6 Questions with Dr. Steve Gunther, Founder of Shoulder Innovations
Shoulder Innovations was founded 11 years ago. When all the device companies were focused on their early reverse shoulder designs, an entrepreneurial surgeon and his partners focused on a better glenoid implant design.
I sat down with Dr. Steve Gunther, co-founder to learn the Shoulder Innovations story.
#1 – How did Shoulder Innovations get started? Take us back to the inception of the idea. We would love to hear the backstory.
Shoulder Innovations began as an idea in my head. I performed a 6-hour total shoulder revision surgery in the late 1990s when I was a young faculty member at UCSF/Stanford Healthcare. The previous bone grafted total shoulder, performed 22 years previously, loosened and the loose fixation screws migrated out of the joint. The anterior screw fragment was lost in the anterior soft tissues. After 4 hours of anterior soft tissue dissection, I carefully removed the screw fragment from the axillary sheath, right next to the axillary artery and vein. This was my wake-up call. There must be a better way to perform shoulder replacement surgery on deficient bone without bone grafts and screws!
#2- How was Shoulder Innovations initially created, funded, and staffed?
After I left UCSF, I moved to northern California on the border of wine country and lumber country. I treated lots of manual laborers, millwrights, loggers, truckers, etc… with severe shoulder arthritis and bone loss. So, I designed a new implant and surgical method that could be imprinted in deficient bone like a man-hole cover on the road. My wife and I boot-strapped the company. There was no staff at that time. I wrote my original patent with my cousin, who is a patent attorney. Five years later, I met a venture capitalist (Mike DeVries) at a meeting. After he learned about the inset glenoid, the less invasive surgical approach, and the highly successful early clinical results in bone deficient patients, we joined together and created Shoulder Innovations, LLC. He also brought a brilliant engineer (Des O’Farrell) to help us expand our IP, develop some new concepts, and gain FDA approval for our total shoulder system.
#3 – What does the team look like in 2020?
In 2015, Shoulder Innovations partnered with a world class group of shoulder executives and engineers with extensive senior level industry experience, expertise, and success in the shoulder market. The team at Genesis Innovation (Rob Ball, Jeff Ondrla, Don Running, Matt Ahearn, David Blue) provided the company with decades of executive, R&D, quality, regulatory, sales, and marketing experience from previous senior roles at DePuy/J&J, Tornier, Biomet, DVO, Zimmer, etc… The talent pool has grown even more over the past few years.
#4 – Please describe the benefits of inset technology versus onlay? Why hasn’t a company done this before?
The most important advantage of inset glenoid technology is the dramatically improved fixation strength from the peripheral wall of “containment” around the entire perimeter of the imbedded implant. The bony containment rim provides long-term protection from the typical “rocking horse” forces that tend to loosen classic onlay glenoid implants. This mechanical advantage has been proven in multiple clinical and scientific analyses published in the Journal of Shoulder and Elbow Surgery (2012, 2012, 2016, 2017, 2019) including long term results up to 10 years after surgery. The low depth profile of the implant also allows both version realignment and strong fixation in severely deficient bone. Finally, the surgical method provides a peripheral wall of containment surrounding the implant that protects both the edge of the polyethylene implant from poly wear and protects the bone-cement interface. Classic onlay glenoid implants rely solely on backside keel or peg fixation.
This shows an inset glenoid trial in an SLA shoulder model with deficient bone (blue), inset glenoid (left), and inset augmented glenoid (right)
The initial response from the Shoulder Innovation head R&D engineers, who came to us from other prominent orthopedic device companies, was “This is so simple. I can’t believe that I didn’t invent this!” Surgeons have also enjoyed the simplicity of the procedure, the low profile tray, and the increased strength of fixation. Dr. Colin Eakin said “The exposure is very similar to the Tornier system that I have used for 23 years, but I find the inset to be much easier to do.” Dr. Nick Capito and his surgical team like the simple surgical technique and the simple 1-tray system. “Shoulder Innovations reduces the burden we have seen with other companies requiring 5-6 trays.” Dr. Rob Gillespie switched to inset glenoid implants for improved fixation and better results. “It gives me excellent stability, great fixation, and very little risk of the rocking horse type phenomenon that we often see with onlay glenoid implants that can contribute to early loosening.”
#5 – What other products and new technology will we see in the future from Shoulder Innovations?
Shoulder Innovations, Inc. is developing a full product portfolio of novel shoulder arthroplasty products utilizing the inset method. SI released a convertible humeral mini-stem in 2019 and a new inset augmented glenoid implant in 2020. The R&D team is finalizing the development of our novel reverse ball and socket arthroplasty system and our new stemless humeral implant. The goal is to provide the market with a comprehensive suite of shoulder arthroplasty products to be completed in 2020.
Aside from the implants, one of our most impactful innovations has been the development of a unique 1-tray system that simplifies the sterilization process for hospitals, simplifies the OR process for nurses, and simplifies the surgical technique for surgeons. This also decreases the cost of manufacturing and the hospital storage and sterilization expenses. The ease of this streamlined efficiency is a natural fit for more outpatient services including sports medicine. In fact, I think the SI system is probably a better fit than any other shoulder system for the ambulatory surgery setting.
#6 – Where do you see Shoulder Innovations going in the future?
Shoulder Innovations has disruptive technology, streamlined OR efficiency, and proven clinical and commercial results. Even though the Shoulder Innovations business plan targeted only small, isolated markets initially, our novel technique and products attracted many prominent shoulder surgeons from across the country who have become dedicated customers. I think this company has the potential to lead the transition of shoulder replacement surgery from hospitals to the lower cost ambulatory surgery environment. Today, we are in active discussions with top level investment groups interested in providing Shoulder Innovations the capital to expand our commercial footprint and become the next Tornier.
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