The key to Cleveland Clinic Innovations' 20 years of patents, licensing agreements, spinoff companies: Razor-sharp market focus

Peter O'Neill, executive director of Cleveland Clinic Innovations, can't choose just one of Cleveland Clinic's innovation initiatives to highlight: "It's hard to pick your favorite child," he told Becker's Hospital Review.

Cleveland Clinic Innovations is the commercialization arm of the academic medical center. Since its 2000 founding, the group has been dedicated to transforming the breakthrough inventions of its caregivers into marketable medical products and companies, resulting in thousands of patents, hundreds of licensing agreements and dozens of spinoff companies.

Prior to joining the group more than a decade ago, Mr. O'Neill, whose background is in aeronautical engineering, served as deputy director of the Great Lakes Industrial Technology Commercialization Center.

Here, he explains how Cleveland Clinic is navigating the challenges of managing health data and why the aggressive "move fast and break things" mindset of Silicon Valley doesn't always translate well to healthcare.

Editor's note: Responses have been lightly edited for length and clarity.

Question: What does innovation look like at Cleveland Clinic? What are your goals and priorities for Cleveland Clinic Innovations?

Peter O'Neill:
At our core, we are about commercializing the intellectual property of the Cleveland Clinic. The core of that looks like 300 invention disclosures and many different layers of assessments leading to patents, to prototyping and product development, to license agreements, to spinoff companies and to commercialization deals.

The focus of our team is to translate those inventions into products that could help patients and then negotiate deals that are fair for the Cleveland Clinic. In a broader sense, we are part of helping identify and crystallize opportunities to impact the future of healthcare, and then working with colleagues around the Cleveland Clinic and with our partners to deliver solutions to the marketplace.

Q: Has your background outside of healthcare been an advantage or disadvantage as you've navigated the industry?

PO:
It's been both. I didn't educate through biomedical engineering nor have classical medical training, but my brother's a doctor, so I had some awareness of medicine, and I've been at the Cleveland Clinic for 14 years, so I've picked it up along the way.

I have an aeronautical engineering education and background, and there are lots of similarities between aerospace technology and healthcare technology. They're both highly regulated; they both have products that, when they fail, people die; they're both relatively extreme environments from an engineering perspective, whether you're designing an airplane or something in space or in the human body.

Q: What are some barriers to healthcare innovation? How have you, within Cleveland Clinic Innovations, overcome those obstacles?

PO:
"Barriers" makes it seem like they're insurmountable, so I would use the word challenges, but what has been highlighted to us specifically through work we've been doing recently with Plug and Play is when we want to partner with a group that may have some really interesting technology that could apply to healthcare, but they don't come from a historically healthcare background, doing demonstration validation work in healthcare is harder than most other industries. Aerospace, for example, is highly regulated, but doesn't have patient data that needs to be protected or de-identified before it's used. In healthcare, if you want to do a study of 20,000 patients, then you have to manage the data rights of 20,000 patients.

We are continuing to address this and get better at figuring it out, because a lot of healthcare innovation is in the world of data analytics and digital health, and data is at the core of all of it. Having good, high-quality data, and lots of it, is essential; whether it's machine learning, AI or blockchain, you need data to be able to refine the algorithms that drive those value opportunities. So the largest challenge that we and lots of others in healthcare are navigating is that we have lots of data that can enable amazing new ways of delivering healthcare, but we have to be incredibly respectful of that data.

Q: How are you navigating that challenge?

PO:
When it's appropriate to de-identify data, we will de-identify data. When there's any other kind of patient data involved, we will make sure we are treating that data exactly as it needs to be treated, according to HIPAA and other kinds of regulations. We also have to make data available and do analytics.

Q: Building off those challenges, what is the biggest mistake players in the healthcare industry are making when it comes to innovation?

PO:
I recently watched a documentary about Theranos and Elizabeth Holmes, and while some part of that was an indictment of her and her inner ring, another part seemed to be questioning this aggressive "Silicon Valley" mindset. I am a huge proponent of being entrepreneurial, but that suggestion — that you can create a vision, go sell that vision, align influential people in other fields who maybe are not sufficiently experts in healthcare so that you don't have to reveal to them all of what you're doing and raise a lot of money — seems to be more than tolerated; it seems to be encouraged in some places, and I don't think that that is healthy for healthcare. With Theranos, people's lives were hurt, there were patients who got bad information.

Part of the reason for the statistics about the number of startups that fail is a "fake it until you make it" mindset. That's not OK in healthcare. So much healthcare advancement is based on peer-reviewed, published research and really needs to stand up to a lot of scientific scrutiny that is not as necessary and certainly doesn't seem to be as prevalent in a lot of other industries.

Ultimately, at its core, it comes down to Cleveland Clinic's tagline: "Patients First." We treat millions of patients, and individual safety events for a single patient get significant attention. So, when you're talking about healthcare, where the results are really bad when things are not done well — just like aerospace — those other approaches are not as appropriate.

Q: Can you talk about an innovation initiative you're especially excited about?

PO:
It's hard to pick your favorite child. We have pipelines of work; we have three domains: medical devices, drugs and digital health. We have interesting projects in each of those. Today there's more attention and investor interest in digital health solutions — that makes our medical device technologies feel less loved, but the fact is for people who are inventing medical device technologies and for patients who are receiving the benefits of those medical devices, those are damn important things.

A natural answer is to pick some digital health project in our pipeline and that might sound intriguing, but then if I compensate and pick some medical device just to zig when others are zagging, that may seem comparatively less interesting. So I'd rather not pick out an individual one, because we have so many really interesting, potentially impactful projects.

Q: Do you have a final piece of advice for other healthcare innovators? Anything they really need to know?

PO:
We receive inventions from people who are truly world-leading experts in that clinical specialty, but that doesn't mean they're world-leading experts on how to bring that solution to market. Most of our technologies go to market through license agreements with existing companies, and those existing companies often have some kind of market-focus perspective.

That's not unique about us, but it is certainly something that we emphasize and that distinguishes us from lots of people: As a commercialization office, and as an MIT aeronautical engineer who loves technology, we are marketfocused. No matter what you're innovating, no matter how clever or profound the technology is, you have to stay marketfocused.

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