Smart Medical Devices Inc., a startup based in Las Vegas, Nevada, believes surgeons should have access to surgical tools and devices that deliver real-time and actionable data. Smart Medical Devices, Inc. was created by three physicians who recognized the inefficiency and inherent risks involved when using current orthopedic drilling technology, and believed there should be a better way. They have created the SMARTdrill™ which works to simplify the process of drilling and placing screws. The novel features of the SMARTdrill™ includes depth control, depth measurement, performance feedback, drilling energy, and its autoclavable wireless communication.

Medgadget had the opportunity to talk to Wayne Anderson MD/MBA, the co-founder of Smart Medical Devices Inc., about the technology.
The SMARTdrill has been listed with the FDA and is now available in the United States for some of the most common orthopedic surgical procedures. 
Akash Premkumar, Medgadget: Tell me a little bit about how Smart Medical Devices was founded. Dr. Anderson: Well, it was in 2008.  I was an anesthesiologist working at Mammoth Lakes. We’d see a lot of ski injuries in the winter and bike park injuries in the summer. We usually fixed a few femurs, tibial plateaus and wrist fractures each day. One day that winter, there were about 10 cases and it was well past 3AM. I was working with Dr. Karch and I noticed that the screws would have to be taken out several times because they were either too short or too long. Too short and you don’t purchase enough bone, leading to hardware failure. Too long and you end up damaging other nearby structures like tendons or arteries. So I asked him, “why can’t you put the right size screw in the first time?” We found out that about 30% of screws are placed incorrectly the first time and have to be removed. And if you cant use that screw later in the surgery, you have to throw it out. That happens about to about 50% of the screws. So about 15 out of every 100 screws are thrown away. Each screw costs about 150 bucks. Now, that’s no small sum of money. In addition to the cost, you have the time and the safety of the surgery to think about too! So in the coming months we did our market landscape analysis, prototyped, and prototyped some more. That’s how Smart Medical Devices was borne. Medgadget: Could you describe how the SMARTdrill works to someone who knows nothing about orthopedic surgery? Dr. Anderson: The drill is like a handheld drill press and controls the rate that the drill bit goes into the bone. There are several important features to our device. First, the drill provides depth measurement, which current drills do not do. This allows surgeons to know where their tools are. Moreover, they can improve the safety of the surgery and control costs. Second, our drill has depth control technology that allows surgeons to safely drill without the risk of hitting vital structures. Third, we have a performance feedback mechanism in the drill that gives surgeons insights to help them determine if the cutting tool is working optimally. Fourth, this drill is the only drill that provides real-time drilling energy, an important metric for surgeons to make decision about implants. Lastly, our device is autoclavable and wireless! Medgadget: What did testing your device look like, and what sorts of metrics did you use? Dr. Anderson: We started out using saw bones, cadaver bones, and animal bones. The metrics we were guided by questions like “How easy or difficult is it to learn how to use the drill?” And “Are surgeons able to interact with the use interface easily in current clinical workflow?” Medgadget: How you describe the value add of your device to surgeons considering using your device? Dr. Anderson: Our technology provides surgeons bone strength, the location of they are operating, save cost and also decrease complication rate. We divide our value into three big buckets that I’ll go over briefly. First is safety: Our technology provides surgeon bone strength and the location of their tools while they operate. This way, they don’t plunge into arteries or nerves while operating. The second is savings: The depth measurement and depth control that our drill has means that surgeons can use the right hardware the first time. Out of the first 100 screws placed with our drill, only 1 was changed, as opposed to the 30 screws that are changed right now. This is a big cost saver! Lastly is our data: We are in process of getting FDA approval to essentially create a global bone density database. Because we are able to measure bone strength, we plan to match this data up with a given patient’s medical conditions and medications. This will provide a really rich database that helps surgeon understand how different conditions and medicines affect bone strength. A surgeon can then mine this database to predict a particular patient’s bone strength. And from that, they will be able to make more informed decision about what hardware to use. Medgadget: You said that this will allow surgeons to make better decisions about hardware. Is the hardware used in a particular surgery not standardized? Dr. Anderson: Sometimes it is, sometimes it isn’t. For example, orthopedic surgeons are taught that you’re supposed to have 3 screws on each side of a plate for an upper extremity long bone fracture. If it’s the lower extremity, then it’s 4. We looked, and there’s no data on this! We want to measure joules required on each side of plate, rather than the number of screws. This way, we can help  optimize how hardware is used in particular conditions. Medgadget: Have you encountered resistance from other surgeons that think this much information is too much? Or whether it will interrupt workflow? Dr. Anderson: Absolutely. I’ll start by saying that we have lots of surgeons who think information is useful. In a survey we conducted, 97% said they want intraoperative bone strength data. Regarding workflow, we have had about 70 operations done with the smart drill now and we have encountered issues with workflow. But we have done our best to create workarounds. We’ve done small things like move buttons around on the drill to completely change our software. We’re currently on our 33rd version. Current standard of practice requires surgeons to  to drill a hole and then use a wire depth gauge to measure the depth of the hole and that tells you what size screw to use. You also have to guess how strong the bone is to determine what type of screw to use. Our workflow gives you the depth and bone strength for free, without a wire depth gauge. Medgadget: How have you dealt with barriers to adoption? Dr. Anderson: Change is always difficult in medicine. We are starting by targeting younger surgeons as well as residency programs. Your generation is much more into data and the latest new gadgets! Medgadget: Have you encountered resistance regarding the cost of the device? Dr. Anderson: Sometimes. We have deployed drills in 5 different hospitals and we have letters of intent to purchase from all of them. So that’s a good sign. Our drill is more expensive than a regular drill but the surgeons that have learned to use it have given us positive feedback. Some of them  have actually said they no longer feel comfortable using normal drills after using our device. Imagine you’re part of a hospital board. When a group of surgeons at your hospital wants something bad enough, they often get it given their revenue stream. So we are hoping the value add certainly justifies a price bump. Medgadget: If you had 1 million dollars, what do you think you’d do with it? Dr. Anderson: I wish! We want to move into robotic surgery, and I think a million dollars would expedite that process. But to be honest, we are doing that a bit right now. Currently, medical robots know how to put a tool in the right space at the right time. It’s programmed. Our technology tells you what that tool is doing. We are looking into partnerships with robotics company and offering this last part to create a feedback mechanism. Medgadget: Thanks so much for chatting this afternoon. Anything else you’d like to add before we end? Dr. Anderson: Yes! I’d like to give a shoutout to some people and one organization in particular. Dr. John ‘’Jack” Perry and Dr. Michael Karch, my cofounders, have been very important in this entire process. And also a shoutout to the TMX Medical Accelerator Program!

LEAVE A REPLY

Please enter your comment!
Please enter your name here