In What Direction Will Surgical Nav/Robots Go From Here?

Two pioneers of the surgical navigation and robotics revolution who sold their companies for massive amounts of money (Rony Abovitz, co-founder of MAKO Surgical Corp. and Eric Timko, CEO of BlueBelt Technologies, Inc.) have moved on—but in ways that point to where this market basket of technologies which we refer to as surgical navigation or robotics is heading.

Prepare to be amazed.

Moore’s Law

Surgical navigation and robotic assist devices are, essentially, processors of visual, sensory and other data.

So, what happens when the “brains” of these systems get smarter, faster and cheaper?

Fifty years ago, the then head of research for Fairchild Semiconductor and later co-founder of Intel, Gordon Moore, was asked by Electronics Magazine to predict the evolution of integrated circuits. His answer, that the number of transistors that could fit on a single chip of silicon would likely double every year making twice the computing power available for just a little bit more money, was so accurate that it was later dubbed “Moore’s Law.”

In 1975, he modified his prediction to a doubling roughly every two years.

On the 50th anniversary of his prediction, Moore recalled those early days in an interview with the New York Times’ Thomas Friedman, “I had been looking at integrated circuits—[they] were really new at that time, only a few years old—and they were very expensive. I was beginning to see, from my position as head of a laboratory, that the technology was going to go in the direction where we would get more and more stuff on a chip and it would make electronics less expensive.…I had no idea it was going to turn out to be a relatively precise prediction, but I knew the general trend was in that direction.”

Intel’s newest computer chip, the fifth-generation Core i5 processor, is 3,500 times more powerful, 90,000 times more energy efficient and about 60,000 times cheaper than Intel’s 1971 4004 chip.

If a 1971 Volkswagen Beetle had improved at the same rate as computer processors, the car would hit a top speed of 300,000 miles per hour, get two million miles per gallon of gas and cost 4 cents.

Here’s a chart which shows Moore’s Law in action.

Medtronic’s StealthStation Evolution From 1995 – 2019

One way to see the Moore’s Law effect in surgical tools like navigation systems or robotic assist devices is to look at the changes in StealthStation, Medtronic’s surgical navigation system and, soon, part of the surgical suite eco-system which includes the Mazor X robotic assist system.

StealthStation was introduced to surgeons in 1995 at a price of about $300,000—or more accurately, $3,000 per 100 MHz of computing speed and processing power. The system could integrate CT and MRI images into a surgical plan and gave surgeons a targeted entry point and, in effect, a “map” of where to go next.

The 2019 version of StealthStation is approximately 350x more powerful than the 1995 version and 1/200th the cost per 100 MHz ($15/100 MHz).

And today’s StealthStation is like an interactive Google or Waze map versus the 1994’s static, non-interactive image of a map.

It also integrates into an eco-system of robotic-assist devices, smart power-tools and instruments and all the imaging tools including O-Arm.

Cheaper, faster, more powerful and functional.

What possibilities does that open up over the next 10 years?

Rony’s Magic Leap

Rony Abovitz co-founded MAKO Surgical, the largest supplier of surgical robotic arm assist devices for large joint recon surgery, in 2004. Stryker Corporation bought MAKO nine years later in 2013 for $1.65 billion.

Using some of the lessons from MAKO, Rony, who was 53 years old when he sold MAKO, founded Magic Leap, a mixed/augmented reality company. In 2014 Google put $540 million into Magic Leap. In 2018 a group of other venture investors (including Saudi Arabia’s Public Investment Fund) put another $1.7 billion in.

Rony describes his new system as a computing platform designed for working in open space (like surgery, for example). It is a “wearable computer that gives the user the ability to do spatial computing.”

At MAKO Rony innovated a haptic feedback loop from the robotic arm to the surgeon which gave surgeons the ability to “feel” where they were in the anatomy even though they were using a mechanical arm.

Magic Leap made feedback its central theme.

Now the computer is wearable, it senses the user with biomarkers AND maps the world around the user. Like MAKO’s haptic interface, these tools give the user context. Magic Leap’s data and images don’t just float in space. They interface literally with the physical space around the user—bookshelves, other people (a patient?), the room, desks, open spaces and so forth.

Said Rony, “Our goal was to gently slip stream into a user’s neuro anatomy the computer-generated data in a non-disrupting way. We want to talk to the visual cortex in a really biologically friendly way.”

Magic Leaps central processor, which crunches more data than a dozen smart phones, fits into the user’s pocket. The other computers are in see-through goggles the user wears.

