March 25, 2011
Device Certification and the Laboratory
How do you turn a classic client pain point into an excellent way to push the technology boundaries in the lab space? Change the business model and the dialog. This is what the DeviceWorks arm of Cerner Corporation did a few years ago.
Surrounded by a rapidly expanding list of bedside devices that needed interfaces, they were trapped in an endless loop of building “one-off” interfaces at each client site. To break the cycle, this group called the proverbial “time out” and started talking directly with the device makers about building interfaces in advance of clients going to market. What happened next was truly game changing. First, our clients’ immediate pain points surrounding drivers began to subside as Cerner associates and device makers started to work together to build or enhance the interfaces needed in the field.
Definitely significant, but perhaps more important were the downstream changes that happened later. After going through the certification process, the device makers realized the advantage of standardizing their side of the device interface, further streamlining the work needed around the construction of the interfaces. Next, the device makers realized the ability to walk into a potential Cerner client with the knowledge that a driver has already been built, tested, etc. with Cerner immediately advances the dialog beyond the usual first roadblock of “can it be interfaced?” This type of enhanced “sell-ability” soon opened the door for various re-sale arrangements between device makers and Cerner, and we now have Cerner associates able to resell various medical and laboratory devices with certified connectivity to our client base.
From my perspective as an engineer and hopefully yours also, the last downstream change is the most important. Through this program, Cerner has entered into co-development arrangements with some of these certified device partners to build innovative solutions across the healthcare spectrum that are amalgams of device maker and Cerner technology. The most recent example of this involves infusion management, the control of the bedside delivery of medications via infusion pumps via the EMR. This project is the result of co-development between Cerner and Hospira
, and it is breaking ground at the bedside for patient safety.
Now what does this mean for the lab space? In my recent blog post
about building a software ecosystem, the main point is that we, Cerner, have to move faster to help you, our clients, adjust with your rapidly changing world. Device certification is a key enabler of this acceleration. Think about the traditional way lab innovation reaches you. Concept gets incubated somewhere, maybe a startup company or academic lab or a new device from an existing device maker. The idea gets traction and has an initial splash of early adopters followed by a slow climb to the masses. Right about the time the mass adoption starts to take hold, the talk about the interface begins, either by our clients or the device makers. Unfortunately, this happens after many clients have purchased the new device. Once the LIS companies get engaged in the process, there is extra time needed to build, test, and certify the driver and creating any missing IP (software) that may be needed in the LIS. From start to finish, that process takes too long and slows the uptake of new innovations in the lab space by you. With this Device Certification program, we are breaking that old cycle and bending the curve of innovation to rapidly deliver innovation to our client base by partnering with these companies.
My only ask of our client base is to directly engage the device makers in your lab and find out if they are in the program. If they are, pat them on the back and say “Thanks. Keep at it.” If they are not, please tell them about it and how it directly benefits your lab. We even have some clients now making it a requirement contracts with device makers. Caliper Life Sciences and Leica are the newest members of the family, having signed agreements and starting work with our engineering teams. You will hear more about this over the months ahead as we add to the roster of certified device partners in the lab space. Stay tuned!John David Larkin Nolen, MD/PhD/MSPH calls himself “the engineer who went medical school” and he leads the design and implementation of Cerner’s laboratory solutions and enables the vision of the future of laboratory medicine. He joined Cerner in January 2010 and has been instrumental in guiding the incorporation of new technologies, such as RFID, advanced diagnostics, and integrated reports into current and new Cerner solutions. Prior to joining Cerner, he worked as a medical director in a reference lab and as the medical director of a blood center. He received bachelor’s degrees in electrical engineering and mechanical engineering and cell and molecular biology, a master’s degree in public health, and a medical degree and a doctorate in biomedical engineering, all from Tulane University in New Orleans. He completed his pathology residency at Emory University in Atlanta, and subspecialty fellowships at the University of Iowa in Iowa City. Nolen is board certified in pathology with sub-specialty boards in transfusion medicine and hematopathology. He has extensive experience in HLA, coagulation, molecular diagnostics, and informatics and is fluent in multiple computer languages.