by Kimberly McGhee
Founded in 2012, the Zucker Institute for Applied Neurosciences (ZIAN), a technology accelerator embedded in MUSC, is a bold experiment in bringing the worlds of medicine and engineering together to speed the translation of technological innovation in the neurosciences into the clinic. ZIAN taps into the creativity of clinicians and provides them access to the expertise in engineering, intellectual property and business development needed to develop their ideas into viable products. The vision of ZIAN’s founder, Sunil J. Patel, M.D., chair of the Department of Neurosurgery at MUSC, is for this to be a self-sustaining model of innovation, in which the licensing of inventions provides the funds needed for the development of new technologies. On a trajectory to achieve sustainability, ZIAN offers a model of successful translational research that could be adopted by other specialties.
When Jerry Zucker, a prominent Charleston businessman, received a diagnosis of glioblastoma in 2006, he and his family were surprised at how few treatment options were available. This led to a series of conversations with Patel about why the pace of innovation in medicine was so slow and how it could be accelerated. Patel explained that obstacles to innovation existed in both academia and industry. Physicians, who are involved with patient care every day, often have ideas for new technology, but most abandon these ideas because they do not have the time or support to carry them forward. In contrast, industry has the engineering and product design know-how as well as the business expertise needed to bring a technology into the clinic, but that technology is often less than ideal because it is designed with little input from frontline clinicians.
Zucker and Patel thought there had to be a better way. “We wanted to bring these two worlds together and change the culture,” said Patel. After Zucker’s death in 2008, Zucker’s wife, Anita, donated the money to make that happen, and ZIAN was born.
Patel had witnessed firsthand that bridging the divide between these two worlds could spur innovation while working as a fellow under the famed neurosurgeon and inventor Kenichiro Sugita, M.D. “In his OR, in addition to junior faculty, residents and students, he always had a couple of engineers working on how to improve this and that,” said Patel. That memory stuck with Patel and would become one of the inspirations behind ZIAN.
One of Patel’s first tasks in establishing ZIAN was finding an engineer with a passion for medical innovation and deep industry experience. Enter Mark Semler, who serves as ZIAN’s chief executive officer. While in high school, Semler lost both parents and, like Zucker, became frustrated at the slow pace of innovation. “I watched my parents die in hospital rooms full of equipment,” remembered Semler. Later, when he worked on his first medical device as an engineer, he knew he had found his calling. “I wondered whether I could affect this equipment so that I could have kept my parents alive,” said Semler. Rounding out the ZIAN team are Jesse Goodwin, Ph.D. vice president for development, and biomedical engineer Chris Hapstack.
The ZIAN offices are embedded in the neurosurgery department, so clinicians can easily stop by between cases to brainstorm ideas for devices. Each of the ZIAN offices has an entire wall painted to serve as a large white board. Many of ZIAN’s products have begun as a sketch on Semler’s wall.
ZIAN sparks innovation by encouraging clinicians and engineers to learn to converse with one another. “Engineers speak a language I don’t understand and vice versa,” said Jessica Barley, Ph.D., CNIM, one of the ZIAN inventors. “I had to bring the engineers into the operating room to show them what the real issue was. There’s a translation that has to occur between two worlds.” But when that translation occurs, magic happens and medical devices are designed that are grounded in the clinical realities of care.
Because ZIAN wants to focus its efforts on devices that will help as many patients as possible and is mandated to be self-sustaining, it must be selective in the ideas it decides to take forward. To be chosen, inventions must address an unmet clinical need, be buildable at a competitive cost, have a clear path to intellectual property and have a wide market. “We don’t want to just create a ‘me too’ device,” said Goodwin. “We want to push the limits of what’s possible.” Thus far, of the more than 150 ideas that have been pitched, ZIAN has pursued only seven. This selectivity has paid off; one of the technologies has been FDA approved, two more are licensed and a fourth is being licensed (see Box).
That impressive track record is due in part to the care with which ZIAN “de-risks” its products to make them more attractive to potential licensors. Intellectual property rights are secured, market analysis is performed, a clear pathway to regulatory approval is defined and manufacturable prototypes are created. “Those all reduce risks that could kill a project,” said Semler. “If we’ve done our work in those areas, the device is more attractive to companies because there’s very little risk they can’t get it into the market.”
Perhaps most important of all, the ideas have been thoroughly vetted as inventors pitch to their fellow clinicians, to ZIAN and finally to a shark tank of local investors. “When you go in front of a shark tank, you are going to show up with a better analysis, business model and pitch,” said Semler.
ZIAN has helped create a new culture of innovation in the neurosurgery department. “Medical science is supposed to be done to bring solutions to patients, but often it remains science,” said Patel. “With ZIAN, we developed a more solution-driven science, and that has changed the culture and the way our faculty and trainees think.” Due to that culture of innovation, the department is receiving residency applications from some of the most inventive minds in the country. “We are beginning to see applicants that I would never have
dreamed possible,” said Patel. “We just finished interviewing about 30 potential residents — they all knew about ZIAN and were creative people, some of whom already had patents themselves.”
