Medical Device Link.

Originally Published IVD Technology July 2004

In Person

Jim Love, PhD, is chair of the American Association for Clinical Chemistry industry division and principal scientist in the clinical chemistry assay research and development division of Ortho-Clinical Diagnostics (Rochester, NY). He can be contacted at JLove@ocdus.jnj.com.

Why become active in a group geared toward the needs of the IVD industry? Such a group calls manufacturers to shape the regulations that they will eventually need to follow. It serves as a venue where laboratorians can voice their wishes for improved technology. It offers education programs geared specifically toward industry interests and the clarification of foggy or complex issues. Potentially, such a group could have a great influence on the future of the IVD industry across the globe. 

The American Association of Clinical Chemistry’s (AACC; Washington, DC) industry division has made great strides toward filling such a role. And for those interested in keeping their fingers on the pulse of industry, becoming active in this division may be a wise move.

To learn what the division has accomplished over this past year and what projects are forthcoming, IVD Technology editor Richard Park spoke with Jim Love, PhD, chair of the AACC industry division and principal scientist in the clinical chemistry assay research and development division of Ortho-Clinical Diagnostics (Rochester, NY). In this interview, Love talks about the goals of the industry division as well as the importance of the division to all who work with IVDs or have a hand in the IVD industry.

IVD Technology: Since becoming an official division of the American Association of Clinical Chemistry (AACC; Washington, DC), how has the industry division been received by those within the IVD industry as well as by those outside of the industry?

Jim Love: I think within the industry, the division has been well received. Our membership is holding its own relative to other divisions, and it seems to be well supported. As far as outside of the IVD industry, again I think the division has been well received. It has been a welcome addition, it is being supported by nonindustry members, and I think we have a solid future at AACC. 

What efforts are being made by the industry division to increase its membership and its outreach to those outside of the industry?

We have put together a promotional letter that will be sent to all AACC members inviting them to join the industry division. We are not just talking about people who work in industry—the letter will also go out to laboratorians and members of the government who are AACC members. 

I think the activities and interests of the industry division touch upon the work of a lot of our members. A lot of the AACC members are customers of industry, and I think they will provide some useful input into the programs that we offer.

It is important to get that cross-fertilization of ideas within the industry division—to have input from people who work in the laboratories on what educational programs should be offered. 

Disseminating Information

From the very beginning, one of the goals and objectives of the industry division has been education. What education programs has the division been involved in?

Last year at the annual AACC meeting in Philadelphia, we sponsored three Edutraks, three workshops, a seminar, and the OEM Lecture Series. We had a special update on the activities of the Joint Committee on Traceability in Laboratory Medicine. In addition, there was a separate two-day Webcast on the uncertainty of calibrator value assignment. 

How does the division decide what sort of education programs it wants to set up, sponsor, organize, and make available for the members?

There is a program coordinating commission within the AACC, and it uses survey tools and techniques to solicit input from AACC members at large as to what topics are of interest. Those survey results are distributed among the various divisions and other agencies within AACC. So, we know what members want and we try to provide that.

Just recently our Industry Division Listserve became active, and I put out a request for topics of interest among the division members and got some good feedback. For example, one of the topics that came up frequently was the interaction between pharmaceuticals and the IVD industry. 

What networking efforts has the industry division been engaged in?

Last year some of our key members coordinated with the National Institute of Standards and Technology (NIST; Gaithersburg, MD) and AdvaMed in developing and organizing the Uncertainty of Calibrator Value Assignment Webcast. This year we are participating in a joint mixer at the annual AACC meeting in Los Angeles with the pediatric maternal-fetal and the molecular pathology divisions.

Does the industry division have any other plans to work again with NIST and AdvaMed on other projects or programs having to do with traceability or uncertainty?

Yes. Actually, there is a desire to put on another program on that same topic and to have a more hands-on presentation of the determination of uncertainty. We have already had one or two conference calls to begin planning a presentation that incorporates more real-world examples presented by speakers from diagnostic companies. I think we are going to try to plan it for either this fall or early 2005. 

Has the industry division been involved in any governmental lobbying efforts?

We provide support for the dissemination of information on standards in draft form among those in industry and also for FDA documents that are circulating for comment. For example, recently FDA placed documents on its Web page requesting input on ways to reduce the regulatory hurdles to medical product design and development. So, the industry division placed a link on its Web page to these documents. Instead of broadcasting our comments on the draft to our members, we invited them to comment and actually requested that they send their comments back through the AACC since the organization is preparing a comment.

So, you try to get out there and encourage division members to get involved and actually participate in commenting on FDA standards. 

Right. We let them know that the information is out there and that they are given access to it and certainly invited to participate.

Interests Outside of Industry

How have the relations been between the industry division members and the vast majority of the AACC members, specifically laboratorians?

They have been good. Again our programs have been generally well supported by nonindustry members. I think we have been getting good feedback; good evaluations of our programs. 

Have you found that there is continued and growing interest in the industry division by nonindustry people like laboratorians?

Yes, and I think we are seeing more and more of our programs being accepted and a part of the annual meeting.

