When Eric Ledet, Ph.D., was studying biomedical engineering in graduate school at Rensselaer Polytechnic Institute, he had the opportunity to work with an orthopedic surgeon on a NASA project involving the human hand.
That initial experience with orthopedics would come to steer his professional life: He conducted his doctoral research in spine biomechanics, and since then has focused on translational orthopedic biomechanics research that addresses clinical need.
Today, he leads the Innovative Medical Devices Laboratory in the Department of Biomedical Engineering at Rensselaer Polytechnic Institute, where he’s also a professor. Dr. Ledet is also Chief Technology Officer at inSense Medical and Chief Science Officer of ReVivo Medical. ReVivo recently closed a private equity funding round and is slated to start an FDA-approved, 50 patient clinical study for its spinal device.
Dr. Ledet spoke with us about finding professional balance and innovating through technology in orthopedics.
You’ve maintained your academic career while serving in chief science and technology roles for multiple companies over the years. What unique perspective has that professional balance afforded you?
Dr. Ledet: I believe there should be a common foundation between academic research and the product development priorities in industry: both should be driven by clinical need. However, there is a lot of biomedical research conducted in academic institutions that has limited clinical relevance and there are product development efforts in industry that are based on limited science or engineering. I have been lucky to be able to maintain a balance between academic research and translation of that research toward marketable products. The professional balance for me has meant that the clinical need for a new product or technology motivates my research and, in turn, that research provides the science and engineering that drives product development decisions.
Back in 2012, you wrote an article for BONEZONE about wireless implantable sensors, which is the technology underlying inSense Medical. ReVivo Medical just secured new funding and is about to start patient trials for its load-sharing, implantable spinal devices. Do you have any advice on maintaining staying power when technology takes years – or decades – to develop?
Dr. Ledet: The maturity that a new product or startup company needs to achieve prior to acquisition is significant, and the product development path for a new technology or disruptive product in a startup is circuitous. This combination can test longevity.
I think there are three key factors in surviving this test. One, do end-users really want the technology? If there truly is a need, if the technology will really make a difference, if it eliminates a real problem, then the support for the technology will not go away as fads in the market come and go. Two, listen and be prepared to pivot. Specific needs may evolve or change during technology development. Continuous dialog with a significant number of end-users is critical. Recognizing changes and being able to respond to them is key to not being left behind.
And three, set realistic milestones and meet them. Focusing on getting to the next milestone while keeping each in the context of the overall goals is crucial. Achieving each milestone is a tangible success and a means to increase valuation of the company and continue to attract funding from investors or through grant mechanisms.
What is the future of implanted sensors in orthopedics?
Dr. Ledet: Smart implants are the future of orthopedics. When reimbursements are tied to outcomes, and evidence-based medicine drives practice decisions, data are key. The more data that are available, the more care can be optimized. And smart implants are the conduit to this information. Intra-operative data can facilitate optimal decisions and make surgery more efficient. Post-operative data can enable personalized medicine for optimal care regimens which facilitate faster recovery and quicker return to work. As research tools, smart implants can provide data to drive next generation implant designs.
The key to clinically useful smart implants – and what has been lacking for decades – is transparency of the technology. Integrating sensors into implants must not require modification of the implant, which adds complexity to surgery or diminishes the implant’s performance in any way.
inSense Medical’s wireless sensor technology has the potential to meet these needs because of its simplicity. Applications for the technology include smart fracture plates, smart intramedullary rods, smart spinal fusion cages and an injectable wireless intra-compartmental pressure monitor.
Finally, what one piece of advice do you have for young engineers rising through the ranks of orthopedic companies?
Dr. Ledet: Ask why. Engineers are typically good problem solvers. Give an engineer a problem and they go right to work developing a solution. The real challenge for most engineers is figuring out which are the right problems to solve.
In medicine, we have a tendency to accept things for the way they are, because that is the way they have been. Many subscribe to the mantra, “Why change things if they aren’t broken?”
But that philosophy leads to incremental improvements only. If Henry Ford had asked that question, he would have become a horse breeder and not an automobile manufacturer. Even if things aren’t broken, even if the way something is done is working, that doesn’t mean that there isn’t a better, faster, easier or less expensive way of doing it.
The right question to ask is, “What is the fundamental goal, and can that be achieved in a superior way?” This approach requires domain expertise, maturity and the ability to take a step back and look at the details in the context of the bigger picture. But asking questions like this, asking why we do something the way we do it, often results in defining a new problem that has opportunity for a revolutionary solution.
Annie Zalenski is an ORTHOWORLD Contributor.