How did you decide to start a medical device business?
Most often, it’s a personal experience with the transformational power of healing.
At the just completed North American Spine Society (NASS) 2023 annual meeting, we asked the CEO of a young and emerging technology company that question. How did you decide to start your business?
Her answer turnout out to be both interesting and inspiring.
We want to share it with you.
The young CEO is Alyssa Huffman, 44 years old, M.B.A, founder and CEO of Allumin8.
Here is her remarkable story.
When Revisions Become Personal
Huffman had been working for years as a rep distributing for many of the biggest total joints, trauma, extremity, spine, sports medicine, and biologics companies. She had been in hundreds of surgeries, sold thousands of products, and worked with many of the top surgeons.
Then, her uncle, Richard Whittington, in 2010 at 63 years old, had a failed lumbar fusion. His screws backed out and his rod broke. Coincidentally, Huffman’s 21-year-old cousin was living with incomplete quadriplegia and experienced the same result.
That’s when the downside of her business became personal.
Her uncle would eventually have six spine surgeries. “If someone is 45 and in good health, things are fairly straightforward. But if you have a diabetic patient—like my uncle—then the risk of a poor outcome, infection or immune system issues sky rocket.”
“I simply grew tired of watching failures occur while seeing the effects they had on the patient and their loved ones,” remembers Huffman. “The industry needed a new perspective on design which would more closely reflect research and build on what is available to surgeons within the hospitals but also incorporate gold standard practices and the emerging advanced manufacturing technologies.”
In 2009, Huffman began sketching out some design concepts for reducing screw pull out and rod breakage.
She then ran across a paper published in Biomaterials & Tissue Biomechanics, written by Professor Amir A. Zadpoor, Ph.D., which compared the architecture of bone in the vertebrae to other areas in the body. “Vertebral bone is much more porous…the lattice structure is thinner and more rounded. Which helps explain why bone in the spine needs more assistance with respect to the demands of hardware.”
Tapping into some engineers in her network, Huffman looked more closely at the trabecular pattern of bone in the spine and used that to re-imagine what a pedicle screw might be.
“We engineered hundreds of micro and macro changes to the design of a pedicle screw. Our engineering team took my ideas and created functional art,” remembers Huffman.
In effect, she was aligning pieces of a complex puzzle for, she hoped, one of the companies she was repping for. Perhaps, she thought, they would get excited about her ideas and agree to take them through the regulatory process and ultimately to spine surgeons.
But, as thousands of entrepreneurs have learned before Huffman, “By 2019 I realized it was up to me to bring it to life.”
Breaking the Mold
Alyssa Huffman’s father was an orthopedic flight surgeon in the Air Force. Like him, she enjoyed research, thinking limitlessly, and focus. Surgery was where she found her calling.
In college, at 19 years old, Huffman was aiming for medical school. But life has a way of laughing at our best laid plans and intentions.
Medical school, at least at that stage in life, was not an option, so she pivoted to journalism—a career that is also, at its core, research based. To pay the bills, Huffman took advertising and medical equipment gigs while also applying—repeatedly it turns out—for sales rep jobs at orthopedic companies.
It took six years. Six long years.
“Finally, I heard from a distributor at Smith & Nephew who had just interviewed my brother. He wound up going to NASA (smart family!) but he recommended they contact me. Through some divine intervention, I gratefully accepted my first role as a total joint rep in 2007. It was a phenomenal, yet character-building experience…Smith & Nephew was great to me, and I made lifelong friends.”
Huffman rose through the ranks becoming over the years a comprehensive orthopedic and spine product distributor rep, managing spine, biologics, total joints, trauma, sports medicine, computer navigation, and foot-and-ankle products through various manufacturers.
And, breaking the mold.
“I recall being at a Smith & Nephew meeting where there were hundreds of men—and me—the only woman who wasn’t an assistant.”
Huffman also learned about the less savory aspects of the medical device business. “I was once criticized by a manager who stated I needed to stop reading research because my job was to sell. It’s easy to say I overlooked it, but comments like that creep into the psyche.”
“Just because I wasn’t a researcher didn’t mean I couldn’t read data from all over the world and correlate the emerging trends.”
And then there were the short cutters. “I’ve seen it all. From shady business partners to unethical management, and poor business practices.”
There are no short cuts to quality medicine.
The Indelible Power of a Good Mentor
At the persistent urging of her mentor, the late Dr Luke Vaughan, former Orthopedic Oncology Director at the Scripps Institute, Huffman kept working on her personal project—reducing pedicle screw failure. “At that time, I didn’t have a lot of support and honestly didn’t believe a woman without a research or surgical background in the Midwest could go up against the likes of titans in the field.”
The year 2018 took a turn for the worse for Huffman.