From MAKO to Magic Leap, Rony shrank the computing box, dropped the price (Magic Leap starts at just $10k) and blasted functionality into the stratosphere.

Here’s a link which demonstrates Rony’s Magic Leap.

Eric Timko’s OrthoAlign

Eric Timko, formerly CEO of MAKO’s main competitor BlueBelt Technologies, sold BlueBelt to Smith & Nephew in 2016 for $275 million.

BlueBelt’s robotic assist device was based on Carnegie Mellon University (arguably the top computer intelligence research center in the world) technologies and its elegant software and very powerful computing power gave surgeons a lower cost, but highly functional robotic-controlled device for orthopedic procedures, particularly knee replacements.

As Timko described it, BlueBelt’s “Footprint was smaller, the cost was a third of MAKO’s, and we were open architecture, meaning we worked with all the implant companies that wanted to work with us.”

After guiding BlueBelt from development to regulatory clearance to successful commercial launch, what did Eric, 51 years old, do?

He joined California based OrthAlign, Inc.—a provider of navigation and surgical alignment tools for large joint surgeons.

As OrthAlign’s CEO, Timko’s been driving the company towards a new smart surgical assist device that is as amazing as Rony’s Magic Leap.

Shrinking the Big Box to a Disposable Handheld Computer

OrthAlign’s smart surgical assist device is a DISPOSABLE handheld computer (the size of a smart phone with equivalent speed and processing power) which attaches to the patient and delivers intraoperative surgical guidance rivaling the accuracy and precision of the big box systems.

It was awarded Frost & Sullivan’s 2019 North American Technology Leadership award.

Eric channeled Moore’s Law when he said, “The future of technology in the OR is smaller, smarter, and more economically feasible. We’re building out a portfolio of applications for Total Knee, Partial Knee, and approach-agnostic Total Hip Replacement and pushing surgeon-driven handheld technologies past the capabilities of old, bulky, and expensive systems such as robotics and big box navigation.”

Here are some details about OrthAlign’s smaller and smarter navigation tools.

1. Uses “smart phone” gyroscopes and accelerometers to register the patient’s anatomy
2. Aligns, balances and synchs anatomy to implant
3. No capital expenditure
4. No pre-op imaging
5. Real-time information
6. High definition video screens for images and videos as required in the OR
7. Faster and more powerful I/O processors
8. Data collection and connectivity capabilities to drive “big-data” mining

According to Bhargav Rajan, Leader, Medical Devices & Imaging Team at Frost & Sullivan “Because OrthAlign’s smart technology is in a disposable single-use form-factor and not reliant on any capital equipment, a hospital or surgery center can simultaneously deploy the tech in multiple operating rooms, and at any care site within its network.”

“The economic benefits of a single-use device compares favorably against robotic systems without compromising clinical outcomes.”

OrthAlign’s Systems Clinical Performance Data

Unlike Rony’s Magic Leap, Timko’s OrthAlign technologies are in surgeons’ hands now and its potentially disruptive “smart phone” approach will be formally introduced at 2020 AAOS (American Academy of Orthopaedic Surgeons).

A new study from Japan which tested the use of OrthAlign’s handheld computer system reported that the average absolute error in measurement using OrthAlign’s system was 2.6 + 2.7 (inclination) and 2.8 + 2.7 (anteversion).

Bottom line wrote the Japanese investigators (who had no conflicts of interest related to OrthAlign) this accelerometer-based portable navigation system is more accurate for cup placement in anteversion than conventional imageless navigation systems.

The learning curve for the Japanese team was five cases. Accuracy was consistent throughout learning curve. Set-up time to navigation was six minutes.

Where Surgical NAV and Robotic Assist Is Heading

MAKO and BlueBelt used their processing power to direct autonomous robotic arms to more precisely burr bone or move drill guides into place while the surgeon inserts cutting tools.

To hit their marks precisely and consistently these computers process massive amounts of imaging and pre-op planning data fast.

They also require the surgeon to cede a degree of control to the large and, say some users, ergonomically challenged robot assist devices.

OrthAlign and Magic Leap are shrinking the big box to pocket or hand-sized computers. And both of their CEOs, each pioneers in the robotic assist device industry, are, ironically perhaps, pushing to augment, not off-load, user capabilities.

While you can’t see Rony’s Magic Leap at AAOS or other orthopedic meetings, you can test drive Timko’s OrthAlign systems and, increasingly, read clinical studies and case reports of its performance.

I mean, six minutes from set up to navigation.

That’s something.