7D Surgical Inc.
October 23, 2017 Issue
Q&A with Beau Standish, CEO of 7D Surgical Inc. using Cutting-edge Optics, Advanced Software Algorithms, Machine Vision, and Machine Learning to take Image Guided Surgery to Another Level allowing Surgeons to Perform Delicate Procedures Without Radiation
Chief Executive Officer
7D Surgical Inc.
Interview conducted by:
Lynn Fosse, Senior Editor, CEOCFO Magazine, Published Ė October 23, 2017
CEOCFO: Dr. Standish, what is the idea behind 7D Surgical?
Dr. Standish: At 7D Surgical, we use modern technologies that include cutting-edge optics, advanced software algorithms, machine vision, and machine learning to make dramatic, and clinically significant advancements for image guided surgery.
CEOCFO: What does that mean while a surgeon is doing a procedure?
Dr. Standish: Think of the last time you had to hang a picture on the wall. You want to put a screw or nail into a stud behind the drywall so your picture remain securely fixed to the wall. The difficulty with this task is that you cannot see where the stud is behind the drywall. Very similarly in spine or cranial procedures, the surgeon needs to implant devices deep into the patient, but cannot see beyond the surface of the tissue. What image guided surgery does is provide GPS-like information to allow the surgeon to see where important structures are beneath the surface of the tissue.
CEOCFO: How are you able to do that?
Dr. Standish: We have created an advanced imaging system using machine vision cameras. This in combination with our object registration algorithms allows our technology to automatically identify tissues or anatomical structures of interest very quickly and very accurately. For example, the surgeon can visualize where the pedicle canals are below the top level of bone or through tissue. The surgeon then uses our optically tracked surgical tools, which are virtually overlaid on the patientís pre-operative data (CT, MRI) via a high definition monitor in the operating theatre. Thinking of the drywall analogy, the surgeon can visualize where the studs (parts of the patientís spine) are underneath the drywall (patientís tissue) for screw insertion. We have also achieved this without the need for any additional intraoperative radiation, which improves safety for not only the patient but all of the operating room staff. The next step in our product development process includes refining these algorithms with artificial intelligence.
CEOCFO: What is the artificial intelligence? What is being considered to come up with a conclusion as to where the surgeon should go?
Dr. Standish: An analogy that people can understand relates to self-driving cars. There are cameras on the car, which look down the road and onboard computers continuously identify objects in the path of the car to help guide the car down the road. For example, visualize yourself driving down a road and there is a pedestrian on the right side. The camera will draw a green square around the pedestrian and the car may react differently based on what the pedestrian is doing. The car may slow down if the pedestrian comes to close to the road or do nothing if the pedestrian continues to walk on the sidewalk. So how does that relate to our technology? Our advanced optical hardware has been designed into the form-factor of a surgical light and rather than looking down the road like the car analogy, our cameras are looking down into the patientís anatomy and we are working towards the system automatically identify features like tissue, bone, blood, the sorts of elements that can help to optimize the surgeon workflow and/or help improve their intraoperative decision making process.
CEOCFO: Are surgeons ready?
01^ 01^ @ň8 į+Õ ė1^ P1^ @ P1^ h: I believe they are ready for modern imaging technologies. Surgeons consistently work to improve their surgical workflows, improve patient outcome all while trying to reduce costs. In fact, other image guidance technologies have been around for almost twenty years, but with long and tedious work-flows, and in my opinion, using way too much radiation. To understand our competitors current approach, I need to use another analogy. Imagine you are going to your cabin or a cottage and that destination is about an hour and a half from your house, but before you could use your GPS, you had to call a technician to calibrate your GPS and drive your car around the block for 20-40 minutes before it would lock on to enough satellites. Finally, to use this GPS you also must use a massive amount of radiation. That would drive most people crazy, yet this directly applies to the current image guidance market, where radiation, disruptive workflows and adding 20 to 45 of minutes to a procedure is standard. So yes, I absolutely think surgeons are ready for fast, radiation free intraoperative imaging technologies like ours.
CEOCFO: What is involved in learning how to use the process?
Dr. Standish: Originally, we thought 7D Surgical was a surgical navigation company. Now, our continuous improvements and the incorporation of elements like machine vision and artificial intelligence all strive towards improving the surgeonís workflow. This attention to detail also lends itself to our training process. I love the mantra, complexity is our enemy, and the simplicity of our system is that only requires a couple of surgical procedures for the surgeon to become confident with the system and using its features. All without the need of additional specially trained staff as is required with our competitors.
CEOCFO: Would the surgeon be using the same tools and methods they have always used?
Dr. Standish: Yes. We have achieved our technological integration with minimal impact to the surgeonís workflow. The surgeon can use the same types of tools that they are used to. In addition, we also provide what are called tracked tools. These tools are part of our overall turnkey solution, so the system can be unpacked, turned on and the surgeon is ready to go.
