Medical Device Daily Washington Editor

Companies that acquire other companies as a means of expanding their product portfolios have been very busy of late, but venture capital funding for med-tech research wobbled as the latest recession took hold, falling by more than 30%. Some may have thought this would lead to a narrower pipeline of innovation, but even as venture capital moves back into med-tech development, innovation in med-tech was never entirely reliant on monies from the world of private sector investors.

University researchers continue to avail themselves of grants and other sources of funding, including a recent award of more than $18 million from the National Science Foundation (NSF) for research into sensorimotor neural engineering (Medical Device Daily, July 19, 2011). While a set of exhaustive numbers is difficult to obtain about the amount of money invested into university research into medical technology in the U.S., an inference about the level of university med-tech research might be divined by examining a number of sources.

For instance, the NSF website offers fairly detailed reports of its grants, listing them by state and by institution. Although specific numbers for med-tech research are difficult to break out, the total NSF grants to academic research in California rose from about $538 million in 2001 to more than $855 million in 2010, an increase of nearly 63%. Much of that sum went to research into other areas, but assuming the increase for med-tech research is proportional, the jump in spending on university med-tech research is substantial, even after accounting for inflation.

Lesa Mitchell, VP of innovation for the Kaufmann Foundation (Kansas City, Missouri) spoke with Medical Device Daily yesterday to talk about how this branch of research has evolved. She said she works with a number of life science foundations, although she acknowledged that philanthropy has not funded med-tech in sums that match other sources.

“Other than corporate philanthropy, there is very little philanthropy in this space other than the [Wallace] Coulter Foundation (Miami),“ Mitchell said, but she remarked that med-tech research has caught on with universities “because the field has figured out how to treat illness in a non-biologic way,“ a fact that offers advantages of which device firms are keenly aware.

Mitchell mentioned that the Biomedical Engineering Society (BMES; Landover, Maryland) was established in part by philanthropy, but she indicated that serendipity had something to do with the emergence of university interest in devices and diagnostics. “The med-tech field was simply one of those boundary-spanning opportunities that came out of the link-up between the engineering profession and the medical profession,“ she said. Mitchell made note of a paper by Frank Rothaermel, PhD, of the Georgia Institute of Technology (Atlanta), which she said outlined the evolution of university med-tech research. “The field really started at the University of Minnesota (Minneapolis), where the focus was more electrical engineering,“ Mitchell said, which may have been “the spillover that created Medtronic“ (Minneapolis).

“The other huge benefit is the ability to get technology to market much more easily than the 12-15 year pathway for biologics and pharmaceuticals,“ Mitchell pointed out. “We've also seen significant funding come out of NSF and NIH as well as the Defense Advanced Research Projects Agency at the Department of Defense directly to universities, which is where the bigger dollars are, not from philanthropy,“ she said.

While NIH is known for research into biomedical imaging and the molecular bases of diagnostics, Mitchell said NIH also conducts work on wireless technology – including for home care applications – outside of the collaborative work it conducts with FDA. However, she also pointed out that a consortium of engineering research centers (ERCs) has formed an association, replete with a website. An ERC grant from NSF “is one of the biggest grants you can get. It's like a clinical trial grant from the NIH,“ Mitchell commented. ERCs are a long-standing funding mechanism, Mitchell said, noting that the University of Illinois recently applied for a sizable grant from NSF that is “almost all med-tech stuff.“

Mitchell gave the keynote speech last year at the annual gathering of the Engineering Research Centers Association, so she has some familiarity with how these grants are handled. Regarding the sources of funding for university research, “I would assume the majority of funding that's going into universities relative to med-tech is from federal agencies.“

“I think if you look at Frank Rothaermel's paper in terms of the origination of all this, predominantly it originated in the interventional cardiology space,“ Mitchell said. “That started all the exponential growth into med-tech,“ she noted, adding that “now its so much broader,“ including substantial efforts in the area of prosthetics. A good example of this is the recent effort by DARPA, which has the now-well known artificial limb collaboration with FDA. Another example is the research into the use of nanoscale materials to build artificial muscles at the University of Dallas (Dallas), an institution with a demonstrated interest in cardiovascular science as well.

“The field has become so broad in terms of context versus where it started. I think we'll continue, as we think about health prevention and diagnostics, to see the med-tech field expand even more as we get into these wireless sensors and all the technologies you could operate out of your home,“ Mitchell observed.

Despite the fascination with emerging fields of endeavor, Mitchell said she sees no loss of interest in cardiovascular at most universities. “Universities will be interested based on the expertise of the people who work there,“ she observed, and as a consequence, “if you have interventional cardiologists, you're going to see a lot of that research funded.“ She said she has not looked at the trend lines of graduate degrees recently, but said an NSF study of several years' vintage provided numbers that strongly suggested that the degrees held by graduates “are absolutely correlated with the level of funding from the federal government.“

Mitchell noted that the doubling of the NIH budget drove enrollment in life science programs at colleges and universities, but that enrollment may have exceeded demand. “I think we have more life scientists than we could ever process,“ she said, remarking that there were approximately 50,000 post doctoral students available for hire last year, a number she said may be an all-time high. The problem is that big pharma and biotech are not hiring, “so they're all over-educated, underemployed post-docs,“ she said.

FDA amends notice of panel meeting

FDA announced in July that it will hold a meeting of the obstetrics and gynecology devices advisory committee to review safety data for transvaginal surgical mesh, and announced in the Aug. 15 edition of the Federal Register that it would open a slot during the two-day hearing for representatives from industry to make their views know. The time for industry presentations will be separate from the open public hearing portion of the proceedings, the FR notice states.

Problems associated with the use of surgical meshes to help treat transvaginal repair of pelvic organ prolapse sparked a July 13 advisory by FDA in which the agency said that most of the adverse events reported in association with this device type were tied to those implanted “through an incision made in the wall of the vagina.“ Some of the complications associated with this include injury to nearby organs, including bowel, bladder and vasculature, but some patients have had surgery to deal with mesh that had absorbed into the vaginal wall.

As the agency had reported in July, the hearing is slated to take place at the Holiday Inn in Gaithersburg, Maryland.

Mark McCarty, 703-268-5690