Accelerating Regional Life Sciences Growth: A Role for Innovative Surgeons

This article was written by Garrett Coyan, MD, MS, from the Department of Cardiothoracic Surgery.

The expertise of cardiothoracic surgeons is highly valuable in developing new technology for clinical use. Unfortunately, the training pathways and clinical responsibilities of most cardiothoracic surgeons make it difficult to participate in clinical technical innovation. Garrett Coyan, MD, MS, has a passion for translational research, clinical innovation, and developing medical products, and he has found ways to overcome these hurdles. While training as a resident in the UPMC Department of Cardiothoracic Surgery, Dr. Coyan has also served as the chief medical officer of Neoolife, Inc., a start-up company focused on heart valve therapy. 

Clinicians are always cognizant of clinical needs related to their specialty — patient needs, device needs, physician needs, health system needs — and have always had ideas of how to solve the problems they observe and encounter. Moreover, their expertise is increasingly necessary to translate innovation to the clinical setting, but most clinicians do not know how to convert ideas into clinical innovation. It is the responsibility of each cardiothoracic surgeon to learn and to leverage available assistance if they wish to innovate the field. 

Overcoming Hurdles

There are clear challenges to participating in clinical innovation while busy with clinical practice. The traditional model of carrying clinical responsibilities while running a laboratory and doing research is difficult for cardiothoracic surgeons due to clinical time commitments and the need for multidisciplinary science teams. Moreover, cardiothoracic surgeons do not routinely get formal training in research or how to translate ideas into innovations unless they seek it out. 

While training as a cardiothoracic surgeon at UPMC in Pittsburgh, I took advantage of opportunities to learn and participate in innovative translational research that have evolved into life sciences entrepreneurship. I obtained formal training in research by taking a hiatus from my clinical training, doing a postdoctoral fellowship, and completing a program at the Center for Medical Innovation at the Swanson School of Engineering at the University of Pittsburgh during my fellowship. This program exposed me to engineering design, management of the engineering design process, entrepreneurship and start-up development, and the basics of intellectual property, culminating in being awarded a Certificate in Medical Product Innovation. 

There is a big gap between good science and an investible product, and it can be a struggle to find funds to support innovation after early money is exhausted but before venture capitalists are willing to invest. In 2020, UPMC pledged a $1 billion investment in life science start-up companies over a four-year period to develop new drugs, diagnostics, and medical devices. This UPMC Enterprises initiative provides a substantial resource for filling the capital gap. Supporting physicians so that they have time to innovate is another challenge. UPMC has supported me throughout my training here, but this is not the standard nationwide. Fortunately, the ability to run a company remotely has made innovation while practicing medicine easier. Virtual board and management meetings make it possible for me to serve as Chief Medical Officer (CMO) for Neoolife, Inc., while maintaining clinical responsibilities. I advise would-be innovators to fit it in whenever you can.

The Process of Innovation

Clinicians are well positioned to lead innovation efforts. Cardiothoracic surgeons are established leaders of very complex teams both inside and outside of the operating room. We need to realize that these are marketable and translatable skills when stepping into this new arena. To begin, all cardiothoracic surgeons can participate in the ideation phase of the innovation process, as this is a straightforward role that does not require additional training. All cardiothoracic surgeons know what the problems are when practicing their specialty. A concrete first step is to write down the problem you wish to solve and start talking about it. Are others having this problem? If there were a solution to this problem, would you use it? Would a patient use it? Would the health care system support it? You don’t need to have a solution to begin the process. Getting the details in writing and bringing them to a multidisciplinary team for discussion can spark a lot of ideas on how to solve any given problem or fill any need. This is where innovation research starts. 

Admittedly, after the ideation phase, there is a huge amount of space that a cardiothoracic surgeon needs to become familiar with to bring new therapies to patients. You can’t hesitate to enlist the assistance of other team members. If you are developing new technology, you must include team members in adjacent fields with design and prototyping experience, such as engineers and computer analysts. A little further along in the process, entrepreneurial and business experts must be recruited to guide the innovative endeavor. 

The process of innovation begins when a need is defined. A team can then be set up to fill that need whether it is using an existing technology, developing a new process, or developing a new technology, which is what my team and I did when we founded Neoolife, a start-up company specializing in heart valves. 

Improving Heart Valve Prostheses

Currently, when a heart valve needs to be replaced, the patient and the surgeon must decide between a mechanical valve or bioprosthetic valve. Bioprosthetic valves have the known disadvantage of structural valve deterioration, which limits the valve’s lifespan to 10–15 years and necessitates reoperation. Mechanical valves require that the patient be placed on lifelong anticoagulation therapy, which may increase their risk of bleeding if not managed appropriately. Valves made of a biodegradable scaffold that becomes populated by natural tissue are a unique solution that may solve both problems. Antonio D’Amore, PhD, and William Wagner, PhD, began experimenting with scaffold-based heart valves while working on polymer technology at the University of Pittsburgh McGowan Institute for Regenerative Medicine. After these valves are implanted into the heart, the polymer provides a scaffold for tissue remodeling while simultaneously functioning as a valve. The body lays down its own native tissue in the scaffold, and the prosthetic degrades over the course of one to two years. The natural replacement heart valve might then last for a lifetime. Anticoagulation is not required after insertion of these scaffold-based valves, and the end product is more durable than current bioprostheses. I tested more than 40 of these scaffold-based heart valves at different positions in vivo using animal models. 

In the fall of 2019, my team and I won the Pitt Innovation Challenge, a pitch award competition sponsored by the University of Pittsburgh Clinical and Translational Science Institute. This provided funding for us to conduct 30-day studies of the valves, which were completed in late 2021. We are now conducting a 90-day experiment that will pave the way for regulatory testing. 

We spun Neoolife, Inc., out of the McGowan Institute in the fall of 2020. In my role as CMO of Neoolife, I am responsible for ensuring that the valves Neoolife produces are ready for preclinical and clinical testing. I developed and update roadmaps for the regulatory submissions for Neoolife’s products and work with contract research organizations (CROs) that specialize in the regulatory pathways instituted by the U.S. Food and Drug Administration (FDA). I also assist with record keeping, consult with quality management experts, and use my network to bring in people with necessary expertise. Neoolife made sure that we had business expertise by recruiting a Chief Executive Officer (CEO) who was not from academia. A sound business plan with five- and 10-year projections is crucial for a start-up company focused on life sciences innovation, and all members of the leadership team must have some understanding of these plans. 

Innovation in Pittsburgh

There is a robust and growing local ecosystem to support innovation in Pittsburgh. UPMC and the University of Pittsburgh have been continually improving their resources to help physician-entrepreneurs expand their ideas beyond academia. UPMC Enterprises and the University of Pittsburgh Innovation Institute offer expertise in intellectual property and commercialization, and connections with experienced business leaders who can serve as mentors. The Center for Medical Innovation at the University of Pittsburgh awards financial support for projects through several initiatives. Additionally, the $1 billion investment by UPMC Enterprises is helping to recruit both scientific and management talent to Pittsburgh. Outside of UPMC and the University of Pittsburgh, other helpful local resources include LifeX Labs LLC, the Pittsburgh Life Sciences Greenhouse, and Innovation Works. 

Young cardiothoracic surgeons can and should be taught how to execute great ideas. To make their ideas a reality, clinicians must take the onus of learning the processes of life sciences innovation. Don’t hesitate to take the first step. Even if you don’t have the necessary experience, there are people who do, and many of them call Pittsburgh home. Use your network to build your team. UPMC is widely recognized as an innovator in health care and is spurring innovation and promoting the growth of life science industries in western Pennsylvania and beyond.