Huffman’s marriage was unraveling. She had a young son. At about the same time, she jumped into a taxi cab and on the way to her destination, was slammed by a drunk driver speeding along at 77 mph. She was gravely injured with a traumatic brain injury. That started her on a journey of multiple surgeries, trigeminal neuralgia, and lawsuits. She asked her employer for sick leave for emergency brain surgery and was laid off—which, to her, seemed incomprehensible given her string of promotions and performance. Then there was the PTSD.
She was at a crossroads in her life.
“Giving up wasn’t an option. Working for a large company wasn’t an option anymore. I was tired of being disposable after delivering great successes for companies. If I wasn’t willing to bet on myself, why should anyone else?” says Huffman.
“I wanted to teach my son he could thrive through life’s failures by growing mentally, physically, and spiritually. So, the first thing I did was invest in myself to bring my pet pedicle screw project to fruition by getting an MBA at Washington University – St Louis. I had always believed these designs could really help patients, surgeons, and hospitals alike. Now I had to prove it.”
Going for Gr8
She gave her pedicle screw project a name. A8 Integr8™. She formed a company named Allumin8.
Huffman’s next move was to reach out to Dr Khoi Than, M.D., a neurosurgeon at Duke University. “Dr Than published a powerful paper at the North American Spine Symposium (NASS) 2019. If anyone was going to give me honest feedback, it was going to be him.”
Dr. Than’s reaction to Huffman’s new pedicle screw was encouraging. He, in turn, took it to several of his colleagues around the U.S.—Wilson Zach Ray, M.D., M.B.A., and Chief of Neurosurgery at Washington University – St Louis, Alekos Theologis, M.D. at the University of California, San Francisco, and later Mayur Jayarao, M.D. at Cox Health and University of Missouri.
For about a year, Huffman, Than, Ray, & Theologis met regularly to write grants and review design concepts. Of course, this journey led Huffman to the Dean of Spine and Orthopedic engineering—Mike Sherman. Also joining the initial small team was Charlie Barfield.
“We went through eight full redesigns with several engineers over the last four years and through some careful considerations for corrections finally found the one that could take the title of A8 Integr8 with additive manufacturing design guru Matthew Shomper.
“In the last series of tests, we threw everything we could think [of] into the designs while testing 16 different versions. To say the Allumin8 team was on the edge of our seats during the testing would be an understatement. We couldn’t have done this without the support of our manufacturers.”
Classic Bootstrapping
To pay Alumin8’s bills, Huffman consulted with start-ups, small device companies, and private equity groups.
And she learned about how to start, fund and develop a start-up organization.
“The A8 team and I were methodical and very selective as far as investors. We got lucky because capital has been exceedingly challenging to come by in the U.S. Through the team’s long-standing industry friendships, we found excellent manufacturers in India who not only invested in us but are also helping commercialize the A8 Integr8 Porous Pedicle Screw in Asia. We couldn’t be more grateful for the support of 3D Incredible (the largest patient specific customized implant manufacturer in India) and Solco India for all their extraordinary efforts. This is truly what working globally and supporting a belief in helping the patient looks like.”
Bill Walth, Ph.D. and Matt Pelletier, Ph.D., got interested.
“Once Bill showed interest, I knew we had something that could be profoundly impactful, said Huffman.”
A Difference With a Distinction
“The A8 Integr8 Porous Pedicle Screw System offers a unique lattice structure commensurate with vertebral bone that internally collects freshly harvested autograft during insertion. Combined with the ability to draw in bone marrow, A8 Integr8 is designed to facilitate cell adhesion to the autograft. In essence, we aim to study if we can create a long-term biological ripple effect that demonstrates an increase in bone mineral density through regenerative processes. It’s taking what is done in an interbody cage and translating it to pedicle screws without multiple steps.”
And, of course, her A8 Integr8 is 3D printed.
“While we aim to focus within the spine market due to the high revision rates, we recognize this technology can help in many applications and are meeting with manufacturers to license the IP out. The goal is to solve global problems by providing options.”
FDA Submission Q1 2024
Huffman and her small Allumin8 team are on track to submit 510(k) data to the FDA in Q1 2024.
“Honestly, I regard this pedicle screw as a masterpiece of macro and micro changes! This is such a clear ‘win’ for surgeons, patients, hospitals, and insurance companies alike that we have named our campaign, ‘Why not?’—as in, ‘If you’re not changing your surgical technique, pricing, post-op or pre-op care, yet providing options that never before existed in hardware…then why not try A8 Integr8?’”
In addition, Huffman plans to study the effects of injecting off-the-shelf injectables through the pedicle screw to see if, with these new designs, surgeons will be able to reduce the sometimes catastrophic need for removal of hardware due infections, which she personally experienced with her uncle.
If the business of supplying orthopedic and spine surgeons is all about solving tough clinical problems, then Huffman has certainly chosen a promising market—the market for reducing spine surgery revision risk.
And, if we were to bet on any young entrepreneur, Alyssa Huffman would be at the top of the list.
