Lisa Ferrara

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Intending to become a cardiac surgeon, Lisa Ferrara began her career as a biology student in Bridgewater, USA. A lecture on future technologies and prosthetics captured her imagination, leading her towards the innovative and exciting world of micro-electrical-mechanical systems (MEMS) in medicine. Going on to head two research departments at the Cleveland Clinic, Cleveland, USA, Ferrara used her experiences with medical devices to start two companies focussed on bringing novel technologies to market. She speaks to Spinal News International about her career, her academic work, and the latest developments in the spinal device arena.

How did you get into biomedical engineering, and what appealed to you in particular about spine?

I originally received a biology degree with the intent to go to medical school to become a cardiac surgeon in 1985. During that time, I attended a lecture on future technologies related to prosthetics. This changed my focus to engineering with a goal to enter into developing cutting-edge medical technologies. I then went back to school and obtained a degree in electrical engineering in 1989 and worked as a bioengineer for a few years, before obtaining a Master’s Degree in Neuroscience and Bioengineering at Syracuse University and my doctorate in Biomedical Engineering with a concentration in MEMS (micro-electro-mechanical systems) technology.

During my education, I also worked for the Department of Orthopedics at the State University of New York in Syracuse, where my research focused on the effects of osteoporosis on bone mechanics and morphology, as well as studying different stabilisation systems and their effects on spinal biomechanics.

Who have been your career mentors and what wisdom have they taught you?

I was incredibly fortunate to have started my career working under the direction of Dr Hansen Yuan, a world-renowned spine surgeon and entrepreneur, who was an incredible role model and mentor to me. He continues to be a wonderful mentor, colleague, and friend to the present day. The wisdom he imparted helped to foster my growth academically and in business. His extensive knowledge of new technologies and business acumen sparked my enthusiasm in the medical device industry.

What has been your proudest career achievement so far, and why?

Obtaining my doctorate in engineering was a personal achievement that opened new and exciting opportunities towards my future career. My dissertation involved a new technology at that time; using MEMS for the development of smart spinal devices. This significantly broadened my experience with new technologies and escalated my academic career, where I became actively involved with teaching and lecturing at numerous medical and engineering conferences worldwide.

I was able to maintain an academic role while pioneering new technological areas and paving the way for new regulatory and testing strategies. I currently serve on editorial boards for a number of medical and engineering journals, and continue to move forward with my work in nanotechnology.

You have been involved extensively with musculoskeletal research, heading two departments at the Cleveland Clinic in your time. Which piece of research are you most proud of, and why?

Lisa Ferrara

I enjoyed those research opportunities where I was involved in the development of early-stage medical technologies originating from military applications. My research incorporated MEMS technology onto spinal devices with the goal to create smart implants that could monitor tissue healing (ie. spinal fusion). Multiple microsensors that could fit within the eye of a needle were capable of sensing pressures and strains, which are the basic parameters that we use for characterising biomechanical properties. These sensors could be incorporated into spinal devices or other medical devices that could provide real-time in vivo information related to local tissue healing or, when used in spinal applications, could provide the status of a fusion.

At that time, MEMS was still in its infancy and the opportunity to develop new applications for this technology, as well as new pathways to validate the technology for medical applications was exciting. It was at that time that US President George W Bush focussed on MEMS in medicine after his visit to the Cleveland Clinic to review these technologies. Today, MEMS has been implemented in numerous medical applications and has morphed into nanomedicine, which has changed the course of treatment for many aetiologies, including the area of spinal disorders.

What do you think has been the biggest development in spinal surgery during your career?

The biggest development with respect to treating spinal degeneration has been the total artificial disc, which changed the traditional treatment of fusion for spinal instability. Now that this technology has been available in the USA for over a decade, its long-term clinical performance has been evaluated for the earlier systems which can and have provided new insight into understanding how motion preservation of a degenerative spinal segment may affect or improve the clinical outcome.

Currently, we are at a new and exciting turning point in medicine. With gaining popularity of 3D-printed technology used to manufacture open structures and scaffolds for tissue incorporation into medical devices, bioprinting is in its early stages of development where human tissue can be printed, including neurons, seeded scaffolds, and eventually entire organ systems. Although this technology is still in its research and development stage, it offers a very promising future for regenerative medicine which stands to significantly change the treatment plan for spinal patients.

What are your current main research interests?

Although the majority of my research in the early years was focused towards spinal biomechanics, I had also spent many years studying musculoskeletal injuries and trauma, with a concentration in craniomaxillofacial and traumatic brain injuries.

Currently, my two companies create a turn-key approach for the assessment of medical devices from the early stages of development to post-commercialisation, where both regulatory and test strategies, along with clinically relevant testing scenarios are designed and implemented to effectively assess devices for safety and potential high risk situations.

Outside of your own work, what has been the most interesting paper that you have seen in the last 12 months?

I tend to favour articles that are related to new technologies and materials that focus on tissue incorporation or regeneration, from the nano to macro level. For example, nanotechnology has been used to augment cellular differentiation and organised tissue formation by creating nanostructures or scaffolds that can be seeded with stem cells.1 The structures can provide mechanical stimulation to guide preferred cell differentiation and growth, resulting in the efficient formation of specific tissue matrices. It is encouraging to see that medicine has advanced to a stage where the potential for organ or neural regeneration is not that far off into the future.2

You founded OrthoKinetic Technologies in 2005 and OrthoKinetic Testing Technologies in 2008. What is the most challenging part of bringing a device to market?

