The vision of Spine Align was to create a means of measuring the 3D shape of the spine and contextualizing how the current point in surgery compares to the end goal. Quantitative measurements and visualization mid-surgery would provide surgeons with the information they need to adjust more appropriately, succeed more consistently, and minimize trauma to the patient along the way. That’s a big deal, because about two-thirds of spinal alignment surgeries have complications and many of them don’t achieve their desired state and instead require additional surgery. 

The launchpad for this medical device startup was Johns Hopkins University’s Center for Bioengineering Innovation and Design (CBID). Seven years ago, a class of 25 graduate students embarked on the program, doing rounds with doctors and becoming embedded in the healthcare delivery process. They did rotations through specialties, and using their varied backgrounds, they made observations and identified issues faced by doctors and patients. They amassed more than 400 problems and then filtered and prioritized them in terms of impact, feasibility, commercialization potential, etc. In the last couple weeks of observations, Amir, Dave and Dr. Nick Theodore met to discuss the biggest limitations in spinal deformity surgery, and it became immediately clear that solving this pain point for surgeons and patients can make a tremendous impact on spine surgery. 

The challenges were significant. First, they had several constraints that were self-imposed but they believed were critical to adoption: no additional radiation, and no interruption to the surgical process developed and honed by doctors over decades. That means, for example, no 40-minute detour for more imaging. The solution had to be instant and not just minimally-invasive, but non-disruptive to the process. 

Immediately after graduation, the core team of three coalesced around the startup that was incorporated in Maryland. They knew they needed funding, so they jumped on the grant treadmill. They scored an early Abell Foundation fellowship aimed at keeping entrepreneurs and innovation in Baltimore. They then received early grant and mentorship support from VentureWell, a non-profit that focuses on growing entrepreneurs that come out of academia. The Spine Align team eventually really gained speed when they won a NSF Small Business Innovation Research (SBIR) grant in 2019, which enabled them to subsequently validate their technology prototypes and hire employees. 

One of the most daunting aspects of the startup, from the perspective of an outsider, was that it was a combination of a physical product and a software solution. The physical product would be a handheld device that the surgeon would use to take measurements. The software would be able to calculate and visualize the progress towards the planned endpoint of the surgery, leveraging the existing computing power and displays available to spinal surgeons. As a result, this startup would require programming expertise, CAD engineering expertise to design the device, and manufacturing expertise to actually create the physical product. 

But, this is a team of Johns Hopkins biomedical engineers and neurosurgeons, so they had all the right components to make this dream a reality. They built the prototypes themselves, doing the CAD design work, machining and 3D-printing parts, and assembling it themselves. They wrote their own code and software interfaces, often rewriting an entire demo every few weeks. And then Amir put the product demo in a suitcase and spent most of 2019 traveling to conferences and meeting surgeons. He sat down with surgeons and asked them about their techniques and pain points. He was so immersed in spinal surgery that when he used technical jargon to ask follow up questions, they assumed he was a surgeon, too. 

By the end of 2019, it was time to freeze the design and commercialize it. That process needed investor funding, because grant funding is too slow and hard to come by. So Amir set out to meet what seemed like most of the Angel investors in America. The trip culminated in a March 11, 2020 presentation to 300+ investors at the Angel Capital Summit for the Rockies Venture Club in Denver. The next day he landed in Baltimore not knowing whether he’d landed any funding. He was immediately locked down, just like everyone else, thanks to COVID mitigation measures. He answered questions remotely for a couple months while the investor world tried to sort out whether they would be heading for their bunkers or investing as usual. Slowly commitments started to come in. Then he started to syndicate the investment, and soon he had investors from every time zone in continental America, from Pasadena, Berkeley, Seattle, Denver, New Orleans, Virginia, New York and Baltimore. 

Investor funding enabled Spine Align to move faster. They leveraged outside software companies to validate and enhance their code. They partnered with experts to make final design tweaks to design for manufacturing and make the hardware sterilizable and reusable to drive down costs for hospitals. And, they opened discussions with strategic industry partners. That’s when they found the ideal partner, one with other spinal surgery products, one with a history of delivering new innovations, and one with an ambition that matched that of the Spine Align team to advance spine surgery. The platform will still take perhaps a couple more years to commercialize at scale. There is an FDA process, after all. 

Amir and his co-founders faced years of challenges, setbacks and failures. Like all entrepreneurs, they wondered whether the time they were spending would eventually be wasted. Was this just another set of fancy technologies that will never make it to the operating room? But, Spine Align is well on its way. The acquisition was a validating milestone, but it wasn’t what the team thinks to be “success.” That will come when it’s in operating rooms all over the globe and an integral part of how surgeons perform the next generation of spinal surgery. One measurement at a time.