Jay Pierce, CEO of OrthoSensor, on taking a bit of the guesswork out of a field that has historically been somewhat of a feel-based art.

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Orthopedic surgery can often seem like car repair as wrenches, hammers, and other metal tools are put to work on the human body. And just like car mechanics of decades past, surgeons with years of experience develop the necessary intuition when performing certain procedures. Hoping to bring modern technology to orthopedic implants, and take a lot of the guesswork out of implantation and help monitor the devices post surgery, OrthoSensor, a company with offices in Florida and Arizona, has developed a system that can monitor various parameters, like movement and applied forces from within the implant, and relay the data wirelessly to the surgeon. We had a chance to ask Jay Pierce, CEO of OrthoSensor, a few questions about the technology and how it came to be.

How did the original OrthoSensor concept come to be?

The company was founded by an orthopedic surgeon named Dr. Martin Roche, who performed a lot of hip and knee replacements, and also trained a lot of surgeons on those procedures. Total joint replacement surgery has historically been somewhat of a feel-based art, as it requires the ability to feel when an implant is properly positioned. His students would ask him, "How do you know when it feels right?" Roche realized there had to be a way to quantify the process and give surgeons intra-operative feedback. He began a quest to develop the technology to address this gap, founding the company in 2006 and focusing it on products that marry sensor technology with conventional orthopedic surgery.

A lot of our readers are biotech innovators. Can you mention some of the challenges you faced getting this product to market.

Designing the technology architecture to support multiple platforms in both the short and long term was a challenge. For example, much foresight was needed to develop a custom integrated circuit that could drive the basic needs of our Surgical Platform (low cost, single use, intelligent instruments) and also meet the longer term, complex needs of our Intelligent Implant Platform (infection, load, loosening, osteolysis, pain control, etc.). Getting the ASIC right early with few revisions was a strategic win in that it allowed for timely market introduction and minimized cash burn.

Another key challenge was addressing the variety of needs and priorities of all the stakeholders: surgeons, hospitals, implant companies, payors, and patients. It requires an innovative business model and the ability to communicate a succinct value proposition to each audience. For example, we require the resources of the hospital CIO so that the cloud computing platform enabling our Analytics Platform can interact with the hospital information system. We deliver value to them because by investing their resources in facilitating our system, we are able to meet their needs for device charge capture, surgical implant records and purchasing reconciliation.

What kind of challenges do you run into integrating OrthoSensor into different tibial insert designs?

Early on we had challenges miniaturizing the technology footprint for some of the smaller sizes and uni condylar configurations. Our second generation architecture enabled us to fit the technology in virtually any size and any implant company's geometry.

Do you envision surgeons using your product instead of computer-guided navigation or do you envision a more synergistic function?

Computer navigation has not been adopted in the U.S. primarily because of the upfront capital cost, incremental procedure time, and inelegant devices that are not built into the surgical workflow. OrthoSensor is creating a new category called Intelligent Orthopedics, which harnesses sensor technology to deliver low cost, single use, intuitive devices that present data on a standard laptop, tablet, or phone. Orthopedics navigation will be replaced by consumer electronics and elegant user interfaces.

Have there been any case series or clinical trials detailing the results and experience of using OrthoSensor in actual patients?

We are in the process of a limited release in selected hospitals. A multi-center clinical study is being initiated in Q2 2012.

Are the trials re-usable? Or are they meant for single patient use?

The OrthoSensor Knee Balancer is single use and low cost -- just $459.

How many and which knee replacements is OrthoSensor currently compatible with?

It's currently compatible with the Stryker Triathlon knee implant but there is the potential to make it compatible with any implant.

What has been your general sense of the reception you have received so far from joint surgeons when either using/hearing about this device?

The response from surgeons has been extremely enthusiastic. They are excited to have, for the first time, quantitative data to verify their feel-based technique. They like how intuitive it is and that it requires no change in their surgical workflow and does all this at a cost that is quite affordable. They have really embraced our vision for sensor-assisted surgical instruments, intelligent implants and analytics.

Are there any plans to extend this technology to other joints like the hip?

Yes, we have other intraoperative surgical instruments in development, such other balancers and alignment devices, for the hip and shoulder, as well as spine. We are also developing our first Intelligent Implant -- a 'Smart Knee' -- and plan to extend the technology to other joint implants as well.

This post also appears on medGadget, an Atlantic partner site.

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