The major manufacturers call upon her expertise, as does the FDA. A biomedical engineer, Lisa Ferrara, Ph.D., founder of OrthoKinetic Technologies and OrthoKinetic Testing Technologies, knows medical device technology.
The Birth of an Engineer
The underpinnings of her success began with two parents who said, “Well, of course you can.” Dr. Ferrara: “My two siblings and I grew up south of Boston in a blue collar family. My dad, who came to this country as a laborer at the age of 17, and my mom, an administrative assistant, instilled in us a sense of drive and purpose. They always made us believe we could do whatever we set out to do.”
And what she wanted to do was study cells, tissues, and artificial organ systems….and what could be done with them. “I obtained two undergraduate degrees, one in biology from Bridgewater State University and another in electrical engineering from the University of Lowell, Massachusetts. Although I took the MCAT exams at Harvard University, after sitting through a lecture on myoelectric prosthetics, I was captivated, and switched tracks to bioengineering. I then went to Syracuse University and obtained a masters degree in biomedical engineering and neuroscience. After two years at the university’s Institute for Sensory Research, I went to Cleveland State University, where I earned a doctorate in applied biomedical engineering with a concentration in microelectromechanical systems (MEMS) and nanotechnology.”
It was in the lab at Syracuse that Lisa Ferrara met a true sage of the medical device world. “I worked alongside Dr. Hansen Yuan, an icon in the field and my greatest mentor. Because he was one of the leading innovators in the field, I was fortunate to learn about the latest in cutting edge spinal technologies and conducted numerous research studies related to novel medical devices. At that time, new technologies in spine implantation were starting to blossom.
Through my experiences in Syracuse and through Dr. Yuan, I had ample opportunity to learn about the industry and was given the chance to branch into many different areas of research. It was very exciting to take things from the early concept stage to seeing it commercialized. I especially loved the challenge of applying my knowledge of electrical and mechanical systems combined with the basic fundamentals of engineering and applying them to a living system.
Creating Her Own Testing Universe
Having gleaned inside knowledge of what it takes to make a lab run efficiently, Lisa Ferrara then received the opportunity to create her own testing universe. “In the mid-90s I was offered a fellowship and the chance to build and run my own lab at the University of New Mexico (UNM) through Dr. Edward Benzel, an acclaimed neurosurgeon. I decided to take on the challenge. I was given space at the university and the chance to develop new technologies for medical applications, such as MEMS, which was a collaborative effort with Sandia National Laboratories at the time. I was given further collaborative opportunities when I was able to work with Dr. Shahinpoor at UNM on artificial muscles, where we made such progress in the area that we were actually interviewed by ABC News.”
They likely made so many leaps and bounds in part because Dr. Ferrara’s vantage point was shifting…and her thinking was expanding. “Because of my position in the Department of Neurosurgery, I had the chance to learn a totally different discipline. I began to look at the spine from a neurosurgical viewpoint and got a better understanding of how orthopedists and neurosurgeons differ in their thought processes, but work well as a team. For example, orthopedists know the physiology and nuances of bone, whereas neurosurgeons are comfortable with the treatment of the neural structures. I was fascinated to watch them work as a team in the treatment of devastating spinal injuries. I got an excellent grounding in the science of the neurological system and how devastating the injuries can be.”
Galvanized by this work, when Dr. Benzel left the UNM lab, Dr. Ferrara accompanied him. “Dr. Benzel departed for Cleveland Clinic and asked me to join him and build a research facility there. The effort was a more substantial political and logistical challenge. I was given a computer, but no space to work—just a room the size of a closet. Because they had just built a new research center and had evacuated an older building, I put in a proposal for the entire floor of the old building and subsequently received $1.5 million for renovations. Suddenly I was a construction manager as well, writing budgets and creating a business plan.”
But as her parents had assured her long ago, her hard work would pay off.
Out of these efforts I formed Cleveland Clinic’s Spine Research Lab. Upon completion I held an open house, which was attended by 300 people, including representatives from NASA, industry executives and the upper echelon of the Clinic. They had fun examining our robotic arm and other interesting equipment that had been generously donated by various companies. My Chairman was so pleased with our success that he wrote me a lovely letter and provided additional funding for the lab.
Some of that funding would go toward mentoring individuals who may not otherwise have had a chance to explore their engineering or medical talents. “During this time I was mentoring a number of young people from the inner city who needed a chance to excel and experience a hands-on approach towards understanding engineering in medicine. The mentees would spend one or two years with me, even getting their names on publications in many cases. I was so proud to have been named Mentor of the Year by John Hay high school in 2002. Even better is when I received letters from my former mentees saying that they had gone on to college and were doing well academically.”
