a daily workflow to make their lives easier while delivering on custom devices for patients.

CustoMED Co-founder Or Benifla said,

“CustoMED’s patient-specific surgical tools enable more precise orthopedic surgeries through affordable, real-time solutions delivered directly into the operating room. By putting scalable, personalized technology directly in surgeons’ hands, our mission is to make computer-guided surgery fast, accessible, and routine, transforming what was once a boutique process into standard of care for every patient.”

The company is a spin-out of of Sheba Medical Center’s 3D Printing and Innovation Lab.

Professor Eyal Zimlichman, Chief Innovation, Transformation, and AI Officer at Sheba Medical Center, and leader of its innovation arm ARC, said that,

“CustoMED is embedding precision and surgeon-directed tools into everyday workflows, shortening the path from imaging to the operating room while preserving governance, quality, and safety. The company exemplifies ARC’s mission to translate clinical insight into scalable, real-world impact.”

Raissa Hacohen, Managing Partner at Longevity Venture Partners, stated,

“We were immediately impressed by the ARC team’s world-class experience and CustoMED’s mission to improve surgical performance and patient outcomes, CustoMED’s platform gives surgeons everywhere access to personalized planning and surgical tools that can raise the standard of care in orthopedic surgery.”

The company stated that it has performed hundreds of procedures to date using the tool and hopes that the funding will be used to expand the tool. Use in more orthopedic procedures, as well as working towards both EU and US regulatory approval, are also being planned. CustoMED wants to be active in reverse shoulder arthroplasty, total shoulder arthroplasty, total knee replacement, hip resurfacing, and distal radius fractures, among others.

The tool will aim to do things such as Glenoid Plane Analysis (using CT or other imaging to look at the shoulder and determine the best fit), baseplate positioning, and the alignment of components. Traditionally, this may take up a lot of time and also take up time in the OR, or just generally valuable surgeon time. Speeding things up with AI could be significantly cheaper. The company also believes that fewer CT scans and better outcomes could result, and aims to enable 3D printing “at the 3D lab or point of care,” a whole roster of challenges.

If the tool works well, it could lead to people then ordering parts from CustoMED. This can lead not only to 3D printed implants but also to tools. The platform is designed to handle surgical planning, do automated imaging segmentation, and thinks that, “Our technology learns, adapts, and refines. Every scan, every plan, every detail becomes part of a system that never stops improving.”

CustoMED clearly has has a very ambitious vision. I worry that it is too ambitious. In the company’s drive to become the vasculature of AI-driven customized implants, they may very well not be able to produce good outcomes for surgeons and patients. A lot of the individual elements of this firm’s vision could be startups in their own right. A lot of complexity, a lot of criticality, and many moving parts make the difficult near impossible at times. And $6 million is not a lot of money at all for such a vision.

If we look at just one element, the patient information going into a cloud solution and then being used by the software to improve the algorithm for future procedures, I’m guessing that EU approval will be tricky. The FDA will probably be very proactive in trying to be the regulator of choice for a potential AI medicine bonanza. Indeed, the FDA has been very forthcoming with Additive Manufacturing companies and in customized implants. It would be very interesting to see how they look at developments such as these.

Previously, the FDA has taken a dim view of patient-specific implant firms that simply wanted to define minimum and maximum values for implants. If any implant design falls between the two extremes, many failures may arise. How will the FDA look at these AI workflows? How will the AI test them and require them to be stabilized? Will surgeons trust AI? Will there be ghosts in the machine that will all of a sudden start misaligning things or changing implants willy-nilly? I have no idea, frankly. But we should brace for impact for any number of AI-driven application startups that see 3D printing as a side dish, rather than the main menu item.

All images courtesy of CustoMED