From Removing Broken Bones to Minimally Invasive TKR: We’ve Come a Long Way

When my grandfather emigrated from Germany in 1906 at the age of 5, a broken bone almost cost him his entry to the United States. At 3, he’d fallen down a flight of stairs and fractured his leg. At the time, German doctors apparently didn’t know that bones could be set and healed, so they removed the bone. My grandfather was left with a lifelong limp, and immigration officials considered designating him a cripple and denying him citizenship.

Fast-forward 110 years, and we’re now restoring mobility to about 1 million people a year through total knee replacement. Robots are performing surgery, devices implanted in the body deliver pharmacologics, and stem cells treat a range of ailments previously considered incurable.

In addition to producing space-age technology that my grandfather never imagined, we’re also coming up with creative ways to meld science, materials, and procedures for innovative ways to improve health.

Over the course of the 10,000 surgeries Tom Grotz has performed, he’s replaced every limb joint in the human body. The microsurgeon and inventor has also developed and marketed a variety of medical devices. He says while the shared industry focus has always been on patient welfare, he’s pleased to see a culture shift over the past few decades to embrace novel approaches to maintaining that focus.

“The shift is partly a function of society,” Grotz said. “Basically I think the trend in the last few decades is from a benign acceptance of status quo to the expectation that wellness is, if not a right, an opportunity that should be available to all human populations. That has motivated Western and undeveloped countries to encourage the creation and use of implants and methods of surgery that bring forth the best of art and science.”

The intersection between art and science is the starting point for revolutionary innovation. In the 25 years I’ve worked in the medical device sphere, I’ve witnessed mind-boggling advances toward best patient outcome. When I worked at the FES Center, I worked on truly life-changing technology. This was where I watched quadriplegics take their first steps. Electrodes surgically placed on large muscle groups in paraplegic and quadriplegic patients contracted muscles, assisted transfers, prevented muscle atrophy, and minimized pressure sores. 

It was a personal and professional milestone. Thanks to this technology, I watched a friend walk down the aisle to her future husband. It was a poignant reminder of the power of the medical device industry. With that power comes great responsibility; regulatory agencies are critical partners that ensure we meet that responsibility. 

“With regulation on the books, safety and efficacy can still be tested while modernization is appropriate,” Grotz said. “We’re achieving a balance and making sure what we use works, which is the way it was for over half a century. We’ve been stalled replacing joints ‘the old way’—using hard plastic and metal to replace joints. Now, assimilating advanced FDA-cleared design with proved materials is warranted for better orthopedic care.”

That’s partly why inventors, surgeons, manufacturers, regulatory agencies, and other drivers of the medical device industry are coming at problems from new, more open-minded perspectives.

“I’m saying that intelligent evolution in the orthopedic industry is starting to catch up to the information revolution that has evolved from the Internet and electronic social expression,” Grotz said.

For Grotz, that means applying existing, U.S. Food and Drug Administration (FDA)-cleared materials and designs in novel ways. In the regulatory sphere, the practice of establishing substantial equivalence is a critical part of that process, he said. Developing a new device through a 510(k) rather than a premarket approval process speeds the path to market for devices that essentially combine the best of existing technology and practices for even better patient outcomes.

“I think the FDA is becoming more patient-friendly, more logical because they’re getting smarter in their ability to capture how the best of science and the best of engineering can be put together to help people heal in a unique, safe, and efficacious fashion,” he said. 

That was also my takeaway from my tenure working as one of the FDA’s Entrepreneurs-in-Residence. This program, which brought in industry experts from a variety of backgrounds, was launched to help the FDA streamline its processes and ideally speed up the clearance process. It was a major change in thought for a governmental institution; rather than falling back on its accepted practices, FDA essentially opened its doors as part of its commitment to breaking down barriers. They welcomed my perspective and advice and took steps to make changes based on the feedback our panel of experts offered. 

As an inventor, Grotz sees the industry in terms of creating and marketing technology. He described his Resilient Arthroplasty Device, which is in development, as an example of this same progressive approach within his corner of the industry. It’s a less invasive, safer alternative to total knee replacement, he said, one that preserves much more of the patient’s body, minimizes risk of infection, shortens recovery time, and improves long-term results.

The device, made partly from Bionate, pads damaged cartilage, restores joint cushioning, and aids cartilage regeneration by delivering stem cells and pharmacologics. It’s produced on a 3D printer that allows for precise customization to the individual’s knee, he said. The elements of the device are FDA-cleared, so Grotz is pursuing a 510(k) for the RAD.

“In this example, by integrating the best of orthopedics and engineering, by bringing together validated art and science, we’ll be able to pause, if not reverse, arthritis, which is a thrilling opportunity,” he said.

It’s indicative of a new chapter in device development, and a mindset that brings us all to the same page, he said.

“I think what is new recently is truly positive,” Grotz said. “It’s all about best outcomes, what’s best for the patient. That’s really what it’s about.”  

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Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within ASTM and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the FDA’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.