Once it attains sustainability, ZIAN is a model that could be rolled out to other clinical departments at MUSC. “In my mind, every academic department — surgical or nonsurgical — needs to have an entity like this, where an engineer can give feedback on how to make the innovation impactful,” said Patel. In addition to assisting clinicians develop their innovative ideas into viable products, ZIAN also plans to serve as a think tank for industry, providing early clinician feedback about products in development. ZIAN views this as the best way to fulfill its mission of helping patients benefit sooner from innovative, clinically relevant technology.
|Blink Reflexometer™||Nancey Trevanian Tsai, M.D.||Licensed||A portable device for measuring the blink response|
|HEALx™||Bruce M. Frankel, M.D.||Being licensed||An expandable corpectomy device|
|NaviCap™||Raymond Turner, M.D., Alejandro Spiotta, M.D., Aquilla Turk, M.D., Imran Chaudry, M.D.||A “screw-less” cranial anchoring port system|
|SIMelectrode™||Jessica Barley, Ph.D., and Jonathan Edwards, M.D.||Licensed||An improved needle electrode for intraoperative neurophysiological monitoring|
|Sinu-Lok®||Bruce M. Frankel, M.D.||FDA-approved||A novel replacement for a standard rod implant used in lumbar spine surgery|
|TranZform™||Stephen P. Kalhorn, M.D.||A novel interbody device that expands both vertically and horizontally|
|VayuClear™||Stephen P. Kalhorn, M.D.||A surgical suction wand declogging device|
“If we know there is an unmet clinical need — if a patient is hurting and needs help — it motivates the whole team to get moving and get this product to market to help patients.“
— Stephen P. Kalhorn, M.D.
TranZform™ is a new type of expandable interbody device that could improve outcomes for patients undergoing lumbar spinal fusion surgery. Interbody devices are implanted between vertebrae and grafted with bone to encourage the bony ingrowth that is required for a stable spinal fusion. Unlike static interbody devices, expandable ones are small enough to be introduced during minimally invasive surgery but can be expanded once in place.
Although there are expandable interbody devices currently on the market, they expand only vertically or horizontally and do not fill the disk space adequately or provide enough of a graft window for the needed bony ingrowth. As a result, short-term and long-term patient outcomes suffer.
TranZform™, which expands both vertically and horizontally, provides a class-leading graft volume for bony ingrowth, facilitating better spinal fusion.
“I think this will have a tremendous benefit for patient outcomes, and we will be able to help patients in a less invasive way and give them a more durable and consistent solution for their problem,” said Kalhorn.
“It is wonderful when you have a team behind you that says ‘Thank you for sharing your idea. We will take it from here and develop it and you can be as involved as you want.’”
— Nancey Trevanian Tsai, M.D.
The Blink Reflexometer™, which has been licensed to BLINKtbi (Charleston, SC), is a portable device that uses high-speed video to capture and quantitatively analyze a series of blinks that it stimulates with puffs of air. The blink reflex has been shown to be sensitive to a number of neurological conditions, including traumatic brain injury, Parkinson’s disease and Huntington’s disease, suggesting that it could be a useful tool for neurological assessment. The device analyzes the recorded blinks to determine whether the patient has experienced neurological insult.
The device could make it possible to include the blink reflex as a metric or vital sign in medical examination. Because it is portable, it could be taken into the field for on-site neurological assessments. Potential uses are field-side assessment of athletes for concussion or field sobriety tests for marijuana intoxication. The device was recently awarded the 2018 Technical Team Project of the Year by the Charleston Engineers Joint Council.
“When you can provide quantitative, objective data, it’s a game changer,” said Nancey Trevanian Tsai, M.D. “It’s analogous to the difference between saying someone is feverish and measuring the patient’s temperature with a thermometer.”
“You don’t go into this thinking you are going to get a home run, but when it happens, it is a feeling of accomplishment that I cannot even begin to describe.”
— Jessica Barley, Ph.D., CNIM
SIMelectrode™ solves a serious safety problem with intraoperative neurophysiological monitoring (IONM) — the risk of needle sticks. As many as 60 disposable needle electrodes are taped to the patient — from the scalp to the feet — so that neurological function can be monitored during surgery. Although IONM is crucial to patient safety, the needles can stick personnel as they dislodge the electrodes or move the patient. Needles can also become snagged in the many wires that connect the electrodes to the IONM specialist’s computer, making accidental sticks more likely.
The innovative design of SIMelectrode™ solves these problems. The needles are covered in a protective sheath and retract immediately after use. The market for the device is substantial, since intraoperative monitoring is used by neurosurgery, orthopaedic surgery, urology, radiology and cardiac surgery.