Reimbursement and competitive bidding are hot political issues that directly affect laboratorians and they can affect manufacturers and IVD companies as well. Has there been any effort to further educate division members about these two issues?

Well, I think the fact that there has been a stalemate, and that nothing has taken effect would suggest that any educational or lobbying efforts, at least so far, have been effective. And I think, as you say, the whole industry is very interested in the topic.

What other issues are the industry division and laboratorians finding common ground that they can work together on?

This question has yet to be answered. As we recruit members outside of industry proper, I believe common ground will surface and be addressed. 

So, you feel that these issues will emerge naturally?

Most definitely—as we open our membership outside of just industry employees. The tag line that we are using in our recruitment promotional is, “The division that unites,” as in terms of uniting all the different areas that have an interest in clinical chemistry.

Last year in his interview, the prior chairman of the industry division, Lou Dunka Jr., PhD, mentioned that there was an area of conflict between the industry division and laboratorians when it comes to point-of-care testing. How has the division worked on these differences, and what was the outcome of those efforts?

Members of our division partnered with members of the critical and point-of-care testing division to come up with appropriate standards of practice for point-of-care testing. These standards have been drafted. That is one example of addressing this conflict between the industry division and laboratorians.

What other differences with laboratorians does the industry division still have to overcome and how is the division tackling these issues?

Cost containment while maintaining high quality exerts pressure on both industry and laboratories and creates a natural tension between us. Both industry and laboratories benefit when lab tests are used appropriately and those types of studies are ongoing. There is information that can be shared on process improvement tools and techniques such as six-sigma quality and lean concepts that are mutually beneficial to industry and laboratories. Reducing medical errors and the role of the laboratory are other potential areas where a convergence of viewpoints is possible.

What efforts is the division making to cosponsor, with another division perhaps, programs on reducing medical errors and so forth?

The industry division and the management division have come together to sponsor programs on process improvement at the annual AACC meeting.

Upcoming Activities

What other programs does the industry division have planned for this year’s annual AACC meeting?

In addition to the joint mixer that we are having with the pediatric maternal-fetal division and the molecular pathology division, we are sponsoring Edutraks on the progress being made by the Joint Committee on Traceability in Laboratory Medicine. We are also sponsoring workshops on the management of product evaluations and clinical trials. We are sponsoring an Edutrak on global IVD standards, and workshops on six-sigma quality. And lastly, we are sponsoring the OEM lecture series again this year, which always draws interested listeners. 

What new goals is the industry division planning to pursue this year?

One of our goals this year is to increase membership—hence, the promotional letter that will be going out soon to all AACC members. We will also be staffing the division’s booth again this year at the annual AACC meeting. We will have copies of our newsletter available there. 
The other goal for this year was to publish two newsletters. These letters will get information into the hands of every member of the division. We have already published a spring newsletter and we plan to publish one for the fall.

Do you have a certain target or number in mind of how much you want to increase the membership? 

No. I really have not come up with a particular target. Any and all increase will be welcomed. There is something to be shared and gained by both the industry division and people outside of industry employment by being members of the industry division. 

Certainly the impact of what happens in industry affects every discipline within laboratory sciences, regardless of the specialized area of interest. I think that people employed outside of the industry can gain early information on developing events or issues within industry before they affect the labs. Some of the newest and most exciting technology is being developed within industry. This exposure will give people employed outside of industry the chance to network with the highly diverse group of professionals represented by industry. 

Division Outreach

Is there any plan to perhaps broaden the scope and the role of the industry division by getting more involved in other areas besides education, for example networking and lobbying?

We are beginning to make inroads into those other areas you just mentioned. We have and will continue to place information on our Web page and get information out to the industry members about the availability of standards or FDA documents that are out there for comment and input. As we continue that effort, that will naturally broaden the kind of input we provide and actually the influence of the Industry division.

As a representative of the entire IVD industry within the major laboratory medicine organization in the United States, if not the entire world, the division seems to have the potential to become a rather significant force in terms of pushing issues that the industry would like to the forefront.

Yes, that is very true, but I think we have made significant progress in just the two or three years we have been a division, and we certainly hope to grow upon that progress. 

Does the division plan to become more involved with OIVD?

Steve Gutman, director of OIVD, wrote an article for our newsletter. Steve has also spoken at several industry division events. So, we have been encouraged by his participation. 

What are the reasons for AACC members to join the industry division?

The industry division does impact every discipline related to IVDs, and the fact that division members receive targeted information on educational programs and live issues of primary concern that could affect your laboratory or your IVD company would be reason enough to be active in the division.

So, the information that members get from being involved with the industry division could ultimately benefit their companies, laboratories, or whatever the case may be. At the same time, the members’ involvement could have an impact on the industry.

Exactly. How many times have FDA’s documents been out there for comment and very few except perhaps the regulatory people know that they are even there? The industry division provides a needed conduit to let members know that this kind of information is available and out there. 

Information on the AACC’s industry division is available on-line at www.aacc.org/divisions/industry. 

Copyright ©2004 IVD Technology