The most challenging part is ensuring that all of the research studies, testing, and evaluations performed on a new technology prove the device is safe and effective and has been subjected to intense evaluation to avoid unforeseen complications or catastrophic failures upon human use. This is a difficult task, as many potential complications cannot be predicted, modelled, or measured in a clinical study. Therefore, there is a balance to achieve between appropriate evaluation and potential risk. Since it is impossible to mitigate every risk, added tests may be needed to address risks with greater chances of occurring.

How has the regulatory approval process changed in your time as a researcher and consultant?

The regulatory approval process has changed significantly over the past few years. There are a greater number of new hires at the US Food and Drug Administration (FDA) and new device branches due to the increased number of device submissions. This created a situation where the FDA cannot keep up with the fast-paced innovation, making it challenging for the regulatory processes and policies to stay current.

Presently, the FDA works closely with industry to create a team approach towards innovation, where there is a unified mission of the team to develop safe devices where the criteria for the standardised tests are met, and additional potential risks based on information gathered from current marketed systems are addressed. The end goal is to minimise patient complications and enhance quality of life.

What are the main challenges facing researchers and product developers today?

The biggest challenges are financial; establishing the necessary funding to bring an idea to market, which include the costs that are needed to ensure the device is functional, durable, surgically safe, and will provide the long-term stabilisation needed to satisfy the specific clinical objective. Establishing the appropriate team to achieve the goal is just as important as the financial and equally as challenging.

Of the product developments you have overseen in your work, which have been the most exciting?

There are many that have been exciting. The rapid adoption of new manufacturing techniques for creating innovative orthopaedic and spinal implants that could not be manufactured conventionally has changed implant design considerably. Such fabrication technologies have the potential to change how implants behave in the body.

The open architecture created by additive manufacturing for spinal devices could not be produced easily with conventional machining and is particularly noteworthy, as it has the potential for quicker osseointegration and earlier stabilisation. Additive manufacturing has provided a vehicle for manufacturing many different types of medical implants that could optimise cellular mechanics at the bone interface with the potential to provide earlier stabilisation, less particulate generation, improved fusion rates.

Your work with societies stretches from presenting lectures to chairing committees. What are the most important things such societies can offer?

Societies can offer a community where the healthcare professionals can go to learn about current concepts, strategies, and technologies from their peers. Additionally, they can establish an environment where clinicians, surgeons, scientists, engineers, and industry can work together as a team to innovate novel technologies to address unmet clinical needs.

A society not only informs us about strategies and techniques that work, but also works to inform us about the strategies and techniques that do not work, and allows the professional community to have candid, open discussions about surgical techniques, implant characteristics or implementation, successes, and failures. Such discussions provide a non-biased evaluation of the science. All of these factors can take a good innovation and make it great.

What are the three questions in spinal surgery that still need an answer?

  • Are motion preservation devices truly effective at reducing adjacent segment disorder?
  • How do motion preservation implants alter the long-term biomechanical environment for the ageing and degenerative spine?
  • Will robotics effectively improve surgical outcomes and reduce the complication and revision rate for spinal surgeries, and reduce cost long-term?

What do you think will be the next big development in spinal surgery?

In my opinion, the development of regenerative technologies that are created in the laboratory setting, such as that of bioprinting neurons, and implanted to regenerate and innervate portions of an anatomical structure may be the next big milestone in spine.

What advice would you give to someone who was starting their career in biomedical engineering?

Be a team-player and realise that the success of the company is based on a successful team of skilled co-workers and colleagues. We all possess different experiences and talents which, when combined, equal success.

Go above and beyond what is expected of you and aim to provide true value to the company and your team.

Work hard and conscientiously, stay honest and ethical, do not take shortcuts, and work towards an end goal that benefits the team.

Innovation requires the ability to “think outside of the box”. Early brainstorming sessions with the team can lead to ground-breaking innovations.

Outside of research and entrepreneurship, what are some of your hobbies and interests?

Outside of my work, I enjoy painting in acrylics and watercolours. I also like gardening and have a large herb garden.

References

  1. Raspa A, et al. Nanoscale 2016 7; 8(1): 253–65
  2. Tsintou M, et al. Neural Regen Res 2015 May;10(5): 726–42

Fact file

Education

1981–1985     BSc in Biology, Bridgewater State College, Bridgewater, USA
1985–1988     BSEE in Electrical Engineering, University of Lowell, Lowell, USA
1994–1997     MSc in Neuroscience, Syracuse University, Syracuse, USA
2002–2008     DEng in Applied Biomedical Engineering, Cleveland State University, Cleveland, USA

Research appointments

1999–2003     Director, Spine Research Center, The Cleveland Clinic Foundation,             Cleveland, USA

1999–2003     Director, Spine BioMEMS and Nanotechnology Lab, The Cleveland Clinic Foundation, Cleveland, USA
1997–1999     Senior research specialist, University of New Mexico School of Medicine, Albuquerque, USA
1990–1997     Research specialist, SUNY Health Sciences Center, Syracuse, USA

Entrepreneurship

2005–present President, OrthoKinetic Technologies
2005–present President, OrthoKinetic Testing Technologies

Selected society involvement

2014              NASS, Executive Review Committee – Spine Motion Technologies
2011–present ISASS, Program Committee Board, Chairman for ISASS Research Committee
2004–2007     NASS, SCRUBBS Member of the Board of Directors
2003–2006     NASS, Basic Science Review Committee

Selected editorial positions

2014               International Journal of Spine Surgery, Editor, Testing and Regulatory
2009–present  American Society for Mechanical Engineers, Manuscript reviewer
2006, 2010     International Journal of Spine Surgery, Editorial board member
2006–present  Spine, Manuscript reviewer,
2006–present  Journal of Biomechanics reviewer

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