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With an investment and business development background, Kenneth L. Londoner’s career is proof no set or predictable path to running a biomedical company exists. Londoner considers himself to be an entrepreneur first, one who achieved success inside and outside the biomedical industry long before he co-founded BioSig Technologies, Inc.
BioSig is a proprietary technology company aiming to become a player in the burgeoning $4 billion electrophysiology (EP) marketplace. BioSig is preparing to commercialize the PURE EP™ System, a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system designed to help electrophysiologists make clinical decisions in real time. The company relocated from Los Angeles to Minneapolis last year to be closer to the region’s cardiology industry hub around the Mayo Clinic.
In an interview with Ashton Tweed, Mr. Londoner discusses the various turns his entrepreneurial career has taken and the importance of establishing a summer internship program for his alma mater.
When I was an analyst at a mutual fund company in New York, and then a money manager investing in growth stocks, healthcare was a major sector – although back in the late 80s and early 90s it wasn’t as prominent a growth sector as it is today. At that time, the area of healthcare in which we were most interested was medical technology and medical devices, which has a rich history of success for improving outcomes for various types of diseases. Wall Street is a trend follower. If there’s success in a category, the money flows in. And if there’s a lot of success in a category, the money pours in. We had a lot of success investing in medtech because laparoscopic instruments, pacemakers, stents, among other things, were all burgeoning back in the 90s.
I left Wall Street after 9/11 in part because I developed an interest in building companies as opposed to just managing money. The first company I worked on was Safe Ports. My business partner realized that the Panama Canal’s third set of locks were about to be completed and opened, which would allow large ships with big containers of goods to go from China through the Panama Canal to the East Coast ports. The East Coast ports are all landlocked and there’s no way to add additional capacity to the tarmacs where they bring in the containers. So we came up with an inland port concept that would service the ports of Charleston, S.C., and Savannah, Ga. We ended up selling that project after several years of development to Dubai Ports World, one of the largest players in the port management business. That was a fascinating project; very different from what I’d been involved with in the past.
Small enterprises – especially life science companies – have a long road through the regulatory process. While there are many great scientists and doctors who might come up with a novel approach, getting that idea from conception to market is as hard a road as any road I’ve seen. You really have to be committed – and it’s a long-term commitment. You don’t find too many people willing to make that journey because it requires really committing their lives to it.
You need a diversified team that brings a lot of capability to the table. A lot of what these small companies miss is the financial piece – the ability to build a shareholder base, to raise quality capital and do it so the architecture is correct. That’s very hard to do.
A lot of people outsource for that financial expertise, and when they do, they often don’t get it right. It’s helpful to have a team member with a background like mine in financial markets. Many of these small medical companies lack that, and they run into hardship as a result – always around the architecture and execution of capital raising and investment development.
I was approached by the inventor of the technology. He knew I was an entrepreneur and a business builder with several cardiology investments. I did almost a year’s worth of homework to understand what the industry looked like and talked to a lot of leading medical centers and industry participants. It appealed to me for a variety of reasons, so I invested, and we formed the company and started building it in February 2009.
I focus on capital markets, money raising, business strategy, business development, human talent acquisition, and I work with the board to make sure the company is being managed properly. BioSig relocated from Los Angeles to Minneapolis last year. In the cardiology industry, a large majority of companies are clustered in Minneapolis. You also have the Mayo Clinic, which is about an hour south of Minneapolis. I spend my time between L.A., Minneapolis and New York – that’s my triangle.
We did it for the first time last summer as an experiment. Lafayette College approached me as an alumni and donor, and I explained to them that, based on my entrepreneurial background, I’m really not much for just giving money away. So I asked what Lafayette was doing about internships. That led to a discussion about the student debt in this country and the fact that kids are graduating burdened with financial challenges, and can’t take the type of risks that I took in my career. We talked about how we could help students get a better understanding of the industries they may want to work in and help alleviate some of the student debt at the same time.
These kids are so much smarter today than we were – or at least I’ll speak for myself – because of computerization and all the information at everyone’s fingertips. They’re also so much more competitive. But a lot of internships offered in this country are unpaid. So we created what we call an immersive internship program. We studied the leading schools in the United States to see what they were doing about student debt and internships. We recognized an opportunity to help students get advanced internships where they would be paid well and put into high-impact projects.
Last summer, while the students were doing their advanced project work for us, they were also exposed to 12 different educational experiences. We wanted to help them understand what makes our company tick. So, for example, we spent a day at the Office of Intellectual Property at UCLA learning about patents and how patents are organized and filed. That was a very well received experience. We also had an executive from Ogilvy & Mather teach the students about public relations.
Project work, plus the educational component, plus good pay made the students’ experience very successful – and it was good for the company. Based on what we learned, we – Lafayette College, me and a few other alumni – made a financial commitment to launch the program formally. Lafayette is in the process of rolling it out. Hopefully, over time, it will prove successful enough to be used as a model for what other schools can do.
Our interns will most likely be heading to graduate school. Our company has 13 or 14 employees right now, and we’re growing but not by the dozens—we’re not that type of company. We would hire an intern if we found the right person, but the summer intern program I’m developing is really for larger organizations. Nonetheless, we’ll still take on interns because we get a lot of value from them.
Our biggest challenges are the classic challenges – product development, manufacturing, FDA approval, and becoming a NASDAQ company. These are all processes with which we’re very familiar, but they’re not easy to execute. In an environment where political discourse is lousy and there seems to be some resistance to emerging growth companies, we have to constantly highlight the value we’re bringing to all our constituents. I wouldn’t say they’re acute challenges; they’re just the challenges of any young business looking to grow. We’re a little over seven years old, so we’re certainly survived the gestation period during which a lot of companies fail.
We’re now about a year away from launching our product. Commercialization is no walk in the park. It’s a ton of work, and you have to be effective.
We’re a small company and we’re launching in the U.S. first with the early adopters that you’d expect to embrace new technology. We’ll be properly educating them, helping them understand the merits of the technology, and then going through the hospital’s new product acquisition committees. We’re optimistic because we have the essential value proposition that gives us the chance to be successful. We have the ability to reduce costs through our medical technology innovation and we also believe – although we have to prove it to folks – that we can add clinical value and improve the outcomes.
We’ve done some animal studies and we’ve gotten some very good results in the pre-clinicals. Next year we’ll be into the human clinicals. We’re in an interesting niche where we don’t need human trials to get FDA approval because we’re developing a 510(K) device; our product is a computer system that essentially helps users get better information. We don’t touch or invade the body, so it’s a much easier FDA approval process. Once we get 510(K) clearance, we’ll be doing human clinical trials, and those will help support the product marketing.
Trying to get the right team on the field. I think every CEO struggles with getting people to believe in the mission of the company and really connect to it. First you have to be doing something that people believe in, then you have to get people to work well together – you have to know how to build teams. With BioSig, I’m very gratified at how well the team is working together. That’s essential and, if you don’t have that as a small company, it shows.
Ashton Tweed would like to thank Kenneth L. Londoner for this interview. If your company needs help from members of the Ashton Tweed Life Sciences Executive Talent Bank, we can supply that assistance either on an interim or a permanent basis. Additionally, if you are among the many life sciences professionals affected by the changes in the industry, Ashton Tweed can help you find the right placement opportunity — from product discovery through commercialization at leading life sciences companies — including interim executive positions and full-time placements. In either case, please email Ashton Tweed or call us at 610-725-0290. Ashton Tweed is pleased to continue to present insightful articles of interest to the industry.
TAKING THE REINS OF A HEALTHCARE TECHNOLOGY INVESTMENT COMPANY French by birth, based in London and doing business in the...