CEOCFO: Where does cost come into play?
Dr. Standish: We know that everything we do in our industry must be focused on how to improve patient outcomes while reducing costs. Our technology does not suffer from that time detriment of five, ten, thirty or forty-five additional minutes, so we have tangible time savings. In an average OR in the US, costs run between 100 to 200 dollars per minute. Every minute, we can shorten that procedure beneficially affects the hospitalís bottom line. Another product differentiator with our technology is that we have figured out how to accomplish all this intraoperative feedback without the need for additional intraoperative ionizing radiation such as x-rays, or intraoperative 2D or CT scanners. These intraoperative scanners can cost over a million dollars. In addition to the obvious capital cost savings, the other technologies using intraoperative ionizing equipment need a specially trained person to run that piece of equipment called a radiation technician. We have removed not only the footprint of that other technology (CT scanner), but also the need for additional costly operating room staff.
CEOCFO: What has been the reaction from the medical community?
Dr. Standish: It has been fantastic. We are in the early launch phase of our products, having achieved regulatory approvals in both the US and Canada in early 2017. We have started clinical evaluations in June of this year and we are now working on multiple system placements throughout the US. We are coming up to the major trade show season for our sector in October, which will translate into a very busy fall and winter for our team.
CEOCFO: How do you decide who to reach out to?
Dr. Standish: Even though we have only been commercial for a couple of months, I have been able to surround myself with fantastic advisors and team members. Some in this group have even have grown companies from zero to billion-dollar corporations. A great starting point for deciding who to reach out to includes securing a surgeon champion, someone that can see the future and is amiable to advanced technologies to improve their workflow while reducing costs. You also want to make sure that you are working with potential institutions that will help you define the capabilities of the system such as setting up research collaborations. Ultimately in all our businesses, the goal is to generate revenue, so you want to also make sure you are choosing institutions that are in a funding cycle with respect to their budget.
CEOCFO: How does it get into the light? Are you making the light or partnering with companies that do?
Dr. Standish: Our team is involved in every aspect of our system design, software and surgical tool creation in addition to our manufacturing processed. There was not a suitable light available to alter, so we have designed and fabricated our own surgical light. Our light has also been manufactured to integrate with a boom arm that is attached to a mobile cart. This keeps the system flexible enough easily move around the hospital into different ORs at different times of the day.
CEOCFO: Would you tell us about your agreement with Spartan Medical?
Dr. Standish: Part of our sales strategy was to offset some of the early and costly expenses of developing an entire direct sales team. Our direct sales are driven by Brian Stuart, our VP of Sales and Marketing, and my own activities. To supplement this, we have developed an experienced network of agents and distributors. Those agents and distributors are organizations who have their own established sales team and who already have intimate relationships with our customers. One of these key partners is Spartan Medical. They have established themselves as leaders in our spine industry and have extensive relationships with not only surgeons but with the hospitals to expedite the process of placing our 7D Surgical image guidance systems.
CEOCFO: What surprised you as the products have been developed, reviewed and are starting to move forward?
Dr. Standish: If I think about several years ago, the joy I felt when our technology was being used (initial prototype) to help patients for the first time, really felt like we had overcome the largest hurdle in bringing our product to market. However, we quickly realized that this was just the beginning of the commercialization process. Anyone who has, or is bringing advanced products through the commercialization process in a highly regulated industry, such as medical devices, will understand immediately what our team has gone through for the last couple of years. Luckily, we have a great hard-working team that has overcome all the bumps in the road and we are positioned for explosive growth.
CEOCFO: Are you seeking investment or additional partnerships?
Dr. Standish: If we want to continue our explosive growth rate, additional funding will be required. Any company in our sector, in fact I think any CEO or CFO would say you are always fundraising to start a new project, launch a new product or to expand into new geographies. With respect to the strategic partner aspect, we are focusing more on the sales and marketing partnerships as opposed to other company or product partnerships at this stage.
CEOCFO: What is the barrier to entry for someone who looks at your idea and thinks they can do that?
Dr. Standish: I think the barrier to entry is definitely the technological knowledge required to create a product like ours. The founders of 7D Surgical, myself included, all have PhDs in medical imaging and advanced computation along with medical physics backgrounds, engineering backgrounds and surgeon backgrounds. It has taken our team years to develop our proprietary hardware and algorithms. We also hire the best recent engineering graduates and complement this with team members who have proven track records in sales, marketing, manufacturing, operations, legal, to turn the ideas into viable products. Finally, we have a very strong IP estate, where I believe it would prove very challenging to develop something like what we have without infringing on our intellectual property. With all of that said, I know there are other clever people out there who have great ideas and I am a strong believer that competition drives everyone to deliver the best product.
CEOCFO: Are there potential applications in other types of surgeries?