Building Her Own Companies
By day she ran the spine lab; by night she worked on completing her dissertation. “I had become increasingly intrigued by the possibilities inherent in the ‘micronano’ world. Because of this, I wrote my dissertation on MEMS and the development of implantable wireless biosensors that contain a full electronic system on a microsized (1mmx1mm) chip. While it sounds futuristic, we are actually starting to see people using MEMS in certain devices like implantable blood pressure sensors, glucose monitors and for various heart conditions. These biochips emanated from the military, which would have soldiers wear them in the field in order to detect biological and chemical agents. We are moving toward the day when microchip systems can be used diagnostically and therapeutically for long-term implantation into living systems, including drug delivery systems and nano cantilevers for cancer detection.”
“Originally, says Dr. Ferrara, “the potential of this technology for medical applications lacked enthusiasm by the medical community, perhaps because it was too futuristic and would take too long to commercialize. Then people began to realize that there are real needs that could be met by these novel technologies. For example, if used in the prevention of implant loosening, the microchips will not damage the surrounding areas and can provide early detection of implant failure. They can also be used to map entire diagnostic and therapeutic strategies over time. The initial medical utilization of MEMS technology is in the realm of smart implants, which can detect what’s happening with the surrounding tissues, monitor the movement of molecules, or let the surgeon know why the patient’s bone isn’t fusing.”
Homing in on her work with this technology, Dr. Ferrara notes,
I have developed an implantable MEMS that monitors pressure, along with a smart cervical implant to monitor strain. My colleagues and I demonstrated that as the mechanics of fusion changed, the pressure oscillation and strain would change as well, and you could predict when fusion would occur. This was the feasibility, or early stage work that led to the development of the MEMS biosensor and the formation of OrthoMEMS, a company dedicated to developing the technology that can expand the diagnostic and treatment options available to surgeons and patients.
Not only versed in MEMS, Dr. Ferrara also grew comfortable with the business world. “This work provided the background I needed to move forward and develop my own testing center. Although I left Cleveland Clinic to do forensic engineering expert witness work for two years, I quickly realized that there were more suitable opportunities related to the medical device industry. In 2005 I launched OrthoKinetic Technologies LLC, a business aimed at helping companies with their proof of concept and regulatory testing, testing strategies, analysis of the device performance, FDA submissions, publications in peer reviewed journals, creation of marketing materials for industry and due diligence investigation of new technologies.”
Dr. Ferrara, named Entrepreneur of the Year for Healthcare in Coastal North Carolina for 2009, notes, “After spending two years as a forensic engineer, I was able to understand the legal thought processes and strategies used to defend or attack a medical device. It was then that I started OrthoKinetic Technologies, a consulting business in which I solely worked with medical device companies to evaluate and validate their implants, and was able to incorporate what I had learned as a forensic engineer into protecting the medical device companies from future liabilities. Within the last year I built a ‘one stop shop’ testing facility—OrthoKinetic Testing Technologies. I did so because I came to realize that there was no need to outsource testing. We manage a company’s entire preclinical package, including the animal studies. I also sit on several clinical and scientific advisory boards for industry and Healthpoint Capital, an activity that lets me focus on the assessment of implant performance, and related engineering or mechanical risks that could affect clinical outcomes.”
To share what she has learned thus far, Dr. Ferrara developed a book—Spinal Mechanics for Product Development in the New Millennium—with the help of two wonderful innovators and mentors, Dr. Hansen Yuan and Dr. Vijay Goel, as coeditors. “I felt there was a need to outline the process of innovation from biomechanical theory to the regulatory process.”
Living Her Life to the Fullest
Disparate thoughts flow together and click, thus leaving the creator with something new. In addition to experiencing this process at work, Dr. Ferrara has such moments in the garden and at the canvas. “I have a large herb garden, raise orchids, and enjoy jogging, sailing, and painting. My hobbies bring a sense of relaxation and achievement to my life. My husband Jim, who runs the test lab and is an incredible engineer, is my real strength and best friend.”
She and her husband use their resources—wisdom, time, love, and money—to impact the lives of those in need. “My husband and I devote what we can to Faith Friendship, a personal care home for mentally challenged individuals. It is a place where folks who need extra care live as one big family; the people who maintain the home and care for everyone are our true heroes. Jim and I hope to eventually donate extra time and money to make the residents’ lives more comfortable. I think the greatest lesson learned from our involvement with Faith Friendship is humility.”
Dr. Lisa Ferrara… expanding possibilities in medical technology and in life.
