By Linda Barney, Barney and Associates

Dr. Thomas J. Fogarty is an internationally renowned cardiovascular surgeon and innovator who is widely regarded as one of the pre-eminent inventors of medical technologies of his generation. He has dedicated his entire career to improving patient care and is now working to train other medical and bioscience personnel on the art of bioscience innovation. As a keynote speaker at the Oregon Bioscience Association 2014 conference, Dr. Fogarty presents his views of the current state of bioscience innovation and what is needed to improve the climate for bringing medical and bioscience products to market in the United States.

Dennis McNannay, Executive Director of the Oregon Bioscience Association states, “No one better represents innovation in the medical device sector than Dr. Fogarty. We consciously researched the best examples of incubation and believe that as Oregon tries to build its entrepreneurial ecosystem there is no better example to follow than the Fogarty Institute.”

Importance of innovation for medical and bioscience advancement

Fogarty believes that innovation is the lifeblood of medical advancement and the key to raising the bar for patient care. Yet the traditional process for medical innovation in the U.S. is fraught with obstacles that hinder development of new ideas—including skyrocketing costs, complicated regulations and bureaucracy, inertia in the academic environment, lack of mentorship, difficulty obtaining financing and pressure to go offshore. Dr. Fogarty believes that “there has to be a better way.”

Dr. Fogarty’s career highlights:

• Inventor of the balloon catheter used in more than 300,000 procedures worldwide per year, estimated to have saved the lives/limbs of 20M patients
• Named inventor on 135 surgical instrument patents
• Awarded 2000 Lemelsen-MIT Prize for Invention & Innovation
• Member of the National Inventors Hall-of-Fame
• Founder of more than 30 medical device companies
• Co-founder of Three Arch Partners venture capital firm
• Managing Partner of Emergent Medical Partner

The Fogarty Institute for Innovation

In 2007, he founded the nonprofit Fogarty Institute for Innovation on the campus of El Camino Hospital in Mountain View, California as a way to address the problems Fogarty sees in innovation and bringing medical and bioscience products to market. The mission of the Fogarty Institute for Innovation is “to promote medical innovation by providing support to promising innovators and researchers as they transform their creative ideas into practical solutions to improve patient care.” The Institute offers three distinct programs, (Innovation/Cultivation, Clinical Research/Validation, and Outreach/Education) each representing a different aspect of medical technology innovation.

Since 2007, the Fogarty Institute has received more than 150 requests for assistance from innovators and entrepreneurs and has provided support to more than 10 innovative entrepreneurs. Innovators at the Fogarty Institute involve companies involved in a wide range of endeavors (click here to see a list) from medical and monitoring devices, to companies working to prevent wound infections, providing care and diagnosis of cardiac disease, restoring valve function in deep leg veins, reducing childbirth-related injuries, improving newborn monitoring, providing web-based anatomy / physiology education and providing electrical muscle stimulation.


“The main goal of the Fogarty Institute for Innovation is to take science and convert it into technology that is useful for the patient and to do this in an environment where this is encouraged, supported and nurtured. We help commercialize products so they can be used by patients. Everyone on our team is focused on the concept of making the patient better, reducing the cost of medicine and developing a technology that is specifically addressed to do that.”
Thomas J. Fogarty, M.D., founder of the Fogarty Institute for Innovation


 

Changes in medical-related product funding in the U.S.

Fogarty indicates that there have been significant changes in how bioscience and medical products are funded in the United States. These changes are not beneficial to early stage startup companies. The regulatory path and reimbursement issues we are dealing with in the U.S. make it very difficult for the venture community.


It is so expensive to innovate in United States that the venture capital firms can’t make money and many have gone out of business. This makes it hard for medical tech firms to get funding and many potential good ideas never see the light of day.”
Thomas J. Fogarty, M.D., founder of the Fogarty Institute for Innovation


Advice on obtaining funding

When asked about his advice for Oregon bioscience companies and researchers who need to get funding to commercialize a product from their research or ideas, Dr. Fogarty states, “There is one thing you need to understand about those who invest in this area. They do not invest in science or research projects; they want to see patient benefit. Most of us who do these kinds of things are not scientists in the pure sense of the word but are rather technologists.

I have created a number of products throughout the years and have found that you must relate to a number of people such as engineers, patent attorneys and regulators. You must form a network of people who understand how funding is obtained and the rules associated with creating products.”


It is critical for those who want to create a bioscience or medical product to be able to articulate the reason for creating the product to the investment community and to be able to stress that the primary reason for creating the product is to benefit the patient. Another goal should be to design the product at a lower cost to help reduce the cost of health care in the United States.”
Thomas J. Fogarty, M.D., founder of the Fogarty Institute for Innovation


Solutions to the funding and innovation issues

Fogarty believes that “We will need multiple solutions to this problem but the most important thing is to make our community of research centers, academic institutions, hospitals, and physicians realize that change is needed to put the U.S. back on top for medical research, product development and medical care.”


“We need to realize that science often takes place in the university setting but that most universities are not familiar with commercialization of research and turning the research into viable companies and products. It is critical that we change the focus so that universities don’t view business and products as bad and work to create environments to help researchers turn research ideas into companies who create products that benefit patients.

All of us need to work to create an environment that gives those creating products access to people with experience in commercializing bioscience and medical products. Benefiting patients is the greatest reward that physicians, allied healthcare personnel, regulators and the medical industrial complex can have. By working together and understanding each other, we can all get there. Let us make it happen.”

Thomas J. Fogarty, M.D., founder of the Fogarty Institute for Innovation


 

Oregon bioscience innovation and entrepreneur support programs

Oregon’s bioscience entrepreneurs and researchers face the same challenges addressed by the Fogarty Institute for Innovation. Not everyone agrees on the best tactic for developing entrepreneurs and incubation but one thing that everyone agrees on is that it is all about the people. You must have strong mentoring programs to develop viable bioscience companies. Oregon is working on solving the issues of funding, innovation and mentoring by establishing the Oregon Nanoscience and Microtechnologies Institute (ONAMI), Oregon Translational Research and Development Institute (OTRADI), and the OTRADI Bioscience Incubator (OBI). According to Dr. Jennifer Fox, OTRADI Executive Director, OTRADI’s BioMentoring program has been created to serve early-stage bioscience ventures by bringing together resources and partners to assist bioscience entrepreneurs in creating viable, successful and profitable businesses. This partnership will better prepare company owners for the diversity of tasks required when running their own companies.”

 


 

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Linda Barney is the founder and owner of Barney and Associates, a technical / marketing writing, training and web design firm in Beaverton, Oregon that provides writing, training and web content for the high-tech, government, biotechnology, medical, sustainability and scientific communities. Linda has written articles for a variety of clients as well as the Software Association of Oregon, the Oregon Bioscience Association, the Clean Technology Alliance, CitizenTekk, Innotech, EclipseCon, OSCON and Supercomputing Conferences. She has acted as editor of the Microsoft Application Development Resources ezine and the Oregon Bioscience Association newsletter. Contact Linda at linda@barneyassoc.com.