Interview with Jim Keller, ECRI Institute’s Vice President
for Health Technology Evaluation and Safety
(1) Could you please
introduce yourself and provide a little background about what ECRI Institute is
and what your role in it is?
I’m Jim Keller and am ECRI Institute’s Vice President for
Health Technology Evaluation and Safety.
ECRI Institute is a nonprofit health services research
organization. We’re probably best known
for our Consumer Reports-like comparative evaluations of medical devices. I am responsible for our evaluation program
along with several other services including Health Devices Alerts which
distributes notices on medical product recalls and other safety-related
concerns.
(2) How would you
describe ECRI Institute’s organizational structure? Would you say it’s more of a Functional
Structure (staff grouped by function) or a Divisional Structure (grouped by
products and services), or a hybrid of the two?
I would say that we mostly use a divisional structure but do
have quite a bit of cross-group collaboration between groups/service lines.
(3) Why do you think
ECRI’s structure works?
I think that it allows groups to focus on their strengths to
produce our various products. The
cross-collaboration between groups allows us to be efficient in that we can
call on support from other groups during busy periods or when unexpected
projects come up. Otherwise each of our
product line groups would need more staff to support work “overages” and we
would likely end up with overall higher costs.
(4) ECRI, as a
nonprofit and independent organization, has alliances with FDA but is
independent of them as well. How does
this alliance and collaboration work when it comes to research and ECRI’s
impartiality? In what other ways are the
two partnered?
We mostly call on FDA for subject matter expertise review of
projects we are working on that address regulatory matters. We also ask FDA to review reports that we
have written that discuss and/or comment on FDA. On the other side of the coin, FDA calls on
us for subject matter expert review of its reports and has occasionally
contracted with ECRI Institute for certain projects. The most recent contract involved review of
issues related to unique medical device identification. Our collaborations with FDA have helped us
with our independence and impartiality by providing perspectives to balance out
input we receive from other sources (e.g., from medical device manufacturers
who are asked to review reports we write about them).
(5) Can you provide
another example of an alliance with ECRI and an organization that isn’t FDA,
and how and why that alliance was formed, and what the benefits were?
We’ve had an alliance with the Association for the
Advancement of Medical Instrumentation which is also known as AAMI. AAMI puts on an annual conference. Our alliance started through our staff’s
support of the conference. We’ve
provided many different presentations at the conference and have participated
on conference planning committees. The
alliance has benefited both organizations.
AAMI has been able to take advantage of our subject matter experts and
improved the value of its conferences.
We’ve benefited from the exposure offered by a national conference.
(6) If you would
describe ECRI as a hybrid organization based on the above definitions, how does
the structure of the organization affect its work with other
organizations? Is it designed so that
engineers are able to collaborate with FDA colleagues with ease and not having
to go through lots of channels and bureaucracy?
The hybrid approach allows multiple groups within ECRI
Institute to participate in FDA projects.
We don’t have much, if any bureaucracy on our end. Because FDA is such a large government
agency, it can sometimes take quite a while to get an FDA proposed contract
underway. We’ve also been blocked out of
certain contracts that we thought we were most qualified for because of FDA
rules. One, for example, required the
contractor to be a minority owned small business. We didn’t meet the requirement and the
project went to an organization with much less experience than we had on the
topic. The project had to do with
management of a medical device problem reporting system, which we’ve been doing
for over forty years.
If I had the time to go back and follow up with Keller, I
would want to delve deeper into ECRI’s alliance with FDA. According to Kanter (1994, p. 100), there are
three aspects of business alliances: It must be beneficial for partners,
organizations work together, and interconnectedness enhances learning. And that
is the relationship that Keller describes.
ECRI's creed is "The discipline of science, the integrity of independence. I find the dynamic of the non-profit partnership interesting in that we
are competitors (is there really such thing as a non-profit?), yet aren’t.
From working there, I can say that this partnership does
work for ECRI and FDA. The collaboration
isn’t competitive, although, outside of these defined alliances, we are
competitors, only coming together for research and consultation here and
there. And I suspect this happens
because we are both non-profits and are what Barney and Hansen (1994, p. 182)
define as having “semi-strong” trust.
ECRI and FDA fit the idea that “When two or more strong form
trustworthy individuals or firms engage in exchange, they can all be assured
that any vulnerabilities that might exist in this exchange will not be
exploited by their partners” (Barney & Hansen, 1994, 184). There is no reason for either organization to
take advantage from the other, so much so that it would probably be detrimental
to each organization.
References:
Barney,
J.B. & Hansen, M.H., (1994). "Trustworthiness as a Source of Competitive
Advantage." Strategic Management Journal, Vol. 15, pp. 175-190.
Kanter,
R. (2010). "Collaborative Advantage: The Art of Alliances." Harvard
Business Review. pp. 1-16. (Full Article)
Interesting interview, Justin. You say that ECRI and FDA have semi-strong trust, but then you define strong trust right below it. Which do you think they exemplify? Do you find the FDA to be a trustworthy organization? Are governance mechanisms needed for the alliance between these two organizations? What vulnerabilities are there in this alliance?
ReplyDeleteHi, Justin. You describe ECRI's alliances with FDA and AAMI, but does ECRI have any partnerships with organizations that could be competitors? Also, how does ECRI manage business relationships with companies whose products it has to review? Are there ethical guidelines to establish trust? I'm interested to hear how the organization walks the line between partnership and impartiality.
ReplyDeleteHi Dr. Pade,
ReplyDeleteI think the partnership with ECRI and FDA fit into all categories of Barney and Hansen's writings detailing semi-strong trust. They both operate with an assurance that "any vulnerabilities that might exist in this exchange will not be exploited" (184) because there is no reason for either to act in an opportunistic manner, as it would be detrimental to both organization's reputations. I think the strongest case to make from Barney and Hansen's writings is both are open to outside auditing (187) and in fact have to be. The FDA has oversight over what ECRI does, and ECRI provides a third-party checks-and-balance system over the FDA.
I find FDA to be trustworthy because of an organization like ECRI that will disagree with it and its position and prove why, FDA just has more power when it comes to oversight and regulation (but much less than people realize).
I would say the obvious vulnerabilities are what happens when there is disagreement, but this happens and both organizations end up sticking to their own opinions allowing clients and consumers to decide for themselves.
Thinking about this now though, because neither are out to really turn a profit but only grow and support themselves, can a true trustworthiness exist between two for-profit organizations? Isn't it human nature to be opportunistic and benefit you and your organization?
Hi Andrew,
There are competitors but not ones that are actually competitive. ECRI has been around for too long and cultivated too good of a reputation. While it's slow to change, that slowness is deliberate so that there are no mistakes or loss in quality or reputation.
The question of managing relationships is an interesting one. It's a fine line. At the end of the day though, most organizations, say one we're releasing research on their devices, and the news isn't good -- they want to work with us because it's much more damaging to them than us. They'll fight tooth and nail with teams of lawyers, but if we can prove what we are saying is accurate and lives are in jeopardy, odds are the report is coming out.
It's a pretty cut and dry line when it comes to anything involving ethics and impartiality. There is no gray area, only right and wrong. And if you're wrong you'll probably job hunt.
Hi Justin, I'm more familiar with the FDA, but who mainly funds ECRI? Do they get a bulk of Federal funding? I couldn't help but feel a tension in his responses when it came down to contract eligibility and how ECRI doesn't meet certain requirements for FDA contracts. Could this be the reason that leads to a "semi-strong" trust?
ReplyDelete