The contrast is pretty striking between the tone of a conversation at St. Jude Medical, where they are planning on a very busy year of product launches, and what you may hear from a medical device entrepreneur or venture capitalist.
With venture capital as scarce for life science start-ups as it’s been since the mid-1990s, there may be a dry spell in innovation coming unless the bigger companies like St. Jude fill part of that role.
I went to see John Heinmiller, executive vice present of St. Jude, and his colleague Frank Callaghan, president of its cardiovascular and ablation technologies division, because St. Jude has made its pipeline of new technologies and product families central to its story for investors.
St. Jude, like a lot of the industry, has seen its sales growth stall recently, but Heinmiller said its objective of “superior” growth is very much alive.
“We don’t think of it where we are so big and a lot of things have already been developed, so it’s not a rich environment” for innovation, Heinmiller said. “We think of it as a very rich environment. It just requires constant vigilance and the long-term perspective to make it all pay off.”
St. Jude Medical’s new MediGuide is as good an example as any. St. Jude bought the MediGuide technology in a more than $300 million deal in late 2008, explaining in 2010 that it had spent $10 million more on development and would spend $20 million more to make it ready for market. That’s a lot of money, even for St. Jude.
The result today is a technology platform with several applications. MediGuide is a three-dimensional navigation system for working around the heart that dramatically cuts down on the amount of X-ray imaging a given procedure might require, sparing staff and the patient the radiation, and it provides a very clear view inside the patient’s body. The company plans to install one system a month this year.
Could MediGuide, so expensive and so long in development, eventually deliver the kind of returns on investment that home-run medical innovations have generated in the past?
“Sure,” Heinmiller said. “But it also required a significant upfront investment and a long-term perspective. The financial strength and overall capability of a St. Jude Medical almost has to be at the core of where something like this gets developed.”
St. Jude started on this project by grabbing the technology in an acquisition, a common strategy for big firms. Thomas Gunderson, a longtime analyst with Piper Jaffray & Co., said bigger companies have treated the start-up and venture-backed segment as the minor leagues.
Through acquisitions or licensing deals, the most promising technologies get brought up to the big leagues like prized rookies by companies like St. Jude and Medtronic. But it’s getting pretty bleak in the farm system.
Last year had the fewest first-time venture funding deals in life sciences since 1995, with dollars invested in first-time deals down 41 percent from 2011, according to PricewaterhouseCoopers and the National Venture Capital Association.
The veteran venture capitalist Pete McNerney of Thomas, McNerney & Partners explained that medical device companies are taking more time and more money to reach fruition, killing investment returns.
It once took five or six years and perhaps $50 million in capital to successfully develop the kind of complex device that takes extensive trials to be approved for sale. Now the assumption is maybe 10 or 11 years and $90 million. Venture capital is expensive capital, and besides, a venture partnership is typically set up for only 10 years.
“That seems like a long time, but in today’s world it’s not a very long time at all,” McNerney said. “And it really calls into question the viability of the model.”
Part of the explanation is regulatory, as the Food and Drug Administration was found in 2011 to be taking 75 percent longer to approve a complex device for sale than it took in 2007, according to a report by the Milken Institute.
Another factor, Gunderson said, is that the device industry’s old practice of commercializing a new product by convincing leading physicians to try it no longer gets the same good results.
Government programs and commercial health insurers increasingly act like customers. They demand data on effectiveness and cost, and that data takes time to collect.
Gunderson, for one, is hopeful the device industry is adapting. He said part of the change has to be cultural, for companies and their development teams to fully grasp that health care providers and payers are customers who have needs to be met, too.
Meanwhile, he said, “what we are doing right now is harvesting the last of the VC plantings. We are going to be in an innovation drought for a while.”
What’s interesting is that the St. Jude team sees no reason for such pessimism. In a quick follow-up, Heinmiller said St. Jude’s spending on internal research and development has created a “balanced portfolio” in the pipeline, enabling the company to be “disciplined and strategic” when it does look outside for promising technologies. A thin crop of development-stage opportunities, apparently, doesn’t mean no crop.
And St. Jude points out that nothing has fundamentally changed in an aging population that will have a great many health problems.
“When you stick to the large, epidemic-like diseases where there is a substantial clinical need,” St. Jude’s Callaghan said, “and you focus on better outcomes and lower cost, generally speaking, the math is going to work in your favor.”