Universal

As I’ve written previously, I think the medical device/technology industry is well-positioned to invent and commercialize products that will improve health in the under-resourced countries albeit with the need for companies to also be innovative in their business practices (see my posts, “New and Improved” and “To Boldly Go”).  It is competitive (6,000 companies in the US, most with fewer than 100 employees), research-intensive (R and D expenses are 12% of sales), and has been effective in improving US health care while accounting for 5% of overall health expenditures (AdvaMed Fact Sheet).  Or at least according to Advanced Medical Technology Association (AdvaMed) which last week held one of the biggest gatherings of representatives of medical technology and device industry here in Boston with more than 2000 attendees representing about 200 companies (AdvaMed 2012).  As a quick reality check, I scanned the meeting’s program to gauge the attendees’ interest in global health, but didn’t find much.  Although companies from 22 countries were there, only a couple sessions were oriented toward markets outside the developed world; most were focused on the effects of the re-making of US health care to be more “value-driven.”  So much for quick checks of reality.

Perhaps AdvaMed needs more members representing early stage, proto-companies including those that are trying to commercialize products for the under-served and under-developed markets.  Perhaps the organizers could offer a discounted membership fee and have a session where nascent ventures could demonstrate their gee-whiz technologies to get feedback and learn how to turn their gadgets into products.  I think they would find a decent pool of applicants. I have noted lots of interesting prototype devices and proto-ventures coming out of universities, advised a few in my volunteer mentoring at MIT, and have I written about a handful of global health diagnostics companies (e.g., “Thinking Outside the Box”  and “TB Bx:  Getting There”).  Recently, I heard about the Center (or Consortium) for Affordable Medical Technology (CAMTech) that has as one objectives deploying affordable technologies in the low and middle income countries through licensing and new ventures, and it may generate future AdvaMed members.  Interestingly, CAMTech evolved from a program for which I had tried volunteer three years ago, the Global Health Initiative of the Center for the Integration of Medicine and Innovative Technology (CIMIT) which was started by Kris Olson, a clinician and pioneer of affordable medtech, who is CAMTech’s medical director.

One company I noted that could benefit from and contribute to an association with its industry peers is Gradian Health Systems (GHS).  GHS was started in 2010, is based in New York City, and is funded, possibly solely, by a grant from the Simons Foundation, a philanthropy that funds basic science and mathematics research (Simons).  GHS’s lead product is a “universal anesthesia machine” (UAM) that was designed by the company’s scientific founder, Paul Fenton, is fully-engineered and manufactured, and has earned a CE mark (a European Union medical device approval process based on a safety demonstration and intended use; see Medcitynews for a comparison to the USFDA approval process [Medcitynews article ]).  To learn more about the commercialization of the UAM, I watched a December 2011 TED (Technology, Entertainment, Design) talk by Erica Frenkel, GHS’s Director of Business Strategy, (UAM talk) which has had about 250,000 views (congrats!).  Unfortunately, Ms. Frenkel spoke mostly about the need for safe anesthesia (“35 million annual surgeries without safe anesthesia”), some about the machine’s unique features (has a backup battery and can use room oxygen), a bit about its current use (some number are in 13 hospitals, donated or sold?), and nothing about affordability/pricing, distribution, partnering, funding, revenue projection, or other bits of a business strategy.

I expect that the management of GHS has worked out a commercialization strategy since the CEO, a consultant, and one board member have medical device company start-up experience (GHS Team).  To me, such a strategy is key for convincing funders, whether grantors or investors, that GHS can effectively address the need.  Whatever plan exists though, it apparently needs additional details since the company is advertising for a Director of Product Management (GHS Blog) among whose responsibilities are:  develop a marketing plan; liaise with the manufacturer for production, R and D, and introduction; find distribution partners in target countries; and create training programs for use and maintenance along with eleven others.

I am clearly an amateur in the medical device field and not knowledgeable about surgical anesthesia, but my quick search indicates that there is some research that GHS can draw on to build its marketing plan.  A study by Hodges et al. gathered data that defined the problems in anesthesia delivery in Uganda (Hodges et al. 2007) and Jochberger et al. gathered similar data for Zambia (Jochberger et al. 2008).  I also found that the World Ananesthia Society (WAS) is dedicated to supporting anesthesiology in the developing world including through training, so may be helpful in assessing UAM adoption and use.  GHS could also contract with consultants for specific parts of its plan to get a handle on pricing, adoption rate, and customer preferences and ability to pay, but the consultants would need to understand emerging world markets which may be a rarity.  While GHS as done an amazing job of building and testing its UAM, it still needs to leap over the commercialization valley-of-death.  Perhaps it needs a consultant to find a consultant?

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